HK1218404B - External ear canal pressure regulation device - Google Patents

Description

External auditory canal pressure adjustment device

This International Patent Cooperation Treaty patent application is a continuation-in-part of U.S. non-provisional patent application No. 14/316,668, filed on June 26, 2014, and claims priority to U.S. Provisional Patent Application No. 61/983,865, filed on April 24, 2014, and U.S. Provisional Patent Application No. 61/841,111, filed on June 28, 2013, each of which is incorporated herein by reference.

Technical Field

The invention relates to an external auditory canal pressure regulating device.

Background Art

Pain or discomfort associated with disorders, including neuroregulatory disorders such as craniofacial pain syndrome or headache syndrome, can affect a patient's quality of life. In addition to the burden on the individual, chronic neurological conditions can be a major strain on family members, employees, and the health insurance system.

With migraine, associated symptoms such as pain, nausea, dizziness, photophobia, and imbalance can place a significant burden on the public. Epidemiological studies indicate that approximately 18% of women and 6% of men in the United States suffer from frequent migraines, and 2% of the general population suffers from chronic migraines. Furthermore, people who suffer from chronic migraines or other headaches of similar severity and disability are at significant risk for depression and suicide attempts. Therefore, it is crucial for physicians and researchers to continue searching for devices and methods that are effective in alleviating or treating the symptoms associated with these disorders.

Standard medications, typically tailored to relieve headaches, either prevent pain or alleviate it. Various agents falling into these two broad categories can exhibit a wide range of effectiveness and also carry varying degrees of side effects. From an economic perspective, the cost of these medical products can be a major source of financial burden for consumers. In addition, advanced interventions, such as botulinum toxin injections, nerve blocks, neurosurgical alterations, and implanted electrical stimulation, can significantly increase the costs associated with treatment while subjecting patients to potential changes in their anatomy and physiology without guaranteeing complete or permanent relief of symptoms or resolution of the disorder.

There is a rapidly evolving understanding and application in neuroscience that seeks to bring about positive physiological changes in the nervous system through non-pharmacological and non-surgical applications. This field of "functional neurology" views the human nervous system as a receptor-driven system that can be activated and stimulated in specific ways to produce adaptive, long-term changes through the process of neuroplasticity. This approach to neurorehabilitation utilizes, but does not exclusively include, various forms and patterns of receptor activation or deactivation to promote positive neurophysiological adaptations in the central nervous system, including the brain, brainstem, and spine, which can improve the physiological function of associated tissues, organs, and systems.

It would be a great advantage to provide a device or method capable of generating one or more stimuli that can alleviate one or more symptoms associated with a disorder such as craniofacial pain syndrome or headache symptoms or treat one or more disorders.

Summary of the Invention

A broad object of a specific embodiment of the present invention may be to provide an external auditory canal pressure adjustment device, which includes a fluid flow generator capable of generating a fluid flow, and an earplug having an axial earplug duct communicating between a first end of the earplug and a second end of the earplug, the axial earplug duct being fluidically coupled to the fluid flow generator, the earplug having a compatible earplug outer surface, the compatible earplug outer surface being configured to sealingly engage the external auditory canal of the ear as a barrier between the external auditory canal pressure and ambient pressure.

Another broad object of a specific embodiment of the present invention may be to provide an external auditory canal pressure adjustment device having the fluid flow generator capable of generating a pressure difference between the external auditory canal and the ambient pressure.

Another broad object of a specific embodiment of the present invention may be to provide an external auditory canal pressure adjustment device, which has a fluid flow generator capable of generating pressure difference oscillations, and the pressure difference oscillations drive the fluid flow back and forth between a first direction of fluid flow and a second direction of fluid flow in the axial ear plug tube.

Another broad object of a specific embodiment of the present invention may be to provide an external auditory canal pressure adjustment device, which includes a fluid flow temperature adjuster fluidically coupled between the fluid flow generator and the external auditory canal catheter, and the fluid flow temperature adjuster is operable to adjust the fluid flow temperature of the fluid flow.

Another broad object of a specific embodiment of the present invention may be to provide an external auditory canal pressure adjustment device, which includes a fluid flow generator capable of generating a fluid flow and a plurality of earplugs, each earplug having an axial earplug duct communicating between a first end of the earplug and a second end of the earplug, each axial earplug duct being fluidically coupled to the fluid flow generator, and each earplug having a compatible earplug outer surface configured to sealingly engage the external auditory canal of the ear as a barrier between the external auditory canal pressure and the ambient pressure.

Another broad object of a specific embodiment of the present invention may be to provide an external auditory canal pressure adjustment device, which includes a fluid flow generator capable of generating corresponding multiple fluid flows and multiple earplugs, each earplug having an axial earplug duct communicating between a first end of the earplug and a second end of the earplug, each axial earplug duct fluidly coupled to the fluid flow generator, and each earplug having a compatible earplug outer surface, which is configured to sealingly engage the external auditory canal of the ear as a barrier between the external auditory canal pressure and the ambient pressure.

Another broad object of a specific embodiment of the present invention may be to provide an external auditory canal pressure adjustment device, which includes a memory element and a processor in communication with the memory element, wherein the memory element contains computer code that can be executed to adjust the operation of one or more fluid flow generators.

Another broad object of a specific embodiment of the present invention may be to provide an external auditory canal pressure adjustment device having computer code that can be executed to provide a transceiver controller that communicates with a transceiver that can be wirelessly connected to a controller device separate from the external auditory canal pressure adjustment device.

Naturally, further objects of the invention are disclosed in other areas of the description, the drawings and the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration of a method of using a specific embodiment of an external auditory canal pressure regulating device.

FIG. 2 is an illustration of a method of using a specific embodiment of an external auditory canal pressure regulating device.

FIG. 3 is an illustration of a method of using a specific embodiment of an external auditory canal pressure regulating device.

FIG. 4 is an illustrative diagram of a specific embodiment of an external auditory canal pressure regulating device sealably engaged with the external auditory canal.

FIG. 5A is an illustration of a specific embodiment of an external auditory canal pressure regulating device sealably engaged with a first external auditory canal.

FIG. 5B is an illustration of a specific embodiment of an external auditory canal pressure regulating device sealably engaged with a second external auditory canal.

FIG6 is a perspective view of a specific embodiment of the external auditory canal pressure regulating device.

FIG7 is a perspective view of a specific embodiment of the external auditory canal pressure regulating device.

8 is a schematic block diagram of a specific embodiment of the external auditory canal pressure adjustment device shown in FIG. 7 , operable to achieve a pressure difference between the external auditory canal pressure and ambient pressure.

9A is a first interior plan view of a specific embodiment of the external auditory canal pressure adjustment device.

9B is a second internal plan view of the specific embodiment of the external auditory canal pressure regulating device shown in FIG. 9A .

FIG10 is an enlarged perspective internal view of a specific embodiment of the external auditory canal pressure regulating device shown in FIG9B .

FIG11 is a perspective view of an earplug of a specific embodiment of the external auditory canal pressure regulating device.

FIG. 12 is a first side view of a specific embodiment of an earplug of an external auditory canal pressure regulating device.

FIG. 13 is a second side view of a specific embodiment of the earplug of the external auditory canal pressure regulating device.

FIG. 14 is a top view of an embodiment of an earplug of an external auditory canal pressure regulating device.

FIG. 15 is a bottom view of an earplug of a specific embodiment of the external auditory canal pressure regulating device.

16 is a first end view of a specific embodiment of an earplug of an external auditory canal pressure regulating device.

17 is a second end view of a specific embodiment of the earplug of the external auditory canal pressure adjustment device.

FIG18 is a cross-sectional view 18-18 shown in FIG13 of a specific embodiment of the external auditory canal pressure regulating device.

FIG19 is a perspective view of an earplug of a specific embodiment of the external auditory canal pressure regulating device.

FIG20 is an exploded view of a specific embodiment of the earplug of the external auditory canal pressure regulating device shown in FIG18 .

FIG. 21 is a first side view of a specific embodiment of an earplug of an external auditory canal pressure regulating device.

FIG. 22 is a second side view of a specific embodiment of the earplug of the external auditory canal pressure regulating device.

FIG. 23 is a top view of an embodiment of an earplug of an external auditory canal pressure regulating device.

FIG. 24 is a bottom view of an earplug of a specific embodiment of the external auditory canal pressure regulating device.

25 is a first end view of a specific embodiment of an earplug of an external auditory canal pressure regulating device.

26 is a second end view of a specific embodiment of the earplug of the external auditory canal pressure adjustment device.

FIG27 is a perspective view of a specific embodiment of the external auditory canal pressure regulating device.

28 is a schematic block diagram of a specific embodiment of the external auditory canal pressure adjustment device shown in FIG. 27 , operable to achieve a pressure difference between the external auditory canal pressure and ambient pressure.

29A is a first internal plan view of a specific embodiment of the external auditory canal pressure adjustment device.

29B is a second internal plan view of the specific embodiment of the external auditory canal pressure regulating device shown in FIG. 29A .

FIG30 is a top view of a specific embodiment of the external auditory canal pressure regulating device.

FIG31 is a bottom view of a specific embodiment of the external auditory canal pressure regulating device.

FIG32 is a first side view of a specific embodiment of the external auditory canal pressure regulating device.

FIG33 is a second side view of a specific embodiment of the external auditory canal pressure regulating device.

34 is a first end view of a specific embodiment of the external auditory canal pressure adjustment device.

35 is a second end view of a specific embodiment of the external auditory canal pressure adjustment device.

36A is an illustration of a specific embodiment of a graphical user interface depicted on a display surface of a computer device and a method of using the graphical user interface to control the operation of an embodiment of an external auditory canal pressure adjustment device.

36B is an illustration of a specific embodiment of a graphical user interface depicted on a display surface of a computer device and a method of using the graphical user interface to control the operation of an embodiment of an external auditory canal pressure adjustment device.

FIG. 37A is a positive pressure adjustment curve that may be produced by a specific embodiment of an external auditory canal pressure adjustment device.

FIG. 37B is a positive pressure adjustment curve that may be produced by a specific embodiment of an external auditory canal pressure adjustment device.

FIG. 37C is a positive pressure adjustment curve that may be produced by a specific embodiment of an external auditory canal pressure adjustment device.

FIG. 37D is a positive pressure adjustment curve that may be produced by a specific embodiment of an external auditory canal pressure adjustment device.

FIG. 37E is a positive pressure adjustment curve that may be produced by a specific embodiment of an external auditory canal pressure adjustment device.

FIG37F is a positive pressure adjustment curve that may be produced by a specific embodiment of the external auditory canal pressure adjustment device.

FIG37G is a positive pressure adjustment curve that may be produced by a specific embodiment of an external auditory canal pressure adjustment device.

FIG. 38A is a negative pressure adjustment curve that may be produced by a specific embodiment of an external auditory canal pressure adjustment device.

FIG. 38B is a negative pressure adjustment curve that may be produced by a specific embodiment of the external auditory canal pressure adjustment device.

FIG. 38C is a negative pressure adjustment curve that may be produced by a specific embodiment of an external auditory canal pressure adjustment device.

FIG. 38D is a negative pressure adjustment curve that may be produced by a specific embodiment of an external auditory canal pressure adjustment device.

FIG. 38E is a negative pressure adjustment curve that may be produced by a specific embodiment of an external auditory canal pressure adjustment device.

FIG. 38F is a negative pressure adjustment curve that may be produced by a specific embodiment of an external auditory canal pressure adjustment device.

FIG. 38G is a negative pressure adjustment curve that may be produced by a specific embodiment of an external auditory canal pressure adjustment device.

FIG. 39A is a pressure adjustment curve that may be produced by a specific embodiment of an external auditory canal pressure adjustment device.

FIG. 39B is a diagram illustrating a pressure adjustment curve that may be produced by an embodiment of an external auditory canal pressure adjustment device.

FIG. 39C is a diagram illustrating a pressure adjustment curve that may be produced by an embodiment of an external auditory canal pressure adjustment device.

FIG. 39D is a diagram illustrating a pressure adjustment curve that may be produced by an embodiment of an external auditory canal pressure adjustment device.

FIG. 39E is a diagram illustrating a pressure adjustment curve that may be produced by an embodiment of an external auditory canal pressure adjustment device.

FIG. 40 is a diagram illustrating valve position scheduling for the embodiment of the present invention shown in FIG. 28 .

DETAILED DESCRIPTION

Now, with reference primarily to Figures 1, 4, 5A, and 8, a specific method of using an external auditory canal pressure adjustment device (1) is illustrated, wherein the external auditory canal pressure adjustment device (1) includes a first fluid flow generator (2) and a first earplug (3), the first earplug (3) having a first axial earplug conduit (4) fluidically coupled to the first fluid flow generator (2). The specific method of use may include sealably engaging a first external auditory canal (5) of a first ear (6) with a first earplug outer surface (7) of the first earplug (3), generating a first fluid flow (8) between the first fluid flow generator (2) and the first axial earplug conduit (4), and adjusting a first pressure differential (9) between a first external auditory canal pressure (10) of the first ear (6) and an ambient pressure (11). The first pressure differential (9) may be effective for alleviating symptoms of one or more disorders or treating one or more disorders.

Now, referring mainly to Figures 2, 5A, 5B and 8, which illustrate a specific method of using the external auditory canal pressure adjustment device (1), the external auditory canal pressure adjustment device (1) includes a first fluid flow generator (2), a first earplug (3) and a second earplug (12), each of the first earplug (3) and the second earplug (12) having a corresponding first axial earplug conduit (4) and a second axial earplug conduit (13) fluidically coupled to the first fluid flow generator (2). The method of use may include sealably engaging a first external auditory canal (5) of a first ear (6) with a first earplug outer surface (7) of a first earplug (3), sealably engaging a second external auditory canal (14) of a second ear (15) with a second earplug outer surface (16) of a second earplug (12), generating a first fluid flow (8) between a first fluid flow generator (2) and a first axial earplug conduit (4), adjusting a first pressure differential (9) between a first external auditory canal pressure (10) of the first ear (6) and an ambient pressure (11), and adjusting a second pressure differential (17) between a second external auditory canal pressure (18) of the second ear (15) and an ambient pressure (11) to be effective in alleviating symptoms of one or more disorders or treating one or more disorders.

Now mainly refer to Figures 3, 5A, 5B and 28, which illustrate the specific method of using the external auditory canal pressure adjustment device (1), which includes a first fluid flow generator (2), a first earplug (3) having a first axial earplug tube (4) fluidically coupled to the first fluid flow generator (2), a second fluid flow generator (19) and a second earplug (12) having a second axial earplug tube (13) fluidically coupled to the second fluid flow generator (19). The method of use may include sealably engaging a first external auditory canal (5) of a first ear (6) with a first earplug outer surface (7) of a first earplug (3), sealably engaging a second external auditory canal (14) of a second ear (15) with a second earplug outer surface (16) of a second earplug (12), generating a first fluid flow (8) between a first fluid flow generator (2) and a first axial earplug conduit (4), adjusting a first pressure differential (9) between a first external auditory canal pressure (10) of the first ear (6) and an ambient pressure (11), generating a second fluid flow (20) between a second fluid flow generator (19) and an axial earplug conduit (13), and adjusting a second pressure differential (17) between a second external auditory canal pressure (8) of the second ear (15) and an ambient pressure (11), which is effective for alleviating symptoms of one or more disorders or treating one or more disorders.

The term "pressure differential" for the purposes of the present invention refers to the difference in pressure between two locations.

The term "pressure differential magnitude" for the purposes of the present invention refers to the numerical value of the pressure difference between two locations. The pressure differential magnitude can be expressed as an unsigned (positive or negative) number, regardless of whether the pressure is greater or less at the first location relative to the second location. As an illustrative example, a first external auditory canal pressure (10) or a second external auditory canal pressure (18) of +50 kPa above ambient pressure (11) and a first external auditory canal pressure (10) or a second external auditory canal pressure (18) of -50 kPa below ambient pressure (11) can both have a first pressure differential magnitude (9) or a second pressure differential magnitude (17) of 50 kPa.

The term "external auditory canal pressure" for the purposes of the present invention refers to the force exerted in the first external auditory canal (5) or the second external auditory canal (14) and is not intended to be a broad limitation of the above, but refers to the force exerted in the first external auditory canal (5) or the second external auditory canal (14) by a fluid volume (21), the fluid volume (21) being a preselected fluid volume (22) of the first fluid flow (8) or the second fluid flow (20) delivered to the first external auditory canal (5) or the second external auditory canal (14) or generated therein by operation of the external auditory canal pressure adjustment device (1).

The term "preselected" for the purposes of the present invention refers to parameters that are previously selected for delivery to, generated in, or applied to the first external auditory canal (5) or the second external auditory canal (14) by interaction with the external auditory canal pressure regulating device (1) and subsequently delivered to, generated in, or applied to the first external auditory canal (5) or the second external auditory canal (14) by interaction with the external auditory canal pressure regulating device (1). For example, a preselected fluid volume (22) of 10 milliliters may be previously selected for delivery to the first external auditory canal (5) or the second external auditory canal (14) by interaction with the external auditory canal pressure regulating device (1), and subsequently, a fluid volume (21) of 10 milliliters can be delivered to the first external auditory canal (5) or the second external auditory canal (14) by interaction with the external auditory canal pressure regulating device (1).

The term "ambient pressure" for the purposes of the present invention refers to the force applied externally to the first external auditory canal (5) or the second external auditory canal (14) in the ambient environment and, without limitation to the above generality, refers to the force applied to the first earplug (3) or the second earplug (12) on the ambient side of the corresponding first barrier (102) or the second barrier (103) created by sealably engaging the corresponding first earplug outer surface (7) or the second earplug outer surface (16) with the corresponding first external auditory canal (5) or the second external auditory canal (14).

The term "sealably engageable" for purposes of the present invention means a seal between the outer surface of the earplug and the external auditory canal that is capable of maintaining a pressure differential, a pressure differential magnitude, or a preselected pressure differential magnitude, or a pressure adjustment curve over a period of time or a preselected period of time to be effective in alleviating symptoms of one or more disorders or treating one or more disorders.

The term "symptom" for the purposes of this invention refers to any discomfort or combination of discomforts associated with a disorder. Without limiting the foregoing broadness, symptoms may include: dizziness, vertigo; nausea; loss of balance; paresthesia; dysesthesia, sensitivity to light; sensitivity to smell; sensitivity to sound; anxiety, insomnia, irritability, fatigue; loss of appetite; blurred vision, intestinal disturbances; acute or chronic pain of various characteristics, including but not limited to throbbing, tearing, sharp; dullness; tingling, throbbing, burning, aching, stinging, stabbing; lightning-like; redness, swelling, or tingling, etc., or a combination thereof.

The term "disorder" for the purposes of the present invention refers to an abnormal or unhealthy physical or mental condition. Without limiting the above broadness, disorders may include: neuropathic head and face pain syndromes, such as neuralgia, for example, trigeminal neuralgia, temporomandibular joint syndrome, headache syndromes such as migraine, chronic daily headache, cluster headache, muscle tension headache, post-traumatic headache, or chronic paroxysmal migraine; intralabyrinthine hydrops; vertigo; tinnitus; syndromes resulting from brain injury; syndromes resulting from impaired neurological function, including cognitive disorders such as attention deficit disorder, mood disorders such as anxiety disorders or epileptic seizures; phantom limbs; middle ear diseases; inner ear disorders, etc.; or combinations thereof.

Now referring primarily to Figures 8, 9A, 9B, 28, 29A and 29B, a specific embodiment of the external auditory canal pressure adjustment device (1) may include a first fluid flow generator (2), which may have a large number and wide range of configurations capable of generating a first fluid flow (8) between the first fluid flow generator (2) and the first axial earplug (4) of the first earplug (3). For specific embodiments, the first fluid flow generator (2) may include a volume adjustable element (23) capable of operating between a larger volume and a smaller volume. As an illustrative example, operating the volume adjustable element (23) from a larger volume to a smaller volume may generate a first fluid flow (8) away from the first fluid flow generator (2), while operating the volume adjustable element (23) from a smaller volume to a larger volume may generate a first fluid flow (8) toward the first fluid flow generator (2).

For specific embodiments, the first fluid flow generator (2) can include a positive displacement pump (24), which can be configured as a rotary positive displacement pump, such as a gear pump, a screw pump, or a rotary vane pump; a reciprocating positive displacement pump, such as a plunger pump, a diaphragm pump, or a piston pump; or any pump configuration capable of moving a fluid volume (21) between the first fluid flow generator (2) and the first axial ear plug tube (4) or generating the first fluid flow (8). As an illustrative example, a positive displacement pump (24) that can be used in specific embodiments of the external auditory canal pressure adjustment device (1) can be SP 100EC or SP 100EC-LC, which can be obtained from Schwarzer Precision GmbH + Co., Am Lichtbogen 7, 45141 Essen, Germany. As an illustrative example, an axial earplug tube (4) (13) fluidically coupled to a positive displacement pump (24) that can be used in a specific embodiment of the external auditory canal pressure adjustment device (1) can be a multi-chamber micro-extruded tube, which can be obtained from Microspec Corporation, 327 Jaffrey Road, Peterborough, NH, 03458, USA.

Referring now primarily to Figures 8, 9A, and 9B, the first fluid flow generator (2) can be configured as a piston pump in which a piston (26) reciprocates in a barrel (27) to adjust the volume (28) within the barrel between a larger volume and a smaller volume. As an illustrative example, the piston (26) can be operated to reduce the volume (28) within the barrel, thereby generating a first fluid flow (8) from the first fluid flow generator (2) toward the first axial earplug conduit (4). For a specific embodiment in which the first earplug outer surface (7) is sealably engaged with the first external auditory canal (5), as shown in the illustrative examples of Figures 4 and 5A, the first fluid flow (8) can flow from the first axial earplug conduit (4) toward the first external auditory canal (5), which can generate a first external auditory canal pressure (10) that is greater than the ambient pressure (11). Conversely, the piston (26) can be operated to increase the volume (28) within the barrel, thereby generating a first fluid flow (8) from the first fluid flow generator (4) toward the first fluid flow generator (2). For a specific embodiment in which the first earplug outer surface (7) is sealably engaged with the first external auditory canal (5), a first fluid flow (8) can flow from the first external auditory canal (5) into the first axial earplug tube (4), which can generate a first external auditory canal pressure (10) that is less than the ambient pressure (11).

Now referring primarily to Figures 8 and 9B, for a specific embodiment, the piston (26) can be operably coupled to an actuator (29), which can be used to move the piston (26) within the barrel (27) to generate a first fluid flow (8) between the first fluid flow generator (2) and the first axial ear plug tube (4). For a specific embodiment, the piston (29) can be configured as a linear actuator (30), including a mechanical actuator, a pressure actuator, a pneumatic actuator, a piezoelectric actuator, an electromechanical actuator, a linear motor, a retractable linear actuator, or any linear actuator capable of generating linear motion. As an illustrative example, the linear actuator (30) used in a specific embodiment of the external auditory canal pressure adjustment device (1) can be a miniature linear actuator AS-03, which can be obtained from Lunematic. For a specific embodiment, the linear actuator (30) can be configured as a threaded shaft that moves linearly when rotated. The linear actuator (30) can be arranged next to the barrel (27) of the first fluid flow generator (2). The linear movement of the threaded shaft can be coupled to the movement of the piston (26) of the first fluid flow generator (2) through the connector (32), so that the linear movement of the threaded shaft causes the piston (26) to move linearly in the barrel (27) to adjust the volume (28) in the first barrel, thereby generating a first fluid flow (8) in the first fluid flow generator (2) and the first axial ear plug tube (4).

For other embodiments, the first fluid flow generator (2) can be configured as a diaphragm pump, which can include an elastically flexible wall having a chamber volume. The elastically flexible wall in a deformed state can reduce the chamber volume, thereby generating a first fluid flow (8) from the first fluid flow generator (2) to the first axial ear plug conduit (4). For embodiments in which the first ear plug outer surface (7) is sealably coupled to the first external auditory canal (5), the first fluid flow (8) can flow from the first axial ear plug conduit (4) to the first external auditory canal (5), which can generate a first external auditory canal pressure (10) that is less than the ambient pressure (11). Conversely, the elastically flexible wall can return from the deformed state to the non-deformed state, increasing the chamber volume and thereby generating the first fluid flow (8) from the first axial ear plug conduit (4) to the first fluid flow generator (2). For a specific embodiment in which the first earplug outer surface (7) is sealably engaged with the first external auditory canal (5), a first fluid flow (8) can flow from the first axial earplug tube (4) into the first external auditory canal (4), which can generate a first external auditory canal pressure (10) that is less than the ambient pressure (11).

For a specific embodiment, the diaphragm can be a piezoelectric diaphragm having an elastically flexible wall that vibrates when a sinusoidal voltage is applied. The vibration can generate a first fluid flow (8) having a flow rate of up to 0.8 liters per minute and a typical pressure of up to 1.5 kilopascals, which can be achieved with a 15 Vp-p 25 kHz signal. The piezoelectric diaphragm can be operated above the normal audible range with a 24-25 kHz signal.

Referring now primarily to Figures 4 and 5A, the first fluid flow generator (2) can be configured to generate a first fluid flow (8) between the first fluid flow generator (2) and the first axial ear plug conduit (4) having a fluid volume (21) typically in the range of 0 milliliters to about 20 milliliters; however, embodiments can have smaller or larger fluid volumes (21) depending on the application. For specific embodiments, the fluid volume (21) or preselected fluid volume (21) can be selected from one or more of the group consisting of: between 0 ml and about 2 ml, between about 1 ml and about 3 ml, between about 2 ml and about 4 ml, between about 3 ml and about 5 ml, between about 4 ml and about 6 ml, between about 5 ml and about 7 ml, between about 6 ml and about 8 ml, between about 7 ml and about 9 ml, between about 8 ml and about 10 ml, between about 9 ml and about 11 ml, between about 10 ml and about 12 ml, between about 11 ml and about 13 ml, between about 12 ml and about 14 ml, between about 13 ml and about 15 ml, between about 14 ml and about 16 ml, between about 15 ml and about 17 ml, between about 16 ml and about 18 ml, between about 17 ml and about 19 ml, and between about 18 ml and about 20 ml.

One or more fluid volumes (21) (or preselected volumes (22)) can be produced with the external auditory canal pressure adjustment device (1) depending on the method of use, which can be affected by the anatomy, physiology or biochemistry of the user (33), such as the auditory canal (34); the symptoms of the disorder as the target to be alleviated; the disorder as the target to be treated; the observable effect of using one or more fluid volumes (21) (or preselected fluid volumes (22)) in a specific method of use of the external auditory canal pressure adjustment device (1); or a combination thereof; thereby, the one or more fluid volumes (21) (or preselected fluid volumes (22)) can be applied to be effective in alleviating one or more symptoms of the disorder or treating one or more disorders, but not so much as to cause discomfort to the user (33) or damage to the auditory canal (34) or eardrum (35).

Referring again primarily to Figures 4 and 5A, the first fluid flow generator (2) can be capable of generating a first pressure differential (9) between a first external auditory canal pressure (10) and an ambient pressure (11). For specific embodiments, the external auditory canal pressure adjustment device (1) can be operated to achieve a first external auditory canal pressure (10) that can be less than or greater than the ambient pressure (11). The effective range of the first external auditory canal pressure (10) can be from slightly above or slightly below the ambient pressure (11) to increase to the first external auditory canal pressure (10); above or below the ambient pressure (11), just without causing discomfort to the user (33) or injury to the auditory canal (34) or eardrum (35). Although authorities have different opinions on the first external auditory canal pressure (10) that causes discomfort to the user (33) or injury to the auditory canal (34) or eardrum (35), a typical embodiment of the external auditory canal pressure adjustment device (1) will not be configured to operate below about -50 kPa above the ambient pressure (11) or above about +50 kPa above the ambient pressure (11).

Thus, the first fluid flow generator (2) can be capable of generating a first pressure differential (9) having a first pressure differential magnitude (36) between 0 kPa and about 50 kPa; however, depending on the application, embodiments can generate a smaller or larger first pressure differential magnitude (36). For specific embodiments, the first pressure differential magnitude (36) or first preselected pressure differential magnitude (37) can be selected from one or more of the group consisting of: between 0 kPa and about 5 kPa, between about 2.5 kPa and about 7.5 kPa, between about 5 kPa and about 10 kPa, between about 7.5 kPa and about 12.5 kPa, between about 10 kPa and about 15 kPa, between about 12.5 kPa and about 17.5 kPa, between about 15 kPa and about 20 kPa, between about 17.5 kPa and about 22.5 kPa between about 20 kPa and about 25 kPa, between about 22.5 kPa and about 27.5 kPa, between about 25 kPa and about 30 kPa, between about 27.5 kPa and about 32.5 kPa, between about 30 kPa and about 35 kPa, between about 32.5 kPa and about 37.5 kPa, between about 35 kPa and about 40 kPa, between about 37.5 kPa and about 42.5 kPa, between about 40 kPa and about 45 kPa, between about 42.5 kPa and about 47.5 kPa, and between about 45 kPa and about 50 kPa.

One or more first pressure difference magnitudes (36) (or first preselected pressure difference magnitudes (37)) can be generated by the external auditory canal pressure adjustment device (1) depending on the method of use, which can be affected by the anatomy, physiology or biochemistry of the user (33), such as the auditory canal (34); the symptoms of the disorder as the target to be alleviated; the disorder as the target to be treated; the observable effect of using one or more fluid volumes (21) (or preselected fluid volumes (22)) in the specific method of use of the external auditory canal pressure adjustment device (1); or a combination thereof; thereby, the one or more first pressure difference magnitudes (36) (or first preselected pressure difference magnitudes (37)) can be applied to be effective in alleviating one or more symptoms of the disorder or treating one or more disorders, but not so much as to cause discomfort to the user (33) or damage to the auditory canal (34) or the tympanic membrane (35).

For a specific embodiment, the first fluid pressure differential (9) generated by the first fluid flow generator (2) can be able to move the eardrum (35), which is on the first external auditory canal (5) to separate the first external auditory canal (5) from the middle ear (38), which is effective in alleviating one or more symptoms of a disorder or treating one or more disorders. The eardrum (35) includes three layers, including an intermediate layer (lamina propria) disposed between an outer epidermal layer and an inner mucosal layer. The intermediate layer includes modified mechanoreceptive vaterpacinian corpuscles ("mechanical receptors"), which can be sensitive to deformation or stretching of the eardrum (35). Therefore, these mechanoreceptors act as baroreceptors and send afferent signals associated with the inward ("toward the middle ear") or outward ("away from the middle ear") movement of the eardrum (35) to the central nervous system.

Mechanical stimulation receptors can send afferent signals to the auriculotemporal nerve via A-β pseudo-unipolar fibers, which then merge with the mandibular nerve. The mandibular nerve converges with the maxillary nerve and ophthalmic nerve to form the trigeminal ganglion, and primary afferent pressure-transmitting fibers reside in the trigeminal ganglion. Afferent fibers are transmitted to the ventrolateral aspect of the mid-abdomen of the pons by the sensory root of the trigeminal nerve. Like this, the trigeminal nerve can send sensory signals ("pain signals") from the skull and face to the central nervous system. Afferent fibers then enter the synapses on various parts of the brainstem and trigeminal nucleus system, including the deep layers of the trigeminal nucleus caulis (Trigeminal Nucleus Caudalis), where afferent fibers can induce GABAergic interneurons to prevent noxious transmission to the hyperpolarized noxious fibers and interneurons in the surface layer.

The first pressure differential (9) or second pressure differential (17) generated by the first fluid flow generator (2) between the corresponding first external auditory canal (10) or second external auditory canal (18) and the ambient pressure (11) can induce an anti-nociceptive barrier to nerve impulses derived from the mechanical stimulus receptors, so that the various related neural nuclei of the brainstem pain matrix can become attenuated and maintain normal, steady-state activity. In addition, parasympathetic-induced intracranial vasodilation can stop and restore quiescent vascular flow and tone within the cranial blood vessels, part of which can be associated with the trigeminal nerve and trigeminal nerve fibers as part of the trigeminal system. In addition to modulating vascular dynamics, biochemical changes can also be induced, such as downregulating inflammatory cytokines or other pain-promoting compounds in or around the intracranial vascular bed, so that vascular normalization can cause further quiescence of trigeminal nociceptive afferents, which can ultimately lead to alleviation of one or more disorder symptoms or treatment of one or more disorders.

Referring now primarily to FIG4 and FIG5A , for a specific embodiment of the external auditory canal pressure adjustment device (1), a first fluid flow (8) in a first external auditory canal (5) of a first ear (6) can generate a first external auditory canal pressure (10) greater than an ambient pressure (11) that causes a corresponding movement of the eardrum (35) toward the middle ear (38), thereby increasing the concavity of the eardrum (35). Similarly, a first fluid flow (8) in a first external auditory canal (5) of a first ear (6) can generate a first external auditory canal pressure (10) less than an ambient pressure (11) that causes a corresponding movement of the eardrum (35) away from the middle ear (38), thereby decreasing the concavity of the eardrum (35). For specific embodiments or methods, the first pressure differential (9) or the second pressure differential (17) generated by the first fluid flow generator (2) can move the eardrum toward or away from the middle ear (38) one or more times within a time period (39).

Movement of the eardrum (35) can stimulate mechanical stimulation receptors, which can alleviate one or more symptoms of a disorder or treat one or more disorders. As an illustrative example, movement of the eardrum (35) can generate neural signals that can reduce the transmission of nociceptive signals to the central nervous system, which can result in non-analgesic stimulation of the central nervous system. As an additional illustrative example, movement of the eardrum (35) can counteract central nervous system habituation.

Now referring primarily to Figures 8 and 9B, the external auditory canal pressure adjustment device (1) may further include a first pressure differential magnitude selection element (40) and a first fluid flow generator controller (41), wherein the first fluid flow generator controller (41) adjusts the operation of the first fluid flow generator (2) to achieve a first preselected pressure differential magnitude (37) in response to the operation of the first pressure differential magnitude selection element (40). As an illustrative example, the first pressure differential magnitude selection element (40) may be configured as a variable resistor (42), such as a variable resistance control element (43), which can adjust the current by adjusting the resistance of the circuit (for a specific voltage, the current is inversely proportional to the resistance). Therefore, the variable resistance control element (43) can be used to adjust the current to control the operation of the first fluid flow generator (2) (directly by changing the current to the fluid flow generator (2) or indirectly by analyzing the current changes within the circuit to generate a fluid flow generator drive signal (44) accordingly) to achieve the preselected pressure differential magnitude (37). For specific embodiments, the variable resistance control element (43) can be operated to increase the resistance of the circuit coupled to the first fluid flow generator (2), which can reduce the first preselected pressure differential magnitude (37). Conversely, the variable resistance control element (43) can be operated to reduce the resistance of the circuit coupled to the first fluid flow generator (2), which can increase the first preselected pressure differential magnitude (37). For specific embodiments, the variable resistance control element (43) can include a linear rheostat having a linear conductive coil or a rotary rheostat having a conductive coil configured as a toroid to reduce volume.

4 , the first fluid flow generator can be capable of generating first pressure differential magnitude oscillations (45) that can reciprocate between a first fluid flow first direction (46) and a first fluid flow second direction (47) within the first axial ear tip conduit (4). For specific embodiments, the first pressure differential magnitude oscillations (45) can have a first pressure differential magnitude oscillation frequency (48) ranging between 0 Hz and approximately 10 Hz; however, embodiments can generate smaller or larger first pressure differential magnitude oscillation frequencies (48) depending on the application. For specific embodiments, the first pressure difference magnitude oscillation frequency (48) or the first preselected pressure difference magnitude oscillation frequency (49) can be selected from one or more of the group consisting of: between 0 Hz and about 1 Hz, between about 0.5 Hz and about 1.5 Hz, between about 1 Hz and about 2 Hz, between about 1.5 Hz and about 2.5 Hz, between about 2 Hz and about 3 Hz, between about 2.5 Hz and about 3.5 Hz, between about 3 Hz and about 4 Hz, between about 3. The frequency range of the FM frequency spectrum is preferably between about 5 Hz and about 4.5 Hz, between about 4 Hz and about 5 Hz, between about 4.5 Hz and about 5.5 Hz, between about 5 Hz and about 6 Hz, between about 5.5 Hz and about 6.5 Hz, between about 6 Hz and about 7 Hz, between about 6.5 Hz and about 7.5 Hz, between about 7 Hz and about 8 Hz, between about 7.5 Hz and about 8.5 Hz, between about 8 Hz and about 9 Hz, between about 8.5 Hz and about 9.5 Hz, and between about 9 Hz and about 10 Hz.

One or more first pressure difference magnitude oscillation frequencies (48) (or first preselected pressure difference magnitude oscillation frequencies (49)) can be generated by the external auditory canal pressure adjustment device (1) depending on the method of use, which can be affected by the anatomy, physiology or biochemistry of the user (33) such as the external auditory canal (34); the symptoms of the disorder as a target to be alleviated; the disorder as a target to be treated; the observable effect of using one or more first pressure difference magnitude oscillation frequencies (48) (or first preselected pressure difference magnitude oscillation frequencies (49)) in a specific method of use of the external auditory canal pressure adjustment device (1); or a combination thereof; wherein the one or more first pressure difference magnitude oscillation frequencies (48) (or first preselected pressure difference magnitude oscillation frequencies (49)) can be applied to be effective in alleviating one or more symptoms of the disorder or treating one or more disorders, but not so much as to cause discomfort to the user (33) or damage to the auditory canal (34) or eardrum (35).

Referring again primarily to Figures 8 and 9B, the external auditory canal pressure adjustment device (1) may further include a first pressure difference magnitude oscillation frequency selection element (50). The first fluid flow generator controller (41) may adjust the operation of the first fluid flow generator (2) to achieve a first preselected pressure difference magnitude oscillation frequency (49) in response to the operation of the first pressure difference magnitude oscillation frequency selection element (50). As an illustrative example, the first pressure difference magnitude oscillation frequency selection element (50) may be configured as a variable resistor, such as a variable resistance control element (43), which may have a similar configuration to the variable resistance control element (43) described above for the first pressure difference magnitude selection element (40). Changes in the current in the circuit may be analyzed to generate a correspondingly changing fluid flow generator drive signal (44) to change the first pressure difference magnitude oscillation frequency (48) of the first fluid flow (8). Thus, as an exemplary embodiment, the variable resistance control element (43) may be operated to increase the resistance of the circuit coupled to the first fluid flow generator (2), which may reduce the first preselected pressure difference magnitude oscillation frequency (49). Conversely, the variable resistance control element (43) may be operated to reduce the resistance of the circuit coupled to the first fluid flow generator (2), which may increase the first preselected pressure differential magnitude oscillation frequency (49).

Now referring primarily to Figures 8, 9B, 28, 29A, and 29B, the external auditory canal pressure regulating device (1) may further include a fluid flow manifold (51) that can be shut off by operation of one or more valves (52) to correspondingly change the configuration of the manifold fluid flow path (54) within the fluid flow manifold (51) to regulate the first fluid flow (8) (or the second fluid flow (20)) within the fluid flow manifold (51). As an illustrative example, the valve (52) that can be used in a specific embodiment of the external auditory canal pressure regulating device (1) can be a solenoid valve, such as Lee's High Density Interface (LHD Series) Solenoid Valves, which can be obtained from The Lee Company, 2 Pettipaug Road, Westbrook, CT, 06498, USA.

Although the accompanying drawings schematically illustrate a specific construction of the fluid flow manifold (51), which correspondingly defines a specific construction of the manifold fluid flow path (54), these embodiments need not be so limited with respect to the construction of the fluid flow manifold (51) or the manifold fluid flow path (54), and embodiments may include any of a wide variety of constructions, which may include fluidly coupling a first fluid flow generator (2) to a first axial ear plug conduit (4) (or a second fluid flow generator (19) to a second axial ear plug conduit (13)), whether defined by multiple separate conduits, a single-piece manifold, or a housing (125) that is formed, molded, three-dimensionally printed, or similarly manufactured as a single-piece construction or assembled from multiple pieces, in which valves (52) may be positioned, assembled, or similarly coupled to produce a fluid flow manifold (51) that can be shut off by one or more valves (52).

The valve (52) can have any type of valve configuration capable of operating between a closed condition and an open condition to unidirectionally regulate the flow of the first fluid (8) or the second fluid (20). The valve (52) can be operated between a closed condition that can be substantially leak-proof to the reverse flow or the second fluid flow (20) on the opposite side of the valve (52), and an open condition that can have a forward flow in the range of about 0.2 milliliters per second to about 10 milliliters per second relative to the flow of the first fluid (8) or the second fluid (20). For specific embodiments, the pressure difference between the opposite sides of the valve (52) or the forward flow of the first fluid (8) or the second fluid (20) in the open condition of the valve (52) can be regulated by the configuration of the valve (52), the non-restrictive cross-sectional area of the manifold fluid flow path (54), the like, or a combination thereof. Additionally, although the disclosed external auditory canal pressure adjustment device (1) can generate a first pressure differential magnitude (36) of up to about 50 kilopascals in the first external auditory canal (5) or a second pressure differential magnitude (63) of up to about 50 kilopascals in the second external auditory canal (14), these examples are not intended to teach or imply that all embodiments of the external auditory canal pressure adjustment device (1) must achieve these amounts of the first pressure differential magnitude (36) or the second pressure differential magnitude (63). Rather, specific embodiments of the external auditory canal pressure adjustment device (1) can be configured to achieve a smaller or larger first pressure differential magnitude (36) or second pressure differential magnitude (63) that is effective for alleviating one or more symptoms of a disorder or treating one or more disorders.

Referring again primarily to Figures 8, 9B, 28 and 29A, the external auditory canal pressure adjustment device (1) may further comprise a first pressure relief valve (55) fluidically coupled to the first axial earplug conduit (4). The first pressure relief valve (55) allows the first external auditory canal pressure (10) to return to ambient pressure (11) in an open condition, whether from a first external auditory canal pressure (10) greater than ambient pressure (11) or a first external auditory canal pressure (10) less than ambient pressure (11). By operating to relieve the first pressure differential (9) when the first pressure differential magnitude (36) exceeds the first preselected pressure differential magnitude (37), the risk of discomfort or injury to the auditory canal (34) or tympanic membrane (35) when using the external auditory canal pressure adjustment device (1) can be reduced.

8 and 28, the external auditory canal pressure adjustment device (1) may further include a first pressure sensor (56) that can generate a first pressure sensor signal (57) that can change based on changes in the first pressure difference (36). For specific embodiments, the pressure sensor (56) that can be useful for specific embodiments of the external auditory canal pressure adjustment device (1) can be an EPB miniature pressure detection sensor, which can be obtained from Measurement Specialties, 45738, Northport Loop West, Fremont, CA, 94538, USA.

The first pressure sensor signal (57) can be sent to a first pressure sensor signal analyzer (58) including a first pressure differential magnitude comparator (59) for comparing a first preselected pressure differential magnitude (37) with a first pressure differential magnitude (36) actually generated in the first external auditory canal (5). As an illustrative example, the user (33) can select a first preselected pressure differential magnitude (37) of approximately 25 kilopascals using the first pressure differential magnitude selection element () as described above. The first pressure differential magnitude comparator (59) can be used to compare the first preselected pressure differential magnitude (37) of approximately 25 kilopascals with the first pressure differential magnitude (36) actually generated in the first external auditory canal (5). When the operation of the first fluid flow generator (2) results in a first pressure differential magnitude (36) of approximately 25 kilopascals in the first external auditory canal (5) within an error margin, the operation of the first fluid flow generator (2) can be weakened as long as the first preselected pressure differential magnitude (37) can be maintained for a selected time period (39).

For specific embodiments, the first pressure sensor signal analyzer (58) can also be used to generate a first pressure differential magnitude compensation signal (60). For example, when the operation of the first fluid flow generator (2) results in a first pressure differential magnitude (36) that changes from a first preselected pressure differential magnitude (37), the first pressure sensor signal analyzer (58) can generate a first pressure differential magnitude compensation signal (60), and the first fluid flow generator controller (41) can respond to the first pressure differential magnitude compensation signal (60) to achieve the first preselected pressure differential magnitude (37). As an illustrative example, the user (33) can select a first preselected pressure differential magnitude (37) of approximately 25 kilopascals using the first pressure differential magnitude selection element (40) as described above. The operation of the first fluid flow generator (2) can result in a first pressure differential magnitude (36) of approximately 20 kilopascals within the first external auditory canal (5), for example, due to an improper sealing engagement of the first earplug outer surface (7) with the first external auditory canal (5). The first pressure differential magnitude comparator (59) can be used to compare the first preselected pressure differential magnitude (37) of approximately 25 kilopascals with the sensed first pressure differential magnitude (36) of approximately 20 kilopascals. When the operation of the first fluid flow generator (2) results in a change in the first pressure differential magnitude (36) from the first preselected pressure differential magnitude (37) by, in this example, 5 kilopascals, the first pressure signal sensor signal analyzer (58) can generate a first pressure differential magnitude compensation signal (60) that correspondingly drives the first fluid flow generator (2) at a rate that increases the sensed pressure differential magnitude (36) by approximately 5 kilopascals to achieve the first preselected pressure differential magnitude (37) of approximately 25 kilopascals.

Referring again primarily to FIG8 and FIG28, the first pressure sensor signal analyzer (58) may further include a first pressure differential magnitude oscillation frequency comparator (61) that may be configured to compare the first preselected pressure differential magnitude oscillation frequency (49) with the first pressure differential magnitude oscillation frequency (48) sensed by the first pressure sensor (56) in the first external auditory canal (5). As an illustrative example, the user (33) may select the first preselected pressure differential magnitude oscillation frequency (49) of approximately 5 Hz using the first pressure differential magnitude oscillation frequency selection element (50) as described above. The first fluid flow generator controller (2) may adjust the operation of the first fluid flow generator (2) to generate the first fluid flow (8) having the first pressure differential magnitude oscillation frequency (48) of approximately 5 Hz in response to the operation of the first pressure differential magnitude oscillation frequency selection element (50). The first pressure differential magnitude oscillation frequency comparator (61) may be configured to compare the first preselected pressure differential magnitude oscillation frequency (49) of approximately 5 Hz with the first pressure differential magnitude oscillation frequency (48) of approximately 5 Hz generated in the first external auditory canal (5). When operation of the first fluid flow generator (2) results in a first pressure differential magnitude oscillation frequency (48) that corresponds to a first preselected pressure differential magnitude oscillation frequency (49) within an error margin, operation of the first fluid flow generator (2) may be continued without compensation as long as the sensed pressure differential magnitude oscillation frequency (48) corresponds to the first preselected pressure differential magnitude oscillation frequency (49).

For specific embodiments, the first pressure sensor signal analyzer (58) can also be used to generate a first pressure differential magnitude oscillation frequency compensation signal (62). For example, if the operation of the first fluid flow generator (2) results in a first pressure differential magnitude oscillation frequency (5) that is changed from a first preselected pressure differential magnitude oscillation frequency (49), the first pressure differential sensor signal analyzer (58) can generate the first pressure differential magnitude oscillation frequency compensation signal (62) to control the first fluid flow generator (5) to achieve the first preselected pressure differential magnitude oscillation frequency (49).

As an illustrative example, the user (33) can use the first pressure differential magnitude oscillation frequency selection element (50) as described above to establish a first preselected pressure differential magnitude oscillation frequency (49) of approximately 5 Hz. Operation of the first fluid flow generator (2) can result in a first pressure differential magnitude oscillation frequency (48) of approximately 2.5 Hz within the first external auditory canal (5), for example, due to improper sealing engagement of the first earplug outer surface (7) with the first external auditory canal (5). The first pressure differential magnitude oscillation frequency comparator (61) can be used to compare the first preselected pressure differential magnitude oscillation frequency (49) of approximately 5 Hz with the sensed first pressure differential magnitude oscillation frequency (48) of approximately 2.5 Hz. If the operation of the first fluid flow generator (2) results in a change in the first pressure differential magnitude oscillation frequency (48) from the first preselected pressure differential magnitude oscillation frequency (49), in this example, by 2.5 Hz, the first pressure signal sensor signal analyzer (58) generates a first pressure differential magnitude compensation signal (62) that drives the first fluid flow generator (2) to increase the first pressure differential magnitude oscillation frequency (48) to achieve the first preselected pressure differential magnitude oscillation frequency (49) of approximately 2.5 Hz. When the operation of the first fluid flow generator (2) results in a first pressure differential magnitude oscillation frequency (48) that corresponds to the first preselected pressure differential magnitude oscillation frequency (49) within an error margin, the operation of the first fluid flow generator (2) can be continued without further generating the first pressure differential magnitude oscillation frequency compensation signal (62).

Referring now primarily to Figures 2, 3, 5B, 7, 8, and 27 to 29B, the external auditory canal pressure adjustment device (1) may further comprise a second earplug (12) having a second earplug outer surface (16), the second earplug outer surface (16) being configured to sealably engage the second external auditory canal (14) of the second ear (15) as a barrier between the second external auditory canal pressure (18) and the ambient pressure (11). The second earplug (12) may comprise a second axial earplug conduit (13). The second earplug (12) may be configured as described above with respect to the first earplug (3).

Referring now primarily to Figures 8 to 10, the second axial earplug conduit (13) can be fluidically coupled to the first fluid flow generator (2). Thus, the first fluid flow generator (2) can be capable of generating a second pressure differential (17) between the second external auditory canal pressure (18) and the ambient pressure (11), which can have a second pressure differential magnitude (63) and a second pressure differential oscillation frequency (64) that are substantially similar to or substantially correspond to the first pressure differential magnitude (36) and the first pressure differential oscillation frequency (48) described above. As an illustrative example, the first fluid flow generator (2) can generate a first pressure differential (9) and a second pressure differential (18) that can each have a pressure differential magnitude (36) (63) of approximately 25 kilopascals and a pressure differential magnitude oscillation frequency (48) (64) of approximately 5 Hz. Thus, operation of the first fluid flow generator (2) can generate a first fluid flow (8) between the first fluid flow generator (2) and the first axial earplug conduit (4), and between the first fluid flow generator (2) and the second axial earplug conduit (13). For a specific embodiment, the first earplug outer surface (7) can be sealably engaged with the first external auditory canal (5), and the second earplug outer surface (16) can be sealably engaged with the second external auditory canal (14). The first fluid flow generator (2) can be operated to generate a first fluid flow (8) flowing from the first axial earplug conduit (4) to the first external auditory canal (5) and from the second axial earplug conduit (13) to the second external auditory canal (14), thereby generating a first pressure differential (9) having a first external auditory canal pressure (10) greater than the ambient pressure (11) and a second pressure differential (17) having a second pressure differential (18) greater than the ambient pressure (11). Similarly, the first fluid flow generator (2) can be operable to generate a first fluid flow (8) flowing from the first external auditory canal (5) into the first axial ear plug tube (4) and from the second external auditory canal (14) into the second axial ear plug tube (13), thereby generating a first pressure difference (9) having a first external auditory canal pressure (10) less than the ambient pressure (11) and a second pressure difference (17) having a second pressure difference (18) less than the ambient pressure (11).

For specific embodiments in which the first axial eartip conduit (4) and the second axial eartip conduit (13) are fluidically coupled together to the first fluid flow generator (2), the first fluid flow generator (2) can be capable of generating a second pressure differential magnitude oscillation frequency (64) that is substantially similar to the first pressure differential magnitude oscillation frequency (48) described above.

Referring now primarily to Figures 27 to 35, for a specific embodiment, the external auditory canal pressure adjustment device (1) can include independently a first fluid flow generator (2) and a second fluid flow generator (19), which are capable of generating separate first fluid flows (8) and second fluid flows (20). The second fluid flow generator (19) can be constructed in a substantially similar configuration as described above for the fluid coupling of the first fluid flow generator (1) to the first axial ear plug conduit (4) and fluidly coupled to the second axial ear plug conduit (13) of the second ear plug (12). Thus, the second fluid flow generator (19) can be capable of generating a corresponding separate second fluid flow (20) that is independently adjusted to generate a second pressure difference (17) having a second pressure difference magnitude (63) and having a second pressure difference magnitude oscillation frequency (64), all of which can have a substantially similar range as described above for the first fluid flow (8). In addition, the second fluid flow generator (19) can be operably adjusted by a second pressure difference size selection element (53) and a second pressure difference size oscillation frequency selection element (54), both of which can have a substantially similar construction to the corresponding first pressure difference size selection element (40) and first pressure difference size oscillation frequency selection element (50) that operably adjust the first fluid flow generator (2) as described above.

For embodiments having a second fluid flow generator (19), the external auditory canal pressure regulating device (1) may further include a second pressure relief valve (66) having a substantially similar configuration as the first pressure relief valve (55) described above. The second pressure relief valve (66) may be fluidically coupled to the second axial earplug conduit (13) to relieve a second pressure differential (17) exceeding a second preselected pressure differential magnitude (67) between 0 kPa and approximately 50 kPa.

For a specific embodiment having a second fluid flow generator (19), the external auditory canal pressure adjustment device (1) may further include a second pressure sensor (68), which may have a substantially similar configuration to the first pressure sensor (56) described above. The second pressure sensor (68) may generate a second pressure sensor signal (69), which may change based on a change in the second external auditory canal pressure difference magnitude (63). The second pressure sensor signal analyzer (70) may have a substantially similar configuration to the first pressure sensor signal analyzer (58) described above, which may include a second pressure difference comparator (71) for comparing the second preselected pressure difference magnitude (67) with the sensed second pressure difference magnitude (63). The second pressure sensor signal analyzer (70) may generate a second pressure difference magnitude compensation signal (72), whereby the second fluid flow generator controller (73) may control the second fluid flow generator (19) to achieve the second preselected pressure difference magnitude (63) in response to the second pressure difference magnitude compensation signal (72).

For a specific embodiment, the first fluid flow generator controller (41) and the second fluid flow generator controller (73) can control the corresponding first fluid flow generator (2) and the second fluid flow generator (19) in response to signals generated by a plurality of selection elements. As shown in the illustrative examples of Figures 27 and 28, the external auditory canal pressure adjustment device (1) having the first fluid flow generator (2) and the second fluid flow generator (19) can be configured so that the first fluid flow generator controller (41) can respond to signals generated by the first selection element (187) and the second selection element (189), and the second fluid flow generator controller (73) can respond to signals generated by the third selection element (186) and the fourth selection element (188).

For a specific embodiment, the second pressure sensor signal analyzer (70) may further include a second pressure difference magnitude oscillation frequency comparator (135) that can be used to compare the second preselected pressure difference magnitude oscillation frequency (180) with the second pressure difference magnitude oscillation frequency (64). The second pressure sensor signal analyzer (70) can generate a second pressure difference magnitude oscillation frequency compensation signal (181), and the second fluid flow generator controller (73) can control the second fluid flow generator (19) to achieve the second preselected pressure difference magnitude oscillation frequency (180) in response to the second pressure difference magnitude oscillation frequency compensation signal (181).

Now referring mainly to Figure 28, an external auditory canal pressure adjustment device (1) comprising a first fluid flow generator (2), a first earplug (3) having a first axial earplug conduit (4) fluidly coupled to the first fluid flow generator (2), and a second earplug (12) having a second axial earplug conduit (13) fluidly coupled to a second fluid flow generator (19) can be operable to generate a first pressure difference (9) in the first external auditory canal (5) and a second pressure difference (17) in the second external auditory canal (14) by generating corresponding separate first fluid flows (8) and second fluid flows (20), the first fluid flow (8) being between the first fluid flow generator (2) and the first axial earplug conduit (4) and the second fluid flow (20) being between the second fluid flow generator (19) and the second axial earplug conduit (13).

Now referring mainly to Figures 28 and 40, for the specific embodiments of the external auditory canal pressure regulating device (1) having the configuration shown in Figures 27 to 35, in order to generate the first pressure difference (9) and the second pressure difference (17), the valves V1, V2, V3L, V3R, V4 and V5 can be in an open state and the valves V6, IL and IR can be in a closed state. For other specific embodiments, in order to generate the first pressure difference (9) only in the first external auditory canal (5), the valves V1, V3L and V4 can be in an open state and the valves V2, V3R, V5, V6, IL and IR can be in a closed state. For other specific embodiments, in order to generate the second external auditory canal pressure difference (17) only in the second external auditory canal (14), the valves V2, V3R and V5 can be in an open state and the valves V1, V3L, V4, V6, IL and IR can be in a closed state.

For a specific embodiment having a first fluid flow generator (2) and a second fluid flow generator (19), each of the first fluid flow generator (2) and the second fluid flow generator (19) can include a corresponding first fluid flow generator pair (74) and a second fluid flow generator pair (75) respectively fluidly coupled to the first axial ear plug conduit (4) and the second axial ear plug conduit (13). Each of the first fluid flow generator pair (74) and the second fluid flow generator pair (75) can include a positive pressure fluid flow generator (76) and a negative pressure fluid flow generator (77). The positive pressure fluid flow generator (76) can generate a first fluid flow (8) and a second fluid flow (20) flowing out from the corresponding first axial ear plug conduit (4) and the second axial ear plug conduit (13) to the corresponding first external auditory canal (5) and the second external auditory canal (14). Therefore, the first fluid flow (8) and the second fluid flow (20) can flow into the corresponding first external auditory canal (5) and the second external auditory canal (14), generating the corresponding first pressure difference (9) and the second pressure difference (17), so that the corresponding first external auditory canal pressure (10) and the second external auditory canal pressure (18) can be greater than the ambient pressure (11). The negative pressure fluid flow generator (77) can generate the first fluid flow (8) and the second fluid flow (20) that flow from the corresponding first external auditory canal (5) and the second external auditory canal (14) into the corresponding first axial earplug tube (4) and the second axial earplug tube (13). Therefore, the first fluid flow (8) and the second fluid flow (19) can flow out from the corresponding first external auditory canal (5) and the second external auditory canal (14), generating the corresponding first pressure difference (8) and the second pressure difference (17), so that the corresponding first external auditory canal pressure (10) and the second external auditory canal pressure (18) can be less than the ambient pressure (11).

Now referring primarily to Figures 8 and 9B, for a specific embodiment, a fluid flow temperature regulator (78) can be fluidically coupled to the first fluid flow generator (2). The fluid flow temperature regulator (78) can be operated to generate a first fluid flow (8) or a second fluid flow (19) having a fluid flow temperature (79) greater than body temperature (80). The first fluid flow (8) having a fluid flow temperature (79) greater than body temperature (80) can flow through the first axial ear plug conduit (4) or the second axial ear plug conduit (13), and out of the first axial ear plug conduit (4) or the second axial ear plug conduit (13) to the corresponding first external auditory canal (5) or the second external auditory canal (14). Therefore, the first fluid flow (8) having a fluid flow temperature (79) greater than body temperature (80) can flow into the first external auditory canal (5) or the second external auditory canal (14).

Referring now primarily to Figures 28 and 29A, the external auditory canal pressure adjustment device (1) may further comprise a fluid flow temperature adjuster (78) fluidically coupled to the first fluid flow (8) and the second fluid flow (20). The fluid flow temperature adjuster (78) may be operable to adjust the fluid flow temperature (79) of the first fluid flow (8) or the second fluid flow (19), adjusting the fluid flow temperature (79) of the first fluid flow (8) or adjusting the fluid flow temperature (79) of the second fluid flow (20) to be lower than or higher than body temperature (80). Typically, the fluid flow temperature (79) may be in a range between 10 degrees Celsius and approximately 50 degrees Celsius; however, depending on the application, embodiments may have a lower or higher fluid flow temperature (79).

Now referring mainly to Figures 28 and 40, for the specific embodiment of the external auditory canal pressure regulating device (1) having the configuration shown in Figures 27 to 35, in order to generate the first pressure difference (9) in the first external auditory canal (5) and adjust the fluid flow temperature (79) of the second fluid flow (20) in the second external auditory canal (14), the valves V1, V3L, V3R, V4 and IR can be in the open state and the valves V2, V5, V6 and IL can be in the closed state. For other specific embodiments, in order to generate the second pressure difference (17) in the second external auditory canal (14) and adjust the first fluid flow temperature (79) of the first fluid flow (8) in the first external auditory canal (5), the valves V2, V3R, V3L, V5 and IL can be in the open state and the valves V1, V4, V6 and IR can be in the closed state.

Referring now primarily to FIG. 28 , the external auditory canal pressure adjustment device (1) may further comprise a third fluid flow generator (81) capable of generating a third fluid flow (82) having a third fluid flow rate (83) in the range of 0 to approximately 10 liters per minute. For specific embodiments, the third fluid flow generator (81) may be similar to the first fluid flow generator (2) and the second fluid flow generator (19) described above. For specific embodiments, a fluid flow temperature adjuster (78) may be fluidically coupled to the third fluid flow generator (81) that is operable to adjust a third fluid flow temperature (84) of the third fluid flow (82). The third fluid flow generator (81) may be fluidically coupled to the first axial earplug conduit (4) and the second axial earplug conduit (13), allowing the third fluid flow generator (81) to generate a third fluid flow (82) having a third fluid flow temperature (84), which may be delivered to the first external auditory canal (5) and the second external auditory canal (14) through the corresponding first axial earplug conduit (4) and the second axial earplug conduit (13).

Typically, the third fluid stream temperature (84) can be in the range of between 10 degrees Celsius and about 50 degrees Celsius; however, depending on the application, embodiments can have a lower or higher third fluid stream temperature (84). For specific embodiments, the third fluid stream temperature (84) (or third preselected fluid stream temperature) can be selected from one or more of the group consisting of: between about 10 degrees Celsius and about 20 degrees Celsius, between about 15 degrees Celsius and about 25 degrees Celsius, between about 20 degrees Celsius and about 30 degrees Celsius, between about 25 degrees Celsius and about 35 degrees Celsius, between about 30 degrees Celsius and about 40 degrees Celsius, between about 35 degrees Celsius and about 45 degrees Celsius, and between about 40 degrees Celsius and about 50 degrees Celsius.

One or more third fluid flow temperatures (84) (or third preselected fluid flow temperatures) can be generated by the external auditory canal pressure adjustment device (1) depending on the method of use, which can be affected by the anatomy, physiology or biochemistry of the user (33) such as the external auditory canal (34); as a symptom of the disorder to be alleviated; as a disorder to be treated; the observable effect of using one or more third fluid flow temperatures (84) (or third preselected fluid flow temperatures) in a specific method of use of the external auditory canal pressure adjustment device (1); or a combination thereof; thereby one or more of the third fluid flow temperatures (84) (or third preselected fluid flow temperatures) can be effective in alleviating one or more symptoms of the disorder or treating one or more disorders, but not so much as to cause discomfort to the user (33) or damage to the auditory canal (34) or eardrum (35).

Typically, the third fluid stream flow rate (83) can be in the range of between 0 liters per minute and about 10 liters per minute; however, depending on the application, embodiments can have a smaller or larger third fluid stream flow rate (83). For specific embodiments, the third fluid stream flow rate (83) (or third preselected fluid flow rate) can be selected from one or more of the group consisting of: between about 0 liters per minute and about 2 liters per minute, between about 1 liter per minute and about 3 liters per minute, between about 2 liters per minute and about 4 liters per minute, between about 3 liters per minute and about 5 liters per minute, between about 4 liters per minute and about 6 liters per minute, between about 5 liters per minute and about 7 liters per minute, between about 6 liters per minute and about 8 liters per minute, between about 7 liters per minute and about 9 liters per minute, and between about 8 liters per minute and about 10 liters per minute.

One or more third fluid flow rates (83) (or third preselected fluid flow rates) can be generated by the external auditory canal pressure adjustment device (1) depending on the method of use, which can be affected by the anatomy, physiology or biochemistry of the user (33), such as the external auditory canal (34); the symptoms of the disorder as a target to be alleviated; the disorder as a target to be treated; the observable effect of using one or more third fluid flow rates (83) (or third preselected fluid flow rates) in a specific method of use of the external auditory canal pressure adjustment device (1); or a combination thereof; thereby one or more of the third fluid flow rates (83) can be an amount effective for alleviating one or more symptoms of the disorder or treating one or more disorders, but not so much as to cause discomfort to the user (33) or damage to the auditory canal (34) or eardrum (35).

Referring now primarily to Figures 28 and 29A, a specific embodiment of the external auditory canal pressure regulating device (1) having a third fluid flow generator (81) may further include a first valve-controlled conduit (85) having a first valve-controlled conduit valve (86) operable to shut off the third fluid flow (82) to the first axial ear plug conduit (4). In an open state, the first valve-controlled conduit valve (86) allows the third fluid flow (82) to flow from the third fluid flow generator (81) to the first axial ear plug conduit (4) and, therefore, to the first external auditory canal (5). In a closed state, the first valve-controlled conduit valve (86) prevents the third fluid flow (82) from flowing from the third fluid flow generator (81) to the first axial ear plug conduit (4).

Referring again primarily to Figures 28 and 29A, a specific embodiment of the external auditory canal pressure adjustment device (1) having a third fluid flow generator (81) can also include a second valve-controlled conduit (87) having a second valve-controlled conduit valve (88), the second valve-controlled conduit valve (86) being operable to shut off the third fluid flow (82) to the second axial ear plug conduit (13). In an open state, the second valve-controlled conduit valve (88) allows the third fluid flow (82) to flow from the third fluid flow generator (81) to the third axial ear plug conduit (13) and thus to the second external auditory canal (14). In a closed state, the second valve-controlled conduit valve (88) prevents the third fluid flow (82) from flowing from the third fluid flow generator (81) to the second axial ear plug conduit (13).

Now referring mainly to Figures 28 and 40, for the specific embodiment of the external auditory canal pressure regulating device (1) having the configuration shown in Figures 27 to 35, in order to generate the third fluid flow (82) having the third fluid flow temperature (84) and the third fluid flow rate (83) in the first external auditory canal (5) and the second external auditory canal (14), the valves V3L, V3R, IL, IR and V6 can be in the open state and the valves V1, V2, V4 and V5 can be in the closed state. For other specific embodiments, in order to generate the third fluid flow (82) having the third fluid flow temperature (84) and the third fluid flow rate (82) only in the first external auditory canal (5), the valves V3L, IL and V6 can be in the open state and the valves V1, V2, V3R, V4, V5 and IR can be in the closed state. For other specific embodiments, in order to generate only a third fluid flow (82) having a third fluid temperature (84) and a third fluid flow rate (83) in the second external auditory canal (14), valves V3L, IR and V6 can be in an open state and valves V1, V2, V3L, V4, V5 and IL can be in a closed state.

Now mainly referring to Figures 8, 9A, 28 and 29B, a specific embodiment of the external auditory canal pressure adjustment device (1) may also include a manifold discharge valve (89), which, when open, can allow the first fluid flow (8) or the second fluid flow (20) to flow out of the fluid flow manifold (51) to the ambient pressure (11), thereby alleviating the first pressure difference (9) or the second pressure difference (17).

Now referring mainly to Figures 28 and 40, for a specific embodiment of the external auditory canal pressure regulating device (1) having the structure shown in Figures 27 to 35, in order to discharge the fluid flow manifold (51), valve V6 can be in an open state and valves V1, V2, V3L, V3R, V4, V5, IL and IR can be in a closed state.

Now referring mainly to Figures 1 to 8 and Figures 11 to 28, the external auditory canal pressure adjustment device (1) may include a first earplug (3) or a second earplug (12), which has a compatible corresponding first earplug outer surface (7) or a second earplug outer surface (16), and the first earplug outer surface (7) or the second earplug outer surface (16) is configured to sealably engage the first external auditory canal (5) or the second external auditory canal (14), thereby serving as a corresponding first barrier (102) or a second barrier (103) between the corresponding first external auditory canal pressure (10) or the second external auditory canal pressure (18) and the ambient pressure (11). Embodiments of the first earplug (3) or the second earplug (12) can be configured to effectively sealably engage the first external auditory canal (5) or the second external auditory canal (14) to prevent axial or lateral displacement, given normal anatomical variations of the first external auditory canal (5) or the second external auditory canal (14) over a normal range of operating temperatures between about 20°C (about 68°F) and about 50°C (about 122°F), and to allow generation and maintenance of a normal range of operating pressures of about -50 kPa below ambient pressure (11) to about +50 kPa above ambient pressure (11).

Referring now primarily to Figures 11 to 18, as for specific embodiments, the first earplug (3) or the second earplug (12) of the external auditory canal pressure adjustment device (1) can be formed of a compatible material that can be correspondingly compressibly deformed when engaged with the corresponding first external auditory canal (5) or second external auditory canal (14), thereby allowing the first earplug (3) or the second earplug (12) to sealably follow the corresponding first external auditory canal (5) or second external auditory canal (14). For these specific embodiments, the first earplug (3) or the second earplug (12) can be formed, molded, three-dimensionally printed, or similarly manufactured from any of a variety of materials that can sealably engage with the corresponding first external auditory canal (5) or second external auditory canal (14), including or consisting of silicone, foam (including polyurethane foam), polyvinyl siloxane, low-hardness elastomer, or the like, or combinations thereof.

For specific embodiments, the first earplug (3) or the second earplug (12) can be generally uniform and formed of one material, for example, a relatively low-hardness elastomer. For other specific embodiments, the first earplug (3) or the second earplug (12) can be formed of multiple layers, for example, an inner core layer having a higher hardness surrounded by an outer layer having a lower hardness, or an inner core layer having a lower hardness surrounded by an outer layer having a higher hardness.

For specific embodiments, a portion of the first earplug outer surface (7) or the second earplug outer surface (16) can be tapered inwardly from the earplug first end (92) toward the earplug second end (93). As an illustrative example of a specific embodiment of this configuration, the first earplug outer surface (7) or the second earplug outer surface (16) can be in the overall form of a cross-sectional cone that tapers inwardly toward the earplug second end (93). For specific embodiments, the first earplug outer surface (7) or the second earplug outer surface (16) can further include a plurality of circumferential ribs disposed in a spaced relationship between the earplug first end (92) and the earplug second end (93).

The first earplug outer surface (7) or the second earplug outer surface (16) can be maintained in sealable engagement with the corresponding first external auditory canal (5) or second external auditory canal (14) by friction between the first earplug outer surface (7) or the second earplug outer surface (16) and the corresponding first external auditory canal (5) or second external auditory canal (14). For specific embodiments, the first earplug outer surface (7) or the second earplug outer surface (16) can be maintained in sealable engagement with the corresponding first external auditory canal (5) or second external auditory canal (14) by strongly abutting against the external auditory canal pressure adjustment device (1) during normal operation. For other specific embodiments, a retention element (182) can be coupled to the earplug (3) (12) or the external auditory canal pressure adjustment device (1), which can be worn in the ear (6) (15), around the ear (6), around the head (95) or around the neck (183) to assist in retaining the earplug (3) (14) in the external auditory canal (5) (14).

Referring now primarily to Figures 11 to 18, a retention element (182) can be provided as a resiliently flexible member (182) coupled about the earplug (3)(4). For specific embodiments, the resiliently flexible member (182) can be provided within the concha region of the ear (6)(15) and can assist in retaining the earplug (3)(14) within the external auditory canal (5)(14) when strongly abutted within the concha region (183). For specific embodiments, the resiliently flexible member (182) can be configured as an arcuate annular member (184) having a plurality of radially disposed spokes.

Now referring primarily to Figures 8, 9B, 10, 19 to 26, 28 and 29B, for a specific embodiment, the external auditory canal pressure adjustment device (1) may also include a fourth fluid flow generator (96) capable of generating a fourth fluid flow (99). The fourth fluid flow generator (96) can be constructed in substantially the same manner as the first fluid flow generator (2) or the second fluid flow generator (19) described above. The first coaxial earplug conduit (97) can be arranged around the first axial earplug conduit (4), and the second coaxial earplug conduit (98) can be arranged around the second axial earplug conduit (13) (as for an embodiment including the second axial earplug conduit (13)). The first coaxial earplug conduit (4) and the second coaxial earplug conduit (13) can be fluidically coupled to the fourth fluid flow generator (96). A first elastomeric sleeve (100) and a second elastomeric sleeve (101) can be respectively disposed about the first axial earplug conduit (4) and the second axial earplug conduit (13) to provide a corresponding first earplug outer surface (7) and a second earplug outer surface (16), the first earplug outer surface (7) and the second earplug outer surface (16) being configured to sealably engage the first external auditory canal (5) and the second external auditory canal (14) to provide a corresponding first barrier (102) and a second barrier (103) between the first external auditory canal pressure (10) and the second external auditory canal pressure (18) and the ambient pressure (11). The first elastomeric sleeve (100) and the second elastomeric sleeve (101) can be fluidically coupled to the first coaxial earplug conduit (97) and the second coaxial earplug conduit (98). The fourth fluid flow (99) in the first coaxial earplug conduit (97) and the second coaxial earplug conduit (98) can generate a corresponding first coaxial earplug conduit pressure difference (104) and a second coaxial earplug conduit pressure difference (105) between the corresponding first coaxial earplug conduit pressure (106) and the second coaxial earplug conduit pressure (107) and the ambient pressure (11). The first coaxial earplug conduit pressure (106) and the second coaxial earplug conduit pressure (107) can be capable of respectively expanding the first elastomeric sleeve (100) and the second elastomeric sleeve (101) to respectively sealably engage the first external auditory canal (5) and the second external auditory canal (14).

Referring now primarily to Figures 28 and 29B, a specific embodiment of the external auditory canal pressure regulating device (1) having a fourth fluid flow generator (96) may further include a third valve-controlled conduit (108) having a third valve-controlled conduit valve (109) operable to shut off the fourth fluid flow (99) to the first coaxial earplug conduit (97). In an open state, the third valve-controlled conduit valve (109) allows the fourth fluid flow (99) to flow from the fourth fluid flow generator (96) to the first coaxial earplug conduit (97) and thus to the first elastomeric sleeve (100). In a closed state, the third valve-controlled conduit valve (109) prevents the fourth fluid flow (99) from flowing from the fourth fluid flow generator (96) to the first elastomeric sleeve (100).

Referring again primarily to Figures 28 and 29B, a specific embodiment of the external auditory canal pressure adjustment device (1) having a fourth fluid flow generator (96) may further include a fourth valve-controlled conduit (110) having a fourth valve-controlled conduit valve (111) operable to shut off the fourth fluid flow (99) to the second coaxial earplug conduit (98). In an open state, the fourth valve-controlled conduit valve (111) allows the fourth fluid flow (99) to flow from the fourth fluid flow generator (96) to the second coaxial earplug conduit (98) and thus to the second elastomeric sleeve (101). In a closed state, the fourth valve-controlled conduit valve (111) prevents the fourth fluid flow (99) from flowing from the fourth fluid flow generator (96) to the second elastomeric sleeve (101).

Now referring mainly to Figure 28, the external auditory canal pressure adjustment device (1) may also include a fourth fluid flow generator controller (112), which controls the operation of the fourth fluid flow generator (96) to generate a first coaxial ear plug conduit pressure difference (104) and a second coaxial ear plug conduit pressure difference (105) between the corresponding first coaxial ear plug conduit pressure (106) and the second coaxial ear plug conduit pressure (107) and the ambient pressure (11) to expand the corresponding first elastomeric sleeve (100) and the second elastomeric sleeve (101) to sealably engage the corresponding first external auditory canal (5) and the second external auditory canal (14), thereby providing a corresponding first barrier (102) and a second barrier (103) between the corresponding first external auditory canal pressure (10) and the second external auditory canal pressure (18) and the ambient pressure (11).

28, the external auditory canal pressure adjustment device (1) may further include a third pressure sensor (113) fluidically coupled to the first coaxial earplug tube (97). The third pressure sensor (113) may generate a third pressure sensor signal (114) that varies based on a change in the first coaxial earplug tube pressure difference (104) between the first coaxial earplug tube pressure (106) and the ambient pressure (11).

28, the external auditory canal pressure adjustment device (1) may further include a fourth pressure sensor (115) fluidically coupled to the second coaxial earplug tube (98). The fourth pressure sensor (115) may generate a fourth pressure sensor signal (115) that varies based on a change in a second coaxial earplug tube pressure difference (105) between the second coaxial earplug tube pressure (107) and the ambient pressure (11).

Now referring mainly to FIG28 , the external auditory canal pressure regulating device (1) may further include a coaxial earplug duct pressure sensor signal analyzer (117) for identifying a stable first coaxial earplug duct pressure difference (104) and a second coaxial earplug duct pressure difference (105) between the corresponding first coaxial earplug duct pressure (106) and the second coaxial earplug duct pressure (107) and the ambient pressure (11). The coaxial earplug duct pressure sensor signal analyzer (117) may generate a sealing signal (118) when a stable first coaxial earplug duct pressure difference (104) and the second coaxial earplug duct pressure difference (105) occur.

Referring again primarily to FIG6, FIG8, FIG9A and FIG28, a specific embodiment of the external auditory canal pressure adjustment device (1) may further include an elastomeric sleeve seal indicator (119) responsive to the seal signal (118). The elastomeric sleeve seal indicator (119) may generate a sensory perceptible mark (120) upon receiving the seal signal (118). The sensory perceptible mark (120) may include one or more of a sound mark, a light mark, a tactile mark, etc., or a combination thereof.

28 and 29B , the external auditory canal pressure regulating device (1) may further include a third pressure relief valve (121) and a fourth pressure relief valve (122) respectively fluidly coupled to the first coaxial earplug conduit (97) and the second coaxial earplug conduit (98). In an open state, the third pressure relief valve (121) and the fourth pressure relief valve (122) may respectively relieve the first coaxial earplug conduit pressure difference (104) and the second coaxial earplug conduit pressure difference (105) between the corresponding first coaxial earplug conduit pressure (106) and the second coaxial earplug conduit pressure (107) and the ambient pressure (11).

8, the external auditory canal pressure regulating device (1) may further include a pressure relief selection element (123). The fourth fluid flow generator controller (112) may, in response to the operation of the pressure relief selection element (123), reduce the operation of the fourth fluid flow generator (96) and operate the third pressure relief valve (121) and the fourth pressure relief valve (122) to respectively return the first coaxial ear plug conduit pressure difference (104) and the second coaxial ear plug conduit pressure difference (105) between the corresponding first coaxial ear plug conduit pressure (106) and the second coaxial ear plug conduit pressure (107) and the ambient pressure (11) to the ambient pressure (11) to contract the corresponding first elastomeric sleeve (100) and the second elastomeric sleeve (101).

Reference is now made primarily to Figures 37A to 39E, which provide graphs of pressure adjustment curves (136) that can be applied by embodiments of the external auditory canal pressure adjustment device (1) to be effective for alleviating one or more symptoms of a disorder or treating one or more disorders. Each graph shows a pressure difference (9) (17) between the external auditory canal pressure (10) (18) and the ambient pressure (11) achieved over a time period (39). For specific embodiments, the fluid flow generator (2) (19) can be operated to generate a fluid flow (8) (20) that flows from the axial earplug conduit (4) (13) to the external auditory canal (5) (14) over a time period (39) to obtain a positive external auditory canal pressure (10) (18) relative to the ambient pressure (11) (as shown in the examples of Figures 37A to 37G). For other specific embodiments, the fluid flow generator (2) (19) can be operated to generate a fluid flow (8) (20) that flows from the external auditory canal (5) (14) toward the fluid flow generator (2) (19) into the axial ear plug tube (4) (13) over a time period (39), resulting in a negative external auditory canal pressure (10) (18) relative to the ambient pressure (11) (as shown in the examples of Figures 38A to 38G).

Referring now primarily to Figures 37A and 38A, the fluid flow generator (1) (19) can be operated to maintain a constant external auditory canal pressure (10) (18) over a period of time (39). For specific embodiments, the constant external auditory canal pressure (19) (18) can be maintained such that the external auditory canal (5) (14) fluid volume () is free (or substantially free) of fluid flow (8) (20) over a period of time (39). As an illustrative example, an external auditory canal pressure adjustment device (1) having an earplug outer surface (7) (16) sealably engaged with an external auditory canal (5) (14) as described above can be operated by controlling a fluid flow generator (2) (19) to generate a fluid flow (2) (19) having a fluid volume (21) or a preselected fluid volume (22) through an axial earplug conduit (4) (13) of an earplug (3) (12) between the fluid flow generator (2) (19) and the external auditory canal (5) (14) to achieve a pressure difference (3) (12) between the external auditory canal pressure (10) (18) and the ambient pressure (11). When the pressure difference (9) (17) is established by the desired fluid volume (21) or the preselected fluid volume (22), the pressure difference (9) (17) can be maintained for a period of time (39) in the absence or substantial absence of an additional fluid flow (8) (20) due to the sealable engagement of the earplug outer surface (7) (16) with the external auditory canal (5) (14). For other embodiments, when the desired pressure differential (9)(17) is achieved, the pressure differential (9)(17) can be maintained for a period of time (39) by additional fluid flow (8)(20) to or from the external auditory canal (5)(14) to compensate for leakage near the junction of the earplug outer surface (7)(16) and the external auditory canal (5)(14). For other embodiments, the external auditory canal pressure (10)(18) can be maintained for a period of time (39) by continuous fluid flow (8)(20) to the external auditory canal (5)(14).

Regardless of the method, the external auditory canal pressure (10)(18) can be maintained constant for a period of time (39) between about +50 kPa above ambient pressure (11) and about -50 kPa below ambient pressure (11) to alleviate one or more symptoms of a disorder or to treat one or more disorders. A positive external auditory canal pressure (10)(18) relative to ambient pressure (11) can be achieved by maintaining the external auditory canal pressure (10)(18) at about 0 kPa to about +50 kPa above ambient pressure (11). Alternatively, a negative external auditory canal pressure (10)(18) relative to ambient pressure (11) can be achieved by maintaining the external auditory canal pressure (10)(18) at about 0 kPa to about -50 kPa below ambient pressure (11).

Referring now primarily to Figures 37B to 37G, Figures 38B to 38G, and Figures 39A to 39E, the fluid flow generator (2) (19) can be configured to generate a fluid flow (9) (20) having a pressure differential wave (124) defining a preselected pressure differential magnitude (37) (67) and a preselected pressure differential magnitude oscillation frequency (49) (180) for each moment in a time period (39). For specific embodiments, the fluid flow generator (2) (19) can be operated to generate a fluid flow (8) (20) having a pressure differential wave (124) including a preselected pressure differential magnitude (37) (67) and a preselected pressure differential magnitude oscillation frequency (49) (180) that flows from the axial ear tip conduit (4) (13) toward the external auditory canal (5) (14) over the time period (39) to result in a positive external auditory canal pressure (10) (18) relative to the ambient pressure (11) (as shown in the examples of Figures 37B to 37G).

For other specific embodiments, the fluid flow generator (2) (19) can be operated to generate a fluid flow (8) (20) having a pressure difference wave (124) including a preselected pressure difference magnitude (37) (67) and a preselected pressure difference magnitude oscillation frequency (49) (180), which flows from the external auditory canal (5) (14) toward the fluid flow generator (2) (19) into the axial ear plug conduit (4) (13) over a time period (29) to obtain a negative external auditory canal pressure (10) (18) relative to the ambient pressure (1) (as shown in the examples of Figures 38B to 38G).

For other specific embodiments, the fluid flow generator (2) (19) can be operated to generate a fluid flow (8) (20) having a pressure difference wave (124) including a preselected pressure difference magnitude (37) (67) and a preselected pressure difference magnitude oscillation frequency (49) (180), which can alternate between flowing out of the axial ear plug conduit (4) (13) to the external auditory canal (5) (14) and flowing from the external auditory canal (5) (14) to the fluid flow generator (2) (19) into the axial ear plug conduit (4) (13) over a time period (39), resulting in an external auditory canal pressure (10) (18) that alternates between a positive external auditory canal pressure (10) (18) and a negative external auditory canal pressure (10) (18) relative to the ambient pressure (11) (as shown in the examples of Figures 39A to 39E).

For other specific embodiments, the pressure differential wave (124) can oscillate within a preselected pressure differential magnitude (67) (37) and at a preselected pressure differential magnitude oscillation frequency (49) (180) in a range of 0 kPa to approximately +50 kPa above ambient pressure (11) (as shown in the examples of Figures 37B to 37G).

For still other specific embodiments, the pressure differential wave (124) can oscillate at a preselected pressure differential magnitude oscillation frequency (49) (180) in the range of about -50 kPa to about 0 kPa below ambient pressure (11) (as shown in the examples of Figures 38B to 38G).

Again referring primarily to Figures 37B to 37G, Figures 38B to 38G, and Figures 39A to 39E, the pressure difference wave (124) can have multiple and a wide range of waveforms depending on the application, which correspond to multiple and a wide range of symptoms of disorders that can be alleviated or symptoms that can be treated by operation of the external auditory canal pressure adjustment device (1). As illustrative examples, the pressure difference waveform (124) can be a sine wave with smooth repeating periodic oscillations (as shown in the examples of Figures 37B, 38B and 39A), a square wave in which the pressure difference wave (124) alternates between a fixed minimum and maximum value at a stable frequency, a rectangular wave, a trapezoidal wave or a top-end wave (in which the apex of the pressure difference wave (124) over the time period (39) has a certain preselected pressure difference magnitude (37)(67)) (as shown in the examples of Figures 37C, 37F, 38C, 38F and 39B), a straight-line wave with a top end, a rectangular wave, a trapezoidal wave or a top-end wave (in which the apex of the pressure difference wave (124) over the time period (39) has a certain preselected pressure difference magnitude (37)(67) ... rectangular wave with a straight-line wave with a top end, a trapezoidal wave with a top end, a A triangular wave of leading and trailing edges (as shown in the examples of Figures 37D, 38D, and 39C), a sawtooth wave (wherein the leading edge has a preselected pressure differential magnitude (37)(67) that changes over a larger time period (39) than the trailing edge) (as shown in the examples of Figures 37E and 39D), a reverse sawtooth wave (wherein the leading edge changes the preselected pressure differential magnitude (37)(67) over a smaller time period than the trailing edge) (as shown in the examples of Figures 37E and 39E), or a combination thereof (as shown in the examples of Figures 37G and 38G).

Now referring mainly to Figures 6, 7, 9A, 9B and 29 to 35, for a specific embodiment, the external auditory canal pressure adjustment device (1) may also include a shell (125), which has an inner surface (126) of the shell, which defines a hollow internal space (127) that can accommodate components of the external auditory canal pressure adjustment device (1).

Although the fluid flow generator (2) (19) of the external auditory canal pressure regulating device (1) described above generally delivers a fluid flow (8) (20) of air to the external auditory canal (5) (14) to achieve a pressure difference (9) (17) between the external auditory canal pressure (10) (18) and the ambient pressure (), it is not intended to limit the wide range of fluids that can be delivered to the external auditory canal (5) (14) by embodiments of the external auditory canal pressure regulating device (1). As illustrative examples, the wide range of fluids may include: pure gases, such as oxygen, nitrogen, etc.; mixtures of partial gas pressures; liquids, such as water, oil, alcohol, etc., or combinations thereof.

Additionally, although the transmission of fluid flow (8)(20)(82)(99) (or gaseous fluid flow) or fluid volume (21)(22) between components of the external auditory canal pressure regulating device (1), between components of the external auditory canal pressure regulating device (1) and the external auditory canal (5)(14), or between components of the external auditory canal pressure regulating device (1) and the ambient pressure (11) may be described above for simplicity as generally between a first point and a second point, the transmission of fluid flow (8)(20)(82)(99) (or other fluid flow) or fluid volume (21)(22) includes all points within the manifold fluid flow path (54) between the first point and the second point.

Referring now primarily to Figures 8 and 28, embodiments of the external auditory canal pressure adjustment device (1) may further include a controller (128). The controller (128) may, for a specific embodiment, be in the form of a single integrated circuit (129) comprising a processor (130) in communication with a memory element (131). The memory element (131) may be in the form of a non-volatile computer storage medium that can be erased and reprogrammed and, for a specific embodiment, is a random access memory for data storage. The memory element (131) may contain computer code (132) that is executable to provide a specified function or a combination of steps for performing a specified function of operating the various components of the external auditory canal pressure adjustment device (1) according to the embodiments described above.

The block diagrams and flowcharts in Figures 8 and 28 illustrate combinations of supporting elements to perform specified functions, combinations of steps for performing specified functions, and executable program elements for performing specified functions. It should be understood that each functional block illustrated in the block diagrams and flowcharts, and combinations of functional blocks in the block diagrams and flowcharts, can be implemented by a dedicated hardware-based computer system that performs the specified functions or steps, or by an appropriate combination of dedicated hardware and computer instructions.

Referring now primarily to FIG8 , the computer code (132) may include a first fluid flow generation controller (41) that may be executed to convert a pressure differential magnitude selection signal (133) received from the first fluid pressure selection element (40) to correspondingly control the first fluid flow generator (2) to generate a first fluid flow (8) flowing out of the first axial earplug conduit (4). For specific embodiments, the first fluid flow generator controller (41) increases or decreases the first fluid flow (8) based on changes in the pressure differential magnitude selection signal (133). For other embodiments, the first fluid pressure differential magnitude selection element (40) may be used to select a preselected fluid volume (22) and the first fluid flow generator controller (41) may correspondingly control the first fluid flow generator (2) to deliver the preselected fluid volume (22) as described above.

For a specific embodiment of the external auditory canal pressure adjustment device (1), which includes a first pressure sensor (56), the computer code (132) may also include a first pressure sensor signal analyzer (58), the first pressure sensor signal analyzer (58) may be executed to provide a first pressure differential magnitude comparator (59), the first pressure differential magnitude comparator (59) may be used to compare a first preselected pressure differential magnitude (37) selected by user interaction with the pressure differential magnitude selection element (40) with a first pressure differential magnitude (36) sensed in the first axial earplug conduit (4). The first pressure sensor signal analyzer (58) may also be executed to provide a first pressure differential magnitude compensation signal (60) that changes based on the difference between the first preselected pressure differential magnitude (37) and the sensed first pressure differential magnitude (36). The first fluid flow generator controller (41) may control the first fluid flow generator (2) to achieve the first preselected pressure differential magnitude (37) in response to the first pressure differential magnitude compensation signal (60).

Referring again primarily to FIG8 , the first fluid flow generator controller (41) can also be executed to convert the pressure differential magnitude oscillation frequency selection signal (134) received from the first pressure differential magnitude oscillation frequency selection element (50) to correspondingly control the first fluid flow generator (2) to generate a first pressure differential magnitude oscillation (45) that drives the first fluid flow (8) in the first axial ear plug conduit (4) between a first fluid flow first direction (46) and a first fluid flow second direction (47).

For specific embodiments, the first fluid flow generator controller (41) changes the first pressure differential magnitude oscillation frequency (48) based on changes in the pressure differential magnitude oscillation frequency selection signal (134). For other embodiments, the first pressure differential magnitude oscillation frequency selection element (50) can be used to select a first preselected pressure differential magnitude oscillation frequency (49), and the first fluid flow generator controller (41) can correspondingly control the first fluid flow generator (2) to deliver the first preselected pressure differential magnitude oscillation frequency (49) within the range described above.

For a specific embodiment of the external auditory canal pressure adjustment device (1) including a first pressure sensor (56), the first pressure sensor signal analyzer (58) can also be executed to provide a first pressure differential magnitude oscillation frequency comparator (61), the first pressure differential magnitude oscillation frequency comparator (59) can be used to compare a first preselected pressure differential magnitude frequency (49) selected by user interaction with the pressure differential magnitude oscillation frequency selection element (50) with a first pressure differential magnitude oscillation frequency (48) sensed in the first axial earplug tube (4). The first pressure sensor signal analyzer (58) can also be executed to provide a first pressure differential magnitude oscillation frequency compensation signal (62) that changes based on the difference between the first preselected pressure differential magnitude oscillation frequency (49) and the sensed first pressure differential magnitude oscillation frequency (48). The first fluid flow generator controller (41) can control the first fluid flow generator (2) to achieve the first preselected pressure differential magnitude oscillation frequency (49) in response to the first pressure differential magnitude compensation signal (62).

For the specific embodiment of the first fluid flow generator (2) shown by the illustrative examples of Figures 8 and 9B, the first fluid flow generator controller (41) can indirectly control the function of the first fluid flow generator (2) by controlling the movement of the linear motor (30) coupled to the piston (26) that can move within the cylinder (27).

For the specific embodiment shown by the illustrative examples of Figures 28, 29A and 29B, the external auditory canal pressure adjustment device (1) may include a first fluid flow generator (2) and a second fluid flow generator (19), as described above, the first fluid flow generator (2) operates to transmit a first fluid flow (8) to the first axial ear plug tube (4), and the second fluid flow generator (19) operates to transmit a separate second fluid flow (20) to the second axial ear plug tube (13) sensed by the second pressure sensor (68). Accordingly, the computer code (132) may also include a second fluid flow generator controller (73) and a second pressure sensor signal analyzer (70), the second pressure sensor signal analyzer (70) including a second pressure differential magnitude comparator (71) and a second pressure differential magnitude oscillation frequency comparator (135), each of which may be used to control the operation of the second fluid flow generator (19), as described above for the first fluid flow generator (2), which allows independent control of the second pressure differential magnitude (63) and the second pressure differential magnitude oscillation frequency (64) in the second axial ear plug conduit (13).

28, 29A and 29B, the first fluid flow generator (2) and the second fluid flow generator (19) can each include a positive fluid flow generator (76) and a negative fluid flow generator (77) that are individually controllable to achieve a first pressure differential magnitude (36) and a second pressure differential magnitude (63) and a first pressure differential magnitude oscillation frequency (48) and a second pressure differential magnitude oscillation frequency (64). Thus, the first fluid flow generator controller (41) and the second fluid flow generator controller (73) can be executed to individually control each positive fluid flow generator (76) and each negative fluid flow generator (77) of the first fluid flow generator (2) and the second fluid flow generator (19) to achieve the first pressure differential magnitude (36) and the second pressure differential magnitude (63) and the first pressure differential magnitude oscillation frequency (48) and the second pressure differential magnitude oscillation frequency (64).

Referring now primarily to Figures 28, 37A to 37G, 38A to 38G, and 39A to 39E, a specific embodiment of the computer code (132) further includes a timer module (137) responsive to a time period selection element (190) and a pressure adjustment curve application module (138) responsive to a pressure adjustment curve selection element (139) that allows selection of one of a plurality of pressure adjustment curves (136) contained in a memory element (131), as described above and shown in the accompanying drawings, or similarly programmed and contained in the memory element (131). The pressure adjustment curve application module (138) is configured to coordinate operation of the first fluid flow generator (2) and the second fluid flow generator (19) to achieve a first preselected pressure differential magnitude (67) and a second preselected pressure differential magnitude (136) at each point in time within a time period (39) corresponding to a selected one of the plurality of pressure adjustment curves (136).

Referring now primarily to Figures 8 and 28, for specific embodiments, the computer code (132) may further include a fluid flow temperature adjustment controller (140) for controlling the fluid flow temperature adjuster (78) to adjust the fluid flow temperature (79) of the first fluid flow (8) or the second fluid flow (20). For the exemplary embodiment shown in Figure 8, the fluid flow temperature adjuster controller () actuates the fluid flow temperature adjuster (78) to increase the fluid flow temperature (78) of the first fluid flow (8) for a period of time (39) upon actuation of the first fluid flow generator (2).

For the exemplary embodiments shown in Figure 28, the fluid stream temperature regulator controller (140) can be executed to convert the fluid stream temperature selection signal (141) received from the fluid stream temperature selection element (147) to correspondingly control the fluid stream temperature regulator (78) to adjust the fluid stream temperature (79) of the third fluid stream (82) within the range of 10° C. to 50° C. as described above. For these embodiments, the computer code (132) can also include a third fluid stream controller (143) for controlling the third fluid stream (82) from the third fluid stream generator (81) to a third fluid stream flow rate (83) of 0 to about 10 liters per minute as described above.

Referring now primarily to Figures 8 and 28, the computer code (132) may also include a fourth fluid flow generator controller (112) which may be executed to control the fourth fluid flow generator (96) as described above to expand the first elastomeric sleeve (100) or the second elastomeric sleeve (101) correspondingly fluidically coupled to the first coaxial ear plug conduit (97) or the second coaxial ear plug conduit (98) to correspondingly sealably engage the first external auditory canal (5) or the second external auditory canal (14) to provide a corresponding first barrier (102) or second barrier (103) between the first external auditory canal pressure (102) or the second external auditory canal pressure (103) and the ambient pressure (11). For these embodiments, the computer code (132) may further include the external auditory canal pressure adjustment device (132). The computer code (132) may further include a coaxial earbud conduit pressure sensor signal analyzer (117) that can be executed to identify a stable first coaxial earbud conduit pressure difference (104) and a second coaxial earbud conduit pressure difference (105) between the corresponding first coaxial earbud conduit pressure (106) and the second coaxial earbud conduit pressure (107) and the ambient pressure (1). The third pressure sensor signal analyzer (117) can generate a sealing signal (118) when the stable first coaxial earbud conduit pressure difference (104) and the second coaxial earbud conduit pressure difference (105) occur to generate a sensory perceptible mark (120) as described above. For these embodiments, the computer code (132) may further include a seal release module (144) that can be executed in response to the operation of the seal release selection element (145) to operate the pressure relief valve (121) (122) as described above.

Referring now primarily to FIG. 40 , the computer code (132) also includes a valve control module (146) that can be executed to actuate one or more of the valves (52) within an embodiment of the external auditory canal pressure regulating device (1) as described above, depending on the selected method of applying fluid flow (8)(20)(82)(99).

Referring now primarily to Figures 28 and 32, the embodiment also includes a graphical display surface (147) and the computer program (132) may also include a graphical user interface module (148) that can be executed to depict a graphical user interface (149) on the graphical display surface (147). The graphical user interface (148) can execute the functions of the computer code (132) to operate the external auditory canal pressure adjustment device (1) through user interaction. Although the user interaction will typically take the form of a touch by the user (33) on the control image (150) depicted on the graphical display surface (147), the entire illustrative example is not intended to exclude any command by the user (33) by which the functions of the computer code (132) can be activated, executed or performed, whether by selection of one or more control images (150), or by user voice command, keyboard stroke, mouse button, etc.

Referring now primarily to Figures 1 and 2, embodiments may further include a computer device (151) separate from the external auditory canal pressure adjustment device (1). The term "151" for the purposes of the present invention denotes any device adapted to receive computer code (132) or to house a computer readable medium (152) containing computer code (132), or to include a computer processor (153) in communication with a computer memory element (154), adapted to communicate with the external auditory canal pressure adjustment device (1) or to download the computer code (132) to the computer memory element (154) in communication with the computer processor (153) via a wide area network (155) such as the Internet (156) or one or more local area networks (157). The computer device (151) may, for a particular embodiment, take the form of a limited capability computer specifically directed to a computer memory element (154) containing computer code (132); however, other embodiments may take the form of a set-top box, a smart television that receives data via an entertainment medium such as a cable television network or digital satellite broadcast, a handheld device such as a smart phone, tablet or slate computer, a personal digital assistant or camera/cellular charge, or a multi-processor system, a multi-processor based or programmable consumer electronic device, a network personal computer, a minicomputer, a mainframe computer, or the like.

1 and 2 , the computer system (151) may encompass one computer system or a plurality of computer systems, each operable by a user (33) to control one or more external auditory canal pressure adjustment devices (1). The user (33) may be a person, a plurality of persons, a business entity, etc., who may access the computer system (151) to retrieve a common format for displaying a graphical user interface (149) on a computer graphics display surface (147).

For specific embodiments, the controller (128) of the external auditory canal pressure adjustment device (1) may further include a communication controller (158), which may include a transceiver (159) associated with an antenna (160) to send and receive communication signals (161) to and from the computer device (151). For specific embodiments, the communication controller (158) may be a Bluetooth controller (e.g., Texas Instruments CC2540 BLUETOOTH System-on-Chip), which includes an associated Bluetooth transceiver and a Bluetooth antenna. For specific embodiments, the communication controller (158) may be a Wi-Fi controller and an associated Wi-Fi receiver and Wi-Fi antenna.

Referring now primarily to FIG36A and FIG36B , an illustrative example of the graphical user interface (149) may include a mode selection list (162) that allows, through user interaction, selection of one or more of the following: a first ear control image (163), a second ear control image (164), or both the first ear control image (163) and the second ear control image (164), which, through user interaction, select application of the first fluid flow (8) or the second fluid flow (20) or both the first fluid flow (8) and the second fluid flow (20) to the corresponding first axial earplug conduit (4) (13); a pressure adjustment curve control image (166) that, through user interaction, displays a list of selectable pressure adjustment curve icons (167) (as shown in the example of FIG36B ), the pressure adjustment curve icon (167) allowing, through user interaction, selection of one of a plurality of pressure adjustment curves (136) to be applied; a large external auditory canal pressure difference; A small control image (168) depicting a selectable pressure difference size control image through user interaction, the pressure difference size control image allowing selection of a list of preselected pressure difference sizes (37); an external auditory canal pressure difference frequency control image (170) depicting a selectable pressure difference size oscillation frequency control image through user interaction, the pressure difference size oscillation frequency control image allowing selection of a preselected pressure difference size oscillation frequency (49) through user interaction; a time period control image (172) depicting a selectable time period control image through user interaction, the time period control image allowing selection of a time period (39) for application or treatment through user interaction; or a temperature adjustment control icon (174) depicting a selectable fluid flow temperature and temperature-adjusted flow rate through user interaction, the fluid flow temperature and temperature-adjusted flow rate allowing selection of applied fluid flow temperature (79) and fluid flow rate (83) through user interaction.

Now referring mainly to Figures 8 and 28, an embodiment of the external auditory canal pressure adjustment device (1) may also include a power supply (177), which can be one of a conversion power supply (178) (such as 110 volt AC converted to 12 volt DC) or a battery (179) (such as a 12 volt DC battery) or a combination thereof.

A method of producing a specific embodiment of an external auditory canal pressure adjustment device (1) may include providing a first fluid flow generator (2) capable of generating a first fluid flow (8); and providing a first earplug (3) having a first axial earplug conduit (4) communicating between a first earplug first end (92) and a first earplug second end (93). The first axial earplug conduit (4) may be capable of being fluidically coupled to the first fluid flow generator (2). The first earplug (3) may have a first compatible earplug outer surface (7) configured to sealingly engage a first external auditory canal (5) of a first ear (6) as a first barrier (102) between the first external auditory canal pressure (10) and an ambient pressure (11).

The method of producing a specific embodiment of the external auditory canal pressure regulating device (1) may also include providing additional components of the external auditory canal pressure regulating device (1) as described above.

As can be readily understood from the above, the basic concept of the present invention can be implemented in a variety of ways. The present invention relates to an external auditory canal pressure regulating device and methods of making and using such an external auditory canal pressure regulating device in multiple and varied embodiments, including the best embodiment.

Therefore, the specific embodiments or elements disclosed in the specification or shown in the drawings or tables attached to this application are not intended to be limiting, but rather to illustrate the multiple and varied embodiments generally encompassed by the present invention or the equivalents encompassed with respect to any specific matter. In addition, the specific description of a single embodiment or element of the present invention may not explicitly describe all possible embodiments or elements, and many alternatives are implicitly disclosed by the specification and drawings.

It should be understood that each element of equipment or each step of method can be described by equipment terminology or method terminology. These terms can be replaced where needed to make the implicit wide range contained in the present invention clear. As just one example, it should be understood that all steps of method can be described as action, the device for accessing the action, or the element causing the action. Similarly, each element of equipment can be disclosed as the action of physical element or the auxiliary action of this physical element. As just one example, the disclosure of "fluid flow" should be understood to cover the action of disclosing "fluid flowing", no matter whether it is clearly discussed, or on the contrary, in the case of the effective disclosure of "fluid flowing", such disclosure should be understood to cover the disclosure of "fluid flow" and even "device for making fluid flow". This alternative term for each element or step is understood to be clearly included in the specification.

Additionally, for each term used, it should be understood that unless its application in this application is inconsistent with such interpretation, the ordinary dictionary definition, as contained in RandomHouse Webster’s Unabridged Dictionary, Second Edition, is understood to be included in the description for each term, each definition being incorporated herein by reference.

It is assumed that a numerical value is modified by the term "about," regardless of whether it is explicitly indicated. For the purposes of the present invention, a range may be expressed as from "about" one specific value to "about" another specific value. When such a range is expressed, another embodiment includes from that specific value to that other specific value. Reciting a numerical range by endpoints includes all values within that range. A numerical range of one to five includes, for example, values of 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, and so on. It should be further understood that the endpoints of each range are important both in relation to the other endpoint and independently of the other endpoint. When a value is expressed as an approximate number by the antecedent "about," it should be understood that the specific value forms another embodiment. The term "about" generally refers to a range of values that a person skilled in the art would consider to be equivalent to the cited value or to have the same function or result. Similarly, the antecedent "substantially" means approximately, but not identical in form, manner, or degree, and that the specific element will have a range of configurations that a person skilled in the art would consider to have the same function or result. When particular elements are expressed as approximations by using the antecedent "substantially," it is understood that the particular elements form another embodiment.

In addition, for the purposes of the present invention, the term "a" or "an" entity refers to one or more entities, unless otherwise limited. Therefore, the terms "a" or "an", "one or more" and "at least one" can be used interchangeably herein.

Therefore, the applicant should be understood to claim protection for at least: i) each of the external auditory canal pressure adjustment devices disclosed and described herein, ii) the related methods disclosed and described, iii) similar, equivalent or even implicit variations of each of these devices and methods, iv) those alternative embodiments that implement each function shown, disclosed or described, v) those alternative designs and methods that implicitly implement the functions disclosed and described, and implement each function shown, v1) each feature, component and step shown as a separate and independent invention, v1i) applications enhanced by each disclosed system or component, v1ii) the resulting products produced by these systems or components, ix) using methods and apparatus substantially as described above and with reference to the accompanying examples, x) each combination and arrangement of each of the foregoing elements disclosed.

The Background section of this application provides a statement of the field to which the invention pertains. This section may also include or contain a paraphrase of the subject title of a particular U.S. patent, patent application, publication, or claimed invention that is useful in light of relevant information, problems, or content related to the state of the art to which the invention is directed. Any U.S. patent, patent application, publication, statement, or other information incorporated herein is not intended to be interpreted, construed, or considered to be an admission that it is prior art with respect to the present invention.

The claims set forth in this specification, if any, are hereby incorporated by reference into a portion of the specification of the invention, and applicants reserve the right to use all or part of the contents of such incorporated claims as additional description to support any or all claims or any elements or components, and applicants further expressly reserve the right to move any or all of the contents of such incorporated claims from the specification into the claims and vice versa as necessary to define the subject matter claimed in this application by any subsequent application or continuation, divisional, or continuation-in-part application thereof, or to obtain any benefit, reduce expense, or comply with the patent laws, rules, or regulations of any country or treaty, and such contents incorporated by reference will survive the continuation, divisional, or continuation-in-part application thereof or any reissue or extension thereof.

In addition, the claims set forth in this specification, if any, are further intended to describe the scope of a limited number of preferred embodiments of the invention and are not to be construed as the broadest embodiment of the invention or a complete list of embodiments of the invention that may be claimed. Applicant does not waive any right to develop further claims based on the embodiments set forth above as part of any continuation, divisional, continuation-in-part, or similar application.

Claims (17)

1. An external auditory canal pressure regulating device, comprising: a first fluid stream generator capable of generating a first fluid stream; a first earplug having a first earplug axial conduit communicating between a first earplug first end and a first earplug second end, the first earplug axial conduit being fluidly coupled to the first fluid flow generator, the first earplug having a first earplug outer surface configured to sealably engage a first external auditory canal of a first ear as a first barrier between pressure in the first external auditory canal and ambient pressure; a first pressure sensor that generates a first pressure sensor signal that changes based on a change in the magnitude of the first pressure difference; a first pressure sensor signal analyzer comprising a first pressure differential magnitude comparator that compares a preselected first pressure differential magnitude with the first pressure differential magnitude; and a first fluid flow generator controller operable to control the first fluid flow generator to adjust the first fluid flow to achieve the preselected first pressure differential magnitude based at least in part on a comparison of the preselected first pressure differential magnitude with the first pressure differential magnitude by the first pressure differential magnitude comparator, The first fluid flow generator is operable to generate the first fluid flow in a first direction to generate a first negative pressure difference in which the pressure of the first external auditory canal is lower than the ambient pressure. 2. The apparatus according to claim 1, further comprising: A first pressure differential magnitude selection element is operable to select the preselected first pressure differential magnitude. 3. The device according to claim 2 further includes a first pressure difference magnitude oscillation frequency comparator, which compares a preselected first pressure difference magnitude oscillation frequency with the first pressure difference magnitude oscillation frequency, and the first fluid flow generator controller is operable to control the first fluid flow generator at least partially based on the result of the first pressure difference magnitude oscillation frequency comparator comparing the preselected first pressure difference magnitude oscillation frequency with the first pressure difference magnitude oscillation frequency, so as to adjust the first fluid flow to achieve the preselected first pressure difference magnitude oscillation frequency. 4. The apparatus of claim 3, further comprising a first pressure differential magnitude oscillation frequency selection element operable to select the preselected first pressure differential magnitude oscillation frequency. 5. The apparatus of claim 1 , further comprising a first pressure relief valve fluidly coupled to the first earplug axial conduit, the first pressure relief valve relieving the first pressure differential magnitude exceeding the preselected first pressure differential magnitude. 6. The apparatus of claim 1, further comprising a first fluid stream temperature regulator operable to regulate a first fluid stream temperature of the first fluid stream. 7. The device according to claim 1 further includes a second earplug having a second earplug axial conduit communicating between the second earplug first end and the second earplug second end, the second earplug axial conduit being fluidically coupled to the first fluid flow generator, the second earplug having a second earplug outer surface configured to engage the second external auditory canal of the second ear as a second barrier between the second external auditory canal pressure and the ambient pressure. 8. The apparatus according to claim 1, further comprising: a second fluid stream generator capable of generating a second fluid stream; a second earplug having a second earplug axial conduit communicating between a second earplug first end and a second earplug second end, the second earplug axial conduit being fluidly coupled to the second fluid flow generator, the second earplug having a second earplug outer surface configured to engage a second external auditory canal of a second ear as a second barrier between a pressure in the second external auditory canal and the ambient pressure; a second pressure sensor that generates a second pressure sensor signal that changes based on a change in a magnitude of a second pressure difference between the second external auditory canal pressure and the ambient pressure; a second pressure differential magnitude comparator that compares a preselected second pressure differential magnitude to the second pressure differential magnitude; and and a second fluid flow generator controller operable to control the second fluid flow generator to adjust the second fluid flow to achieve the preselected second pressure differential magnitude based at least in part on a comparison of the preselected second pressure differential magnitude with the second pressure differential magnitude by the second pressure differential magnitude comparator. 9. The apparatus according to claim 8, further comprising: A second pressure differential magnitude selection element is operable to select the preselected second pressure differential magnitude. 10. The device according to claim 8 further includes a second pressure difference magnitude oscillation frequency comparator, which compares a preselected second pressure difference magnitude oscillation frequency with a second pressure difference magnitude oscillation frequency, and the second fluid flow generator controller is operable to control the second fluid flow generator at least partially based on the result of the second pressure difference magnitude oscillation frequency comparator comparing the preselected second pressure difference magnitude oscillation frequency with the second pressure difference magnitude oscillation frequency, so as to adjust the second fluid flow to achieve the preselected second pressure difference magnitude oscillation frequency. 11. The apparatus of claim 10, further comprising a second pressure differential magnitude oscillation frequency selection element operable to select the preselected second pressure differential magnitude oscillation frequency. 12. The apparatus of claim 8, further comprising a second pressure relief valve fluidly coupled to the second earplug axial conduit, the second pressure relief valve relieving the second pressure differential magnitude exceeding the preselected second pressure differential magnitude. 13. The apparatus of claim 8, further comprising a second fluid stream temperature regulator operable to regulate a second fluid stream temperature of the second fluid stream. 14. The apparatus of claim 1, wherein the preselected first pressure differential magnitude is a negative pressure in the range of 5 kPa to 50 kPa. 15. The apparatus of claim 1, wherein the first fluid flow generator is operable to generate a positive pressure differential magnitude in which the first external auditory canal pressure is higher than the ambient pressure. 16. The apparatus of claim 15, wherein the first fluid flow generator is operable to generate the first fluid flow in the first direction and in a second direction to alternately generate the first negative pressure differential magnitude and the positive pressure differential magnitude. 17. The apparatus of claim 1 , wherein the first fluid flow generator is operable to generate the first fluid flow in the second direction to generate a first positive pressure differential magnitude in the range of 2.5 kilopascals to 50 kilopascals, and wherein the first fluid flow generator is operable to generate the first fluid flow in the first direction to generate a first negative pressure differential magnitude in the range of 5 kilopascals to 50 kilopascals.