JP2023548546A - small hearing aid - Google Patents

Abstract

The present disclosure relates to miniature hearing aids, components thereof, and support systems therefor, and methods for inserting and removing the same. Miniature hearing aids generally include a sensor such as a microphone, an actuating mass, and an energy source to power the miniature hearing aid, enclosed within a housing designed to be inserted through the eardrum during a minimally invasive outpatient procedure. , a processor, and an actuator. In operation, the microphone receives sound waves and converts them into electrical signals. The processor then modifies the electrical signal and provides the electrical signal to the actuator. The actuator converts the electrical signal into mechanical movement, which actuates the actuation mass to modulate the velocity or position of the eardrum. [Selection diagram] Figure 23A

Description

[0001] Embodiments of the present disclosure relate to assistive hearing devices and methods of implanting the same. More particularly, embodiments of the present disclosure relate to miniature hearing aids that are worn internally within the ear canal, e.g., in or across the eardrum, to provide vibrational transduction to modulate the velocity or position of the eardrum. .

[0002] Hearing aids are well known and typically include a microphone, an amplifier, and a speaker. Typically, a microphone receives sound waves and converts the sound waves into electrical signals, an amplifier amplifies the electrical signals, a speaker converts the amplified signals into amplified sound waves, and the sound waves are Vibration is applied to the tympanic membrane or ear drum in the ear. Traditionally, hearing aids are worn outside the ear canal, particularly around the outer ear. Externally mounted hearing aids have the advantage of accessibility for changing batteries and adjusting volume. However, many users find such external hearing aids to be relatively bulky and uncomfortable for cosmetic and comfort reasons.

[0003] An alternative to externally worn hearing aids is an internally worn hearing aid that is placed within the user's ear canal. Although traditional internally worn hearing aids provide good cosmetic appearance, they also have disadvantages. For example, a typical internally worn hearing aid occludes most, if not all, of the ear canal diameter. Such blockage can cause the user's body to produce excessive amounts of earwax within the ear canal and can also cause ear infections. Furthermore, occlusion of the ear canal interferes with the natural transmission of sound waves through the ear canal, negatively impacting hearing quality. Unless the user is completely deaf, any ability of the eardrum to register naturally occurring sound waves is reduced or eliminated. Therefore, the user is substantially dependent on the sound fidelity of the hearing aid. Still further, a typical internally worn hearing aid may still be somewhat visible within the ear canal.

[0004] Some hearing systems transmit audio information to the ear through electromagnetic transducers. The microphone and amplifier transmit the electronic signal to the transducer, which converts the electronic signal into vibrations. The vibrations cause the eardrum or part(s) of the middle ear to vibrate, which transmits sound impulses without converting them back into audio sound waves. Historically, a separate magnet or any suitable actuator was remotely attached to or near the eardrum. The interaction between the magnetic field of the transducer that receives the electronic signal and a magnet mounted on or near the eardrum causes the magnet to vibrate, thus mechanically transmitting sound to the cochlea through vibrations to the ear. Typically, however, the remaining portion of the hearing aid is inserted into the ear canal or onto the outer ear, which can cause the problems discussed above. Still further, the hearing aid transducer and/or magnet are installed using a relatively invasive procedure. For example, one contact transducer with a magnet can drill into the mastoid bone, cut through the tympanic membrane, microscopically drill into the bony structure, and place the magnet into the middle ossicles. by screwing into any one or more of the Such procedures are often painful and expensive, and can lead to serious complications.

[0005] As mentioned above, there are various types of hearing aids used to amplify and transmit sound waves to the hearing centers of the brain, resulting in the perception of sound. However, conventional hearing aids do not selectively suppress background noise and sound waves produced by excessively loud noises while simultaneously transmitting normal speech and other desired acoustic signals. Noise suppression may be used by astronauts involved in long duration missions such as the International Space Station or Mars missions, where astronauts are exposed to sound waves and other noise generated by other astronauts. It is desired to selectively suppress background noise produced by rotating machinery, air handling systems, and environmental control systems while still allowing the astronaut to hear desired acoustic signals. Selective frequency amplification could be used in military operations, where sound waves produced by enemy combatants could be amplified and transmitted to the hearing center of the brain, while all other The sound waves are transmitted in the usual manner. Furthermore, traditional types of hearing aids do not allow the user to receive signals or sound waves that are inaudible to a normal person, such as in covert communication.

[0006] Accordingly, there is a need in the art for improved hearing aids that can be inserted into the ear canal and/or through the eardrum using minimally invasive surgical techniques.

[0007] The present disclosure relates to miniature hearing aids, components thereof, and support systems therefor, and methods of inserting and removing the same. Miniature hearing aids typically provide power to a sensor, such as a microphone, an actuation mass, and a miniature hearing aid enclosed within a housing designed to be inserted through the eardrum during a minimally invasive outpatient procedure. including energy sources, processors, and actuators for. In operation, the microphone receives sound waves and converts them into electrical signals. The processor then modifies the electrical signal and provides the electrical signal to the actuator. The actuator converts the electrical signal into mechanical movement, the mechanical movement actuating the actuating mass to generate inertia within the housing, and the housing is configured to modulate (adjust) the velocity or position of the eardrum. Ru.

[0008] In one embodiment, a tympanic actuation assembly is disclosed. The tympanic membrane actuating assembly includes at least one mass configured to be disposed on at least one of a medial side or a lateral side of a user's eardrum; at least one actuator configured to be disposed on at least one of the medial or lateral side of the tympanic membrane or through the tympanic membrane, the actuator converting electrical signals into mechanical motion to move the mass and modulate the tympanic membrane. It is configured as follows.

[0009] In another embodiment, a hearing aid is disclosed that is insertable through a user's eardrum to amplify certain frequencies and cancel other frequencies. The hearing aid includes a tympanic actuation assembly, the tympanic actuation assembly having at least one mass configured to be disposed on at least one of the inside or outside of the user's eardrum and coupled to the mass and configured to be disposed on the inside or outside of the user's eardrum. at least one actuator configured to be disposed on at least one of the lateral or through the eardrum, the actuator configured to convert the electrical signal into mechanical motion to move the mass and modulate the user's eardrum. It is composed of

[0010] In yet another embodiment, a hearing aid is disclosed that is insertable through a user's eardrum to amplify certain frequencies and cancel other frequencies. The hearing aid includes a housing having a first flange and a second flange and a groove between the first flange and the second flange, the housing including a microphone, a processor coupled to the microphone; a tympanic membrane actuation assembly, the tympanic membrane actuation assembly being a mass having a first battery disposed within the first flange and a second battery disposed within the second flange; the first battery is configured for placement on the outside of the tympanic membrane, the second battery is configured for placement on the inside of the tympanic membrane; a connecting member coupled to the mass and configured for placement through the tympanic membrane; and an actuator coupled to the mass and disposed within the connecting member to move the mass and move the user's body. an actuator configured to convert an electrical signal into mechanical movement to modulate the eardrum.

[0011] How the above-recited features of the present disclosure may be understood in detail, a more detailed description of the disclosure briefly summarized above is provided by reference to embodiments, some of which are illustrated in the accompanying drawings. You can refer to it and get it. It is noted, however, that the accompanying drawings depict only exemplary embodiments and are therefore not to be considered limiting of its scope. This disclosure may admit of equally effective embodiments.

1 is a schematic cross-sectional view of the anatomy of an ear with a hearing aid inserted through the tympanic membrane of the ear; FIG. FIG. 3 is a schematic plan view of the right eardrum. FIG. 1 is a schematic perspective view of a small hearing aid. 4 is a cross-sectional view of the miniature hearing aid of FIG. 3; FIG. FIG. 3 is a plan view of the actuator. FIG. 4 is a top view of an alternative embodiment of an actuator. 1 is a schematic perspective view of an alternative embodiment of a miniature hearing aid; FIG. 1 is a schematic perspective view of an alternative embodiment of a miniature hearing aid; FIG. Figures A-C illustrate alternative embodiments of miniature hearing aids. 1 is a process flow of a method for inserting a miniature hearing aid. 9A and 9B show the miniature hearing aid of FIGS. 9A-C with part of the implantation tool at various stages of implantation. FIG. 2 is a block diagram of an ASIC processor. 2 is a cross-sectional view of a miniature hearing aid with an alternative embodiment of an actuator; FIG. 2 is a cross-sectional view of a miniature hearing aid with an alternative embodiment of an actuator; FIG. Figures A and B illustrate alternative embodiments of embedded tools. Figures A-C illustrate alternative embodiments of miniature hearing aids. 1 is a schematic cross-sectional view of the working assembly of a miniature hearing aid; FIG. FIG. 2 is a schematic cross-sectional view of a small hearing aid. 1 is a schematic cross-sectional view of the working assembly of a miniature hearing aid; FIG. 1 is a schematic cross-sectional view of the working assembly of a miniature hearing aid; FIG. 1 is a top-down cross-sectional view of a portion of a miniature hearing aid actuation assembly; FIG. 1 is a top-down cross-sectional view of a portion of a miniature hearing aid actuation assembly; FIG. A-D show alternative embodiments of miniature hearing aids. A-F show alternative embodiments of miniature hearing aids. FIG. 4 is a cross-sectional view of an alternative embodiment of a miniature hearing aid.

[0037] To facilitate understanding, the same reference numerals have been used where possible to designate the same elements that are common to the figures. It is contemplated that elements and features of one embodiment may be advantageously incorporated into other embodiments without further recitation.

[0038] The present disclosure relates to miniature hearing aids, components thereof, and support systems therefor, and methods of inserting and removing the same. Miniature hearing aids generally include a sensor such as a microphone, an actuating mass, and an energy source to power the miniature hearing aid, enclosed within a housing designed to be inserted through the eardrum during a minimally invasive outpatient procedure. , a processor, and an actuator. In operation, the microphone receives sound waves and converts them into electrical signals. The processor then modifies the electrical signal and provides the electrical signal to the actuator. The actuator converts the electrical signal into mechanical movement, which actuates the actuation mass to modulate the velocity or position of the eardrum.

Ear Anatomy [0039] FIG. 1 is a schematic cross-sectional view of the anatomy of an ear 100 having a hearing aid inserted through the eardrum of the ear 100. Ear 100 includes an outer ear 110 , an ear canal 112 coupled to outer ear 110 , and a tympanic membrane 114 disposed near the proximal end of ear canal 112 from outer ear 110 . The structure of the outer ear 110 provides a "funnel" that directs sound waves into the ear canal 112 and amplifies the amplitude of the sound waves. An ossicular chain 115 located in the middle ear and located on the inside of the eardrum 114 from the outer ear 110 couples and amplifies vibrations from the eardrum 114 to the inner ear, which has a helical structure known as the cochlea 120. . Cochlea 120 converts vibrations into impulses to the brain.

[0040] A hearing aid, such as hearing aid 122 of the present disclosure, may be inserted through the outer ear 110 into the ear canal 112 and at least partially through the eardrum 114. Hearing aid 122 generally includes a sensor, such as a microphone, and at least one ear drum stimulation member, described in more detail below. The hearing aid 122 generally receives sound waves conducted from the outer ear 110 through the ear canal 112, converts the sound waves into electrical or electromagnetic signals, and converts the electrical signals into mechanical motion, which is typically feedforward. called a system. Mechanical motion impacts the tympanic membrane 114 and/or portions of the middle and inner ear, causing damage to the ossicular chain 115, specifically the malleus 118, incus 117, and stapes ( (stapes) 116. These three bones within the ossicular chain 115 act as a set of levers that amplify the amplitude of the vibrations experienced by the eardrum 114. The incus 117 is connected to the entrance of a helical structure known as the cochlea 120, which contains the inner ear fluid. The mechanical vibration of the incus 117 causes the fluid to generate fluid impulses that cause small hair-like cells (not shown) within the cochlea 120 to vibrate. The vibrations are converted into electrical impulses, which are transmitted to neural pathways within the brain's hearing center, resulting in the perception of sound.

[0041] FIG. 2 is a schematic plan view of the eardrum 114 (the right eardrum is shown as an example). The tympanic membrane 114 is generally oval in shape, drawn slightly inward at the center of the tympanic membrane, called the tympanic umbo 202, where the handle of the malleus (shown in FIG. 1 and discussed above) This is where it can be installed. The tympanic membrane is conceptually divided into four quadrants: anterosuperior quadrant 204, anteroinferior quadrant 206, posteroinferior quadrant 208, and posterosuperior quadrant 210.

Miniature Hearing Aids and Components Thereof [0042] The present disclosure relates to miniature hearing aids, components thereof, and support systems therefor. The embodiments described herein provide exemplary configurations of miniature hearing aids contemplated by the present disclosure. However, any other suitable configuration for a hearing aid that modulates the velocity and position of the eardrum by direct or indirect modulation is also contemplated. The embodiments that follow discuss, by way of example, the insertion of the disclosed miniature hearing aid through the eardrum; however, the miniature hearing aid is also free to be used elsewhere within the ear.

[0043] FIG. 3 is a schematic perspective view of a miniature hearing aid 300. FIG. 4 is a cross-sectional view of the miniature hearing aid 300 of FIG. As shown in FIGS. 3 and 4, the miniature hearing aid 300 is contained in a housing 301 that includes two flange portions 302 joined by a connecting portion 304. As shown in FIGS. When implanted, the two flange portions 302 are positioned on either side of the tympanic membrane (i.e., one flange portion is in the outer ear and the other in the middle ear) and is shown as a narrow tube by way of example. Connecting portion 304 crosses the tympanic membrane. The connecting portion 304 is positioned generally along or parallel to the central axis of the miniature hearing aid 300.

[0044] As used herein, the term flange refers to a portion of the disclosed miniature hearing aid that is external or peripheral to a central portion of the miniature hearing aid, such as the connecting portion 304.

[0045] The one or more flanges and connecting members create a generally compact hearing aid body. As used herein, the term body generally refers to one or more flanges and connecting portions as a unit.

[0046] As shown in FIG. 4, the miniature hearing aid 300 is enclosed by a housing 300 that houses the various components of the miniature hearing aid 300. The various components generally include at least one sensor 408 such as a microphone configured to detect the sound to be processed, a mass illustrated as an energy source 410, and an actuator 412 configured to convert electrical signals into mechanical motion. , and a processor 414 that supports signal processing and power conversion by modifying the electrical signal and communicating the electrical signal to at least one actuator, and driving the actuator 412, in this example, the energy source 410. Includes a processor 414 configured to move a certain square. Together, the mass and at least one actuator create a tympanic actuation assembly. In embodiments where energy source 410 is a rechargeable energy source, miniature hearing aid 300 generally also includes recharging circuitry 416.

[0047] Sensor 408 is generally secured within housing 301 and is configured to receive sound amplified by miniature hearing aid 300 and convert the sound wave or acoustic signal into an electrical or electromagnetic signal. This disclosure contemplates a microphone as sensor 408, by way of example; however, it is contemplated that sensor 408 is generally any suitable sensor. Suitable sensors include, but are not limited to, sensitive microphones, piezoelectric micro-electro-mechanical systems (MEMS) microphones, electrostatic microphones, accelerometers, gyroscopes, and optical sensors. Other suitable sensors may be for sensing otoacoustic emissions (OAE) or pressure to diagnose ear infections or other changes in the performance and device health of the user or of the miniature hearing aid 300 itself. Contains sensors that can be used for

[0048] Although one sensor 408, which is a microphone, is shown as an example, further embodiments of the miniature hearing aid described herein include a sensor 408 that is a microphone, around the lateral aspect of the miniature hearing aid, and the medial aspect of the miniature hearing aid. including multiple microphones or other sensors that can be arranged around the hearing aid aspect or on both the inner and outer surfaces of the miniature hearing aid. In still further embodiments, one microphone, such as sensor 408, is disposed within the miniature hearing aid and one or more other microphones are disposed elsewhere, such as within the ear canal. In such embodiments, one or more external microphones are connected directly to or otherwise communicate with the miniature hearing aid 300.

[0049] In another embodiment, sensor 408 can be disposed outside of the housing. In another embodiment, the miniature hearing aid 300 can include a second actuator to ensure that the sensor 408 does not move with the housing or the first actuator. In yet another embodiment, miniature hearing aid 300 may further include a passive mechanical coupler to isolate sensor 408 from movement of the housing or first actuator.

[0050] The mass is any suitable mass material, component, or combination of components that can be actuated to modulate the velocity or position of the eardrum, such as a first portion and a second portion. may contain any suitable number of portions. The mass is generally between about 5 milligrams (mg) and about 40 mg total. For example, in embodiments comprising a first part and a second part, each part being a battery, the weight is generally between about 10 mg for one battery and about 15 mg for one battery (each combined). between about 20 mg and about 30 mg).

[0051] Energy source 410 generally includes any suitable energy source in any suitable configuration, such as a single mass, multiple vertically stacked layers (e.g., between 5 and 20 layers). , a radio thermal generator, a supercapacitor, a thick film battery, or a traditional lithium (Li) ion battery. As shown in FIG. 4, the mass is an energy source 410 that is dumbbell-shaped and centrally located within the miniature hearing aid 300. In such embodiments, the energy source 410 itself can be used as a mass to modulate the velocity or position of the eardrum. In a further embodiment, the energy source 410 is disposed inside or outside the miniature hearing aid and on one side of the eardrum. In still further embodiments, such as FIGS. 13, 14, 16A-C, 17, and 18, one or more mass portions, such as batteries, are disposed both inside and outside the eardrum. , can be connected by a transtympanic connecting member disposed within the housing 301. In still further embodiments, an energy source and countermass connected across the eardrum are used. The counter mass is generally an inert or inactive mass.

[0052] In one embodiment, energy source 410 has a diameter of 2.5 millimeters (mm) or less and a height of 1.5 mm or less. The mass of the energy source 410 is configured to maximize the safety of retaining the miniature hearing aid within the eardrum and/or based on a passive noise transmission attenuation level of, for example, 10 decibels (dB) or less. selected. In one embodiment, the mass is generally no more than 15 milligrams (mg). As discussed below, energy source 410 is generally rechargeable. In such embodiments, the charging time is generally about 3 hours or less and can be charged over 1000 times.

[0053] Actuator 412 generally includes any actuator mechanism or actuators suitable for converting an electrical signal into mechanical movement by moving a mass such that the mass modulates the velocity or position of the eardrum. The mechanism can also be placed inside the eardrum, outside the eardrum, on both sides, or across the eardrum. Actuator 412 is configured to push, eject, or pull the mass relative to the coupling to the eardrum.

[0054] FIG. 5 is a top view of an actuator 500 according to one embodiment that can be used as actuator 412. Actuator 500 includes at least an outer ring 502 and an inner ring 504, with outer ring 502 connected to housing 301 and inner ring 504 connected to a mass, such as energy source 410. The outer ring 502 has a plurality of piezoelectric actuators 506 that are energized to produce the force required to axially modulate the inner ring 504 to ultimately change the velocity or position of the eardrum. can be modulated. In another embodiment, the plurality of piezoelectric actuators 506 are individually addressable to provide non-axial modulation of the velocity or position of the tympanic membrane.

[0055] FIG. 6 is a perspective side view of an actuator 600 according to another embodiment that can be used as actuator 412. Actuator 600 includes a first disk 602 and a second disk 604 that are coupled together by a plurality of piezoelectric actuators 606 sandwiched between both disks. At least one of the first disc 602 or the second disc 604 is movable to modulate the velocity or position of the eardrum. In another embodiment, the plurality of piezoelectric actuators 606 are individually addressable to provide non-axial modulation of the velocity or position of the tympanic membrane.

[0056] FIG. 13 is a cross-sectional view of a miniature hearing aid, such as miniature hearing aid 300, having an alternative embodiment of an actuator. In the embodiment shown in FIG. 13, the actuator is a linearly actuated piezoelectric laminate actuator 1320. The base 1324 of the piezoelectric laminate actuator 1320 is fixed. As shown, one or more connecting members 1322 shown as disposed around the outside of the piezoelectric laminate actuator 1320 connect the first mass 1328 to a trailing mass 1326. The first mass 1328 is displaced by the piezoelectric stack actuator 1320, and the trailing mass 1326 generally follows the movement of the first mass 1328 to move the masses in phase.

[0057] FIG. 14 is a cross-sectional view of a miniature hearing aid, such as miniature hearing aid 300, having an alternative embodiment of an actuator. In the embodiment shown in FIG. 14, the actuator is a piezoelectric microtube 1420. The base 14244 of piezoelectric microtube 1420 is fixed. In operation, piezoelectric microtube 1420 extends linearly to displace first mass 1426. One or more connecting members 1422 connect first mass 1426 and second mass 1428. One or more connecting members 1422 reside within the inner diameter of piezoelectric microtube 1420.

[0058] In still further embodiments, actuator 412 is a linear actuator. For example, the actuator 412 can be a voice coil that has a central mass, typically a magnet, and an outer coil wrapped around the central mass, where the voice coil responds to the mass by energizing the outer coil. Modulate force. Alternatively, the voice coil can be centrally disposed with a magnet disposed around the voice coil. The linear actuator can traverse the eardrum within the miniature hearing aid and, when energized, vibrates and produces a modulating force on the eardrum. In another embodiment, actuator 412 includes multiple actuators coupled to housing 301 and/or energy source 410. In yet another embodiment, actuator 412 is a plurality of concentric actuators that produce linear movement. In yet another embodiment, actuator 412 is a rotary actuator that produces waves that extend radially from the miniature hearing aid. In yet another embodiment, actuator 412 includes a piezo MEMS device or an electrostatic MEMS device with, for example, a stepper motor. In yet another embodiment, the actuator may be formed by a combination of two or more of the actuators described above.

[0059] As discussed herein, the disclosed miniature hearing aids include one or more actuators. When more than one actuator is used, all of the actuators can be the same type of actuator or more than one type of actuator. When more than one type of actuator is used, the stimulation of the actuators may be in different or similar planes. In one embodiment, different types of actuators are configured to operate in different planes at the same time, for example to increase length and/or diameter. Furthermore, as discussed further below, the actuator can utilize impedance matching components, such as MEMs lever arms, depending on the energy and displacement range required to improve the user's hearing.

[0060] As shown in FIGS. 4, 13, and 14, the miniature hearing aid 300 may also include a movement mechanism 418, such as a bearing or a linear slide, that limits movement of the mass relative to the direction of actuation.

Hearing Aid Operation [0061] Processor 414, typically an application specific integrated circuit (ASIC) chip, takes electrical signals indicative of acoustic signals from sensor 408 and uses the signals to drive actuator 412 and transmit mass ( For example, an energy source 410) is converted into a moving electrical signal to modulate the position of the eardrum, thus providing impulses to the user's brain. Trout generally move a distance of about 1 millimeter or less. Direct or indirect modulation of the position of the eardrum improves the user's hearing.

[0062] In addition to converting signals to modulate mass, processor 414 may also bias sensor 408 and provide safety features such as internal temperature and current monitoring.

[0063] In some embodiments, processor 414 includes safety circuitry for energy source 410, including for safely and efficiently properly charging and discharging energy source 410. .

[0064] In yet a further embodiment, the processor 414 also performs a communication function, allowing the miniature hearing aid to transmit information to and receive information from the outside world. For example, processor 414 generally includes circuitry that allows the miniature hearing aid to communicate information regarding the status of the miniature hearing aid and even the status of the user's ears to an external recipient.

[0065] In yet a further embodiment, processor 414 is configured to modify the acoustic input to enable frequency shifting. This frequency shifting process is useful for optimizing mechanical output, addressing different frequency responses and transfer functions, and ultimately providing a superior acoustic experience to the user. For example, the device can capture and shift certain frequencies or nodes that may be missed, but are previously identified, so that the user can You will hear it in terms of frequency.

[0066] FIG. 12 shows a block diagram of an ASIC processor 1200. ASIC processor 1200 can be used as processor 414. ASIC processor 1200 generally includes a wireless communication component 1202, a safety circuit component 1204, a non-volatile memory component 1206, a microphone preamplifier component 1208, a signal processing component 1210, an actuator driver component 1212, an energy source management component 1214, a power supply component 1216, and wireless power component 1218. Wireless communications include, but are not limited to, optical communications, acoustic communications, and radio frequency communications.

[0067] In one embodiment, ASIC processor 1200 uses analog signal processing to reduce power needs and minimize digital components. Additionally, ASIC processor 1200 can be configured to minimize power consumption by programming and/or estimating responses while maintaining acceptable processing. In another embodiment, ASIC processor 1200 may be configured to perform frequency communication and/or registration with an audio device such as a smartphone. For example, the ASIC processor 1200 may be configured to turn on and off a miniature hearing aid depending on the acoustic profile signature. The ASIC processor 1200 uses the acoustic profile signature to change the intensity mode to limit the amplitude of all frequencies and/or to cancel noise, for example, by controlling the amplitude when in an unpleasant acoustic environment. It can also be configured to provide Still further, the ASIC processor 1200 can be configured to recognize emergency tones that automatically turn on the miniature hearing aid, such as fire alarms, doorbells, and the sound of breaking glass.

[0068] In a further embodiment, ASIC processor 1200 uses digital signal processing.

[0069] In another embodiment, ASIC processor 1200 is controlled wirelessly by radio frequency (RF) signals. RF signals are used to turn miniature hearing aids on and off, to change intensity modes to control amplitude in unpleasant acoustic environments, and to allow adjustment and verification of tone responses for diagnostic purposes. can be used.

[0070] ASIC processor 1200 may also be configured to filter certain frequencies. For example, the disclosed miniature hearing aids may additionally or alternatively include a feedforward system that controls feedback by changing a range of frequencies of the input to avoid certain resonant frequencies. The disclosed miniature hearing aids may also or alternatively include a system with a learning algorithm that adjusts the frequency response as unique environments produce unique resonant frequencies. OAEs are sounds produced by the inner ear. More specifically, there are hair cells within the inner ear that respond to signals by vibrating. The vibrations produce a very quiet sound that echoes back inside the middle ear. It is believed that OAE is useful for selectively amplifying certain frequencies. Similarly, the miniature hearing aids disclosed herein can also be configured to generate low decibel and proprietary frequency signals that will help amplify incoming sounds. This extra background sound will help improve the signal-to-noise (STN) ratio, or the background sound will be uniquely useful at certain frequencies. This background sound may be a simple single frequency sound, or this background sound may be a single complex sound created from multiple different frequencies, or This background sound could be several sounds that are separated by a fraction of a second, or this background sound could be these sounds at certain times depending on the frequency being processed. It is possible to generate any sound.

[0071] The disclosed miniature hearing aids are also configurable to self-diagnose by recognizing OAEs and make adjustments within the device itself to optimize hearing for its particular user.

[0072] Further, the disclosed miniature hearing aids produce an output to which the inner ear responds to produce characteristic OAEs, which are correlated to the degree of hearing loss at those frequencies.

Additional Device Components and Configurations [0073] In the embodiment shown in FIG. 4, the miniature hearing aid 300 includes a separate recharging circuit 416; however, as discussed above, in other embodiments, the recharging circuit Many, and sometimes all, can be included in processor 414. Recharging circuit 416 recharges energy source 410.

[0074] In one embodiment, one or more coil arrays for recharging are disposed within or around the flange(s). In another embodiment, one or more coil arrays for recharging are disposed within or around the outer portion of the miniature hearing aid. In yet another embodiment, one or more coil arrays for recharging are disposed within or around the inner portion of the miniature hearing aid. In yet another embodiment, one or more coil arrays for recharging are disposed on both the inner and outer portions of the miniature hearing aid. In yet another embodiment, one or more of the coil arrays for recharging can be the same coils that power the voice coil actuators described above.

[0075] FIGS. 16A-C illustrate an alternative embodiment miniature hearing aid 1600. The miniature hearing aid 1600 includes at least a microphone 1608, a first mass, illustratively shown as a first battery 1626, and a second mass, illustratively shown as a second battery 1628, coupled to the first battery 1626 by a connecting member 1621. , and an enclosure housing 1601 housing a processor 1614 . Connection member 1621 includes or is surrounded by actuator 1620. Actuator 1620 is generally a tubular or cylindrical stacked piezoelectric actuator with a hole therein that allows connection member 1621 to pass through. The height of actuator 1620 is generally between about 1 mm and about 4 mm, and the outer diameter of actuator 1620 is generally between about 1 mm and about 2 mm.

[0076] Compact hearing aid 1600 also includes a recharging coil antenna 1616 disposed around microphone 1608. Recharging coil antenna 1616 is used to recharge first battery 1626 and second battery 1628 on a daily basis. Once positioned within the ear, the first battery 1626 and the second battery 1628 are disposed on opposite sides of the eardrum (ie, inside and outside), and the connecting member 1621 is disposed through the eardrum.

[0077] Factors considered in the design of various components, such as actuators, of the miniature hearing aids described herein are the amount of force applied to the eardrum and the amount of displacement of the eardrum to improve the user's hearing. . The amount of force is between about 0.001 Newton (N) and about 0.05 Newton N based on one or more modulating masses between about 20 mg and about 30 mg over the audio frequency range. The displacement may vary between about 0.05 microns and about 5.0 microns.

[0078] As shown in FIG. 17, the miniature hearing aid includes an actuation assembly 1700 that also includes a first mass, illustrated as an example first battery 1726, and a second mass, illustrated as an example second battery 1728. A displacement multiplier 1725 may be included in conjunction with actuator 1723 to amplify actuation of the mass. Displacement multiplier 1725 is shown as a piezo coupling arm lever by way of example. The arm lever displacement multiplier 1725 includes an actuator leg portion, a pivot on the case portion, and a mass (battery, shown as the leg portion). As shown in FIG. 19, actuation assembly 1900 may also include a fixed coupling 1925 that cooperates with actuator 1923. Fixed coupling 1925 is shown as a fixed coupling to the top of actuator 1923 by way of example. As shown in FIG. 20, actuation assembly 2000 can also include a rigid coupler 2025 that cooperates with actuator 2023. Rigid coupler 2025 is illustratively shown as a rigid coupler between first battery 2026 and second battery 2028 and is positioned around the outside of actuator 2023.

[0079] As shown in FIGS. 21 and 22, various piezo couplings, fixed couplings, and rigid couplers, including arm lever displacement multipliers, surround or are otherwise coupled to actuators 2123 and 2223, respectively. may contain any suitable number of components. Actuator 2123 is illustratively shown as a rectangular prism, and actuator 2223 is illustratively shown as a cylindrical tube. The actuator 2123, 2223 is surrounded by any suitable number of a plurality of combinations of rigid coupler portions 2131, 2231, fixed coupling portions 2135, 2235, and arm lever displacement multiplier portions 2137, 2237.

[0080] In addition to the components described above, the disclosed miniature hearing aids include sensors for detecting changes in the biological condition of the ear, such as infection, inflammation, scar tissue, epithelial cell migration. It may also include further components such as.

[0081] Housing 301 is generally any suitable enclosure that encloses and provides a sealed compartment for device components. Suitable casings include biocompatible materials such as silicone, fluoropolymers, polyethylene, stainless steel, and titanium. Housing 301 is a solid or porous material. In one embodiment, housing 301 has microholes to allow ventilation. In another embodiment, housing 301 is solid with no ventilation holes through the housing. In another embodiment, the housing 301 is solid without any ventilation holes through the housing and utilizes dead space to allow for compression caused by internal movement. In some embodiments, the housing 301 includes straight channels to allow internal pressure equalization by internal movement of the actuator and mass (eg, battery). The straight channel also provides compensation for epithelial migration for the miniature hearing aid 300. Still further, straight channels provide mechanical benefits such as improved stabilization.

[0082] FIG. 18 is a schematic cross-sectional view of a miniature hearing aid 1800. The miniature hearing aid 1800 includes a housing 1801 enclosing a stack of components, including a microphone 1808, a processor 1814, a first part 1826, shown as a first battery, and a second part 1828, shown as a second battery. , and a connecting member 1820 having an actuator disposed therein.

[0083] Housing 1801 has a length between about 5 mm and about 10 mm, such as about 6 mm. Housing 1801 generally has two diameters, a first diameter 1815 and a second diameter 1817. The first diameter 1815, which generally corresponds to the flanged portion(s) that rest on either side of the eardrum, is between about 1 mm and about 5 mm, for example about 3 mm. The second diameter 1817, which corresponds to the portion of the miniature hearing aid 1800 that is disposed through the eardrum, is between about 0.5 mm and about 3 mm, for example about 1.5 mm. The notched portion 1829 in which the eardrum is disposed is generally about 0.15 mm and about 0.5 mm to provide sufficient space for the eardrum without pinching the eardrum resulting in necrosis. For example, the distance is about 0.25 mm.

[0084] Each of microphone 1808 and processor 1814 is between about 0.25 mm and about 1.0 mm thick, eg, about 0.5 mm thick. Each of the first portion 1826 and the second portion 1828 has a height of between about 1 mm and about 2 mm, such as about 1.5 mm, and between about 2 mm and about 3 mm, such as about 2.5 mm. It has an outer diameter of 5mm. The connecting member 1820, which in some embodiments has an actuator disposed within or coupled to the connecting member 1820, has a height of about 0.5 mm and about 3 mm. for example about 1 mm, and has an outer diameter of between about 0.5 mm and about 2 mm, for example about 1 mm. Similarly, in some embodiments, the actuator has a height of between about 0.5 mm and about 3 mm, such as about 1 mm, and between about 0.5 mm and about 2 mm, such as about 1 mm. It has an outer diameter.

[0085] As discussed above, miniature hearing aids can be of any suitable size and shape with respect to components of various sizes and shapes; however, each configuration generally includes the same various components. , requires, for example, a microphone, an energy source, an actuator, and a processor.

[0086] FIG. 7 is a schematic perspective view of an alternative embodiment of a miniature hearing aid 700. As shown in FIG. 7, at least one flange 702, generally an inner flange, is interrupted by a pie-shaped notch 704 therein. Notch 704 is useful for insertion of miniature hearing aid 700 through the eardrum because notch 704 acts as an Archimedean screw, making it easier to fit flange 702 through a smaller incision. be.

[0087] FIG. 8 is a schematic perspective view of an alternative embodiment of a miniature hearing aid 800. The miniature hearing aid 800 is conical in shape and includes at least one flange 802, generally an inner flange, that acts as a dilator when inserted through an incision in the eardrum.

[0088] In a further embodiment, at least one of the first flange and the second flange of the miniature hearing aid is otherwise tapered from its first end to its second end, such that the first or the second flange acts as a dilator when inserted through the incision in the tympanic membrane.

[0089] FIGS. 9A-C are various views of an alternative embodiment miniature hearing aid 900. Compact hearing aid 900 includes a first flange 902 and a second flange 904. First flange 902 has a plurality of first flange tabs 906 coupled thereto, and second flange 904 has a plurality of second flange tabs 908 coupled thereto. The plurality of second flange tabs 908 are offset from the plurality of first flange tabs 906. As shown in FIG. 9B and discussed further below, first flange tab 906 and second flange tab 908 generally oppose miniature hearing aid 900 until after miniature hearing aid 900 has been inserted through the eardrum. and collapse. After the miniature hearing aid 900 is inserted, the plurality of first flange tabs 906 and/or the plurality of second flange tabs 908 are opened to rest parallel to the surface of the eardrum, as shown in FIG. The miniature hearing aid 900 is stabilized as shown in FIG.

[0090] The mounting region of the disclosed miniature hearing aid generally includes one or more flanges, such as a first flange 902 and a second flange 904, positioned to optimize energy transfer to the eardrum; A space 909 between the flanges is configured such that the eardrum is disposed within the space. The mounting area provides retention of a miniature hearing aid, such as miniature hearing aid 900, in the eardrum. Additionally, the mounting area provides balance and stabilization of the miniature hearing aid 900 on the eardrum. In further embodiments, the one or more flanges can deliver actuation or modulation to the tympanic membrane. In some embodiments, one or more flanges include a charging coil or array. Further, in some embodiments, the one or more flanges include pre-designed feature(s) that provide an offset force to avoid entrapment or tightening of the eardrum, since such This is because excessive pinching or tightening often results in necrosis of the tympanic membrane or a hole within the tympanic membrane.

[0091] In a further embodiment, at least one of the first flange and the second flange is compressible and expands or releases to its final shape or position upon insertion through the tympanic membrane. I can do it.

[0092] The embodiments described above provide exemplary shapes and configurations of one or more flanges. However, the present disclosure includes, but is not limited to, a circular flange resembling a top hat, a circular flange resembling a top hat having an upturned brim around its outer edge, a body that is rounded around its edges; A spaced apart skirt, a circular flange that is undercut on the side facing the eardrum while the outer ring faces upward, distributing the clamping force to the outer rim of the flange, and a microwire configuration. Additional shapes and configurations are contemplated, including flanges made by microwire configurations that are covered by a thin film of material or polymer and can also be used as recharging coils for inductive recharging. In some embodiments, the surface of the collar can be a multi-planar surface, such as a wavy or stepped surface.

[0093] In some embodiments, the flanges that stabilize the miniature hearing aid are juxtaposed across the tympanic membrane to avoid opposing pressures, maintain vascular profusion for the tympanic membrane, and avoid necrosis. Such flanges generally include tabs disposed around the circumference of the flange, the tabs extending separately and spaced apart from the flange and the body of the miniature hearing aid. The tabs can be of various shapes including, but not limited to, pie-shaped, lobed, dual-lobed, or clover-shaped.

[0094] In yet another embodiment, the attachment region includes an array of intermittent flanges, the array being undercut on the side facing the tympanic membrane, while the outer edges of the intermittent flanges are facing upwardly and resisting force. to the outer rim of the flange. The arrays may be placed medial and lateral to sandwich the tympanic membrane between the medial and lateral sides, or radially offset to ensure that the tympanic membrane is not trapped between the stabilizing flanges.

[0095] In a further embodiment, the flange is designed to stabilize the miniature hearing aid and is positioned to or has a feature that alleviates the challenge of epithelial migration on the outside of the tympanic membrane. The flange can be juxtaposed on the inside with retention and stabilization features. Suitable features include, but are not limited to, bump patterning, double-sided hatching, linear tracks or channels, axial tracks, teardrop-like raised patterning, and boat-hull-like configurations. In still further embodiments, these features may additionally or alternatively be patterned on other parts of the disclosed miniature hearing aid, such as the body.

[0096] In still further embodiments, at least one of the one or more flanges includes an actuator component extending from the miniature hearing aid to directly modulate the malleus or umbo. In still further embodiments, the actuator can extend from other parts of the miniature hearing aid, such as the body, to directly modulate the malleus or tympanic membrane.

[0097] The flanges disclosed herein can interact with the body and/or tympanic membrane of a miniature hearing aid in any suitable manner, alone or in any combination.

[0098] FIGS. 23A-23D illustrate an alternative embodiment of a miniature hearing aid 2300. The miniature hearing aid 2300 is similar to other embodiments described herein, but includes flexion to actuate one or more masses to adjust the velocity and/or position of the eardrum. Mode actuators 2322 and 2324 are used.

[0099] Note that as used herein, the inner end, side, or surface of a component refers to the end, side, or surface that is proximal to the tympanic membrane when implanted. In contrast, the outer end, side, or surface of a component refers to the end, side, or surface remote from the eardrum when implanted.

[0100] The miniature hearing aid 2300 typically includes a first housing housing 2301 having a first inner wall 2350 (see FIG. 23B) and a first outer shell 2370. Inner wall 2350 and outer shell 2370 together include at least a microphone 2308, a processor 2314 coupled to microphone 2308, and a first active or inert mass (in this example, a first active mass coupled to processor 2314). (illustrated as a battery 2326) and a first actuator 2322 coupled to the first battery 2326. In certain embodiments, a charging coil antenna 2316 is placed around the microphone 2308 to enable daily charging of the miniature hearing aid 2300. In certain embodiments, charging coil antenna 2316 and microphone 2308 are independent of first battery 2326 that is indirectly coupled to first inner wall 2350. The miniature hearing aid 2300 further includes a second housing having a second inner wall 2352 and a second outer shell 2372 integrally enclosing at least a second active or inactive mass (illustrated as a second battery 2328). It includes a housing 2302 (see FIG. 23B) and a second actuator 2324 coupled to a second battery 2328. The first enclosure housing 2301 is connected to the second enclosure housing 2302 by a connecting member 2320 disposed between adjacent inner walls 2350, 2352 of the first and second enclosure housings 2301, 2302, respectively. be combined.

[0101] When implanted, the inner walls 2350, 2352 (which may be planar in configuration) are placed on either side of the tympanic membrane and contact (i.e., are placed opposite) the tympanic membrane, while the connecting member 2320 (illustrated as a tubular structure by way of example) traverses the eardrum along or parallel to the central axis of the miniature hearing aid 2300. In addition to mechanical support, the connecting member 2320 allows for the routing of electrical signal connections between the enclosure housings 2301, 2302 (eg, for recharging and actuation of the mass).

[0102] Although the masses of FIGS. 23A-23D are illustrated and described as batteries 2326, 2328, the bending mode actuators 2322, 2324 may, in certain embodiments, be any suitable type of mass or masses other than batteries. Note that the material can be modulated. For example, the mass can be any suitable mass material, component, or combination of components that can be actuated to adjust the velocity or position of the tympanic membrane.

As shown in FIGS. 23A-23D, actuators 2322, 2324 are indirectly coupled to inner walls 2350, 2352 within enclosure housings 2301, 2302, respectively, on opposite sides of connecting member 2320. However, in certain other embodiments, the actuators 2322, 2324 are indirectly coupled to the outer shells 2370, 2372 (which may take the form of a dome). The actuators 2322, 2324 are each held in place by one or more brackets 2354 (see FIG. 23B) extending from the inner walls 2350, 2352 or the outer shells 2370, 2372, which allow the actuators to be attached to their distal ends. A slot is provided which is fixed at. Bracket 2354 further provides clearance 2356 between each actuator 2322, 2324 and the corresponding inner wall 2350, 2352 to facilitate deflection of the actuator during actuation. As shown, actuators 2322, 2324 are further coupled indirectly to at least batteries 2326, 2328 via extensions 2380, 2382, respectively, such that internal displacement of the batteries by the actuators within each housing housing 2301, 2302 becomes possible.

[0104] An enlarged view of the second actuator 2324 within the second enclosure housing 2302 is shown in FIG. 23C for reference. Unless otherwise specified, the description of the components of second actuator 2324 and second enclosure housing 2302 may also apply to first actuator 2322 and first enclosure housing 2301.

[0105] As mentioned above, the second actuator 2324 is a bending mode actuator, such as a unimorph actuator, a bimorph actuator, a dome actuator, or the like. For purposes of clarity and not limitation, second actuator 2324 is referred to herein as a unimorph actuator having at least one inactive layer 2360 and at least one active layer 2362. Illustrated and explained. Each of the inactive and active layers 2360, 2362 includes a thin film-like layer configured to controllably deform upon application of an electric field to the active layer. Thus, one or more electrodes 2364 may be disposed at both ends of the second actuator 2324 and contact at least the active layer 2362. In particular examples, one or more electrodes 2364 are formed of gold (Au), platinum (Pt), copper (Cu), or any other suitable electrically conductive material.

[0106] As shown in FIG. 23C, the inactive layer 2360 of the actuator 2324 is disposed between the active layer 2362 and the inner wall 2352 of the enclosure housing 2302. Inner wall 2352 is typically less than 1 mm thick and, like outer shell 2372, is formed from a biocompatible material. A bracket 2354 extends from the distal end of the inner wall 2352 or outer shell 2372 and the passive layer 2360 to clamp the passive layer in place while also providing a clearance 2356 to facilitate deformation of the actuator. In certain embodiments, the passivation layer 2360 is formed of titanium (Ti) or titanium oxide (TiO ₂ ) and has a thickness of between about 0.02 mm and about 0.1 mm, such as between about 0.02 mm and about 0.03 mm. For example, it has a thickness of about 0.02 mm.

[0107] The active layer 2362 is coupled to the non-active layer 2360 on the opposite side of the inner wall 2352 and typically has a thickness greater than the thickness of the non-active layer, such as between about 0.05 mm and about 0.2 mm, such as about It has a thickness of between 0.065 mm and about 0.085 mm, for example about 0.075 mm. The active layer 2362 is formed of a piezoelectric type material having a perovskite crystal structure, such as lead zirconate titanate (PZT), barium titanate (BaTiO ₃ ), strontium titanate (SrTiO ₃ ), or other ferroelectric material. be able to. In certain embodiments, the passive layer 2360 and the active layer 2362 each have a length of between about 1 mm and about 4 mm, such as between about 2 mm and about 3 mm, and a width of less than about 3 mm, such as less than about 2 mm. .

[0108] As previously discussed, the active layer 2362 is also indirectly coupled to at least the battery 2328 via the extension 2382 (the active layer 2362 in the first enclosure housing 2301 is coupled via the extension 2380 to the battery 2328). and coupled to at least battery 2326). Extensions 2380, 2382 may be of similar construction and material to connecting member 2320 disposed between inner walls 2350, 2352. In certain embodiments, as shown in FIGS. 23A-23C, the extensions 2380, 2382 are aligned and centered between the lateral surfaces of the active layer 2362 and the inner surfaces of the cells 2326, 2328. This facilitates axial movement of the cell during operation. In such embodiments, the inert layer 2360 may be secured to the inner wall 2350, 2352 or the outer shell 2370, 2371 by two brackets 2354 at both ends thereof. However, in certain other embodiments, the extensions 2380, 2382 are non-axially (e.g., non-aligned) with oblique (e.g., non-centered) positions of the lateral surfaces of the active layer 2362 and the inner surfaces of the cells 2326, 2328. (see FIG. 23D). In such embodiments, the coupling of active layer 2362 and cells 2326, 2328 facilitates rotational (eg, non-linear) movement of the cells during operation. Thus, the non-active layers 2360 may be secured to the inner walls 2350, 2352 or outer shells 2370, 2371 by only one bracket 2354 at the distal end of each non-active layer 2360, thereby allowing the actuators 2322, 2324 to Greater deflection is possible. In some examples, a single bracket 2354 is secured to each inactive layer 2360 at the opposite end of the active layer 2362 that is coupled to the extension 2380 or 2382.

[0109] In operation, the microphone 2308 or other suitable sensor receives the sound to be amplified, and the processor 2314 applies a sound wave or acoustic signal to the first and/or second actuators 2322, 2324. Convert to electrical signal. Electrical signals are transmitted to the active layer 2362 by one or more electrodes 2364 to cause the active layer to morph (eg, deform) in a desired direction. For example, the active layers 2362 of the first and second actuators 2322, 2324 can be similarly or oppositely energized to morph in similar or opposite directions, as desired. Deformation of the active layer 2362 adjusts the tympanic membrane by adjusting the position of the battery 2326 or 2328 (e.g., mass) relative to the tympanic membrane and the connecting member 2320 disposed therebetween, thereby controlling the tympanic membrane and the user's brain via the ossicular chain and cochlea. bring impulse to.

[0110] In certain embodiments, active layer 2362 has a capacitance of less than about 300 picofarads (pF), such as less than about 200 pF. Active layer 2362 may be driven by 40 volts (V) of alternating current (AC) to a frequency between about 7,500 and about 10,500 hertz (Hz), such as between about 8,000 and about 10,000 Hz. In further embodiments, each of the active layers 2362 displaces the inner walls 2350, 2352 and/or the cells 2326, 2328 by a distance of about 1 μm to about 5 μm, such as about 2 μm, and by about 0.02 N to about 0.00 N. A blocking force of between 1N, for example between about 0.04N and about 0.07N is produced.

[0111] As shown in FIGS. 23A-23D, the use of a miniature hearing aid 2300 can facilitate more controlled tympanic membrane modulation. This is because the first and second actuators 2322, 2324 can better utilize the mass inside the hearing aid. For example, including two separate actuators 2322, 2324 allows each mass (e.g., battery 2326 or 2328) to be modulated independently of the other, thereby modulating both masses together. Energy losses due to this are reduced. Additionally, the structure and bending mode functionality of the actuators 2322, 2324 allows for free movement of internal components (eg, masses) within the enclosure housings 2301, 2302. Thus, the actuators 2322, 2324 can provide a more stable internal environment while reducing undesirable micro-movements of the connecting member 2320 and connections disposed therein.

[0112] FIGS. 24A-24F illustrate yet another embodiment of a miniature hearing aid 2400 that utilizes bending mode (eg, unimorph) actuators 2422, 2424 for modulation of the velocity and/or position of the eardrum. Because hearing aid 2400 is substantially similar to hearing aid 2300, similar components between hearing aid 2400 and hearing aid 2300 are labeled with the same reference numerals for clarity.

[0113] Unlike hearing aid 2300, the masses of hearing aid 2400 (shown in this example as batteries 2326, 2328) are not directly coupled to actuators 2422, 2424, but instead are coupled to side shells 2370, 2370, respectively. 2372, directly or indirectly. Thus, the batteries 2326, 2328 in FIGS. 24A-24C are shown separated from the actuators 2422, 2424 by a clearance 2446. In certain embodiments, first battery 2326 is coupled directly and/or indirectly to first side shell 2370 via microphone 2308 and/or processor 2314. In such embodiments, microphone 2308 and/or processor 2314 may be attached to side shell 2370 via any suitable coupling mechanism (eg, adhesive or other support structure). In certain embodiments, a second battery 2328 is coupled directly to the second enclosure housing 2302 on the opposite side of the inner wall 2352. Like microphone 2308 and processor 2314, second battery 2328 may be attached to second side shell 2372 via a suitable coupling mechanism (eg, adhesive or other support structure).

[0114] Further, the first and second actuators 2422, 2424 of the hearing aid 2400 are formed of a flexible membrane (e.g., polymer or silicone) and are disposed along or along the inner walls 2350, 2352, respectively. It is integral with the walls 2350, 2352, so there is no clearance between them. For reference, enlarged views of the second enclosure housing 2302 and actuator 2424 are shown in FIGS. 24C-24F. Unless otherwise specified, the description of the components of the second enclosure housing 2302 and the second actuator 2424 may also apply to the first enclosure housing 2301 and the first actuator 2422.

[0115] As shown in FIGS. 24C-24F, in certain embodiments, the inner surface 2461 of the passive layer 2360 is bonded directly to the inner wall 2352. Inactive layer 2360 thus forms a direct barrier between inner wall 2352 and active layer 2362. In a particular example, the inert layer 2360 is disc-shaped and extends along the entire lateral side 2453 of the inner wall 2352, separating the inner wall from the lateral shell 2372 (see FIG. 24D). In some embodiments, the inert layer 2360 is in the form of a beam or strip that extends linearly along the diameter of the corresponding inner wall 2352 and intersects the outer shell 2372 at its ends. In yet other examples, the disc-shaped or beam-shaped inert layer 2360 extends only along a portion of the lateral sides 2453 of the inner wall 2352 (see FIGS. 24E and 24F). In such examples, the inert layer 2360 forms a partial separation between the inner wall 2352 and the outer shell 2372 (FIG. 24E) or no separation therebetween (FIG. 24F).

[0116] In yet other embodiments, the active layer 2362 of the actuator 2422 has an inner surface (not shown) directly coupled to the inner wall 2352, and the inner wall 2352 itself serves as the inactive layer of the actuator 2442. Function. Inner wall 2352 may thus be formed from a thin, flexible layer of material (eg, polymer or silicone) and configured to controllably deform upon application of an electric field to active layer 2362. In some examples, inner wall 2352 is formed of Ti or TiO ₂ and, like passivation layer 2360, has a thickness of about 0.02 mm to about 0.1 mm, such as about 0.025 mm. In such examples, the active layer 2362 may be formed of PZT, BaTiO ₃ , SrTiO ₃ , or other ferroelectric material and have dimensions similar to those described above in connection with FIGS. 23A-23C. has.

[0117] In operation, applying an electrical signal to the active layer 2362 causes the active layer to deform, thereby modulating the inner walls 2350, 2352 along which the active layer 2362 is disposed. Modulation of the inner walls 2350, 2352 thus modulates the tympanic membrane by adjusting the position of the outer shells 2370, 2372 and their coupled batteries 2328, 2328 relative to the tympanic membrane, which in turn modulates the tympanic membrane through the ossicular chain and the cochlea. Impulses are sent to the brain. By utilizing the first and second housings 2301 and 2302 as moving masses themselves, the hearing aid 2400 allows for better utilization of the total mass and reduces movement of its internal components. The hearing aid 2400 thus provides a more stable internal environment while reducing undesirable micro-movements, and further improves mass utilization by adjusting the housing housings 2301, 2302.

[0118] FIG. 25 is a schematic cross-sectional view of an alternative miniature hearing aid 2500. The miniature hearing aid 2500 includes a housing 2501 having an internal profile configured to house and support a stack of components, including a microphone 2508, a processor 2514, a first portion 2526 (as a first battery) ), and a second portion 2528 (shown as a second battery) coupled to a first battery 2526 by a rigid connection member 2520 . The miniature hearing aid 2500 further includes an actuator 2522 coupled to the side of the second battery 2528 opposite the connecting member 2520 and disposed proximal to the first battery 2526 to function as a modulation guide and a pushing force. A battery support part 2536 is included. Compact hearing aid 2500 is substantially similar to the previously described hearing aids, but with actuator 2522 disposed at the lateral end of second battery 2528 and coupled to the inner surface of the lateral end of housing 2501.

[0119] As mentioned above, miniature hearing aids can be of any suitable size and shape with components of various sizes and shapes, but each configuration typically includes the same various components, such as a microphone. , an energy source, an actuator, and a processor are required.

[0120] Actuator 2522 typically includes a tubular or cylindrical piezoelectric stack actuator with a mechanical amplifier. For example, as shown in FIG. 25, actuator 2522 includes a piezoelectric stack 2542 coupled to a mechanical amplifier 2540. Piezoelectric stack 2542 can include any suitable number of layers (eg, disks) formed of piezoelectric material. For example, piezoelectric stack 2542 can include 1 to 10 layers, such as 2 to 8 layers, such as 5 layers, formed of piezoelectric material. In certain embodiments, one or more of the layers of piezoelectric stack 2542 are formed of PZT or similar ferroelectric material, such as lead magnesium niobate-lead titanate (PMN-PT). Generally, piezoelectric stack 2542 has a height H between about 0.5 mm and about 4 mm, such as between about 1 mm and about 2 mm. Each layer of piezoelectric stack 2542 can have a diameter or width D between about 0.5 mm and about 2.5 mm, such as between about 0.5 mm and about 2 mm.

[0121] Mechanical amplifier 2540 may include any suitable type of displacement amplifier. For example, mechanical amplifier 2540 can include a two-stage bending-based displacement amplifier. Mechanical amplifier 2540 is configured to convert input mechanical energy provided by piezoelectric stack 2542 to magnified output mechanical energy for modulating second battery 2528 and, in turn, first battery 2526 coupled thereto. Ru. Mechanical amplifier 2540 can thus convert a relatively small displacement of piezoelectric stack 2542 into a desired large displacement applied to cells 2526, 2528 for effective modulation. In certain embodiments, the mechanical amplifier provides a displacement amplification of between about 20 times and about 100 times, such as between about 25 times and about 35 times.

[0122] Factors considered in the design of mechanical amplifier 2540 include the amount of force and displacement generated by piezoelectric stack 2542 and the amount of force and displacement applied to the eardrum to improve the user's hearing. included. The amount of force is between about 20 mg and about 30 mg with a displacement of about 0.05 microns to about 5.0 microns, with a force between about 0.001 newtons (N) and about 0.05 N over the audio frequency range. may vary based on the modulation mass or mass of.

Implantation Methods [0123] The disclosed miniature hearing aids can be implanted by any suitable implantation method. FIG. 10 is a process flow of one such method 1000.

[0124] Prior to method 1000, optional disinfection may be performed to disinfect the tympanic membrane and proximal ear canal.

[0125] The method 1000 generally includes, in operation 1010, identifying an optimal location for placement of a miniature hearing aid, in operation 1020, anesthetizing the site for placement, and in operation 1030, identifying an optimal location for placement of a miniature hearing aid. and, in operation 1040, inserting a miniature hearing aid through the incision. The method 1000 generally further includes verifying placement and functionality of the miniature hearing aid at operation 1050.

[0126] In one embodiment, the optimal location is the anteroinferior quadrant of the tympanic membrane. Therefore, the method involves anesthetizing a portion of the anteroinferior quadrant, making a small incision, such as about 2 mm or less, e.g., about 1 mm or less, and making an incision to position a miniature hearing aid in the anteroinferior quadrant of the user's eardrum. This includes inserting a miniature hearing aid through the

[0127] As discussed above, some embodiments of miniature hearing aids include configurations that accommodate easier insertion through the eardrum. For example, at least one flange of the one or more flanges may be configured to assist in placement across an incision in the eardrum by rotating the miniature hearing aid through the incision, such as miniature hearing aid 700 shown in FIG. , slotted or intermittent flanges.

[0128] In another embodiment, such as miniature hearing aid 800 of FIG. 8, at least one flange of the one or more flanges, such as an inner flange, or the body of the miniature hearing aid itself is configured to act as a dilator. The dilator is conically shaped to provide a profile that is pushed through the incision in the eardrum to dilate the incision and allow the inner portion of the miniature hearing aid to pass through the incision.

[0129] In yet another embodiment, at least one of the medial flange and the lateral flange is a self-expanding flange, the self-expanding flange being insertable through the incision and expandable within the middle ear, thereby , the flange, when expanded, will abut the inside of the eardrum. In still further embodiments, the distance between flanges or between intermittent portions of flanges is predetermined to allow implantation and provide adjustment for variable thickness and/or force of the tympanic membrane.

[0130] In still further embodiments, the miniature hearing aid includes multiple pieces that can be joined together to form an entire miniature hearing aid. In such embodiments, the inner and outer flanges are generally connected by an array of connectors, the array of connectors being secured on one or both halves and attached to corresponding receptacles on one or both halves. Join. After one piece of the miniature hearing aid is inserted through the incision, e.g. through the eardrum, the second piece is inserted, e.g. by penetrating the eardrum with an array of pins that mate with the already inserted piece. The pieces are then joined together. In yet a further embodiment, one piece is inserted inside the tympanic membrane through the incision and the second piece is inserted across the tympanic membrane at a distance spaced from the initial placement incision. are combined into pieces. In such embodiments, the initial placement incision will heal.

Method of Removal for Emergency or Safety Reasons [0131] The disclosed miniature hearing aids can be quickly and safely removed for safety and emergency reasons. For example, as discussed above, embodiments of miniature hearing aids are configured to turn off upon recognizing particular audio signature frequencies. If a particular audio signature fails to turn off the miniature hearing aid, or if the miniature hearing aid needs to be removed for emergency reasons, the device can be stopped and/or removed by physical means.

[0132] In one embodiment, the outer flange of the disclosed miniature hearing aid includes a switch, a pressure switch, a contact, a slide, or any combination thereof. Medical professionals use basic medical tools in emergency rooms or other medical environments to touch switches, pressure switches, contacts, slides, or combinations thereof to respond to audio signature frequencies and detect small The miniature hearing aid can be turned off after the hearing aid fails to turn off. In some embodiments, the outer flange of the disclosed miniature hearing aid incorporates features that can be grasped or connected by common medical tools such as tweezers, probes, and forceps to assist in removing the miniature hearing aid. .

[0133] In yet a further embodiment, a user of the disclosed miniature hearing aid is provided with a custom configured deactivation or ejection tool that can be used by a medical professional to remove or deactivate the device in an emergency situation.

Devices for Implantation and Removal [0134] The disclosed miniature hearing aids can be implanted within a patient's ear during a minimally invasive, outpatient procedure. In one embodiment, the disclosed miniature hearing aid is inserted using a scalpel or any suitable cutting instrument to make a small incision or any other puncture, and the tool inserts the miniature hearing aid. Used to hold and position small hearing aids through the eardrum. In another embodiment, the implantation tool generally comprises an elongated rod having a cutting tool at its distal end and is inserted through the ear canal to the appropriate location on the eardrum. The cutting tool positions the miniature hearing aid at the placement site using the distal alignment ring guide and advances a predetermined, appropriately sized cutting device, such as a blade or needle, to create the incision at the placement site. and then advancing the miniature hearing aid across the eardrum to deploy the miniature hearing aid through the eardrum.

[0135] Device configurations for implantation and removal may be varied to more easily insert particular configurations of the disclosed miniature hearing aids. For example, FIGS. 11A-B illustrate the miniature hearing aid 900 of FIGS. 9A-C along with a portion of an exemplary implantation tool. As shown in FIGS. 11A-B, implantation tool 1100 includes a sheath 1102 and an advancement rod 1104. During operation, the sheath surrounds the miniature hearing aid 900 and maintains the plurality of first flange tabs 906 and the plurality of second flange tabs 908 in their non-expanded positions, such that the tabs are shown in FIG. 11A. The user folds the small hearing aid 900 to the side.

[0136] A portion of the sheath 1102 is generally inserted through an incision made in the tympanic membrane, and once the sheath 1102 is inserted through the tympanic membrane, at least a portion of the sheath 1102 is withdrawn. The miniature hearing aid 900 is thus placed through the eardrum, such that the first portion of the miniature hearing aid 900 is placed inside the eardrum and the second portion of the miniature hearing aid 900 is placed outside the eardrum. . Once the portion of the miniature hearing aid 900 with the plurality of first flange tabs 906 is released from the sheath 1102, the advancement rod 1104 maintains its position while the sheath 1102 is withdrawn. The first flange tab 906 expands, flares, or otherwise unfolds to form a flange along the eardrum as shown in FIG. 11B.

[0137] In another embodiment, one or more tools, such as cupped forceps, are inserted through the primary opening to access the inside of the eardrum such that the two or more components are coupled across the eardrum through various mechanisms such as. The one or more tools, such as cupped forceps, are then removed.

[0138] FIGS. 15A-B illustrate an alternative embodiment embedding tool 1500. Implantation tool 1500 includes distal cup 1501, proximal cup 1502, connection member 1503, advancement member 1504, handle 1505, and actuation trigger 1506. The implantation tool 1500 is configured to hold one or more devices to be implanted.

[0139] Operation of implantation tool 1500 is described in the context of inserting a miniature hearing aid through the eardrum. However, it is contemplated that implantation tool 1500 is useful for implanting any suitable device at any suitable location throughout the body.

[0140] As shown in FIG. 15B, the implantation tool is configured to hold a first portion 1508 and a second portion 1510 of a miniature hearing aid, such as the miniature hearing aids disclosed herein.

[0141] During operation, the distal cup 1501 holding the first portion 1508 is advanced through an incision in the tympanic membrane such that the distal cup 1501 and the first portion 1508 are disposed inside the tympanic membrane. while proximal cup 1502 and second portion 1510 are disposed outside the tympanic membrane. Actuation trigger 1506 then snaps the first portion 1508 and second portion 1510 of the miniature hearing aid together through the eardrum at a distance from the incision. 1502. Once the miniature hearing aid is snapped together and implanted through the eardrum, the implantation tool 1500 is withdrawn through the incision and the hearing aid is left in place through the eardrum.

Devices and Systems for Recharging [0142] The present disclosure further contemplates recharger devices and systems for providing a user interface for easily recharging implanted miniature hearing aids. The recharger device and system interacts with charging circuitry to recharge the disclosed miniature hearing aid. Recharger devices and systems are generally disposed within the ear canal, over, around the ear, or near the user's head. Exemplary rechargers include earphones that can be placed in the ear canal, over the ear, around the ear, or near the user's head to interact with the recharging circuit. Including inserts, earmuffs, over-the-ear clips, glass stem clips, devices in or around the pillow, and devices in or around the vicinity of the user's head. In some cases, the recharger device itself will need to be recharged. In one embodiment, the recharging system is a cradle system that provides a support cradle for a recharging device that is coupled to a power source, such as an electrical outlet, a USB port, or a vehicle power source. In another embodiment, the recharging device itself can be connected directly to a power source through a connector such as a prong. The recharging system may be modular, such that the headset is a holder for the ear component to hold the ear component in place while the ear component is being worn by the patient. It is also contemplated that an additional holder would be provided for holding the ear component while the ear component is being recharged. The charging component(s) placed in the ear canal are more discreet and can be separated from the headset system to enable mobile recharging.

Docking Device [0143] This disclosure also contemplates a docking device for docking one or more devices within a user's ear, such as through the eardrum. As with the miniature hearing aid embodiments described herein, the docking device may also include any suitable configuration of a first flange and a second flange connected by a connecting member. However, docking devices generally do not include the hearing aid components described above. Instead, the docking device generally includes a hollow portion extending therethrough, the hollow portion being pre-designed to dock another device therein. Similar to the disclosed miniature hearing aid, the docking device can be inserted during a minimally invasive outpatient procedure. The procedure generally involves identifying the optimal location for placement of a docking device, anesthetizing the placement site, making an incision or any other puncture at the placement site, and including inserting a docking device through the incision. The procedure can also include disinfecting the placement site and verifying the placement and functionality of the docking device after it has been placed.

[0144] Suitable devices to be docked include, but are not limited to, biometric devices, diagnostic equipment, entertainment modules, covert communication modules, therapeutic devices, fitness tracking devices, health tracking devices, tissue stimulation devices, and hearing assistance devices. Not limited. These docking devices advantageously provide a docking station within the ear, such as through the eardrum, which allows various devices to be placed within the eardrum for a predetermined period of time. Because the docking device is already in place for deployment, no additional incisions need to be made at the deployment site once the device is docked within the docking station.

Stimulation and/or Modulation Devices [0145] This disclosure discusses the disclosed devices being used as miniature hearing aids. The present disclosure also contemplates, for example, stimulation and/or modulation devices that are positionable in any tissue throughout a user's body. Such tissue stimulation devices include one or more masses, such as one or more sensors, one or more masses, one or more energy sources, one or more processors, and one or more It also includes a housing having various components therein that can be used as multiple actuators. The one or more sensors are generally any suitable sensors that provide a predetermined output, where the predetermined output is based on a desired effect on the user's body. Exemplary outputs include, but are not limited to, mechanical output, electrical output, and thermal output. During operation, stimulation and/or modulation devices are useful for effecting changes to many different tissues within the body, such as muscles, ligaments, membranes, bones, and cartilage.

Conclusion [0146] Embodiments of the present disclosure provide an improved miniature hearing aid that uses vibration transduction to directly or indirectly modulate the velocity or position of the eardrum. This direct or indirect modulation of the velocity or position of the eardrum significantly improves the sound quality for the user. The disclosed miniature hearing aids are smaller, more comfortable, and cosmetically unobtrusive. In fact, the disclosed miniature hearing aid can be placed within the ear canal and across the eardrum, so that it is invisible to an outside observer. Furthermore, because of the compact design of the disclosed miniature hearing aid, the miniature hearing aid does not completely occlude the ear canal. Instead, the disclosed miniature hearing aid leaves the ear canal unobstructed, thus providing a more natural and improved sound quality for the user. Furthermore, the disclosed miniature hearing aid provides additional features such as avoiding canal occlusion effects and hearing aid feedback associated with conventional hearing aids. Additionally, the disclosed miniature hearing aids can be inserted and removed during minimally invasive outpatient procedures.

[0147] While the above is directed to embodiments of this disclosure, other and further embodiments of this disclosure can be devised without departing from the essential scope of this disclosure, which scope is described below. Determined by the claims that follow.

Claims (20)

A tympanic membrane actuation assembly, the actuation assembly comprising:
at least one mass configured to be placed on at least one of the medial and lateral sides of the user's eardrum;
at least one flexion mode actuator coupled to the mass and configured to be disposed on at least one of the inside or outside of the tympanic membrane, the flexion mode actuator moving the mass to modulate the tympanic membrane. an actuating assembly configured to convert an electrical signal into mechanical motion in order to do so; The actuation assembly of claim 1, wherein the at least one bending mode actuator includes a piezoelectrically active layer. 3. The actuation assembly of claim 2, wherein the piezoelectric active layer has a perovskite crystal structure. 4. The actuation assembly of claim 3, wherein the piezoelectric active layer comprises lead zirconate titanate (PZT). 3. The actuation assembly of claim 2, wherein the at least one bending mode actuator includes an inert layer formed of titanium (Ti) or titanium oxide ( _TiO2 ). The actuation assembly of claim 1, wherein the at least one mass includes a battery coupled directly to the at least one bending mode actuator. a sensor configured to detect and convert sound waves into electrical signals; and a processor in communication with the sensor and the at least one bending mode actuator to modify and modify the electrical signal from the sensor. a processor configured to provide the electrical signal to the at least one bending mode actuator;
7. The actuation assembly of claim 6, further comprising: 8. The actuation assembly of claim 7, wherein the sensor includes a microphone. A tympanic membrane actuation assembly,
at least one housing configured to be placed on at least one of the inside or outside of the user's eardrum;
at least one mass disposed within the at least one housing; and at least one flexure mode actuator coupled to the at least one housing, the actuator transmitting an electrical signal to a mechanical member of the housing for modulating a user's eardrum. at least one bending mode actuator configured to translate into motion;
A tympanic membrane actuation assembly comprising: the at least one bending mode actuator is coupled to a flat membrane of the at least one housing, and the flat membrane is configured to be placed against the medial or lateral side of the user's eardrum; An actuation assembly according to claim 9. 11. The actuation assembly of claim 10, wherein the at least one bending mode actuator includes a piezoelectrically active layer. 12. The actuation assembly of claim 11, wherein the piezoelectric active layer has a perovskite crystal structure. 13. The actuation assembly of claim 12, wherein the piezoelectric active layer comprises lead zirconate titanate (PZT). 12. The actuation assembly of claim 11, wherein the piezoelectric active layer is directly coupled to the flat membrane of the at least one housing. The at least one bending mode actuator is an inert layer formed of titanium (Ti) or titanium oxide ( _TiO2 ) between the piezoelectric active layer and the flat membrane of the at least one housing. 12. The actuation assembly of claim 11, including an inert layer disposed thereon. 12. The actuation assembly of claim 11, wherein deformation of the piezoelectrically active layer results in modulation of the flat membrane of the at least one housing. A hearing aid insertable through a user's eardrum to amplify certain frequencies and cancel other frequencies, the hearing aid comprising a tympanic actuation assembly, the tympanic actuation assembly comprising:
at least one housing configured to be placed on at least one of the inside or outside of a user's eardrum;
at least one mass disposed within the at least one housing; and at least one bending mode actuator coupled to a flat membrane of the at least one housing, the at least one bending mode actuator coupled to the flat membrane of the at least one housing to transmit an electrical signal to the eardrum of the user. at least one bending mode actuator configured to convert mechanical movement of the housing;
Including hearing aids. 18. Hearing aid according to claim 17, wherein the at least one bending mode actuator comprises a piezoelectric active layer formed of lead zirconate titanate (PZT). The at least one bending mode actuator is an inert layer formed of titanium (Ti) or titanium oxide ( _TiO2 ) between the piezoelectric active layer and the flat membrane of the at least one housing. 19. Hearing aid according to claim 18, further comprising an inert layer disposed. 19. Hearing aid according to claim 18, wherein the piezoelectric active layer is bonded directly to the flat membrane of the at least one housing.

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