HEARING AID DEVICE

Abstract

A hearing aid device is presented being configured for direct cochlea vibration stimulation. The hearing aid device comprises: a deformable member configured for contracting and expanding along a deformation axis between its first and second sides in response to an applied external field; and a fastening assembly configured for carrying the deformable member so as to provide rigid coupling of the first and second sides of the deformable member to a bony tissue in the vicinity of cochlea, such that contraction and expansion of said deformable member directly stimulates vibration of the cochlea.

Claims

1. A hearing aid device, comprising: a deformable member including first and second sides, the deformable member configured for contracting and expanding along a deformation axis between the first and second sides in response to an applied external field; and a fastening assembly configured for carrying the deformable member, the fastening assembly having first and second end portions configured for direct rigid coupling to first and second distant surface portions of bony tissue of a cochlea region so as to provide entire rigid coupling of the hearing aid device to the bony tissue of the cochlea, such that contraction and expansion of the deformable member along the deformation axis directly stimulates vibration of the cochlea.

2. The hearing aid device according to claim 1, wherein the fastening assembly is configured such that said first and second end portions of the fastening assembly rigidly couple the first and second sides of the deformable member, respectively, to the first and second distant portions of the bony tissue spaced from one another along the deformation axis of the deformable member, the contraction and expansion of the deformable member along the deformation axis thereby forcing movement of at least one of the first or second distant portions towards and away from the other.

3. The hearing aid device according to claim 2, wherein the fastening assembly comprises first and second fasteners defining said first and second end portions of the fastening assembly spaced from another along the deformation axis of the deformable member and connected to, respectively, said first and second sides of the deformable member, the contraction and expansion of the deformable member along the deformation axis thereby forcing movement of at least one of the first or second distant portions towards and away from the other.

4. The hearing aid device according to claim 1, wherein the fastening assembly comprises an integral rigid member comprising said first and second end portions configured for direct rigid coupling to the first and second distant portions of the bony tissue of a cochlear wall and an intermediate portion between the first and second end portions, the intermediate portion defining a recess, the deformable member being accommodated in the recess being by the first side thereof connected to the intermediate portion, such that when the rigid member is installed in place the deformable member by the opposite second side interacts with the cochlear wall region between the first and second portions thereof.

5. The hearing aid device according to claim 1, further comprising an electronic system for receiving sound pressure waves and transmitting corresponding actuating signals to the deformable member to thereby cause a deformation profile of the deformable member indicative of the received sound pressure waves.

6. The hearing aid device according to claim 5, wherein the electronic system comprises a microphone for receiving sound pressure waves and generating electric output indicative thereof, and a signal processor configured for amplifying the signal and providing a desired spectral profile of the signal.

7. The hearing aid device according to claim 5, wherein the electronic system comprises a microphone configured to be placed in an ear canal of an individual and to be connectable to at least some other parts of the electronic system.

8. The hearing aid device according to claim 5, wherein the electronic system is configured and operable for adjusting one or more parameters of the actuating signals according to predetermined requirements for a specific individual.

9. The hearing aid device according to claim 5, wherein the electronic system comprises internal and external parts in signal communication with one another.

10. A hearing aid device, comprising: a deformable member having first and second opposite sides, the deformable member configured for contracting and expanding along a deformation axis passing through the first and second opposite sides thereof in response to an applied external field; and a fastening assembly comprising a rigid bridge-like member having first and second end portions configured for rigid coupling to the first and second portions of the bony tissue of the cochlear wall, and an intermediate portion defining a recess for accommodating the deformable member being connected to the intermediate portion; wherein the hearing aid device, when installed in place, thereby providing direct contact of the deformable member by the second opposite side thereof with a cochlea region between the first and second portions thereof, such that a deformation profile of the deformable member along the deformation axis in response to a profile of the applied external field thereby directly causes corresponding vibrations of the bony tissue being a portion of the cochlear wall.

11. The hearing aid device according to claim 10, further comprising an electronic system for receiving sound pressure waves and transmitting corresponding actuating signals to the deformable member to thereby cause a deformation profile of the deformable member indicative of the received sound pressure waves.

12. The hearing aid device according to claim 11, wherein the electronic system comprises a microphone for receiving sound pressure waves and generating electric output indicative thereof, and a signal processor configured for amplifying the signal and providing a desired spectral profile of the signal.

13. The hearing aid device according to claim 11, wherein the electronic system comprises a microphone configured to be placed in an ear canal of an individual and to be connectable to at least some other parts of the electronic system.

14. The hearing aid device according to claim 11, wherein the electronic system is configured and operable for adjusting one or more parameters of the actuating signals according to predetermined requirements for a specific individual.

15. The hearing aid device according to claim 11, wherein the electronic system comprises internal and external parts in signal communication with one another.

16. A hearing aid device, comprising: a deformable member extending between first and second opposite sides thereof, the deformable member configured for contracting and expanding along a deformation axis passing through the first and second opposite sides thereof with a deformation profile in response to an applied external field profile; and a fastening assembly comprising first and second fasteners defining first and second end portions of the fastening assembly spaced from another along the deformation axis of the deformable member and connected to, respectively, said first and second sides of the deformable member; wherein the first fastener associated with the first side of the deformable member is configured for rigid attachment to a portion of bony tissue in a vicinity of cochlea, and the second fastener associated with the second opposite side of the deformable member is configured for direct coupling to a distant portion of bony tissue being a portion of a cochlear wall, so as to provide rigid coupling of the first and second sides of the deformable member to the first and second distant portions; such that the deformation profile of the deformable member along the deformation axis between the first and second sides thereof during the contraction and expansion of said deformable member in response to the profile of the applied external field causes a corresponding movement of the fastening assembly forcing movement of at least one of the first and second distant portions towards and away from the other portion resulting in direct transfer of the deformation profile of the deformable member to corresponding vibrations of the bony tissue being a portion of the cochlear wall.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0044] In order to better understand the subject matter that is disclosed herein and to exemplify how it may be carried out in practice, embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:

[0045] FIG. 1 is a schematic representation of an ear;

[0046] FIGS. 2A and 2B schematically illustrate configurations of a device of the present invention in two embodiments thereof, respectively;

[0047] FIG. 3 illustrates a part of an inner ear where the device of the invention can be installed;

[0048] FIG. 4 exemplifies the device of the invention installed in the inner ear part illustrated in FIG. 3;

[0049] FIGS. 5A to 5D show several examples of the configuration of one of the fasteners of a fastening assembly suitable for use in the device of the invention;

[0050] FIG. 6 exemplifies another fastener suitable to be used in the fastening assembly in the device of the invention;

[0051] FIG. 7 shows an example of the device of the invention utilizing the fasteners of FIGS. 5D and 6;

[0052] FIG. 8 shows another example of the device of the invention; and

[0053] FIGS. 9A to 9C show three examples, respectively, of a hearing system utilizing the hearing aid device of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS

[0054] FIG. 1 shows a schematic representation of the ear, showing a region of bony tissue in the vicinity of cochlea. As will be exemplified further below, the hearing aid of the present invention is configured for attachment to the bony tissue in the vicinity of cochlea so as to directly vibrate the cochlea.

[0055] Reference is made to FIGS. 2A and 2B showing, by way of a block diagram, two examples of the configuration of a hearing aid device, generally designated 1, of the present invention. To facilitate illustration and understanding, the same reference numbers are used for identifying components that are common in all the examples of the invention.

[0056] The device 1 includes a deformable member 2 and a fastening assembly 4 that carries the deformable member 2, e.g. the deformable member is attached to the fastening assembly. The deformable member 2 is configured for changing its dimension, i.e. contracting and expanding, in response to an applied external field, e.g. electric field. Typically, the deformable member 2 is configured as or includes a piezoelectric element/structure. The piezoelectric element/structure may be of any suitable configuration; such elements are known per se and therefore need not to be described in details. The fastening assembly 4 is configured for rigidly coupling to a bony tissue in the vicinity of cochlea.

[0057] The device of the present invention is connectable (via wires or wireless signal transmission) to an electronic system 9 which is configured and operable to convert input sound signals (signal profile) into corresponding profile/variations of a field (e.g. electric field/voltage) applied to the deformable member 2. As a result, contraction and expansion of said deformable member directly stimulate vibrations of the cochlea.

[0058] It should be understood, although not specifically shown, that the electronic system 9 may be formed by a single unit, or the functional elements of the electronic system may be distributed in separate units connected between them via wires or wireless signal transmission. For example, a microphone may be associated with an external part of the electronic system and is configured to be attachable to the ear, while some or all other components of the electronic system are associated with another, internal part located inside the middle ear. The electronic system 9 thus includes a microphone 9A that receives sound pressure waves and generates electric output indicative thereof; and an amplifier 9C. Preferably, the electronic system 9 also includes a signal processor 9B which may for example be configured (preprogrammed) for providing a desired spectral profile of the signal, e.g. may include an equalizer utility. The electronic system 9 may be configured for wire-based or wireless transmission of the electric field/signal to the deformable member 2 to cause the deformation profile thereof which, in turn, will cause the vibration of cochlea.

[0059] Generally, the fastening assembly 4 is configured for rigidly coupling the deformable member 2 to first and second distant portions of the bony tissue in the vicinity of cochlea.

[0060] In some embodiments, the contraction and expansion of the deformable member 2 will thus cause a movement of at least one of the first and second distant portions towards and away from the other presenting a vibration movement. As shown, in the example of FIG. 2A, such fastening assembly 4 includes two fastening units 6 and 8, where one of them (unit 6), being referred to at times as anchoring unit or anchoring fastener, is associated with a first side/facet 2A of the deformable member 2, and the other (unit 8), being referred to at times as a mating unit or mating fastener, is associated with a second opposite side/facet 2B of the deformable member 2.

[0061] More specifically, the anchoring unit 6 is by its first end 6A rigidly coupled to the facet 2A of the deformable member 2, and by second opposite end 6B is rigidly coupled to the respective portion of the bony tissue. The mating fastener 8 may also be configured with two opposites sides attached to respectively the facet 2B of the deformable member 2 and the respective portion of the bony tissue; or as will be exemplified below may be constituted by gluing structure for directly gluing/bonding the deformable member to the bony tissue. When the actuating field is being applied to the deformable member 2, it contracts and expands along a deformation axis AD connecting the first and second sides 2A and 2B of the deformable member, which in turn causes movement/displacement of the fastening assembly resulting in corresponding vibrations of the cochlea to which the fastening assembly is directly coupled.

[0062] In some other embodiments, as exemplified in FIG. 2B, the fastening assembly 4 includes an integral element which is by its opposite ends 4A and 4B connectable to the first and second portions of the bony tissue, which are first and second spaced-apart portions of the cochlea. The deformable member 2 is by its one side/facet 2A connected to an intermediate portion 4C of the integral element. As will be described below, the intermediate portion is curved (convex) forming a groove in which the deformable member is located, such that its outer side/facet (side 2B not seen in the view of FIG. 2B) is intended to contact the cochlea. As will be described more specifically further below, such integral element may be configured as a rigid bridge-like member configured for rigid coupling to the distant portions of the cochlea. Thus, when the device is installed in place (i.e. the member 4 is by its opposite ends 4A and 4B rigidly coupled to cochlea), its opposite second side directly contacts/interacts with a cochlea region between the first and second portions thereof. When the actuating field is being applied to the deformable member 2, it contracts and expands along a deformation axis AD (through the figure) connecting the first and second sides 2A and 2B of the deformable member thus directly causing corresponding vibrations of the cochlea.

[0063] Referring now to FIGS. 3 and 4, there is exemplified how the device of the invention can be installed in the bony tissue in the vicinity of the cochlea, e.g. at the region of attic bone. FIG. 3 is a general illustration of such a region of the ear in the vicinity of cochlea. In this example, target surfaces for attachment of the device of the invention include a base surface (first portion of the bony tissue) 10 being constituted by the attic bone, and other target surface (second portion of the bony tissue) 11 being constituted by promontorium of the cochlea.

[0064] FIG. 4 schematically shows the ear portion of FIG. 3 together with the device of the invention attached to it. In this example, the device 10 is configured according to the embodiment of FIG. 2A, namely including a two-part fastening assembly, where the first part (anchoring unit) 6 is rigidly coupled to the deformable member at one side thereof and at the other side is connectable to the attic bone 10, while the second part (mating unit) 8 is rigidly coupled to the deformable member at the opposite side thereof and connectable to the promontorium 11. In this specific not limiting example, the fastening part 8 is constituted by bio-compatible cement 25 that directly bonds the deformable member 2 to the promontorium 11. On the other side, the deformable member is rigidly coupled to a screw type anchoring structure 6 also by cement 23. The screw is inserted into the attic bone, e.g. using a pin inserted into a hole 22 in the screw for rotating it, thus changing a length of the screw inserted into the bone which may also be used to adjust the device length to different patients ears. The promontorium bony issue is more compliant than the attic bone, and therefore, when the device is rigidly attached to both surfaces of the promontorium and of the attic bone, most of the translation of the device will cause the surface of the promontorium to vibrate/oscillate, and, in turn, the fluid inside the cochlea and the entire inner ear capsule will vibrate.

[0065] FIGS. 5A to 5C show some specific non-limiting examples of the configuration of a mating unit 8 which is attachable to the deformable member 2 and the curved surface of the bony tissue such as promontorium.

[0066] In these examples, the mating unit 8 is configured as a structure 30 having one flat surface 32 that can be bonded to the flat surface of the deformable member at the respective side thereof, and an opposite curved surface 34 by which the structure 30 is coupled to the bony tissue. In the examples of FIGS. 5A and 5B, the curved surface 34 has a pattern (surface relief) in the form of an array of spaced-apart protrusions 35. The surface with protrusions may be attached to the promontorium so as to prevent lateral movement of the fastening assembly on the promontorium's surface.

[0067] In the example of FIG. 5A, the protrusions have sharp tips that can be pushed into the surface of the promontorium or into a niche carved in it, with or without bonding cement in between. In the example of FIG. 5B, the protrusions 35 are in the form of pins (having substantially flat upper surface) instead of sharp protrusions. In this case, small shallow round cutouts may be made in the promontorium, for example using a stencil with holes in the correct locations. The mating surface (patterned surface) may then be attached or bonded to the promontorium.

[0068] In the example of FIG. 5C the mating structure 30 which is designed to be directly bonded by bio-compatible cement to the promontorium surface, has a curved surface 34 where in order to make the bonding stronger, curvature of the surface 34 matches that of the promontorium in the target region.

[0069] It should be appreciated that the opposite substantially planar surface 32 of any mating structure 30 may be machined to improve its attachment to the deformable member. For example, surface 32 may have a small cutout or recess (machined into it) so as to accept the respective side of the deformable member. This is exemplified in FIG. 5D. In this specific not-limiting example, the mating structure 30 having the curved surface with pins 35 (example of FIG. 5B) is illustrated, but it should be understood that the configuration of the mating unit is not limited to this specific example, as well as to any one of the above-described examples. As shown in the figure, the opposite surface 32 has a cutout 36 designed to accept the respective side of the deformable member.

[0070] Reference is made to FIG. 6 showing a schematic representation of an example of the configuration of an anchoring unit 6 by which the deformable member is coupled to the other bony tissue in the vicinity of the cochlea, e.g. to the attic bone. In this non-limiting example, the anchoring unit 6 has a screw type anchoring structure 60 for attachment to a bone.

[0071] More specifically, in this example, the anchoring structure 60 has a head portion 64 and a leg, screw portion 62 interconnected by an intermediate portion 65. The head portion 64 has a surface 61 (representing the end portion 6A in FIG. 2A) designed to be attached to the respective side of the deformable member. To this end, the surface 61 has a machined cutout that matches the shape of the respective side of the deformable member. The screw portion 62 (representing the end portion 6B in FIG. 2A) is configured for attachment to the bony tissue. The intermediate portion 65 has a connecting port (hole) 63 that may be used to accept a tool that can assist in turning the screw precisely in order to insert in into the bone and also adjust the length to the ear of the specific patient.

[0072] It should be noted that screw type anchoring units may be used for coupling to the promontorium bone and/or the opposite bone. In this case, the screw portion that should fit to the promontorium should be smaller, and preferably, not pass thought the wall into the ear fluid.

[0073] FIG. 7 schematically illustrates a specific example of the construction of the hearing aid device 1 of the present invention for direct cochlea vibratory stimulation. For sake of clarity, the parts are shown offset from one another. In this non-limiting example, the fastening unit (mating unit) 8 has a pin type anchoring structure 30 (similar to that of FIG. 5B) having a patterned surface 34 with protrusions 35 for attachment to the bony tissue and has a planar surface 32 bonded to the deformable member 2 at facet 2B thereof. Further, in this non-limiting example, the fastening unit (anchoring unit) 6 is configured as that of FIG. 6 described above, namely has an anchoring structure 60, which by its head portion 64 (surface 61) carries the deformable member 3. Also, in this non-limiting example, the deformable member 2 is connected by wires to the electronic system (not shown) to receive the actuating signal/field.

[0074] In this specific example, the implant procedure may be as follows:

[0075] 1. Bore shallow cutouts in the target region on the promontorium, for example by using a stencil in order to precisely locate the cutouts to match the locations of the pin protrusions 35.

[0076] 2. Bond the mating structure 30 to the deformable member 2.

[0077] 3. Screw the anchoring structure 60 into the bone on the opposite target surface on the promontorium. Insert it more than required so as to leave space for inserting the deformable member 2 and the mating unit attached thereto.

[0078] 4. Bond the assembly to the promontorium surface while inserting pins 35 into the corresponding cutouts on the promontorium surface.

[0079] 5. Apply bio-compatible cement to the free side of the deformable member 2.

[0080] 6. Unscrew the anchoring structure 60 from the bone until the gap between it and the deformable member 2 is closed.

[0081] 7. Attach the wires 70 to either external signal source or to a wireless driver circuit implanted in the middle ear.

[0082] Reference is made to FIG. 8 showing a specific but not limiting example of the device 1 of the present invention configured and operable according to the embodiment of FIG. 2B, namely including a fastening assembly 4 having an integral element which is by its opposite ends 4A and 4B connectable to the first and second portions of the bony tissue, which may be first and second spaced-apart portions of the promontorium or another part of the cochlea. The deformable member 2 is by its one side/facet 2A connected to an intermediate curved portion 4C of the integral element. As shown, the element 4 is configured as a rigid (metallic) bridge-like member rigidly coupled to the distant portions of the promontorium or another part of the cochlea. For sake of simplicity, the screws that may be used for attaching the bridge to the bony tissue are not shown here. The intermediate portion 4C has a geometry forming a recess in which the deformable member 2 is located within a gap between the inner surface of the portion 4C and the cochlea. It should be noted that the recess is preferably much larger than the size of the deformable member, to thereby increase efficiency of the vibration transfer to the cochlea. The deformable member 2 by its one side/facet 2A is connected to the portion 4C and by its opposite side/facet 2B contacts the cochlea. When the actuating field is being applied to the deformable member 2, it expands and contracts towards and away from the cochlea thus directly causing corresponding vibrations of the cochlea.

[0083] It is preferable to manufacture all the metallic parts used in the device from non-magnetic metal(s), such as Titanium, so as to make it possible for a patient having this device installed to pass medical examinations that involve high magnetic fields such as MRI.

[0084] Reference is now made to FIGS. 9A to 9C showing by way of block diagrams, several examples of the operation of a system utilizing a cochlea stimulation device 102 and an electronic system 9.

[0085] In the examples of FIGS. 9A and 9B, the system 100 is designed for both direct cochlea vibratory stimulation and electrical cochlear stimulation for the hearing impaired. To this end, the stimulation device 102 includes the hearing aid device 1 of the present invention configured for direct cochlea vibratory stimulation, and a direct cochlea electrical stimulation device 104 that may include one or more implanted electrodes.

[0086] The electronic system 9 includes a microphone 9A, which preferably is to be placed in an ear canal thereby providing a user with spatial perception of the incoming sound source. The electronic system 9 also includes a signal processor 9B (configured as described above) which in this example includes a spectral (frequency) splitter utility 106 that may (or may not) be integrated with an amplifier. The spectral (frequency) splitter operates for spectrally splitting the received signal into two selected spectral ranges, which may be tunable as well as may be overlapping to a certain (e.g. tunable) degree. Signals of one spectral range are selected to meet the requirements of the direct cochlea vibratory stimulation device 1 for a specific patient, and the other spectral range is selected to meet the requirements of the direct cochlea electrical stimulation device (cochlear implant) 104 for said patient. In the example of FIG. 9A, the spectral splitter 106 may include an amplifier and its input and output are connected to respectively the output of the microphone and the stimulation devices 1 and 104 by wires 96 that may protrude through the bone next to an ear 95.

[0087] In the example of FIG. 9B, signal transfer between the modules/utilities of the electronic system 9 located in the outer ear and those in the middle and inner ear is performed in a wireless manner. The electronic system 9 includes a microphone 9A, preferably placed in the ear canal, which may be attached to an external (outside the body) signal splitter 106 (possibly utilizing or being a part of the amplifier 9B) which separates the sound signal into two spectral ranges selected as described above and which includes an appropriate wireless transmission utility (e.g. RF transmission). The external spectral splitter 106 may also be configured for encoding the RF signals in both spectral ranges. The electronic system 106 is associated (communicates) with external antennas which communicate one with another and further antenna 105 that communicates with an internal unit 107 (located in the middle ear) that receives the RF signal and directs portions thereof of the different spectral ranges, by wires 96, to the respective stimulation devices 1 and 104. The electric power supply to the internal unit 107 can be provided by batteries or by wireless energy transfer techniques as known in the art. The power transmitting and receiving circuits may be integrated into one or both of the external unit 106 and internal unit 107 or may be associated with a separate device.

[0088] FIG. 9C shows a system 100 configured for direct cochlea vibratory stimulation. The system 100 includes a hearing aid device 1 of the present invention and an electronic system 9, where the latter is configured generally similar to the above-described system of FIG. 9B, namely in which the connection between the modules/utilities of the electronic system located in the outer ear and middle ear is performed in a wireless manner. The microphone 9A is preferably placed in the ear canal, and is attached to an external unit 111 of the electronic system 9 which may include an amplifier and/or may be configured for modulating the parameters (e.g. frequency) of the microphone signal to meet the requirements of the direct cochlea vibratory stimulation device 1 for a specific patient. Also, the external unit 111 is configured for wireless (e.g. RF) communication with the microphone and an external antenna 108, and accordingly includes appropriate signal formatting utility). The external antenna 108 in turn communicates with an internal antenna (receiver) 105 for communicating the RF presentation of the microphone output to an internal unit 107 that receives the RF signal and creates a corresponding electrical signal to be fed by wires 96 into the stimulation device 1 for actuating deformation of the piezoelectric deformable member (e.g. stack) as described above. Similarly to the above-described example, the internal unit 107 may include batteries or may be configured for wireless energy transfer from the surroundings/external devices. The power transmitting and receiving circuits may be integrated in one or both of the external unit 111 and internal unit 107 and/or in a separate device and the same antennae may be used for transmitting power into the inner ear parts.

[0089] It should be understood, although not specifically illustrated that the device of FIG. 9C can be easily modified to utilize wire-based signal transmission. In this case, there is no need for antenna units.