Patent Publication Number: US-8986187-B2

Title: Optically coupled cochlear actuator systems and methods

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS 
     The present patent application is a continuation of and claims priority to U.S. patent application Ser. No. 12/822,801 filed 24 Jun. 2010, entitled “Optically Coupled Cochlear Actuator Systems and Methods”, which is a non-provisional of and claims priority to U.S. Pat. App. Ser. No. 61/219,861 filed 24 Jun. 2009, entitled “Optically Coupled Cochlear Actuator Systems and Methods”, the full disclosures of which are incorporated herein by reference. 
    
    
     STATEMENT AS TO RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT 
     NOT APPLICABLE 
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention is related to hearing systems, devices and methods. Although specific reference is made to hearing aid systems, embodiments of the present invention can be used in many applications in which a signal is used to stimulate the ear. 
     People like to hear. Hearing allows people to listen to and understand others. Natural hearing can include spatial cues that allow a user to hear a speaker, even when background noise is present. People also like to communicate with those who are far away, such as with cellular phones. 
     Hearing devices can be used with communication systems to help the hearing impaired and to help people communicate with others who are far away. At least some hearing impaired people have a mixed hearing loss. With mixed hearing loss, a person may have a conductive hearing loss that occurs in combination with a sensorineural hearing loss. The conductive hearing loss may be due to diminished function of the conductive components of the ear such as the eardrum and ossicles that transmit sound from the ear canal to the cochlea. The sensorineural hearing loss may comprise diminished function of the cochlea, such that the cochlea does not convert sound waves to neural impulses as effectively as would be ideal. 
     Many of the prior therapies for mixed hearing loss and sensorineural hearing loss are less than ideal in at least some instances. One approach has been to replace, at least partially, one or more of the ossicles of the middle ear with an ossicular replacement prosthesis. Although the ossicular replacement prosthesis can improve the conductive portion of the mixed hearing loss, such treatment may leave the patient with diminished hearing due to the remaining sensorineural hearing loss in at least some instances. Another approach has been to use bone conduction of sound with a bone-anchored hearing aid (hereinafter “BAHA™”). However, bone conduction based hearing devices may not offer sound localization to the user in at least some instances, such that at least some people may not be able localize the source of sound in at least some instances. This lack of sound localization may make hearing difficult for the user in at least some instances. Also, such bone anchoring can be somewhat invasive and may require the user to clean the device in at least some instances. 
     Prior acoustic hearing devices such as conventional in the ear or behind the ear hearing aids can cause feedback at high frequencies such that sound localization cues may not be present with such devices in at least some instances. Although a magnet coupled to the eardrum can result in decreased feedback, such devices can be susceptible to user perceivable noise, for example humming, in the presence of electromagnetic fields in at least some instances. Although optically coupled hearing devices have been proposed, optical coupling can result in user perceptible distortion of the signal in at least some instances that may be related to non-linearities of the optical coupling. 
     For the above reasons, it would be desirable to provide hearing systems which at least decrease, or even avoid, at least some of the above mentioned limitations of the current prosthetic devices. For example, there is a need to provide a hearing prosthesis which provides hearing with natural qualities, for example with spatial information cues, and which allow the user to hear with less occlusion, distortion and feedback than current devices. 
     2. Description of the Background Art 
     Patents and publications that may be relevant to the present application include: U.S. Pat. Nos. 3,585,416; 3,764,748; 3,882,285; 4,498,461; 5,142,186; 5,360,388; 5,554,096; 5,624,376; 5,795,287; 5,800,336; 5,825,122; 5,857,958; 5,859,916; 5,888,187; 5,897,486; 5,913,815; 5,949,895; 6,005,955; 6,068,590; 6,093,144; 6,139,488; 6,174,278; 6,190,305; 6,208,445; 6,217,508; 6,222,302; 6,241,767; 6,422,991; 6,475,134; 6,519,376; 6,554,761; 6,620,110; 6,626,822; 6,676,592; 6,629,922; 6,728,024; 6,735,318; 6,900,926; 6,920,340; 7,072,475; 7,095,981; 7,239,069; 7,289,639; D512,979; 2002/0086715; 2003/0142841; 2004/0234092; 2005/0020873; 2006/0107744; 2006/0233398; 2006/075175; 2007/0083078; 2007/0191673; 2008/0021518; 2008/0107292; commonly owned U.S. Pat. Nos. 5,259,032; 5,276,910; 5,425,104; 5,804,109; 6,084,975; 6,554,761; 6,629,922; U.S. Publication Nos. 2006/0023908; 2006/0189841; 2006/0251278; and 2007/0100197. Non-U.S. patents and publications that may be relevant include EP1845919 PCT Publication Nos. WO 03/063542; WO 2006/075175; U.S. Publication Nos. Journal publications that may be relevant include: Ayatollahi et al., “Design and Modeling of Micromachines Condenser MEMS Loudspeaker using Permanent Magnet Neodymium-Iron-Boron (Nd—Fe—B)”, ISCE, Kuala Lampur, 2006; Birch et al, “Microengineered Systems for the Hearing Impaired”, IEE, London, 1996; Cheng et al., “A silicon microspeaker for hearing instruments”, J. Micromech. Microeng., 14 (2004) 859-866; Yi et al., “Piezoelectric microspeaker with compressive nitride diaphragm”, IEEE, 2006, and Zhigang Wang et al., “Preliminary Assessment of Remote Photoelectric Excitation of an Actuator for a Hearing Implant”, IEEE Engineering in Medicine and Biology 27th Annual Conference, Shanghai, China, Sep. 1-4, 2005. Other publications of interest include: Gennum GA3280 Preliminary Data Sheet, “Voyager TDTM. Open Platform DSP System for Ultra Low Power Audio Processing” and National Semiconductor LM4673 Data Sheet, “LM4673 Filterless, 2.65 W, Mono, Class D audio Power Amplifier”; Puria, S. et al., Middle ear morphometry from cadaveric temporal bone micro CT imaging, Invited Talk. MEMRO 2006, Zurich; Puria, S. et al, A gear in the middle ear ARO 2007, Baltimore, Md.; and Lee et al., “The Optimal Magnetic Force For A Novel Actuator Coupled to the Tympanic Membrane: A Finite Element Analysis,” Biomedical Engineering: Applications, Basis and Communications, Vol. 19, No. 3(171-177), 2007. 
     For the above reasons, it would be desirable to provide hearing systems which at least decrease, or even avoid, at least some of the above mentioned limitations of the prior hearing devices. For example, there is a need to provide a comfortable hearing device which provides hearing with natural qualities, for example with spatial information cues to people with mixed hearing loss, and which allows the user to hear with less occlusion, distortion and feedback than prior devices. 
     BRIEF SUMMARY OF THE INVENTION 
     Embodiments of the present invention provide improved systems devices and methods that overcome at least some of the limitations of the prior hearing devices. Embodiments of the present invention can improve the hearing of people with conductive hearing loss, sensorineural hearing loss and mixed hearing loss. The embodiments described herein can be particularly well suited for use with patients having mixed hearing loss, for example where the conductive component loss is due to otosclerosis. At least some embodiments comprise coupling of healthy ears to communication devices, for example for cell phone calls and entertainment. 
     In many embodiments, a transducer is configured to couple to the cochlear fluid so as to transmit sound with less energy than prior devices so as to improve hearing. The transducer can vibrate the fluid of the cochlea with substantially less energy, such that feed back to a microphone positioned in the ear canal is inhibited substantially. The cochlear fluid coupled hearing device can allow a user to determine from which side a sound originates with vibration of the cochlea and the user can also receive sound localization cues from the device, as feedback can be substantially inhibited. The transducer may be coupled to the cochlear fluid with a thin membrane disposed between the transducer and the cochlear fluid, for example with a fenestration in the cochlea. In some embodiments, a support coupled to the transducer directly contacts the fluid of the cochlea so as to improve coupling. Alternatively or in combination, the transducer may couple to a foot plate of the stapes. For example, the transducer may couple to a support that extends through a fenestration in the footplate of the stapes. An output transducer assembly can be positioned on a first side of the user to vibrate a first cochlear fluid near a first cochlea with a first amount of energy, such vibration of a second cochlea on a second side with a second amount of energy is attenuated substantially, for example at least about 6 db, such that the user can localize the sound to the first side. For example, a microphone may be located on the first side and coupled to the output transducer assembly to vibrate the first cochlea with the first energy and the second cochlea with the second energy, such that the user localizes the sound to the first side. The microphone may be placed in an ear canal of the first side, or outside the ear canal and within about 5 mm of the ear canal opening, such that the microphone can detect sound localization cues diffracted from the pinna, for example, and comprising frequencies of at least about 4 kHz, for example from about 4 kHz to 15 kHz. The first output transducer assembly can vibrate the first cochlea such that the user can determine a location of the sound on the first side with the sound localization cues. In many embodiments, a hearing system comprises a first output assembly on the first side and the second output assembly on the second side. 
     In a first aspect, embodiments of the present invention provide a device to transmit a sound to a user having a middle ear and a cochlea comprising a cochlear fluid. An input assembly is configured to receive a sound input. An output assembly comprises a transducer configured to couple to the cochlear fluid to transmit the sound to the user. 
     In many embodiments, the output assembly is configured to couple to the cochlear fluid with a support configured to contact the cochlear fluid. The support can be configured to contact the cochlear fluid with a fenestration formed in at least one of cochlear bone tissue or a footplate of the stapes. The support may comprise a rigid material, for example, sized to fit within the fenestration formed in the stapes, and the rigid material may comprise a biocompatible material configured to integrate with bone tissue of the stapes. The support may comprise a length and a width, and the width can be sized to fit a diameter of the fenestration. The length can be sized to extend at least across a thickness of the foot plate of the stapes from the middle ear to an oval window of the cochlea. 
     In many embodiments, the support comprises a thin flexible membrane configured to extend across the fenestration to seal the cochlea and vibrate the cochlear fluid. 
     In many embodiments, the transducer comprises at least one of a coil, a magnet, the coil and the magnet, a piezoelectric transducer, a photostrictive transducer, a magnetostrictive transducer or a balanced armature transducer. For example, the transducer may comprise the balanced armature transducer, and the balanced armature transducer can be configured for placement on a promontory of the user. The balanced armature transducer is configured to couple to a footplate of the stapes with a structure extending substantially from the balance armature transducer to the footplate of the stapes. 
     In many embodiments, the transducer comprises the magnet and the coil, and the magnet is configured to couple to a flexible support in contact with the cochlear fluid to vibrate the cochlea fluid. 
     In many embodiments, the input assembly is configured to transmit an electromagnetic signal to the output transducer assembly to vibrate the cochlear fluid in response to the sound input. The electromagnetic signal may comprise a magnetic field from a coil, and the output transducer assembly may comprise a magnet configured to vibrate the cochlear fluid in response to the magnetic field from the coil. The coil can be configured for placement in an ear canal of the user. 
     In many embodiments, the electromagnetic signal comprises light energy and the input assembly comprises at least one light source configured to emit the light energy. The output assembly may comprise at least one photodetector to receive the light energy, in which the photodetector is coupled to the transducer to vibrate the cochlear fluid in response to the light energy. The at least one photodetector may comprise at least one of photovoltaic material. The at least one photovoltaic material may comprise crystalline silicon, amorphous silicon, micromorphous silicon, black silicon, cadmium telluride, copper indium gallium selenide or indium gallium arsenide. 
     In many embodiments, the at least one photodetector comprises at least two photo detectors. The at least two photodetectors can be coupled to the transducer with an opposite polarity. 
     In another aspect, embodiments provide a method of transmitting a sound to a user having a middle ear and a cochlea comprising a cochlear fluid. A sound input is received with an input assembly. The cochlear fluid is vibrated with a transducer coupled to the cochlear fluid in response to the sound input to transmit the sound to the user. 
     In many embodiments, a support coupled to the cochlear fluid contacts the cochlear fluid and the support vibrates in response to the sound input to transmit the sound to the user. 
     The method of transmitting sound to the user may comprise using one or more of the components of an assembly as described herein in accordance with the function of the component as described herein so as to transmit the sound to the user. 
     In another aspect, embodiments provide a device for implantation in a middle ear of a user, the middle ear having a stapes. The device comprises a housing, a transducer and an expandable structure. The transducer is configured to vibrate the stapes, and the transducer is contained at least partially within the housing. The expandable structure is disposed on a portion of the housing, and the expandable structure and the housing are sized for placement at least partially between crura of the stapes to couple the transducer to the stapes. 
     In many embodiments, at least a portion of the housing is sized to contact a footplate of the stapes when the expandable structure and the housing are positioned at least partially between the crura. The expandable structure can be configured to contact the stapes between the crura. 
     In many embodiments, expandable structure comprises at least one of an expandable material, a spring, a sponge, a water absorbent material or a hydrogel. 
     In many embodiments, at least one photodetector is coupled to the transducer to vibrate the stapes. The at least one photodetector can be electrically coupled to the transducer with an electrical conductor sized to position the at least one photodetector on the promontory when the expandable material and the housing are positioned at least partially between the crura. 
     In many embodiments, the transducer comprises at least one of a coil, a magnet, the coil and the magnet, a piezoelectric transducer, a photostrictive transducer or a balanced armature transducer. For example, the transducer may comprise the coil and the magnet, and the coil and the magnet can be sized for placement at least partially between the crura. 
     In many embodiments, the transducer comprises the magnet and the magnet is sized for placement at least partially between the crura, and the coil is sized for placement in an ear canal of the user. 
     In another aspect, embodiments provide a method of implanting a device in a middle ear of a user, in which the middle ear has a stapes. An assembly is provided comprising an expandable structure, a housing and a transducer contained at least partially within the housing. The assembly is placed at least partially within crura of the stapes such that the expandable structure contacts the stapes to couple the transducer to the stapes. 
     The method comprises implanting one or more of the components of an assembly as described herein in accordance with the function of the component as described herein so as to transmit the sound to the user. 
     In another aspect, embodiments provide a device to transmit a sound to a user having a middle ear and a cochlea comprising a cochlear fluid. The device comprises an input assembly means for receiving a sound input, and an output assembly means for coupling to the input assembly means and for transmitting the sound to the user. The means for receiving the sound input may comprise one or more of the components of the input assembly as described herein. The means for coupling to the input assembly means and for transmitting the sound to the user may comprise one or more components of the output assembly so as to couple to the input assembly and transmit the sound to the user. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  shows a cochlear fluid vibration hearing system configured to provide sound localization cues to the user; 
         FIG. 1A  shows an open canal hearing system comprising a BTE unit and a transducer coupled to a round window of a user with a support, in accordance with embodiments of the present invention; 
       FIG.  1 A 1  shows a hearing system comprising an ear canal module and a transducer coupled to a round window of a user with a support, in accordance with embodiments of the present invention; 
       FIGS.  1 B 1  and  1 B 2  show a schematic illustration of the transducer of the output transducer assembly coupled to the cochlear fluid with a support, in accordance with embodiments of the present invention; 
         FIG. 2A  shows a schematic illustration of a transducer assembly with a support coupled to cochlear fluid with a fenestration in the cochlear bone, in accordance with embodiments of the present invention; 
       FIG.  2 A 1  shows a schematic illustration of a transducer assembly as in  FIG. 2A  in which the support comprises a structure extending from an upper surface of the cochlear bone into the fenestra to couple to the endostium, in accordance with embodiments of the present invention; 
         FIG. 2B  shows a schematic illustration of a transducer assembly comprising a magnet with a biocompatible housing positioned on a support in contact with cochlear fluid to couple the magnet to the cochlea; 
       FIG.  2 B 1  shows a magnet comprising a pair of opposing magnets suitable for use with many transducers as described herein, in accordance with embodiments; 
         FIG. 3A  shows a transducer assembly comprising an expandable structure positioned at least partially between crura of the stapes, in accordance with embodiments of the present invention; 
         FIG. 3B  shows transducer assembly of  FIG. 3A  configured for placement at least partially between the crura of the stapes; and 
         FIG. 4  shows a method of transmitting sound to a user with side specificity and sound localization cues, in accordance with embodiments of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     As used herein light encompasses infrared light, visible light and ultraviolet light. 
     Embodiments of the present invention can be used with many users to transmit many sounds. Examples of people who can benefit from the hearing devices described herein include people with conductive hearing loss, sensorineural hearing loss and mixed hearing loss. For example, people with mixed hearing loss can benefit from improved hearing with stereo sound based on bone conduction and sound localization cues based bone conduction. People with sensorineural hearing loss can receive sound localization cues, for example with frequencies above 4 kHz. The devices described herein can be integrated with communications devices, for example for cell phone calls and entertainment, with people who have healthy hearing. 
       FIG. 1  shows a cochlea actuated hearing system  10  configured to provide sound to a user U with fluidic coupling to the cochlea. The system  10  is configured to provide stereo sound based on cochlear fluid coupling and localization cues based on cochlear fluid vibration. The user has a midline M, a first side Si with a first ear E1, and a second side Si with a second ear E1. Ear E1 has a first pinna P1 and ear E2 has a second pinna E2. The first side is disposed opposite the second side. 
     In many embodiments, hearing system  10  comprises a binaural hearing system a first hearing system  10 A on first side S1 and a second hearing system  10 B on a second side S2. However in some embodiments, the user may use only one hearing system, for example a user with one healthy hearing side and an opposite side having compromised hearing such as sensorineural hearing loss. First system  10 A comprises a first input assembly  20 A, and a first microphone  22 A. The first input assembly may comprise a first behind the ear unit (hereinafter “BTE”), for example. First microphone  22 A is shown positioned near a first ear canal opening of first ear E1. Second system  10 B comprises a second input assembly  20 B, and a second microphone  22 B. The second input assembly may comprise second circuitry such as a BTE unit. The second microphone  22 B is shown positioned near a second ear canal opening for second ear E2. 
     A first output transducer assembly  30 A and a second output transducer assembly  30 B are positioned on the first side S1 and second side S2, respectively, such that the user can localize sound to the first side S1 or the second side S2. First output transducer assembly  30 A is positioned on side S1 near a first cochlea of the first side, and coupled to the first input transducer assembly. For example, the first output transducer assembly may be coupled to first mastoid bone or first cochlear bone of the first side of the user so as to vibrate the first cochlea CO1 on the first side with a first amount of energy. Second output transducer assembly  30 B is positioned on side S2 near a second cochlea of the second side, and coupled to the first second input transducer assembly. For example, the second output transducer assembly may be coupled to mastoid bone or cochlear bone of the user on the second side so as to vibrate the second cochlea CO2 on the second side with a third amount of energy. The acoustic vibration from the second output assembly can cross the midline M and vibrate the second cochlea CO2 with a fourth amount of energy. The tissue of the user disposed between the second output transducer assembly and the first cochlea can attenuate the acoustic vibration substantially, and the fourth amount of energy can be substantially less than the third amount of energy, for example at least about 6 dB, such that the user can localize the sound to the second side. With such a configuration, the user can perceive sounds in stereo. 
     In addition to providing localization of the sound to the first side or the second side, the first system  10 A and the second system  10 B can be configured to provide sound localization cues to the user, such that the user can localize the sound to a location within the first side or the second side. A speaker SPK is shown emitting a sound. The sound has a first path SO1 to the first ear E1 and a second path SO2 to the second ear E1. The first pinna can diffract the sound received on first path SO1 so as to provide first spatial localization cue with high frequencies, for example with frequencies above at least about 4 kHz. For example, the first system  10 A can transmit sound frequencies within a range from about 60 Hz to at least about 15 kHz, for example up to 20 kHz or more. The second pinna can diffract the sound received on second path SO2 so as to provide second spatial localization cue with high frequencies, for example with frequencies above at least about 4 kHz. For example, the second system  10 B can transmit sound frequencies within a range from about 60 Hz to about 15 kHz, for example from about 60 Hz to about 20 kHz or more. 
       FIG. 1A  shows an open canal hearing system  10 , which may comprise components of first system  10 A or second system  10 B. The hearing system  10  comprises an input assembly  20  and an output assembly  30 . The input assembly  20  may comprise a behind the ear (hereinafter “BTE”) unit. The output assembly  30  comprises a transducer  32  coupled to bone tissue to transmit the sound to the user. 
     In many embodiments, the hearing device comprises a photonic hearing device, in which sound is transmitted with photons having energy, such that the signal transmitted to the ear can be encoded with transmitted light. 
     Hearing system  10  is configured to transmit electromagnetic energy to an output transducer assembly  30  positioned in the middle ear ME of the user. The ear comprises an external ear, a middle ear ME and an inner ear. The external ear comprises a Pinna P and an ear canal EC and is bounded medially by an eardrum TM. Ear canal EC extends medially from pinna P to eardrum TM. Ear canal EC is at least partially defined by a skin SK disposed along the surface of the ear canal. The eardrum TM comprises an annulus TMA that extends circumferentially around a majority of the eardrum to hold the eardrum in place. The middle ear ME is disposed between eardrum TM of the ear and a cochlea CO of the ear. The middle ear ME comprises the ossicles OS to couple the eardrum TM to cochlea CO. The ossicles OS comprise an incus IN, a malleus ML and a stapes ST. The malleus ML is connected to the eardrum TM and the stapes ST is connected to an oval window OW, with the incus IN disposed between the malleus ML and stapes ST. Stapes ST is coupled to the oval window OW so as to conduct sound from the middle ear to the cochlea. 
     The hearing system  10  includes an input transducer assembly  20  and an output transducer assembly  30  to transmit sound to the user. The BTE unit may comprise many components of system  10  such as a speech processor, battery, wireless transmission circuitry and input transducer assembly  10 . Behind the ear unit BTE may comprise many component as described in U.S. Pat. Pub. Nos. 2007/0100197, entitled “Output transducers for hearing systems”; and 2006/0251278, entitled “Hearing system having improved high frequency response”, the full disclosures of which are incorporated herein by reference and may be suitable for combination in accordance with some embodiments of the present invention. The input transducer assembly  20  can be located at least partially behind the pinna P, although the input transducer assembly may be located at many sites. For example, the input transducer assembly may be located substantially within the ear canal, as described in U.S. Pub. No. 2006/0251278, the full disclosure of which is incorporated by reference. The input transducer assembly may comprise a blue tooth connection to couple to a cell phone and my comprise, for example, components of the commercially available Sound ID  300 , available from Sound ID of Palo Alto, Calif. 
     The input transducer assembly  20  can receive a sound input, for example an audio sound. With hearing aids for hearing impaired individuals, the input can be ambient sound. The input transducer assembly comprises at least one input transducer, for example a microphone  22 . Microphone  22  can be positioned in many locations such as behind the ear, as appropriate. Microphone  22  is shown positioned to detect spatial localization cues from the ambient sound, such that the user can determine where a speaker is located based on the transmitted sound. The pinna P of the ear can diffract sound waves toward the ear canal opening such that sound localization cues can be detected with frequencies above at least about 4 kHz. The sound localization cues can be detected when the microphone is positioned within ear canal EC and also when the microphone is positioned outside the ear canal EC and within about 5 mm of the ear canal opening. The at least one input transducer may comprise a second microphone located away from the ear canal and the ear canal opening, for example positioned on the behind the ear unit BTE. The input transducer assembly can include a suitable amplifier or other electronic interface. In some embodiments, the input may comprise an electronic sound signal from a sound producing or receiving device, such as a telephone, a cellular telephone, a Bluetooth connection, a radio, a digital audio unit, and the like. 
     In many embodiments, at least a first microphone can be positioned in an ear canal or near an opening of the ear canal to measure high frequency sound above at least about one 4 kHz comprising spatial localization cues. A second microphone can be positioned away from the ear canal and the ear canal opening to measure at least low frequency sound below about 4 kHz. This configuration may decrease feedback to the user, as described in U.S. Pat. Pub. No. US 2009/0097681, the full disclosure of which is incorporated herein by reference and may be suitable for combination in accordance with embodiments of the present invention. 
     Input transducer assembly  20  includes a signal output source  12  which may comprise a light source such as an LED or a laser diode, an electromagnet, an RF source, or the like. The signal output source can produce an output based on the sound input. Implantable output transducer assembly  30  can receive the output from input transducer assembly  20  and can produce mechanical vibrations in response. Implantable output transducer assembly  30  comprises a transducer and may comprise at least one of a coil, a magnet, a balanced armature, a magnetostrictive element, a photostrictive element, or a piezoelectric element, for example. For example, the implantable output transducer assembly  30  can be coupled an input transducer assembly  20  comprising an elongate flexible support having a coil supported thereon for insertion into the ear canal as described in U.S. Pat. Pub. No. 2009/0092271, entitled “Energy Delivery and Microphone Placement Methods for Improved Comfort in an Open Canal Hearing Aid”, the full disclosure of which is incorporated herein by reference and may be suitable for combination in accordance with some embodiments of the present invention. Alternatively or in combination, the input transducer assembly  20  may comprise a light source coupled to a fiber optic, for example as described in U.S. Pat. Pub. No. 2006/0189841 entitled, “Systems and Methods for Photo-Mechanical Hearing Transduction”, the full disclosure of which is incorporated herein by reference and may be suitable for combination in accordance with some embodiments of the present invention. The light source of the input transducer assembly  20  may also be positioned in the ear canal, and the output transducer assembly and the BTE circuitry components may be located within the ear canal so as to fit within the ear canal. When properly coupled to the subject&#39;s hearing transduction pathway, the mechanical vibrations caused by output transducer  30  can induce neural impulses in the subject which can be interpreted by the subject as the original sound input. 
     The implantable output transducer assembly  30  can be configured to couple to the cochlea of the inner ear in many ways, so as to induce neural impulses which can be interpreted as sound by the user. The coupling may occur with at least a portion of the transducer coupled to bone, for example affixed to bone, such that the vibration originates near the cochlea such that sound transmitted to a second cochlea is inhibited substantially by tissue as described above. The implantable output transducer assembly  30  can be supported with a substantially fixed structure of the ear, such that vibration of the vibratory structures of the ear is not inhibited by mass of assembly  30 . For example, output transducer assembly  30  may be supported on the promontory PM by a support, housing, mold, or the like shaped to conform with the shape of the promontory PM. The transducer assembly may be affixed with a tissue graft to skin supported with rigid bony structure that defines at least a portion of the ear canal. The transducer assembly  30  can be supported with many of the additional substantially fixed structures of the middle ear such as the bone that defines the round window niche. 
     FIG.  1 A 1  shows an input assembly  20  of system  10  comprising an ear canal module (hereinafter “ECM”). The ECM may comprise many of the components of the BTE unit and vice-versa. The ECM may be shaped from a mold of the user&#39;s ear canal EC. Circuitry (Circ.) can be coupled to microphone  22 . The circuitry may comprise a sound processor. The ECM may comprise an energy storage device PS configured to store electrical energy. The storage device may comprise many known storage devices such at least one of a battery, a rechargeable batter, a capacitor, a supercapacitor, or electrochemical double layer capacitor (EDLC). The ECM can be removed, for example for recharging or when the user sleeps. The ECM may comprise a channel  29  to pass air so as to decrease occlusion. Although air is passed through channel  29 , feedback can be decrease due to coupling of the transducer or electrode array directly to tissue. 
     The energy storage device PS may comprise a rechargeable energy storage device that can be recharged in many ways. For example, the energy storage device may be charged with a plug in connector coupled to a super capacitor for rapid charging. Alternatively, the energy storage device may be charged with an inductive coil or with a photodetector PV. The photodetector detector PV may be positioned on a proximal end of the ECM such that the photodetector is exposed to light entering the ear canal EC. The photodetector PV can be coupled to the energy storage device PS so as to charge the energy storage device PS. The photodetector may comprise many detectors, for example black silicone as described above. The rechargeable energy storage device can be provided merely for convenience, as the energy storage device PS may comprise batteries that the user can replace when the ECM is removed from ear canal. 
     The photodetector PV may comprise at least one photovoltaic material such as crystalline silicon, amorphous silicon, micromorphous silicon, black silicon, cadmium telluride, copper indium gallium selenide, and the like. In some embodiments, the photodetector PV may comprise black silicon, for example as described in U.S. Pat. Nos. 7,354,792 and 7,390,689 and available under from SiOnyx, Inc. of Beverly, Mass. The black silicon may comprise shallow junction photonics manufactured with semiconductor process that exploits atomic level alterations that occur in materials irradiated by high intensity lasers, such as a femto-second laser that exposes the target semiconductor to high intensity pulses as short as one billionth of a millionth of a second. Crystalline materials subject to these intense localized energy events may under go a transformative change, such that the atomic structure becomes instantaneously disordered and new compounds are “locked in” as the substrate re-crystallizes. When applied to silicon, the result can be a highly doped, optically opaque, shallow junction interface that is many times more sensitive to light than conventional semiconductor materials. Photovoltaic transducers for hearing devices are also described in detail in U.S. Patent Applications Nos. 61/073,271, entitled “Optical Electro-Mechanical Hearing Devices With Combined Power and Signal Architectures”; and 61/073,281, entitled “Optical Electro-Mechanical Hearing Devices with Separate Power and Signal”, the full disclosures of which have been previously incorporated herein by reference and may be suitable for combination in accordance with some embodiments as described herein. 
     The output transducer assembly and anchor structure can be shaped in many ways to fit within the middle ear during implantation and affix to structures therein to couple to the cochlea. For example, the output transducer assembly may comprise a cross sectional size to pass through an incision in the eardrum TM and annulus TMA, such that bone that defines the ear canal can remain intact. The annulus TMA can be supported by a sulcus SU formed in the bony portion of the ear disposed between the external ear and middle ear. The eardrum can be incised along the annulus to form a flap of eardrum, a portion of which eardrum may remain connected to the user and placed on the margin of the ear canal when the transducer assembly  30  is positioned in the middle ear. Flap can be positioned after the transducer is positioned in the middle ear. The transducer assembly may comprise at least a portion shaped to fit within a round window niche. Alternatively or in combination, transducer assembly  30  may comprise a rounded concave portion  30 R shaped to receive a rounded promontory of the middle ear. 
     The anchor structure can be configured to attach to many structures of the middle ear. For example, the anchor structure can be configured to affix to bone of the promontory. Alternatively or in combination, the anchor structure may be configured to couple to a bony lip near the round window. 
     The BTE may comprise many of the components of the ECM, for example photodetector PV, energy storage device PS, the processor and circuitry, as described above. 
     FIGS.  1 B 1  and  1 B 2  show a schematic illustration of the transducer  32  of the output transducer assembly  30  coupled to the cochlear fluid with a support  32 S. Output transducer  32  vibrates the fluid of the cochlea such that sound is perceived by the user. The output transducer assembly also comprises at least one transducer  34  configured to receive electromagnetic energy transmitted through the eardrum TM, for example at least one of a coil, a photodetector, or a photostrictive material. The at least one transducer  34  may be coupled to the output transducer  32  with circuitry, such that output transducer  32  vibrates in response to electromagnetic energy transmitted through eardrum TM. Output transducer assembly  30  may comprise an anchor structure  36  configured to affix the output transducer assembly to a substantially fixed structure of the ear, such as promontory PR. The anchor structure  36  may comprise a biocompatible structure configured to receive a tissue graft, for example, and may comprise at least one of a coating, a flange or holes for tissue integration. The anchor structure  36  can be affixed to the bone tissue such that the location of the assembly remains substantially fixed when sound transducer  32  is acoustically coupled to the vibratory structures of the ear. For example, a small hole can be drilled in the promontory PR and the anchor screwed into the hole to couple to the cochlear bone. 
     In some embodiments, the at least one detector  34  may comprise output transducer  32 . For example the photodetector may comprise a photostrictive material configured to vibrate in response to light energy. 
     The transducer  32  may comprise at least one of a coil, a magnet, the coil and the magnet, a piezoelectric transducer, a photostrictive transducer, a magnetostrictive transducer or a balanced armature transducer. For example, transducer  32  may comprise the balanced armature transducer. The balanced armature transducer may comprise a reed  32 R. The reed  32 R can be coupled to the support  32 S with an extension structure extending therebetween, for example a post  32 P. 
     The support  32 S can be configured in many ways to couple to the cochlea fluid. For example, the support may comprise a rigid biocompatible material sized to fit in a fenestration formed in the cochlear bone or in the footplate of the stapes ST. The biocompatible material may comprise many materials, for example hydroxyapatite or titanium. The support comprising the rigid material may be placed in the fenestration as a plug, and contact the cochlear fluid. The support may comprise a thin flexible membrane configured contact the cochlear fluid to couple the transducer to the cochlear fluid. 
     The stapes may be configured in many ways to couple to the transducer to the cochlear fluid. For example, the fenestration may be formed in the footplate to couple the cochlear fluid to the support  32 S. One or more crus of the stapes may be removed. For example one crus of the stapes may be removed such that the other crus remains intact to conduct sound from the eardrum to the cochlea. 
     The at least one detector  34  may comprise at least one photodetector as noted above. For example, the at least one photodetector may comprise a first photodetector  132  and a second photodetector  134 . The first photodetector  132  can be sensitive to a first at least one wavelength of light, and the second photodetector  134  can be sensitive to a second at least one wavelength of light. The first photodetector may transmit substantially the second at least one wavelength of light such that the first photodetector can be positioned over the second photodetector. The first photodetector  132  and the second photodetector  134  may be coupled to the movement transducer  140  with an opposite polarity such that the transducer urges the first component toward the second component so as to decrease the length in response to the first at least one wavelength of light and such that the transducer urges the first component away from the second component so as to increase the length in response to the second at least one wavelength of light. 
     The first light output signal and the second light output signal can drive the movement transducer in a first direction and a second direction, respectively, such that the cross sectional size of both detectors positioned on the assembly corresponds to a size of one of the detectors. The first detector may be sensitive to light comprising at least one wavelength of about 1 um, and the second detector can be sensitive to light comprising at least one wavelength of about 1.5 um. The first detector may comprise a silicon (hereinafter “Si”) detector configured to absorb substantially light having wavelengths from about 700 to about 1100 nm, and configured to transmit substantially light having wavelengths from about 1400 to about 1700 nm, for example from about 1500 to about 1600 nm. For example, the first detector can be configured to absorb substantially light at 904 nm. The second detector may comprise an Indium Galium Arsenide detector (hereinafter “InGaAs”) configured to absorb light transmitted through the first detector and having wavelengths from about 1400 to about 1700 nm, for example from about 1500 to 1600 nm, for example 1550 nm. In a specific example, the second detector can be configured to absorb light at about 1310 nm. The cross sectional area of the detectors can be about 4 mm squared, for example a 2 mm by 2 mm square for each detector, such that the total detection area of 8 mm squared exceeds the cross sectional area of 4 mm squared of the detectors in the ear canal. The detectors may comprise circular detection areas, for example a 2 mm diameter circular detector area. 
     The first photodetector  132  and the second photodetector  134  may comprise at least one photovoltaic material such as crystalline silicon, amorphous silicon, micromorphous silicon, black silicon, cadmium telluride, copper indium gallium selenide, indium gallium arsenide and the like. In some embodiments, at least one of photodetector  132  or photodetector  132  may comprise black silicon, for example as described in U.S. Pat. Nos. 7,354,792 and 7,390,689 and available under from SiOnyx, Inc. of Beverly, Mass. The black silicon may comprise shallow junction photonics manufactured with semiconductor process that exploits atomic level alterations that occur in materials irradiated by high intensity lasers, such as a femto-second laser that exposes the target semiconductor to high intensity pulses as short as one billionth of a millionth of a second. Crystalline materials subject to these intense localized energy events may under go a transformative change, such that the atomic structure becomes instantaneously disordered and new compounds are “locked in” as the substrate re-crystallizes. When applied to silicon, the result can be a highly doped, optically opaque, shallow junction interface that is many times more sensitive to light than conventional semiconductor materials. Photovoltaic transducers for hearing devices are also described in detail in U.S. patent application Ser. No. 12/486,100, filed Jun. 17, 2009, entitled “Optical Electro-Mechanical Hearing Devices With Combined Power and Signal Architectures”; and Ser. No. 12/486,116, filed Jun. 17, 2009, entitled “Optical Electro-Mechanical Hearing Devices with Separate Power and Signal”, the full disclosures of which are incorporated herein by reference and may be suitable for combination in accordance with some embodiments as described herein. 
     The electromagnetic signal transmitted through the eardrum TM to the assembly  30  may comprise one or more of many kinds of signals. For example, the signal transmitted through the eardrum TM may comprise a pulse width modulated signal. The pulse width modulated signal may comprise a first pulse width modulated signal of at least one first wavelength of light from a first source and the second pulse width modulated signal of a second at least one wavelength of light from a second source. The first at least one wavelength of light may be received by a first detector, and the second at least one wavelength of light may be received by the second detector. 
     The components of the output assembly  30  may comprise many biocompatible materials, for example hydroxyapatite, titanium, polymer, or cobalt chrome, and many combinations thereof. The biocompatible material may comprise a material to promote bone growth. 
     The transducer  32 H may be contained within a biocompatible housing  32 H. 
     The assembly  30  may be detachable from the support  32 S such that the assembly can be removed for MRI imaging of the patient, as described in U.S. App. No. 61/219,289 filed on Jun. 22, 2009, entitled “Round Window Coupled Hearing Systems and Methods”, the full disclosure of which is incorporated by reference and may be suitable for combination in accordance with some embodiments described herein. The support  32 S may be affixed to the bone tissue when the assembly  30  is removed. 
       FIG. 2A  shows a schematic illustration of transducer assembly  30  with a support  32 S in contact with cochlear fluid. The support  32 S may comprise a thin flexible membrane. The fenestration may be formed in cochlear bone, for example on the promontory of the cochlea. The transducer  32  may comprise many of the transducers described above. For example transducer  32  may comprise a coil and a magnet  32 M. The magnet  32 M may be positioned in a channel to move as indicated by the arrows. The magnet  32 M may comprise inertial mass that coil and membrane move in opposition to the coil so as to vibrate the membrane in response to the opposing inertial of the magnet. Alternatively, the magnet may be connected to the membrane and vibrate with the membrane, such that the magnet and membrane move opposite the coil and at least one detector  34 . The at least one detector  34 , as described above, is coupled to the transducer  32 . Tissue may be positioned over the membrane, for example surgically positioned, such that the membrane seals the fenestration and the assembly  30  is held in place. Alternatively or in combination, the assembly  30  may comprise anchor  36  as described above. The assembly  30  may be detachable from the support, as described above. 
     FIG.  2 A 1  shows a schematic illustration of a transducer assembly as in  FIG. 2A  in which the support  32 S comprises a structure  32 SP extending from an upper surface of the cochlear bone into the fenestra to couple to the endostium. The support  32 S may comprise an upper flange portion sized larger than the fenestra and the structure  32 SP may have a maximum cross sectional size, for example a diameter, sized smaller than the fenestra such that the structure  32 SP extends from the upper surface of the cochlear bone to the lower surface of the cochlear bone in contact with the endostium, such that vibration of the magnet  32 M is coupled to the cochlear fluid with vibration of the elongate structure of the support coupled to the endostium. The support  32 S may comprise a first upper component comprising the flange sized larger than the fenestra and a second lower component sized for placement in the fenestra. Alternatively, the support  32 S may comprise a single piece of material comprising the upper flange portion and the lower elongate portion. 
       FIG. 2B  shows a schematic illustration of transducer assembly  30  in which the transducer  32  comprising a magnet with a biocompatible housing  32 H. The magnet is positioned on support  32 S. Support  32 S contacts cochlear fluid so as to couple the magnet to the cochlear fluid. The support  32 S may comprise tissue, for example graft tissue such as fascia or vein tissue. The support is positioned over a fenestration formed in the footplate of the stapes. A similar assembly can be positioned over a fenestration in cochlear bone, for example on the promontory. 
     FIG.  2 B 1  shows magnet  32 M comprising a pair of opposing magnets suitable for use with many transducers as described herein. The pair of opposing magnets may comprise a fisrt magnet  32 M 1  and a second magnet  32 M 2 . An adhesive  32 A may adhere the first magnet to the second magnet with the magnetic field of the first magnet opposite the magnetic field of the second magnet. The pair of opposing magnets may decrease sensitivity of the transducer assembly to external electromagnetic fields, for example transient electromagnetic fields such as 60 Hz noise from power sources and, for example, magnetic fields from MRI machines. 
       FIG. 3A  shows transducer assembly  30  comprising an expandable structure positioned at least partially between crura of the stapes, and  FIG. 3B  shows transducer assembly of  FIG. 3A  configured for placement at least partially between the crura of the stapes. The assembly  30  comprises a transducer  32 , as described above. The transducer  32  can be contained within a housing  32 H, as described above. The expandable structure may be positioned on portion of the housing  32 H. The transducer can be configured to vibrate the stapes. The transducer can be contained at least partially within the housing The expandable structure may be disposed on a portion of the housing. The expandable structure and the housing can be sized for placement at least partially between crura of the stapes to couple the transducer to the stapes. 
     At least a portion of the housing is sized to contact a footplate of the stapes when the expandable structure and the housing are positioned at least partially between the crura. Alternatively, a fenestration may be formed in the stapes foots plate and the housing may contact the support, as described above. 
     The expandable structure can be configured to contact the stapes between the crura. The expandable structure may comprise at least one of an expandable material, a spring, a sponge, a water absorbent material or a hydrogel. The expandable structure may comprise a mechanical impedance so as to couple vibration to the cochlear fluid, and may also provide at least partial deformation with static forces so as to provide at least some strain relief, for example. In many embodiments, the impedance of the expandable structure at audio frequencies is greater than the impedance of the cochlear fluid, which is approximately 100,000 Pa-s/m (Pascal-seconds per meter), so as to couple efficiently mechanical vibration of the transducer to the cochlea. For example, water absorbent materials such as sponges and hydrogels can provide at least some static deformation and provide acoustic impedance greater than the cochlear fluid, although many expandable structures as described herein may also be used. 
     The at least one photodetector can be coupled to the transducer as described above so as to vibrate the stapes. The at least one photodetector can be electrically coupled to the transducer with an electrical conductor sized to position the at least one photodetector on the promontory when the expandable material and the housing are positioned at least partially between the crura. 
     The transducer  32  may comprise at least one of a coil, a magnet, the coil and the magnet, a piezoelectric transducer, a photostrictive transducer or a balanced armature transducer. For example, the transducer may comprises the coil and the magnet, and the coil and the magnet can be sized for placement at least partially between the crura. 
     The transducer may comprise the magnet as described above, and the magnet can be sized for placement at least partially between the crura. The coil may be sized for placement in an ear canal of the user as described above so as to couple to the magnet. 
       FIG. 4  shows a method of transmitting sound to a user with side specificity and sound localization cues to locate sound within a side, for example. A step  405  make a first incision in a first tympanic membrane of a first side of the user. A step  410  makes a first channel in first bone, in which the channel may extend to the cochlear fluid. The bone may comprise cochlear bone. A step  415  positions the first output assembly at least partially within the channel. A step  420  covers the first output assembly at least partially with first fascia. A step  425  closes the first incision in the first tympanic membrane. A step  430  positions the input assembly on the first side of the user to couple the input assembly with the implanted output assembly. A step  435  positions a first microphone in a first ear canal or the first ear canal near the ear canal entrance to detect the sound localization cues, as described above. A step  440  measures a first audio signal comprise a sound localization cues on a with the first microphone. A step  445  transmits the first audio signal from the first microphone to the first output assembly with frequencies from about 60 Hz to about 20 kHz. A step  450  vibrates the first output assembly with a first vibration having the first amount of energy. A step  460  repeats the above steps for the second system positioned on the second side, as described above. With a step  470 , the user localizes sound to the first side or the second side with stereo. With a step  475 , the user localizes the sound within the first side or the second side. With a step  475 , the user hears a speaker such as a person in a noisy environment, for example based on the sound localization cues. 
     The sound processor comprising a tangible medium as described above can be configured with software comprising instructions of a computer program embodied thereon implant many of the steps described above. The surgeon may implant the output assembly and the user may position the input assembly, as noted above. 
     It should be appreciated that the specific steps illustrated in  FIG. 4  provides a particular method transmitting a sound to a user, according to some embodiments of the present invention. Other sequences of steps may also be performed according to alternative embodiments. For example, alternative embodiments of the present invention may perform the steps outlined above in a different order. Moreover, the individual steps illustrated in  FIG. 4  may include multiple sub-steps that may be performed in various sequences as appropriate to the individual step. Furthermore, additional steps may be added or removed depending on the particular applications. One of ordinary skill in the art would recognize many variations, modifications, and alternatives. 
     EXPERIMENTAL 
     Based on the teachings described herein, a person of ordinary skill in the art can conduct experimental studies to determine empirically the configuration of the support to couple the transducer to the cochlear fluid, such that the user can localize sound to the left side or the right side, and such that the user can detect sound localization cues to determine a location of the sound within one of the sides. For example, experiments can be conducted to determine attenuation of sound of the second cochlea relative to the cochlea with the output assembly coupled to mastoid bone or to cochlear bone so as to determine suitable configurations of the fenestration and support. 
     While the exemplary embodiments have been described in some detail, by way of example and for clarity of understanding, those of skill in the art will recognize that a variety of modifications, adaptations, and changes may be employed. Hence, the scope of the present invention should be limited solely by the appended claims and the full scope of the equivalents thereof.