EP1035753A1 - Dispositif acoustique implantable - Google Patents

Dispositif acoustique implantable Download PDF

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Publication number
EP1035753A1
EP1035753A1 EP99104444A EP99104444A EP1035753A1 EP 1035753 A1 EP1035753 A1 EP 1035753A1 EP 99104444 A EP99104444 A EP 99104444A EP 99104444 A EP99104444 A EP 99104444A EP 1035753 A1 EP1035753 A1 EP 1035753A1
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EP
European Patent Office
Prior art keywords
acoustic device
canal
implantable
ear
implantable acoustic
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP99104444A
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German (de)
English (en)
Inventor
Nino Rosica
Lamberto Pizzoli
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Individual
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Individual
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Publication date
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Priority to EP99104444A priority Critical patent/EP1035753A1/fr
Publication of EP1035753A1 publication Critical patent/EP1035753A1/fr
Withdrawn legal-status Critical Current

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    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04R—LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
    • H04R25/00—Deaf-aid sets, i.e. electro-acoustic or electro-mechanical hearing aids; Electric tinnitus maskers providing an auditory perception
    • H04R25/60—Mounting or interconnection of hearing aid parts, e.g. inside tips, housings or to ossicles
    • H04R25/604—Mounting or interconnection of hearing aid parts, e.g. inside tips, housings or to ossicles of acoustic or vibrational transducers
    • H04R25/606—Mounting or interconnection of hearing aid parts, e.g. inside tips, housings or to ossicles of acoustic or vibrational transducers acting directly on the eardrum, the ossicles or the skull, e.g. mastoid, tooth, maxillary or mandibular bone, or mechanically stimulating the cochlea, e.g. at the oval window
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04R—LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
    • H04R25/00—Deaf-aid sets, i.e. electro-acoustic or electro-mechanical hearing aids; Electric tinnitus maskers providing an auditory perception
    • H04R25/45—Prevention of acoustic reaction, i.e. acoustic oscillatory feedback
    • H04R25/456—Prevention of acoustic reaction, i.e. acoustic oscillatory feedback mechanically

Definitions

  • the present invention concerns an implantable acoustic device, acting on and over the middle ear.
  • the ear is an organ which transfers the external sounds to the brain.
  • the ear functionality see for example G. Von Bekèsi "The ear” Scientific American 197 (1957) or “Mechanics of hearing” Surgery of the ear - Shambough ed. 1967, page 379.
  • the acoustic external canal will be named simply as canal or conduct.
  • the hearing aids for the neurosensorial hypoacusia nowadays available on the market are external (retroauricolar or pretympanic) and are constituted of a plastic ear mold (obturator or plug) which is inserted into the canal in such a way to plug it and which carries connected elements which have the purpose to amplify the sound waves.
  • Such hearing aids have noticeable disadvantages, first of all due to the difficulty to adapt the plug on the canal because of the elasticity of the skin especially in subjects who have copious hairs in the canal.
  • Such kind of hearing aids produce aesthetic alterations and embarrassing situations as, for instance, for swimming, during the night, during sexual relationships, gymnastic exercises and in some particular kind of professions.
  • the plugs produce feeling of compression into the ears.
  • the "gain of insertion” is defined as result of the global effect given by the amplification of the hearing aid and the effect of the attenuation due to the occlusion of the canal by the mold (plug) of the aid.
  • the current prostheses are conceived in such a way that they have to correct not only the preexisting hypoacusia, but also a superimposed hypoacusia produced by the occlusion of the canal in which the mold is inserted.
  • the conventional prosthesis besides creating a distortion of received sounds, must act with a volume and a potency much higher with respect to those which should be actually requested to treat the real hypoacusia.
  • the external prostheses do not decrease but even amplify (because of the pressure of the mold on the canal) the tinnitus and all the annoying problems given by the temporo-mandibular joint (T.M.J.) arthritis malocclusion (periauricular pins ⁇ feeling of ear occlusion ⁇ tinnitus), and the more the plugs are pushed into the canal, the more those symptoms increase with unbearable situation, especially in elderly people, with unappropriated dental plates.
  • T.M.J. temporo-mandibular joint
  • malocclusion peripheral pins ⁇ feeling of ear occlusion ⁇ tinnitus
  • Plugging the ear canal is unnatural.
  • the present invention has the aim to obviate to all the inconveniences of the conventional hearing aids and it is an object of the invention an acoustic implantable device acting directly on and over the middle ear, anchored in the canal in such a way of not obstructing it.
  • the invented hearing aid requires a minimal potency to cure a patients hypoacusia, in that the resistances of refraction and diffraction of the acoustic waves must not be overcome, like in the case of conventional hearing aids acting over the tympanic membrane and over the ossicular lever mechanism, and, at the same time, ifs not excluded the action of one of the best systems of natural amplification known in nature: auricle and canal.
  • the potency of the invented device has to be set to the minimum, an increased battery duration and an almost irrelevant sound distortion are obtained. Further objects of the invention will be evidenced by the detailed description of the invention itself.
  • the invented device even if it cannot re-establish the natural function of the organ, eliminates the inconveniences of conventional and pretympanic hearing aids; and, as in the case of the intraocular lenses which substitute the crystalline, gives back to the patient the continuity of the function without contraindications for any kind of activity the patient himself wants to perform.
  • the fundamental characteristics of the invented prosthesis is that it is implantable and acts amplifying the sound waves directly over the middle ear without obstructing the canal, maintaining the natural amplification of the auricle and canal and being provided with an element (conveyor element) placed in the middle ear which conveys the acoustic wave in the proximity of the oval window or round window or over the petrosa as clearly specified in the following pages.
  • hypoacusia transmission or perceptive type
  • the acoustic wave will reach directly contact the bony petrosal portion of cochlea (promontory) (transmission hypoacusia), or the oval window (perceptive hypoacusia), hitting the stapes footplate as it happens naturally in a safe ear, or can be addressed over the round window when the ossicles are missing and the suprastructure of the stapes and around it there should be fibrous tissue obstructing the oval window.
  • auricle 21
  • canal 22
  • cartilagineous portion of the canal 23
  • skin of the canal 24
  • bony canal 25
  • anulus 26
  • tympanic membrane 27
  • ossicular chain malleus (28)
  • incus 29
  • stapes (30)
  • oval window 31
  • round window 32
  • promontory 33
  • Eustachian tube 34
  • perforation area 35) for the passage of the sound conveying element
  • cochlea 36
  • acoustic nerve 37
  • vestibular nerve 38
  • the invented device contains the following components in relationship of cooperation among themselves: an electrical feeding battery (1) or (6'), an element with the aim to control the volume of the device (2), a battery detachable connector (3), removable in order to change the battery itself a wire (4) or (7') connecting the battery case and the device, a microphone (5) or (1'), an electronic power station (6) or (3'), an amplifier (7) or (2'), a loudspeaker (8) or (4'), a sound wave conveying element (9) or (5').
  • the invented device way of functioning is the following: the acoustic stimulus amplified by the auricle (21) and canal (22), reaches the microphone (5) or (1') and is amplified by the amplifier (7) or (2').
  • the device can be applied according to figures 4, 8, 9.
  • the amplified acoustic wave as said before, is addressed directly by the conveyor element (9) or (5') which is almost at immediate contact with the promontory (33), which constitutes the bony portion of the cochlea (36).
  • a hearing aid "body” having a shape such to be implanted in the middle ear and containing a microphone (1') connected to an amplifier (2'), that is connected to an electrical station (3') and to a loudspeaker (4'). All the functions of the above mentioned elements are well known by any expert of the specific matter.
  • the loudspeaker is directly connected to a sound conveying element, which, in this case, has the shape of a tube (5'), with preferably an external diameter of about 1.5 mm. Its opened extremity (5') is positioned inside the middle ear, preferably in proximity of the oval window.
  • fixing elements elements which have the aim to block the prosthesis in the ear canal. It's wise remember that the new invented hearing aid doesn't obstruct the canal.
  • fixing elements (8') are in the shape of steel springs.
  • the electrical feeding of the system is provided by a battery (6') that, properly connected to the elements (1'), (2'), (3') and (4') inside the hearing aid body (A) through a specific electric wire (7'), is placed in a remote position with respect to the above mentioned "body" (A).
  • the battery (6') is preferably positioned outside the hearing aid itself, preferably behind the ear lobe.
  • the hearing aid is preferably covered with biocompatible materials, well known to the field experts, such as Teflon ® or Sealastic ®, which don't make any obstacle to the prosthesis implantability.
  • the middle portion (9') of the hook (10') is shaped in such a way to facilitate instead of being an obstacle to the malleus vibrations (for the malleus (28) functionality see fig. 1).
  • a third embodiment of the invented hearing aid consisting in a transduction type prosthesis for recovering transmission type hypoacusia, is represented in fig. 4.
  • the loudspeaker (4') has been substituted by a transductor (12'), to which has been connected a sound conveying element, that is in the shape of a transmission wire (11'), placed inside the tube (5'); said wire (11') is in almost direct contact with the cochlea bony wall and has the aim to transmit the mechanical vibrations of the sounds.
  • the transmission wire (11') can be made in ivory or in a high mechanically conducting metal and can be terminated at the opened extremity (5") of the tube (5').
  • the tube (5'), in which the transmission wire (11') is located can have a middle portion (9') and a hook (10') (not shown in fig. 4 and similar to what illustrated in fig. 3), if the hearing aid has to be hanged to the handle of the malleus.
  • a battery case 13'''
  • the battery elements comprising, for instance, a battery case (13'''), which can be implemented in well known shapes and materials, such as waterproof materials, in order to be water resistant and esthetically accepted by the patients.
  • a female threading can be screwed to a male threading (7''), existing at one end of the wire (7'), preferably interposing a further tightening waterproof element (7''').
  • the wire (7') is made to pass from the external ear canal up to the zone behind the auricle by means of a curved needle (15'), having at one end, a female threading (15''), on which it is screwed the corresponding male threading (7'') of the above mentioned wire (7'), when such wire is still inside the ear, in order to put out together the wire (7') and the needle (15') behind the auricle in a designated point.
  • Fig. 6 illustrates another embodiment of the invented device.
  • the hearing aid is inserted into the external and middle ear.
  • the electrical feeding battery (1) and the hearing aid volume control (2) are inserted, for a better understanding of the representation, in the auricle (21), but the position of those elements is preferably in a not visible location, behind the ear lobe, connected through a removable connector (3) to change the battery itself, with a feeding and programming wire (4), which is passed (like an ear ring) piercing the cartilage of the canal behind the ear lobe or, if the patient doesn't want to have the cartilagineous canal pierced, into the fold of the auricle.
  • the battery can be easily changed removing the battery case from the wire.
  • the wire (4) is connected to a: microphone (5), electronic power station (6), amplifier (7), loudspeaker (8). All of those elements are inserted into an hermetic container (C), realized in bio-compatible material and with such physical dimensions so small as to be inserted into a canal without obstructing it.
  • C hermetic container
  • the container (C) is provided of suitable blocking and anchoring systems to the walls of the canal.
  • Those blocking systems (B) can be made in a shape of a opportunely dimensioned steel spring.
  • the container (C) is connected to a sound conveyor element (9) in the shape of a tube preferably of the diameter of 1.5 mm and the length of preferably about 2 cm, which can be made opportunely shorter by the surgeon, when the hearing aid has been implanted.
  • That tube is realized with already known and implanted plastic bio-compatible material such as bio-compatible Teflon® or Sealastic®, or made bio-compatible via surface treatment processes, like heparinization, well known to the field experts.
  • the microphone (5) can be a microphone of the series EG-EM or EG 3000, Eg 3001, EM 3046, EM 3047, EM 3056, produced by Knowles Electronics, with physical dimensions of about 4 mm.
  • amplifier (7) it can be used the one illustrated in the block diagram of fig. 10, hybrid circuit GS3026 produced by Genum, having the following characteristics: compression ratio 8:1, maximum gain 38 dB (decibels) adjustable over the range of 38 dB, output compression level adjustable over the range of 38 dB, physical dimensions 4.11 x 2.39 x 1.178 mm.
  • the volume control element (2) can be a variable resistor (trimmer) as, for instance, PJ63 produced by Microtronix.
  • the loudspeaker (8) can be a receiver of series EH, produced by Knowles Electronics, as for instance EH 3030 or EH3043, both with nominal impedance of 1000 ⁇ at 1000 Hz and nominal resistance of 400 ⁇ and with dimensions of about 3-5.5 mm.
  • the length of the wire (4) between the device and the battery case (1) can be changed according to the morphology of the ear canal.
  • the electric power source can be a zinc-air battery.
  • the container (C) is positioned inside the canal (22), i.e. in the external ear, while the conveyor (9) passes through a hole performed in the tympanic membrane (world wide diffused technique for ventilation tube application) or under the tympanic anulus (so leaving intact the tympanic membrane) up to reach the proximity of the oval or round window.
  • the loudspeaker is distant from the container (C) and it's implanted beyond the tympanic membrane into a sealed container (C') through a hole in the tympanic membrane itself or under the anulus.
  • the connection between the amplifier (7) and the loudspeaker (8) is done through two tiny wires isolated by means of bio-compatible plastic material.
  • the described embodiment has the advantage that, being the loudspeaker far way from the amplifier and inserted behind the tympanic membrane, any form of feedback (whistling) is cut off and being the loudspeaker in contact with the oval or round windows, the sound doesn't present any distortion and the discrimination of spoken voice is almost perfect.
  • the sound conveyor element is in the shape of a tube and it is placed in almost direct contact with the bony portion of cochlea (petrosa)
  • Such tube is made of a stiff material (plastic or metal). The material is stiff enough to maintain its position even during head movements. The aim if the tube is to directly convey and concentrate the sounds over the petrosa.
  • the loudspeaker is beyond the tympanic membrane, however any other location can be suitable.
  • Fig. 9 represents an embodiment which has all the elements above mentioned in fig.s 6 or 9, but all inserted into the folds of the auricle and with the conveyor (9) which is prolonged for the whole length of the canal (22) until to pass through the tympanic membrane and positioned in the middle ear.
  • That kind of hearing aid is suitable for both transmission hypoacusia and perceptive hearing loss and it is easily applicable in old patient or poor surgical patients or patients who are not interested in aesthetic problems.
  • That kind of device can be applied easily also in small children, doing a simple myringotomy, applying a long tube connecting this inserted tube with the conveyor tube of the prosthesis.
  • the above described device having the microphone outside the canal, doesn't take any advantage of the natural amplification of the auricle and canal itself.
  • the invented prosthesis has a very easy surgical applicability under local anaesthesia as office procedure or as half-day hospital procedure.
  • the invented hearing aid is much smaller than the existing conventional pretympanic prostheses and, not adhering to the ear canal (22), will be preferably fixed in 3 different points:
  • the blockage of the conveyor (9) or (5') is such that it cannot move with the head and body movements.
  • the hearing aid object of the present invention does not require a notable amplification power, moreover the patient does not loose those acoustic frequencies naturally transmitted through the ear canal.
  • a small employed power involves a small consumption of the batteries, a small distorsion of the sounds (therefore small inconveniences for the patient who wears the prosthesis) which are much similar faithful to the normal ones.
  • the new conceived prosthesis is particularly advantageous in case of patients who have a vertical type auditory drop in some intervals of frequencies, that is a sonorous perception falling curve in the range of frequencies of 2000-8000 Hz.
  • the new conceived hearing aid in order to "carry up” the high frequencies, because of plugging of ear canal, also low and middle frequencies are “carried up”, inducing a serious, easily understandable, trouble for the patient.
  • the new conceived hearing aid as it doesn't plug the ear canal, could be programmed for amplifying only the frequencies of interest, for instance, typically those from 2000 to 8000 Hz.
  • the low frequencies typically from 125 to 2000 Hz
  • the hearing aids come also advantageous as far as the phenomenons of the secondary fitting (adaptability), acclimatization and deprivation are concerned.
  • Neuro Central System N.C.S.
  • N.C.S. Neuro Central System
  • the aerial conduction type hearing aid can stimulate only those auditory cells which are responsible of reintroducing into the N.C.S. vanished or diminished frequencies, without stimulating at the same time the normally functioning auditory cells.
  • the bony conduction hearing aid amplifies in the best of the ways, acting directly over the petrosa, which like the ivory conducts the acoustic waves at the highest speed 3013 m/sec (as comparison the sound propagation speed is 344 m/sec in the air and 1437 mt/sec in the water).
  • the vibrations are muffled by the cutaneous, subcutaneous and muscular layers, or with trasductors implanted in the mastoid cavity, whose bone is spongy with several phenomenons of refraction and diffraction. If the nerve is intact or almost intact, the vibrations, acting over the cochlea, reach the nerve in the best way.
  • the ears can be cleaned out of ear wax or cured as in any other patient, while the auditory controls can be simply done disconnecting the external battery.
  • the therapy will be the usual one.
EP99104444A 1999-03-05 1999-03-05 Dispositif acoustique implantable Withdrawn EP1035753A1 (fr)

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Cited By (23)

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WO2008018104A1 (fr) * 2006-08-07 2008-02-14 Med-El Elektromedizinische Geräte Gesellschaft M.B.H Prothèse auditive améliorée de l'oreille moyenne à action directe et procédé de pose associé
EP2757923A1 (fr) * 2011-09-23 2014-07-30 Armbruster Enterprises, Inc. Système de sommeil à oreiller sonore
US20140314262A1 (en) * 2013-02-20 2014-10-23 Kyungpook National University Industry-Academic Cooperation Easily installable microphone for implantable hearing aid
US9055379B2 (en) 2009-06-05 2015-06-09 Earlens Corporation Optically coupled acoustic middle ear implant systems and methods
US9277335B2 (en) 2009-06-18 2016-03-01 Earlens Corporation Eardrum implantable devices for hearing systems and methods
US9544700B2 (en) 2009-06-15 2017-01-10 Earlens Corporation Optically coupled active ossicular replacement prosthesis
US10286215B2 (en) 2009-06-18 2019-05-14 Earlens Corporation Optically coupled cochlear implant systems and methods
US10492010B2 (en) 2015-12-30 2019-11-26 Earlens Corporations Damping in contact hearing systems
US10511913B2 (en) 2008-09-22 2019-12-17 Earlens Corporation Devices and methods for hearing
US10516949B2 (en) 2008-06-17 2019-12-24 Earlens Corporation Optical electro-mechanical hearing devices with separate power and signal components
US10516951B2 (en) 2014-11-26 2019-12-24 Earlens Corporation Adjustable venting for hearing instruments
US10516950B2 (en) 2007-10-12 2019-12-24 Earlens Corporation Multifunction system and method for integrated hearing and communication with noise cancellation and feedback management
US10531206B2 (en) 2014-07-14 2020-01-07 Earlens Corporation Sliding bias and peak limiting for optical hearing devices
US10555100B2 (en) 2009-06-22 2020-02-04 Earlens Corporation Round window coupled hearing systems and methods
US10609492B2 (en) 2010-12-20 2020-03-31 Earlens Corporation Anatomically customized ear canal hearing apparatus
US10779094B2 (en) 2015-12-30 2020-09-15 Earlens Corporation Damping in contact hearing systems
US11058305B2 (en) 2015-10-02 2021-07-13 Earlens Corporation Wearable customized ear canal apparatus
US11102594B2 (en) 2016-09-09 2021-08-24 Earlens Corporation Contact hearing systems, apparatus and methods
US11166114B2 (en) 2016-11-15 2021-11-02 Earlens Corporation Impression procedure
US11212626B2 (en) 2018-04-09 2021-12-28 Earlens Corporation Dynamic filter
US11317224B2 (en) 2014-03-18 2022-04-26 Earlens Corporation High fidelity and reduced feedback contact hearing apparatus and methods
US11350226B2 (en) 2015-12-30 2022-05-31 Earlens Corporation Charging protocol for rechargeable hearing systems
US11516603B2 (en) 2018-03-07 2022-11-29 Earlens Corporation Contact hearing device and retention structure materials

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AU2007282827B2 (en) * 2006-08-07 2010-10-07 Med-El Elektromedizinische Geraete Gmbh Middle ear direct action improved hearing aid and related installation method
US20110213196A1 (en) * 2006-08-07 2011-09-01 Med-El Elektromedizinische Geraete Gmbh Middle Ear Direct Action Improved Hearing Aid and Related Installation Method
US8475530B2 (en) * 2006-08-07 2013-07-02 Med-El Elektromedizinische Geraete Gmbh Middle ear direct action improved hearing aid and related installation method
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WO2008018104A1 (fr) * 2006-08-07 2008-02-14 Med-El Elektromedizinische Geräte Gesellschaft M.B.H Prothèse auditive améliorée de l'oreille moyenne à action directe et procédé de pose associé
US10863286B2 (en) 2007-10-12 2020-12-08 Earlens Corporation Multifunction system and method for integrated hearing and communication with noise cancellation and feedback management
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US9544700B2 (en) 2009-06-15 2017-01-10 Earlens Corporation Optically coupled active ossicular replacement prosthesis
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US9433744B2 (en) 2011-09-23 2016-09-06 Armbruster Enterprises, Inc. Sound pillow sleep system
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