EP1041857B1 - Implantable hearing system with audiometer - Google Patents

Implantable hearing system with audiometer Download PDF

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Publication number
EP1041857B1
EP1041857B1 EP99122698A EP99122698A EP1041857B1 EP 1041857 B1 EP1041857 B1 EP 1041857B1 EP 99122698 A EP99122698 A EP 99122698A EP 99122698 A EP99122698 A EP 99122698A EP 1041857 B1 EP1041857 B1 EP 1041857B1
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EP
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Prior art keywords
hearing system
signal
hearing
signal processing
unit
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EP99122698A
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German (de)
French (fr)
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EP1041857A3 (en
EP1041857A2 (en
Inventor
Hans Dr.-Ing. Leysieffer
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Cochlear Ltd
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Cochlear Ltd
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    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04RLOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
    • H04R25/00Deaf-aid sets, i.e. electro-acoustic or electro-mechanical hearing aids; Electric tinnitus maskers providing an auditory perception
    • H04R25/60Mounting or interconnection of hearing aid parts, e.g. inside tips, housings or to ossicles
    • H04R25/604Mounting or interconnection of hearing aid parts, e.g. inside tips, housings or to ossicles of acoustic or vibrational transducers
    • H04R25/606Mounting 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
    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04RLOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
    • H04R25/00Deaf-aid sets, i.e. electro-acoustic or electro-mechanical hearing aids; Electric tinnitus maskers providing an auditory perception
    • H04R25/50Customised settings for obtaining desired overall acoustical characteristics
    • H04R25/505Customised settings for obtaining desired overall acoustical characteristics using digital signal processing

Definitions

  • Patent 5,814,095 US-A-5 554 096 and U.S. Patent 5,624,376 .
  • these implantable hearing aids use a mechanical, vibratory stimulus as an output signal that directly excites the middle ear or inner ear.
  • the coupling of the mechanical stimulus is done by direct mechanical connection of the vibrating transducer element to the ossicular chain or an ossicle of the middle ear or to the inner ear ( US-A-5,941,814 ) or by a force coupling via an air gap in eg electromagnetic transducers.
  • the coupling quality of the mechanical stimulus is influenced by many parameters and contributes significantly to the rehabilitation of the hearing damage and to the perceived hearing quality. Intraoperatively, this quality of coupling is difficult or even unpredictable, since the motion amplitudes of the vibrating parts, even at the highest stimulation levels, are within a range of or well below 1 ⁇ m and therefore can not be assessed by direct visual inspection. Even if this is possible by other technical measurement methods, for example by intraoperative laser measurements (eg laser Doppler vibrometry), the uncertainty of a long-term stable, safe coupling remains, as they are negatively influenced, among other things by necrosis, tissue neoplasmosis, changes in air pressure and other external and internal influences can.
  • laser Doppler vibrometry eg laser Doppler vibrometry
  • the need to assess the coupling quality of the transducer remains because a full implant does not have the ability to measure individual system components separately at their technical interfaces, if, for example, the implant wearer complains a declined transmission quality by reprogramming individual audiological Matching parameters can not be improved and therefore an operative intervention to improve the situation can not be ruled out. Even if such a case does not exist, there is a fundamental scientific interest in having a meaningful monitor function of the long-term development of the quality of the converter coupling.
  • the object of the present invention is to provide a partially or fully implantable hearing system which, by circumventing the aforementioned disadvantages by psychoacoustic measurements, that is to say by subjective patient responses, determines the coupling quality of the electromechanical transducer to the middle or inner ear. without any further biological-technical interfaces being included in the evaluation, which impair the informative value of the determination of the converter coupling quality.
  • this object is achieved in that the hearing aid is supplemented by an electronic audiometer module that generates audiometric signals for an audiological, subjective examination and evaluation of the coupling quality of the electromechanical output transducer and fed into the audio signal processing path of the hearing implant.
  • the audiometer module preferably consists of one or more externally adjustable or programmable electronic signal generators which feed an electrical auditory test signal into the signal processing path of the implant.
  • the electromechanical output transducer of the implanted hearing system is controlled by the audiometer module technically reproducible and quantitatively determined electrically directly; In this way, distortions of the stimulation level are avoided, as they can occur, for example, by Köpf Anlagener- or in particular acoustic free-field performances of the audiometric test sound, because in this case also the sensor or microphone function with all the associated variability in the psychoacoustic measurement is included.
  • the system according to the invention has, inter alia, the advantage that, for example, frequency-specific hearing threshold measurements with pure sine tones or narrow-band signals (for example, third-party noise) can be reproduced very well even at relatively long time intervals. Furthermore, it is also possible to obtain reproducible psychoacoustic data in the suprathreshold area, such as loudness scaling. Moreover, by offering pure signals such as sinusoidal signals, non-linearities can also be subjected to subjective interrogation, which can arise, for example, as a result of decreasing coupling quality and can be heard as "clinking". Such investigations are limited or even impossible by the initially described objective measurement methods based on evoked potentials.
  • the inventive solution has the advantage that the parameters of the signaling such as the electrical control level of the electromechanical implant converter by the implant-internal generators are quantitatively accurately determined and reproducible and not subject to fluctuations, such as in a full implant by acoustic headphone presentation the test signals are given.
  • the transfer function of the implanted sound sensor is also involved in the transfer; The sensor function can also be subject to temporal fluctuations and thus makes an exact interface definition to the transducer transfer function impossible.
  • an implantable electromechanical output transducer is in particular a converter according to US-A-5,277,694 that is, a transducer in which a wall of the transducer housing is designed as a vibratable membrane, which represents an electromechanically active heteromorph composite element together with a piezoelectric ceramic disc mounted on the membrane inside.
  • transducer assembly for partially or fully implantable hearing for direct mechanical excitation of the middle or inner ear, which is provided with a fixable at the implantation site with respect to the skull housing and with respect to the housing movable, mechanically rigid coupling element, wherein in the housing, an electromechanical transducer is housed, with which the coupling element can oscillate, which are transmitted after implantation of the transducer assembly to a middle ear ossicle or directly to the inner ear.
  • the electromechanical transducer is designed as an electromagnet arrangement which has a component fixed relative to the converter housing, in particular a toroidal coil, and a vibratable component, preferably in the form of a permanent magnet pin immersed in a central opening of the toroidal coil, which communicates with the coupling element in such a manner. that vibrations of the oscillatory component are transmitted to the coupling element.
  • a converter in the older one EP patent application 98 121 613.8 It is a converter for partially or fully implantable hearing for direct mechanical excitation of the middle or inner ear, which is provided with a fixable at the implantation housing and a movable with respect to the housing, mechanically rigid coupling element, wherein in the housing a piezoelectric element is housed, with which the coupling element can oscillate, which are transmitted to a middle ear ossicle or directly to the inner ear after implantation of the transducer, and wherein in the housing further comprises an electromagnet assembly is provided which Having fixed with respect to the housing member and a vibratable component which is in communication with the coupling element such that vibrations of the oscillatory component are transmitted to the coupling element.
  • Such a transducer has the advantage that the frequency response of the transducer can be improved both with respect to purely piezoelectric as well as against purely electromagnetic systems, so that an adequate hearing impression at a sufficient volume level is possible.
  • a substantially flat frequency response of the deflection of the coupling element in a wide frequency band at sufficiently high stimulation levels and low power consumption can be realized.
  • patient-specific signal parameters for the audiometry function can be individually adapted to the requirements and pathological needs of the patient by means of an electronic unit.
  • the electronic signal processing and amplification unit expediently has an amplifier connected downstream of the microphone, an audiological signal processing stage acted upon by the output signal of the amplifier and a driver amplifier connected upstream of the electromechanical output converter.
  • the electronic module can be provided with a signal generator arrangement for generating the signals necessary for the audiometry function and a summing element connected between the signal processing stage and the driver amplifier, via which the driver amplifier receives both the output signal of the audiological signal processing stage and the output signal of the signal generator arrangement.
  • a modified embodiment of the invention may also be provided as audiological signal processing stage, a digital signal processor, which is designed both for the preparation of the audio signal and for generating the necessary for the audiometry function signals and for the combination of the latter signals with the audio signal.
  • the signal processor expediently an analog-to-digital converter upstream and downstream of a digital-to-analog converter.
  • the digital-to-analog converter and the driver amplifier can be combined in one module.
  • the signal processor is preferably equipped with a data memory for storing patient-specific, audiological adaptation parameters and / or parameters for generating the signals for the audiometry function.
  • a microcontroller For controlling at least a part of and preferably all signal-processing and / or -producing stages, a microcontroller may advantageously be provided which expediently has a data memory for storing patient-specific, audiological adaptation parameters and / or operating parameters of the signal generator arrangement.
  • the signal processor can also be designed for controlling at least a part of and preferably all signal processing and / or generating stages.
  • a telemetry unit For data entry into the data memory is a telemetry unit that communicates wirelessly or by wire with an external programming system.
  • the signal processing and amplification unit located in the electronic hearing system path the electronic module for generating and supplying the signals required for the audiometry function and the telemetry unit as electronic module, preferably together with the energy supply unit, are preferably in a hermetically sealed and housed biocompatible implant housing.
  • the electronic module is advantageously connected via an implant lead to a subcutaneously implantable microphone in the posterior auditory canal wall and to the electromechanical output transducer via an implantable lead.
  • This compound can be fixed or detachable.
  • a connector as in US-A-5,755,743 is explained in detail.
  • Such a connection arrangement has at least one first contact, at least one second contact mounted on an elastic body and a closure mechanism for engaging the end face of the first contact with the end face of the second contact, wherein the first contact is surrounded by at least one sealing web, which at a Engagement of the contacts is pressed into the elastic body and seals the contacts to the outside.
  • the output transducer is preferably via a coupling element with an ossicle of the middle ear chain for transmitting the output side mechanical transducer oscillations coupled.
  • a coupling element with an ossicle of the middle ear chain for transmitting the output side mechanical transducer oscillations coupled.
  • the coupling element is preferably sleeve-shaped at least in the fixing and plastically cold formed by means of a crimping tool, while the coupling rod at least in the fixing rod-shaped, provided with a rough surface and under the Influence of the crimping force exerted by means of the crimping tool is not plastically cold deformable, wherein in the fixed state of the sleeve-shaped part of the coupling element coldf gutd deformed by the crimping force on the rod-shaped part of the coupling rod and permanently attached.
  • the remote from the output transducer end of the coupling rod can also be inserted into a bore of a portion of the ossicular chain and fixed there.
  • the output transducer can also be designed so that it can be coupled via an air gap to the ossicular chain or the inner ear, as described in detail in the US-A-5 015 225 is described.
  • a fully implantable hearing device includes an external system for the transcutaneous transmission of patient-specific hearing aid and audiometry programming data to the implant-side telemetry unit.
  • the telemetry unit is additionally designed as a power receiving circuit for the implant-side provision of recharging energy for the power supply unit, while the external system is also constructed as a charger.
  • a charging system are suitable for this US-A-5,279,292 known type or arrangements, as in the older EP patent applications 98 121 496.8 and 98 121 498.4 are described.
  • an implant part has, in addition to the output transducer, an energy and signal reception interface and an electronic system connected between the reception interface and the output transducer with components required for power supply and data regeneration, and an external system part comprises the microphone, an electronic module with the in the hearing aid path signal processing unit and the electronic module for generating and feeding the necessary for the audiometry function signals, a driver unit and connected to the output of the driver unit energy and signal transmission interface.
  • To the partially implantable hearing system preferably further includes an external system for transmitting patient-specific hearing aid and audiometry programming data to the electronic module of the external system part.
  • the implant system according to Fig. 1 has a microphone 10, by means of which the sound signal is recorded and converted into an electrical signal, which in an amplifier 40 is pre-amplified.
  • This pre-amplified signal is further processed in an audiological signal processing stage 50 (AP: "Audio Processor”).
  • This stage may include all known components common in modern hearing aids, such as filter stages, automatic gain controls, noise suppression devices, and so forth.
  • This processed signal is supplied to a summation element 70.
  • Further inputs of the signal combining element 70 are the one or more outputs of one or more signal generators 90 (SG1 to SGn) which generate the audiometer signals. These can be individual sinusoidal signals, narrowband signals, broadband signals and the like whose spectral position, level and phase relationships can be set to one another.
  • the audio signal processed by stage 50, together with the audio signal (s) of generator (s) 90, is supplied to a driver amplifier 80 which drives an electro-mechanical converter 20.
  • the transducer 20 stimulates the damaged inner ear by direct mechanical coupling via a coupling element 21 to a central ossicle or via an air gap coupling in, for example, electromagnetic implantable transducers.
  • the signal processing components 40, 50, 80 and the generators 90 are controlled by a microcontroller 100 ( ⁇ C) with associated data memory (S).
  • ⁇ C microcontroller 100
  • S data memory
  • patient-specific, audiological adaptation parameters as well as the audiometry parameters of the signal generators 90 can be stored in the memory area S.
  • These individual programmable data are supplied to the controller 100 via a telemetry unit 110 (T).
  • This telemetry unit 110 communicates wirelessly or by wire bidirectionally with an external programming system 120 (PS).
  • PS external programming system
  • All electronic components of the system are powered by a primary or a rechargeable secondary battery 60 with electrical operating energy except for the programming system 120.
  • Fig. 2 a further embodiment of the electronic signal module 30 is shown.
  • the signal from the microphone 10 is pre-amplified in the amplifier 40 and converted by means of an analog-to-digital converter 130 (A / D) into a digital signal, which is supplied to a digital signal processor 140 (DSP) with a data storage area S.
  • DSP digital signal processor 140
  • the signal processor 140 performs two tasks: on the one hand, as is customary in fully digital hearing aids, the audio signal is processed in accordance with the described signal processing methods for the rehabilitation of an inner ear damage.
  • the signal generators are digitally or software implemented which generate the described audiometer signals. The sum of these digital audio signals and the processed and amplified audio signal also occurs in the signal processor 140.
  • the digital output signal of the signal processor 140 is converted back to an analog signal in a digital to analogue converter 150 (D / A) and electromechanical via the driver amplifier 80 Transducer 20 is supplied.
  • the D / A converter 150 and the driver amplifier 80 can, as in Fig. 2 is indicated by a block 81, be summarized in a module. This is particularly preferable in the case where an electromagnetic system is used as the transducer 20, and in the output signal of the signal processor 140, the signal information by pulse width modulation is included, so that the required for the conversion back to an analog signal temporal integration directly from the converter 20 becomes.
  • All signal processing components are controlled by a microcontroller 100 ( ⁇ C) with associated data memory (S).
  • ⁇ C microcontroller 100
  • S data memory
  • patient-specific, audiological adaptation parameters as well as the individual operating parameters of the audiometer signal generators integrated in the signal processor 140 may be present in the memory area S of the microcontroller 100 be filed.
  • These individual programmable data are supplied to the controller 100 via a telemetry unit 110 (T).
  • This telemetry unit 110 communicates wirelessly or by wire bidirectionally with an external programming system 120 (PS). All electronic components of the system except the programming system 120 are powered by the primary or secondary battery 60 with electrical operating power.
  • PS external programming system 120
  • the Aus colbrungsform according to Fig. 3 is different from the one of Fig. 2 essentially only in that a signal processor 141 is provided which also performs the functions of the microcontroller 100 according to FIG Fig. 2 takes over. In this case, the patient-specific data of the audio signal processing as well as the audiometer functions are then likewise stored in the data memory area S of the signal processor 141.
  • Fig. 4 is a possible fully implantable embodiment according to Fig. 1 .
  • an electronic module 31 (shown without battery) is housed, which except for the absence of the battery, the module 30 of FIGS. 1 . 2 and 3 equivalent.
  • the housing 56 contains the battery 60 for the electrical supply of the implant and the telemetry device 110.
  • the microphone 10 is preferably in the off U.S. Patent 5,814,095 known manner, optionally using the in the EP-A-0 920 239 described fixation element, subcutaneously implanted in the posterior wall of the auditory canal.
  • the microphone 10 receives the sound and converts it into an electrical signal, which is supplied via the implant line 61 to the electronic module 31 in the housing 56.
  • This transducer 20 is shown in the present example as a directly coupled system, that is, the output side mechanical vibrations of the Transducer 20 are coupled via a suitable coupling element 21 directly to an ossicle of the middle ear chain, in the illustrated case to the anvil 62. Preferably, this is done in the itself US-A-5,277,694 and US-A-5 788 711 known way.
  • the transducer oscillations coupled there arrive via the ossicular chain to the inner ear and call there the corresponding one Auditory impression.
  • the external programming system 120 is shown, with which the patient-specific hearing device data and the audiometer parameters are transmitted transcutaneously through the closed skin 57 to the implant-side telemetry unit 110 as described.
  • a transmitting head 121 which is brought to the (bidirectional) data transmission via the implant and, for example, transfers the data by inductive means.
  • the battery 60 in the implant housing 56 is a secondary, rechargeable element
  • the unit 110 may also be a power receiving circuit for implant-side provision of recharging energy.
  • the external system 120 with the transmitting head 121 is, for example, a portable, wireless charger.
  • a partially implantable system is illustrated schematically.
  • the implantable part is shown as subsystem 220 and the external part to be worn on the outside as block 210.
  • the external unit 210 contains the microphone 10, a signal processing unit 30 and a driver unit 160 which generates the generated signals and operating energy for the implant part Example transmitted via a transmitting coil 170 inductively and transcutaneously through the closed skin 180 to the implanted system part 220.
  • This mode of transmission corresponds to the transmission in known, partially implantable cochlear implants or partially implantable hearing aids (see inter alia US-A-4,741,339 . EP-B-0 572 382 . US-A-5 795 287 ).
  • the electronic unit 30 of the external system part 210 contains all the necessary electronic components for hearing aid signal processing and generation of the audiometer signals, as described, for example, with reference to FIGS FIGS. 1 to 3 are explained.
  • the individual programming of the external system with patient-specific hearing aid data and with audiometer parameters takes place via the programming system 120, which is conventionally coupled to the electronic unit 30 in this case, as in conventional hearing aids.
  • the system 220 comprises a power and signal receiving interface, In the illustrated case, an inductive receiver coil 190.
  • the electronic system 200 contains all components required for power supply and data regeneration, such as demodulators and driver circuits for the electromechanical converter 20.

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  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Otolaryngology (AREA)
  • Neurosurgery (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Acoustics & Sound (AREA)
  • Signal Processing (AREA)
  • Prostheses (AREA)
  • Circuit For Audible Band Transducer (AREA)

Abstract

The implanted hearing aid system has a microphone (10) coupled via an audio signal processing path with electronic signal processing and an amplification circuits (40,50,80) to an electromechanical transducer (20). An electronic audiometer module (90 incorporated in the audio signal processing path of the hearing aid system, for providing audiometry signals for audiological subjective evaluation of the electromechanical transducer.

Description

Seit kurzem sind teil- und vollimplantierbare Hörgeräte zur Rehabilitation einer reinen Innenohrschwerhörigkeit oder einer kombinierten Schalleitungs- und Innenohrschwerhörigkeit mit mechanischer Stimulation des geschädigten Ohres auf dem Markt verfügbar oder befinden sich kurz vor der Markteinführung ( Zeitschrift HNO 46:844-852, 10-1998, H.P. Zenner et al., "Erste Implantationen eines vollständig implantierbaren elektronischen Hörsystems bei Patienten mit Innenohrschwerhörigkeit "; Zeitschrift HNO 46:853-863, 10-1998, H. Leysieffer et al., "Ein vollständig implantierbares Hörsystem für Innenohrschwerhörige: TICA LZ 3001 "; US-A-5 277 694 ; US-A-5 788 711 ; US-A-5 814 095 ; US-A-5 554 096 und US-A-5 624 376 ). Insbesondere bei vollimplantierbaren Systemen entfällt die Sichtbarkeit des Systems, so daß neben den Vorteilen der hohen Klangqualität, des offenen Gehörgangs und der vollen Alltagstauglichkeit von einer hohen zukünftigen Patientenakzeptanz ausgegangen werden kann. Grundsätzlich wird bei diesen implantierbaren Hörsystemen als Ausgangssignal ein mechanischer, vibratorischer Stimulus verwendet, der das Mittelohr oder Innenohr direkt anregt. Die Ankopplung des mechanischen Reizes, der von einem elektromechanischen Wandler erzeugt wird, geschieht durch direkte mechanische Verbindung des schwingenden Wandlerelementes an die Ossikelkette oder ein Ossikel des Mittelohres oder an das Innenohr ( US-A-5 941 814 ) oder durch eine Kraftkopplung über einen Luftspalt bei z.B. elektromagnetischen Wandlern.Recently, partially and fully implantable hearing aids for the rehabilitation of a pure inner ear hearing loss or a combined Schalleitungs- and inner ear hearing loss with mechanical stimulation of the damaged ear are available on the market or are about to be launched ( Journal ENT 46: 844-852, 10-1998, HP Zenner et al., "First implantations of a fully implantable electronic hearing system in patients with inner ear hearing loss "; Journal ENT 46: 853-863, 10-1998, H. Leysieffer et al., "A fully implantable hearing aid for hearing impaired people: TICA LZ 3001 "; US-A-5,277,694 ; US-A-5 788 711 ; U.S. Patent 5,814,095 ; US-A-5 554 096 and U.S. Patent 5,624,376 ). Especially with fully implantable systems eliminates the visibility of the system, so that in addition to the benefits of high sound quality, the open ear canal and the full practicality of a high future patient acceptance can be assumed. Basically, these implantable hearing aids use a mechanical, vibratory stimulus as an output signal that directly excites the middle ear or inner ear. The coupling of the mechanical stimulus, which is generated by an electromechanical transducer, is done by direct mechanical connection of the vibrating transducer element to the ossicular chain or an ossicle of the middle ear or to the inner ear ( US-A-5,941,814 ) or by a force coupling via an air gap in eg electromagnetic transducers.

Die Ankopplungsqualität des mechanischen Reizes wird durch viele Parameter beinflußt und trägt zur Rehabilitation des Hörschadens und zur empfundenen Hörqualität entscheidend mit bei. Intraoperativ ist diese Güte der Ankopplung nur schwer oder gar nicht einschätzbar, da die Bewegungsamplituden der schwingenden Teile auch bei höchsten Stimulationspegeln in einem Bereich um oder weit unter 1µm liegen und daher durch direkte Sichtkontrolle nicht beurteilbar sind. Selbst wenn dies durch andere technische Meßmethoden gelingt, z.B. durch intraoperative Lasermessungen (z.B. Laser-Doppler-Vibrometrie), verbleibt die Unsicherheit einer langzeitstabilen, sicheren Kopplung, da diese unter anderem durch Nekrosenbildungen, Gewebeneubildungen, Luftdruckänderungen und sonstige externe und interne Einwirkungen negativ beinflußt werden kann. Insbesondere verbleibt bei vollständig implantierbaren Systemen die Notwendigkeit, die Ankopplungsqualität des Wandlers beurteilen zu können, da bei einem Vollimplantat nicht die Möglichkeit besteht, einzelne Systemkomponenten an ihren technischen Schnittstellen getrennt zu messen, wenn z.B. der Implantatträger eine nachgelassene Übertragungsqualität beklagt, die durch Reprogrammierung individueller audiologischer Anpaßparameter nicht verbesserbar ist und daher ein operativer Eingriff zur Verbesserung der Situation nicht auszuschließen ist. Auch wenn ein solcher Fall nicht vorliegt, besteht grundsätzlich das wissenschaftliche Interesse, über eine aussagefähige Monitorfunktion der Langzeitentwicklung der Güte der Wandlerankopplung zu verfügen.The coupling quality of the mechanical stimulus is influenced by many parameters and contributes significantly to the rehabilitation of the hearing damage and to the perceived hearing quality. Intraoperatively, this quality of coupling is difficult or even unpredictable, since the motion amplitudes of the vibrating parts, even at the highest stimulation levels, are within a range of or well below 1 μm and therefore can not be assessed by direct visual inspection. Even if this is possible by other technical measurement methods, for example by intraoperative laser measurements (eg laser Doppler vibrometry), the uncertainty of a long-term stable, safe coupling remains, as they are negatively influenced, among other things by necrosis, tissue neoplasmosis, changes in air pressure and other external and internal influences can. In particular, in fully implantable systems, the need to assess the coupling quality of the transducer remains because a full implant does not have the ability to measure individual system components separately at their technical interfaces, if, for example, the implant wearer complains a declined transmission quality by reprogramming individual audiological Matching parameters can not be improved and therefore an operative intervention to improve the situation can not be ruled out. Even if such a case does not exist, there is a fundamental scientific interest in having a meaningful monitor function of the long-term development of the quality of the converter coupling.

In der Druckschrift WO 98/36711 wird hierzu eine Methode vorgeschlagen, die mit objektiven Hörprüfungsmethoden wie beispielsweise ERA (electric response audiometry), ABR (auditory brainstem response) oder Elektrocochleographie bei teil- und vollimplantierbaren Systemen mit mechanischer oder elektrischer Stimulation des geschädigten bzw. ausgefallenen Gehörs arbeitet. Durch elektrische Ableitung über externe Kopfelektroden oder implantierte Elektroden werden objektiv Stimulusantworten ermittelt, die durch Applikation geeigneter stimulierender Reize evoziert werden. Der Vorteil dieser Methode liegt darin, daß intraoperativ bei vollständiger Anästhesie objektive Daten der Übertragungsqualität ermittelt werden können. Der wesentliche Nachteil besteht jedoch unter anderem darin, daß diese objektiven Hörprüfungsmethoden nur qualitativer Natur sein können, im wesentlichen Daten an der Hörschwelle und nicht oder nur eingeschränkt überschwellig liefern und insbesondere nur unzureichende quantitative Genauigkeit bei frequenzspezifischen Messungen aufweisen. Die subjektive Bewertung der Übertragungsqualität sowie subjektive audiologische Messungen im überschwelligen Bereich wie zum Beispiel Lautheitsskalierungen sind nicht möglich.In the publication WO 98/36711 For this purpose, a method is proposed, which works with objective hearing test methods such as ERA (electric response audiometry), ABR (auditory brainstem response) or electrocochleography in partially and fully implantable systems with mechanical or electrical stimulation of the damaged or failed hearing. By electrical discharge via external head electrodes or implanted electrodes objectively stimulus responses are determined, which are evoked by applying suitable stimulating stimuli. The advantage of this method is that objective data of the transmission quality can be determined intraoperatively with complete anesthesia. However, the main disadvantage is, inter alia, that these objective hearing test methods can only be of a qualitative nature, essentially provide data at the threshold of hearing and not or only to a limited extent and in particular have only insufficient quantitative accuracy in frequency-specific measurements. The subjective evaluation of the transmission quality as well as subjective audiological measurements in the over-thresholds such as loudness scaling are not possible.

Die vorliegende Erfindung stellt sich die Aufgabe, ein teil- oder vollimplantierbares Hörsystem zu schaffen, das es erlaubt, unter Umgehung der genannten Nachteile durch psychoakustische Messungen, das heißt durch subjektive Patientenantworten, die Ankopplungsqualität des elektromechanischen Wandlers an das Mittel- beziehungsweise Innenohr zu ermitteln, ohne daß weitere biologisch-technische Schnittstellen in die Bewertung einbezogen sind, welche die Aussagefähigkeit der Bestimmung der Wandlerkopplungsqualität beinträchtigen.The object of the present invention is to provide a partially or fully implantable hearing system which, by circumventing the aforementioned disadvantages by psychoacoustic measurements, that is to say by subjective patient responses, determines the coupling quality of the electromechanical transducer to the middle or inner ear. without any further biological-technical interfaces being included in the evaluation, which impair the informative value of the determination of the converter coupling quality.

Ausgehend von einem teil- oder vollimplantierbaren Hörsystem zur Rehabilitation einer reinen Innenohrschwerhörigkeit oder einer kombinierten Schalleitungs- und Innenohrschwerhörigkeit, mit einem ein Audiosignal abgebenden Mikrofon, einer in einem audiosignalverarbeitenden, elektronischen Hörsystempfad liegenden elektronischen Signalbearbeitungs- und Verstärkungsseinheit, einem implantierbaren elektromechanischen Ausgangswandler und einer Einheit zur energetischen Versorgung des Implantates, wird diese Aufgabe erfindungsgemäß dadurch gelöst, daß das Hörsystem durch ein elektronisches Audiometer-Modul ergänzt ist, das Audiometriesignale für eine audiologische, subjektive Untersuchung und Bewertung der Ankopplungsgüte des elektromechanischen Ausgangswandlers erzeugt und in den Audiosignalverarbeitungsweg des Hörimplantates einspeist.Starting from a partially or fully implantable hearing system for the rehabilitation of a pure inner ear hearing or a combined sound and inner ear hearing, with an audio signal emitting microphone, lying in an audio signal processing, electronic hearing system path electronic signal processing and amplifying unit, an implantable electromechanical output transducer and a unit for energetic supply of the implant, this object is achieved in that the hearing aid is supplemented by an electronic audiometer module that generates audiometric signals for an audiological, subjective examination and evaluation of the coupling quality of the electromechanical output transducer and fed into the audio signal processing path of the hearing implant.

Das Audiometer-Modul besteht vorzugsweise aus einem oder mehreren, von außen einstellbaren beziehungsweise programmierbaren elektronischen Signalgeneratoren, die ein elektrisches Hörprüfungsignal in den Signalverarbeitungspfad des Implantates einspeisen. Der elektromechanische Ausgangswandler des implantierten Hörsystems wird von dem Audiometer-Modul technisch reproduzierbar und quantitativ bestimmt elektrisch direkt angesteuert; auf diese Weise werden Verfälschungen des Stimulationspegels vermieden, wie sie zum Beispiel durch Köpfhörer- oder insbesondere akustische Freifelddarbietungen der audiometrischen Testschalle auftreten können, weil hierbei auch die Sensor- beziehungsweise Mikrofonfunktion mit allen zugehörigen Variabilitäten in die psychoakustische Messung einbezogen ist.The audiometer module preferably consists of one or more externally adjustable or programmable electronic signal generators which feed an electrical auditory test signal into the signal processing path of the implant. The electromechanical output transducer of the implanted hearing system is controlled by the audiometer module technically reproducible and quantitatively determined electrically directly; In this way, distortions of the stimulation level are avoided, as they can occur, for example, by Köpfhörer- or in particular acoustic free-field performances of the audiometric test sound, because in this case also the sensor or microphone function with all the associated variability in the psychoacoustic measurement is included.

Das erfindungsgemäße System hat unter anderem den Vorteil, daß zum Beispiel frequenzspezifische Hörschwellenmessungen mit reinen Sinustönen oder schmalbandigen Signalen (beispielsweise Terzrauschen) auch bei größeren, zeitlichen Untersuchungsintervallen sehr gut reproduzierbar sind. Weiterhin ist auch die Gewinnung reproduzierbarer psychoakustischer Daten im überschwelligen Bereich wie zum Beispiel Lautheitsskalierungen möglich. Darüberhinaus können durch das Anbieten reiner Signale wie beispielsweise Sinussignalen auch Nichtlinearitäten subjektiv abgefragt werden, die zum Beispiel durch nachlassende Ankopplungsqualität enstehen können und als "Klirren" hörbar sind. Solche Untersuchungen sind durch die einleitend geschilderten objektiven Meßmethoden auf der Basis evozierter Potentiale nur eingeschränkt oder gar nicht möglich.The system according to the invention has, inter alia, the advantage that, for example, frequency-specific hearing threshold measurements with pure sine tones or narrow-band signals (for example, third-party noise) can be reproduced very well even at relatively long time intervals. Furthermore, it is also possible to obtain reproducible psychoacoustic data in the suprathreshold area, such as loudness scaling. Moreover, by offering pure signals such as sinusoidal signals, non-linearities can also be subjected to subjective interrogation, which can arise, for example, as a result of decreasing coupling quality and can be heard as "clinking". Such investigations are limited or even impossible by the initially described objective measurement methods based on evoked potentials.

Grundsätzlich besteht bei vollimplantierbaren Systemen durch die erfindungsgemäße Lösung der Vorteil, daß die Parameter der Signalgebung wie zum Beispiel der elektrische Ansteuerungspegel des elektromechanischen Implantatwandlers durch die implantatinternen Generatoren quantitativ exakt bestimmt und reproduzierbar sind und nicht Schwankungen unterliegen, wie sie beispielsweise bei einem Vollimplantat durch akustische Kopfhörerdarbietung der Testsignale gegeben sind. In diesem letztgenannten Fall ist auch die Übertragungsfunktion des implantierten Schallsensors (Mikrofons) mit in die Übertragung einbezogen; die Sensorfunktion kann auch zeitlichen Schwankungen unterliegen und macht somit eine exakte Schnittstellendefinition zur Wandlerübertragungsfunktion unmöglich.Basically, in vollimplantierbaren systems by the inventive solution has the advantage that the parameters of the signaling such as the electrical control level of the electromechanical implant converter by the implant-internal generators are quantitatively accurately determined and reproducible and not subject to fluctuations, such as in a full implant by acoustic headphone presentation the test signals are given. In this latter case, the transfer function of the implanted sound sensor (microphone) is also involved in the transfer; The sensor function can also be subject to temporal fluctuations and thus makes an exact interface definition to the transducer transfer function impossible.

Als implantierbarer elektromechanischer Ausgangswandler eignet sich insbesondere ein Wandler gemäß US-A-5 277 694 , das heißt ein Wandler, bei dem eine Wand des Wandlergehäuses als schwingfähige Membran ausgeführt ist, die zusammen mit einer auf der Membraninnenseite aufgebrachten piezoelektrischen Keramikscheibe ein elektromechanisch aktives Heteromorph-Verbundelement darstellt.As an implantable electromechanical output transducer is in particular a converter according to US-A-5,277,694 that is, a transducer in which a wall of the transducer housing is designed as a vibratable membrane, which represents an electromechanically active heteromorph composite element together with a piezoelectric ceramic disc mounted on the membrane inside.

Eine weitere für die vorliegenden Zwecke geeignete Wandlerbauart ist in der älteren EP-Patentanmeldung 98 121 495.0 beschrieben. Dabei handelt es sich um eine Wandleranordnung für teil- oder vollimplantierbare Hörgeräte zur direkten mechanischen Anregung des Mittel- oder Innenohres, die mit einem am Implantationsort mit Bezug auf den Schädel fixierbaren Gehäuse und einem mit Bezug auf das Gehäuse beweglichen, mechanisch steifen Koppelelement versehen ist, wobei in dem Gehäuse ein elektromechanischer Wandler untergebracht ist, mit dem sich das Koppelelement in Schwingungen versetzen läßt, die nach erfolgter Implantation der Wandleranordnung auf ein Mittelohr-Ossikel oder direkt auf das Innenohr übertragen werden. Der elektromechanische Wandler ist als Elektromagnetanordnung ausgebildet, die ein mit Bezug auf das Wandlergehäuse fixiertes Bauteil, insbesondere eine Ringspule, sowie ein schwingfähiges Bauteil, vorzugsweise in Form eines in eine Mittelöffnung der Ringspule eintauchenden Dauermagnetstifts, aufweist, welches mit dem Koppelelement derart in Verbindung steht, daß Schwingungen des schwingfähigen Bauteils auf das Koppelelement übertragen werden.Another suitable for the present purposes transducer type is in the older EP patent application 98 121 495.0 described. It is a transducer assembly for partially or fully implantable hearing for direct mechanical excitation of the middle or inner ear, which is provided with a fixable at the implantation site with respect to the skull housing and with respect to the housing movable, mechanically rigid coupling element, wherein in the housing, an electromechanical transducer is housed, with which the coupling element can oscillate, which are transmitted after implantation of the transducer assembly to a middle ear ossicle or directly to the inner ear. The electromechanical transducer is designed as an electromagnet arrangement which has a component fixed relative to the converter housing, in particular a toroidal coil, and a vibratable component, preferably in the form of a permanent magnet pin immersed in a central opening of the toroidal coil, which communicates with the coupling element in such a manner. that vibrations of the oscillatory component are transmitted to the coupling element.

Vorteilhaft ist aber auch ein Wandler der in der älteren EP-Patentanmeldung 98 121 613.8 beschriebenen Art. Dabei handelt es sich um einen Wandler für teil- oder vollimplantierbare Hörgeräte zur direkten mechanischen Anregung des Mittel- oder Innenohres, der mit einem am Implantationsort fixierbaren Gehäuse und einem mit Bezug auf das Gehäuse beweglichen, mechanisch steifen Koppelelement versehen ist, wobei in dem Gehäuse ein piezoelektrisches Element untergebracht ist, mit dem sich das Koppelelement in Schwingungen versetzen läßt, die nach erfolgter Implantation des Wandlers auf ein Mittelohr-Ossikel oder direkt auf das Innenohr übertragen werden, und wobei in dem Gehäuse ferner eine Elektromagnetanordnung vorgesehen ist, die ein mit Bezug auf das Gehäuse fixiertes Bauteil sowie ein schwingfähiges Bauteil aufweist, welches mit dem Koppelelement derart in Verbindung steht, daß Schwingungen des schwingfähigen Bauteils auf das Koppelelement übertragen werden. Ein solcher Wandler hat den Vorteil, daß der Frequenzgang des Wandlers sowohl gegenüber rein piezoelektrischen als auch gegenüber rein elektromagnetischen Systemen verbessert werden kann, so daß ein adäquater Höreindruck bei ausreichendem Lautstärkepegel ermöglicht wird. Insbesondere kann ein weitgehend ebener Frequenzgang der Auslenkung des Koppelelements in einem weiten Frequenzband bei ausreichend hohen Stimulationspegeln und geringer Leistungsaufnahme verwirklicht werden.But it is also advantageous to have a converter in the older one EP patent application 98 121 613.8 It is a converter for partially or fully implantable hearing for direct mechanical excitation of the middle or inner ear, which is provided with a fixable at the implantation housing and a movable with respect to the housing, mechanically rigid coupling element, wherein in the housing a piezoelectric element is housed, with which the coupling element can oscillate, which are transmitted to a middle ear ossicle or directly to the inner ear after implantation of the transducer, and wherein in the housing further comprises an electromagnet assembly is provided which Having fixed with respect to the housing member and a vibratable component which is in communication with the coupling element such that vibrations of the oscillatory component are transmitted to the coupling element. Such a transducer has the advantage that the frequency response of the transducer can be improved both with respect to purely piezoelectric as well as against purely electromagnetic systems, so that an adequate hearing impression at a sufficient volume level is possible. In particular, a substantially flat frequency response of the deflection of the coupling element in a wide frequency band at sufficiently high stimulation levels and low power consumption can be realized.

Bei dem Hörsystem nach der Erfindung sind vorzugsweise patientenspezifische Signalparameter für die Audiometriefunktion mittels einer elektronischen Einheit an die Erfordernisse und pathologischen Bedürfnisse des Patienten individuell anpaßbar.In the hearing system according to the invention, preferably patient-specific signal parameters for the audiometry function can be individually adapted to the requirements and pathological needs of the patient by means of an electronic unit.

Die elektronische Signalbearbeitungs- und Verstärkungsseinheit weist zweckmäßig einen dem Mikrofon nachgeschalteten Verstärker, eine mit dem Ausgangssignal des Verstärkers beaufschlagte audiologische Signalbearbeitungsstufe und einen dem elektromechanischen Ausgangswandler vorgeschalteten Treiberverstärker auf. Dabei kann vorteilhaft das elektronische Modul mit einer Signalgeneratoranordnung zum Generieren der für die Audiometriefunktion notwendigen Signale und einem zwischen die Signalbearbeitungsstufe und den Treiberverstärker geschalteten Summierglied versehen sein, über das dem Treiberverstärker sowohl das Ausgangssignal der audiologischen Signalbearbeitungsstufe als auch das Ausgangssignal der Signalgeneratoranordnung zugehen.The electronic signal processing and amplification unit expediently has an amplifier connected downstream of the microphone, an audiological signal processing stage acted upon by the output signal of the amplifier and a driver amplifier connected upstream of the electromechanical output converter. Advantageously, the electronic module can be provided with a signal generator arrangement for generating the signals necessary for the audiometry function and a summing element connected between the signal processing stage and the driver amplifier, via which the driver amplifier receives both the output signal of the audiological signal processing stage and the output signal of the signal generator arrangement.

Entsprechend einer abgewandelten Ausführungsform der Erfindung kann aber auch als audiologische Signalbearbeitungsstufe ein digitaler Signalprozessor vorgesehen sein, der sowohl für die Aufbereitung des Audiosignals als auch für die Erzeugung der für die Audiometriefunktion notwendigen Signale und für die Zusammenfassung der letztgenannten Signale mit dem Audiosignal ausgelegt ist. In einem solchen Fall sind zweckmäßig dem Signalprozessor ein Analog-Digital-Wandler vor- und ein Digital-Analog-Wandler nachgeschaltet.According to a modified embodiment of the invention may also be provided as audiological signal processing stage, a digital signal processor, which is designed both for the preparation of the audio signal and for generating the necessary for the audiometry function signals and for the combination of the latter signals with the audio signal. In such a case, the signal processor expediently an analog-to-digital converter upstream and downstream of a digital-to-analog converter.

Der Digital-Analog-Wandler und der Treiberverstärker können in einem Modul zusammengefaßt sein.The digital-to-analog converter and the driver amplifier can be combined in one module.

Der Signalprozessor ist vorzugsweise mit einem Datenspeicher zum Einspeichern von patientenspezifischen, audiologischen Anpaßparametern und/oder von Parametern für die Erzeugung der Signale für die Audiometriefunktion ausgestattet.The signal processor is preferably equipped with a data memory for storing patient-specific, audiological adaptation parameters and / or parameters for generating the signals for the audiometry function.

Zum Steuern mindestens eines Teils der und vorzugsweise aller signalverarbeitenden und/oder -erzeugenden Stufen kann vorteihaft ein Mikrokontroller vorgesehen sein, der zweckmäßig einen Datenspeicher zum Einspeichern von patientenspezifischen, audiologischen Anpaßparametern und/oder von Betriebsparametern der Signalgeneratoranordnung aufweist.For controlling at least a part of and preferably all signal-processing and / or -producing stages, a microcontroller may advantageously be provided which expediently has a data memory for storing patient-specific, audiological adaptation parameters and / or operating parameters of the signal generator arrangement.

Der Signalprozessor kann aber auch selbst für des Steuern mindestens eines Teils der und vorzugsweise aller signalverarbeitenden und/oder -erzeugenden Stufen ausgelegt sein.The signal processor can also be designed for controlling at least a part of and preferably all signal processing and / or generating stages.

Zur Dateneingabe in den Datenspeicher eignet sich eine Telemetrieeinheit, die mit einem externen Programmiersystem drahtlos oder drahtgebunden kommuniziert.For data entry into the data memory is a telemetry unit that communicates wirelessly or by wire with an external programming system.

Wenn das Hörgerät vollimplantierbar ausgebildet ist, sind vorzugsweise die in dem elektronischen Hörsystempfad liegende Signalbearbeitungs- und Verstärkungsseinheit, das elektronische Modul zur Erzeugung und Einspeisung der für die Audiometriefunktion notwendigen Signale und die Telemetrieeinheit als Elektronikmodul, zweckmäßig zusammen mit der Energieversorgungseinheit, in einem hermetisch dichten und biokompatiblen Implantatgehäuse untergebracht. Dabei ist vorteilhaft das Elektronikmodul über eine Implantatleitung mit einem in der hinteren Gehörgangswand subkutan implantierbaren Mikrofon und über eine implantierbare Leitung mit dem elektromechanischen Ausgangswandler verbunden. Diese Verbindung kann fest oder lösbar ausgebildet sein. Für eine lösbare Verbindung eignet sich insbesondere eine Steckverbindung, wie sie in US-A-5 755 743 im einzelnen erläutert ist. Eine solche Verbindungsanordnung weist mindestens einen ersten Kontakt, mindestens einen auf einem elastischen Körper gelagerten zweiten Kontakt und einen Verschlußmechanismus zum Ineingriffbringen der Stirnfläche des ersten Kontakts mit der Stirnfläche des zweiten Kontakts auf, wobei der erste Kontakt von mindestens einem Dichtungssteg umgeben ist, der bei einem Eingriff der Kontakte in den elastischen Körper eingepreßt ist und die Kontakte nach außen hin abdichtet.If the hearing device is designed to be fully implantable, the signal processing and amplification unit located in the electronic hearing system path, the electronic module for generating and supplying the signals required for the audiometry function and the telemetry unit as electronic module, preferably together with the energy supply unit, are preferably in a hermetically sealed and housed biocompatible implant housing. In this case, the electronic module is advantageously connected via an implant lead to a subcutaneously implantable microphone in the posterior auditory canal wall and to the electromechanical output transducer via an implantable lead. This compound can be fixed or detachable. For a detachable connection is particularly suitable a connector, as in US-A-5,755,743 is explained in detail. Such a connection arrangement has at least one first contact, at least one second contact mounted on an elastic body and a closure mechanism for engaging the end face of the first contact with the end face of the second contact, wherein the first contact is surrounded by at least one sealing web, which at a Engagement of the contacts is pressed into the elastic body and seals the contacts to the outside.

Der Ausgangswandler ist vorzugsweise über ein Koppelelement mit einem Ossikel der Mittelohrkette zur Übertragung der ausgangseitigen mechanischen Wandlerschwingungen koppelbar. Dafür eignen sich insbesondere Lösungen der in US-A-5 277 694 und in US-A-5 941 814 beschriebenen Art. Dabei kann vorteilhaft ein aktiv schwingfähiges Teil des Ausgangswandlers mit einer Koppelstange mechanisch fest verbunden sein, die über ein Koppelelement an ein Teil der Ossikelkette angekoppelt wird. Zum Einstellen der Relativlage von Koppelstange und Koppelelement und zum Fixieren dieser Elemente in der eingestellten Relativlage ist vorzugsweise das Koppelelement mindestens im Fixierbereich hülsenförmig ausgebildet und mittels eines Crimpwerkzeugs plastisch kaltverformbar ist, während die Koppelstange mindestens im Fixierbereich stabförmig ausgebildet, mit rauher Oberfläche versehen und unter dem Einfluß der mittels des Crimpwerkzeugs ausgeübten Crimpkraft nicht plastisch kaltverformbar ist, wobei im fixierten Zustand der hülsenförmige Teil des Koppelelements durch die Crimpkraft kaltfließend verformt auf dem stabförmigen Teil der Koppelstange spielfrei und dauerhaft befestigt ist. Das von dem Ausgangswandler abliegende Ende der Koppelstange kann aber auch in eine Bohrung eines Teils der Ossikelkette eingesteckt und dort festgelegt sein.The output transducer is preferably via a coupling element with an ossicle of the middle ear chain for transmitting the output side mechanical transducer oscillations coupled. For this purpose, in particular solutions of in US-A-5,277,694 and in US-A-5,941,814 In this case, advantageously, an actively oscillatable part of the output transducer to be mechanically fixed to a coupling rod, which is coupled via a coupling element to a part of the ossicular chain. For adjusting the relative position of coupling rod and coupling element and for fixing these elements in the set relative position, the coupling element is preferably sleeve-shaped at least in the fixing and plastically cold formed by means of a crimping tool, while the coupling rod at least in the fixing rod-shaped, provided with a rough surface and under the Influence of the crimping force exerted by means of the crimping tool is not plastically cold deformable, wherein in the fixed state of the sleeve-shaped part of the coupling element coldfließend deformed by the crimping force on the rod-shaped part of the coupling rod and permanently attached. The remote from the output transducer end of the coupling rod can also be inserted into a bore of a portion of the ossicular chain and fixed there.

Ferner kann der Ausgangswandler auch so ausgelegt sein, daß er über einen Luftspalt an die Ossikelkette oder das Innenohr ankoppelbar ist, wie dies im einzelnen in der US-A-5 015 225 beschrieben ist.Furthermore, the output transducer can also be designed so that it can be coupled via an air gap to the ossicular chain or the inner ear, as described in detail in the US-A-5 015 225 is described.

Zu einem vollimplantierbaren Hörgerät gehört in weiterer Ausgestaltung der Erfindung ein externes System zum transkutanen Übermitteln von patientenindividuellen Hörgeräte- und Audiometrie-Programmierdaten an die implantatseitige Telemetrieeinheit.In a further embodiment of the invention, a fully implantable hearing device includes an external system for the transcutaneous transmission of patient-specific hearing aid and audiometry programming data to the implant-side telemetry unit.

Als Energieversorgungseinheit kommen insbesondere eine Primärbatterie oder ein sekundäres, wiederaufladbares Element, das heißt ein nachladbarer Akkumulator, in Betracht. Im letztgenannten Fall ist vorzugsweise die Telemetrieeinheit zusätzlich als Energieempfangsschaltung zur implantatseitigen Bereitstellung von Nachladeenergie für die Energieversorgungseinheit ausgebildet, während das externe System zugleich als Ladegerät aufgebaut ist. Dafür eignen sich insbesondere ein Ladesystem der aus US-A-5 279 292 bekannten Art oder Anordnungen, wie sie in den älteren EP-Patentanmeldungen 98 121 496.8 und 98 121 498.4 beschrieben sind.As a power supply unit in particular a primary battery or a secondary, rechargeable element, that is, a rechargeable accumulator, into consideration. In the latter case, preferably, the telemetry unit is additionally designed as a power receiving circuit for the implant-side provision of recharging energy for the power supply unit, while the external system is also constructed as a charger. In particular, a charging system are suitable for this US-A-5,279,292 known type or arrangements, as in the older EP patent applications 98 121 496.8 and 98 121 498.4 are described.

Zweckmäßig ist auch eine portable Fernbedienungseinheit zum Einstellen oder Verändern von Hörgeräte- und Audiometriefunktionen vorgesehen.It is also expedient to provide a portable remote control unit for setting or changing hearing aid and audiometry functions.

Bei einem teilimplantierbaren System weist vorzugsweise ein Implantatteil zusätzlich zu dem Ausgangswandler eine Energie- und Signalempfangsschnittstelle sowie ein zwischen die Empfangsschnittstelle und den Ausgangswandler geschaltetes elektronisches System mit für die Energieversorgung und Datenregenerierung erforderlichen Komponenten auf, und ein externer Systemteil umfaßt das Mikrofon, ein Elektronikmodul mit der im Hörgerätepfad liegenden Signalbearbeitungseinheit und dem elektronischen Modul zur Erzeugung und Einspeisung der für die Audiometriefunktion notwendigen Signale, eine Treibereinheit und eine an den Ausgang der Treibereinheit angeschlossene Energie- und Signalsendeschnittstelle.In a partially implantable system, preferably an implant part has, in addition to the output transducer, an energy and signal reception interface and an electronic system connected between the reception interface and the output transducer with components required for power supply and data regeneration, and an external system part comprises the microphone, an electronic module with the in the hearing aid path signal processing unit and the electronic module for generating and feeding the necessary for the audiometry function signals, a driver unit and connected to the output of the driver unit energy and signal transmission interface.

Zu dem teilimplantierbaren Hörsystem gehört vorzugsweise ferner ein externes System zum Übermitteln von patientenindividuellen Hörgeräte- und Audiometrie-Programmierdaten an das Elektronikmodul des externen Systemteils.To the partially implantable hearing system preferably further includes an external system for transmitting patient-specific hearing aid and audiometry programming data to the electronic module of the external system part.

Nachfolgend sind vorteilhafte Ausführungsbeispiele der Erfindung anhand der Zeichnungen näher erläutert. Es zeigen:

Fig. 1
ein Blockschaltbild eines erfindungsgemäßen vollimplantierbaren Hörsystems;
Fign. 2 und 3
Blockschaltbilder von abgewandelten Ausführungsformen des voll- implantierbaren Hörsystems;
Fig. 4
eine schematische Darstellung eines vollimplantierbaren Hörsystems im implantierten Zustand; und
Fig. 5
ein Blockschaltbild eines erfindungsgemäßen teilimplantierbaren Hörsystems.
Below, advantageous embodiments of the invention are explained in more detail with reference to the drawings. Show it:
Fig. 1
a block diagram of a fully implantable hearing system according to the invention;
FIGS. 2 and 3
Block diagrams of modified embodiments of the fully implantable hearing system;
Fig. 4
a schematic representation of a fully implantable hearing in the implanted state; and
Fig. 5
a block diagram of a partially implantable hearing system according to the invention.

Das Implantatsystem gemäß Fig. 1 weist ein Mikrofon 10 auf, mittels dessen das Schallsignal aufgenommen und in ein elektrisches Signal umgewandelt wird, das in einem Verstärker 40 vorverstärkt wird. Dieses vorverstärkte Signal wird in einer audiologischen Signalbearbeitungsstufe 50 (AP: "Audio Prozessor") weiterbearbeitet. Diese Stufe kann alle bekannten, bei modernen Hörgeräten üblichen Komponenten wie Filterstufen, automatische Verstärkungsregelungen, Störsignalunterdrückungseinrichtungen und so weiter enthalten. Dieses bearbeitete Signal wird einem Summationsglied 70 zugeführt.The implant system according to Fig. 1 has a microphone 10, by means of which the sound signal is recorded and converted into an electrical signal, which in an amplifier 40 is pre-amplified. This pre-amplified signal is further processed in an audiological signal processing stage 50 (AP: "Audio Processor"). This stage may include all known components common in modern hearing aids, such as filter stages, automatic gain controls, noise suppression devices, and so forth. This processed signal is supplied to a summation element 70.

Weitere Eingänge des signalzusammenfassenden Elementes 70 sind der oder die Ausgänge eines oder mehrerer Signalgeneratoren 90 (SG1 bis SGn), der oder die Audiometersignale generieren. Dies können einzelne Sinussignale, Schmalbandsignale, breitbandige Signale und dergleichen sein, deren spektrale Lage, Pegel- und Phasenverhältnisse zueinander einstellbar sind.Further inputs of the signal combining element 70 are the one or more outputs of one or more signal generators 90 (SG1 to SGn) which generate the audiometer signals. These can be individual sinusoidal signals, narrowband signals, broadband signals and the like whose spectral position, level and phase relationships can be set to one another.

Das durch die Stufe 50 bearbeitete Audiosignal wird zusammen mit dem oder den Audiometersignalen des oder der Generatoren 90 einem Treiberverstärker 80 zugeführt, der einen elektromechanischen Wandler 20 ansteuert. Der Wandler 20 stimuliert das geschädigte Innenohr durch direkte mechanische Kopplung über ein Koppelelement 21 an ein Mittelohrossikel oder über eine Luftspaltkopplung bei zum Beispiel elektromagnetischen, implantierbaren Wandlern. Die Signalbearbeitungskomponenten 40, 50, 80 und die Generatoren 90 werden durch einen Mikrokontroller 100 (µC) mit zugehörigem Datenspeicher (S) gesteuert. In dem Speicherbereich S können insbesondere patientenspezifische, audiologische Anpaßparameter sowie die Audiometrieparameter der Signalgeneratoren 90 abgelegt sein. Diese individuellen, programmierbaren Daten werden dem Kontroller 100 über eine Telemetrieeinheit 110 (T) zugeführt. Diese Telemetrieeinheit 110 kommuniziert drahtlos oder drahtgebunden bidirektional mit einem externen Programmiersystem 120 (PS).The audio signal processed by stage 50, together with the audio signal (s) of generator (s) 90, is supplied to a driver amplifier 80 which drives an electro-mechanical converter 20. The transducer 20 stimulates the damaged inner ear by direct mechanical coupling via a coupling element 21 to a central ossicle or via an air gap coupling in, for example, electromagnetic implantable transducers. The signal processing components 40, 50, 80 and the generators 90 are controlled by a microcontroller 100 (μC) with associated data memory (S). In particular, patient-specific, audiological adaptation parameters as well as the audiometry parameters of the signal generators 90 can be stored in the memory area S. These individual programmable data are supplied to the controller 100 via a telemetry unit 110 (T). This telemetry unit 110 communicates wirelessly or by wire bidirectionally with an external programming system 120 (PS).

Alle elektronischen Komponenten des Systems werden bis auf das Programmiersystem 120 durch eine primäre oder eine nachladbare sekundäre Batterie 60 mit elektrischer Betriebsenergie versorgt.All electronic components of the system are powered by a primary or a rechargeable secondary battery 60 with electrical operating energy except for the programming system 120.

Insbesondere bei einem vollimplantierbaren System bietet es sich an, alle beschriebenen elektronischen signalver- und bearbeitenden Schaltungsteile sowie die Steuerunaskomponenten und die Energieversorgung in einem Modul 30 zusammenzufassen; dies ist in Fig. 1 durch die strichpunktierte Linie angedeutet. An dieses Signalmodul 30 werden implantatseitig lediglich das Mikrofon 10 und der elektromechanische Wandler 20 über entsprechende Leitungen 61 beziehungsweise 59 fest oder gegebenenfalls über implantierbare Steckverbindungen angeschlossen.In particular, in a fully implantable system, it makes sense, all described electronic signal processing and processing circuit parts and the Steuerunaskomponenten and group the power supply in a module 30; this is in Fig. 1 indicated by the dotted line. On the implant side, only the microphone 10 and the electromechanical converter 20 are fixedly connected to this signal module 30 via corresponding lines 61 and 59 or optionally via implantable plug connections.

In Fig. 2 ist eine weitere Ausführungsform des elektronischen Signalmoduls 30 dargestellt. Das Signal des Mikrofons 10 wird in dem Verstärker 40 vorverstärkt und mittels eines Analog-Digital-Wandlers 130 (A/D) in ein digitales Signal verwandelt, das einem digitalen Signalprozessor 140 (DSP) mit einem Datenspeicherbereich S zugeführt wird. Der Signalprozessor 140 übernimmt prinzipiell zwei Aufgaben: einerseits wird wie in volldigitalen Hörgeräten üblich das Audiosignal den beschriebenen Signalbearbeitungsmethoden für eine Rehabilitation eines Innenohrschadens entsprechend aufbereitet. Andererseits werden in dem Signalprozessor 140 die Signalgeneratoren digital oder softwaremäßig realisiert, die die beschriebenen Audiometersignale erzeugen. Die Zusammenfassung dieser digitalen Audiometersignale und des bearbeiteten und verstärkten Audiosignals erfolgt ebenfalls in dem Signalprozessor 140. Das digitale Ausgangssignal des Signalprozessors 140 wird in einem Digital-Analog-Wandler 150 (D/A) in ein analoges Signal rückgewandelt und über den Treiberverstärker 80 dem elektromechanischen Wandler 20 zugeführt.In Fig. 2 a further embodiment of the electronic signal module 30 is shown. The signal from the microphone 10 is pre-amplified in the amplifier 40 and converted by means of an analog-to-digital converter 130 (A / D) into a digital signal, which is supplied to a digital signal processor 140 (DSP) with a data storage area S. In principle, the signal processor 140 performs two tasks: on the one hand, as is customary in fully digital hearing aids, the audio signal is processed in accordance with the described signal processing methods for the rehabilitation of an inner ear damage. On the other hand, in the signal processor 140, the signal generators are digitally or software implemented which generate the described audiometer signals. The sum of these digital audio signals and the processed and amplified audio signal also occurs in the signal processor 140. The digital output signal of the signal processor 140 is converted back to an analog signal in a digital to analogue converter 150 (D / A) and electromechanical via the driver amplifier 80 Transducer 20 is supplied.

Der D/A-Wandler 150 und der Treiberverstärker 80 können, wie in Fig. 2 durch einen Block 81 angedeutet ist, in einem Modul zusammengefaßt sein. Dies ist insbesondere in dem Fall vorzuziehen, in dem als Wandler 20 ein elektromagnetisches System verwendet wird und in dem Ausgangssignal des Signalprozessors 140 die Signalinformation durch Pulsweitenmodulation enthalten ist, so daß die für die Rückwandlung in ein Analogsignal erforderliche zeitliche Integration direkt von dem Wandler 20 übernommen wird.The D / A converter 150 and the driver amplifier 80 can, as in Fig. 2 is indicated by a block 81, be summarized in a module. This is particularly preferable in the case where an electromagnetic system is used as the transducer 20, and in the output signal of the signal processor 140, the signal information by pulse width modulation is included, so that the required for the conversion back to an analog signal temporal integration directly from the converter 20 becomes.

Alle Signalverarbeitungskomponenten werden durch einen Mikrokontroller 100 (µC) mit zugehörigem Datenspeicher (S) gesteuert. In dem Speicherbereich S des Mikrokontrollers 100 können insbesondere patientenspezifische, audiologische Anpaßparameter sowie die individuellen Betriebsparameter der in den Signalprozessor 140 integrierten Audiometer-Signalgeneratoren abgelegt sein. Diese individuellen, programmierbaren Daten werden dem Kontroller 100 über eine Telemetrieeinheit 110 (T) zugeführt. Diese Telemetrieeinheit 110 kommuniziert drahtlos oder drahtgebunden bidirektional mit einem externen Programmiersystem 120 (PS).Alle elektronischen Komponenten des Systems werden bis auf das Programmiersystem 120 durch die primäre oder sekundäre Batterie 60 mit elektrischer Betriebsenergie versorgt.All signal processing components are controlled by a microcontroller 100 (μC) with associated data memory (S). In particular, patient-specific, audiological adaptation parameters as well as the individual operating parameters of the audiometer signal generators integrated in the signal processor 140 may be present in the memory area S of the microcontroller 100 be filed. These individual programmable data are supplied to the controller 100 via a telemetry unit 110 (T). This telemetry unit 110 communicates wirelessly or by wire bidirectionally with an external programming system 120 (PS). All electronic components of the system except the programming system 120 are powered by the primary or secondary battery 60 with electrical operating power.

Die Ausfübrungsform gemäß Fig. 3 unterscheidet sich von derjenigen der Fig. 2 im wesentlichen nur dadurch, daß ein Signalprozessor 141 vorgesehen ist, der auch die Funktionen des Mikrokontrollers 100 gemäß Fig. 2 übernimmt. Dabei werden die patientenspezifischen Daten der Audiosignalbearbeitung sowie der Audiometerfunktionen dann ebenfalls in dem Datenspeicherbereich S des Signalprozessors 141 abgelegt.The Ausfübrungsform according to Fig. 3 is different from the one of Fig. 2 essentially only in that a signal processor 141 is provided which also performs the functions of the microcontroller 100 according to FIG Fig. 2 takes over. In this case, the patient-specific data of the audio signal processing as well as the audiometer functions are then likewise stored in the data memory area S of the signal processor 141.

In Fig. 4 ist eine mögliche vollimplantierbare Ausfübrungsform gemäß Fig. 1, Fig. 2 oder Fig. 3 schematisch dargestellt. In einem hermetisch dichten und biokompatiblen Implantatgehäuse 56 ist ein Elektronikmodul 31 (ohne Batterie dargestellt) untergebracht, das bis auf das Fehlen der Batterie dem Modul 30 der Figuren 1, 2 und 3 entspricht. Weiterhin enthält das Gehäuse 56 die Batterie 60 zur elektrischen Versorgung des Implantates sowie die Telemetrieeinrichtung 110. Das Mikrofon 10 ist vorzugsweise in der aus US-A-5 814 095 bekannten Weise, gegebenenfalls unter Verwendung des in der EP-A-0 920 239 beschriebenen Fixationselements, in der hinteren Gehörgangswand subkutan implantiert. Das Mikrofon 10 nimmt den Schall auf und wandelt ihn in ein elektrisches Signal um, das über die Implantatleitung 61 dem Elektronikmodul 31 in dem Gehäuse 56 zugeführt wird. Das audiologisch bearbeitete und verstärkte Signal, dem entsprechende Audiometersignale durch die elektronische Einheit 31 beigefügt sind, gelangt über die implantierbare Leitung 59 zu dem elektromechanischen Wandler 20. Dieser Wandler 20 ist im vorliegenden Beispiel als direktgekoppeltes System dargestellt, das heißt, die ausgangsseitigen mechanischen Schwingungen des Wandlers 20 werden über ein geeignetes Koppelelement 21 direkt an ein Ossikel der Mittelohrkette gekoppelt, im dargestellten Fall an den Amboß 62. Vorzugsweise geschieht dies in der an sich aus US-A-5 277 694 und US-A-5 788 711 bekannten Weise. Die dort eingekoppelten Wandlerschwingungen gelangen über die Ossikelkette zum Innenohr und rufen dort den entsprechenden Höreindruck hervor.In Fig. 4 is a possible fully implantable embodiment according to Fig. 1 . Fig. 2 or Fig. 3 shown schematically. In a hermetically sealed and biocompatible implant housing 56, an electronic module 31 (shown without battery) is housed, which except for the absence of the battery, the module 30 of FIGS. 1 . 2 and 3 equivalent. Furthermore, the housing 56 contains the battery 60 for the electrical supply of the implant and the telemetry device 110. The microphone 10 is preferably in the off U.S. Patent 5,814,095 known manner, optionally using the in the EP-A-0 920 239 described fixation element, subcutaneously implanted in the posterior wall of the auditory canal. The microphone 10 receives the sound and converts it into an electrical signal, which is supplied via the implant line 61 to the electronic module 31 in the housing 56. The audiologically processed and amplified signal to which corresponding audiometer signals are added by the electronic unit 31, passes via the implantable line 59 to the electromechanical transducer 20. This transducer 20 is shown in the present example as a directly coupled system, that is, the output side mechanical vibrations of the Transducer 20 are coupled via a suitable coupling element 21 directly to an ossicle of the middle ear chain, in the illustrated case to the anvil 62. Preferably, this is done in the itself US-A-5,277,694 and US-A-5 788 711 known way. The transducer oscillations coupled there arrive via the ossicular chain to the inner ear and call there the corresponding one Auditory impression.

Weiterhin ist in Fig. 4 das externe Programmiersystem 120 dargestellt, mit dem wie beschrieben die patientenindividuellen Hörgerätedaten sowie die Audiometerparameter transkutan durch die geschlossene Haut 57 an die implantatseitige Telemetrieeinheit 110 übermittelt werden. Dazu dient ein Sendekopf 121, der zur (bidirektionalen) Datenübermittlung über das Implantat gebracht wird und zum Beispiel auf induktivem Weg die Daten transferiert. Ist die Batterie 60 im Implantatgehäuse 56 ein sekundäres, wiederaufladbares Element, kann die Einheit 110 auch eine Energieempfangsschaltung zur implantatseitigen Bereitsstellung von Nachladeenergie sein. Dann ist das externe System 120 mit dem Sendekopf 121 ein zum Beispiel portables, drahtloses Ladegerät. Dabei können vorzugsweise Anordnungen vorgesehen werden, wie sie an sich aus US-A-5 279 292 bekannt beziehungsweise in den EP-Patentanmeldungen 98 121 496.8 und 98 121 498.4 näher erläutert sind. Weiter ist eine portable Fernbedienungseinheit 65 dargestellt, mit der der Patient wesentliche Hörgerätefunktionen einstellen beziehungsweise verändern kann.Furthermore, in Fig. 4 the external programming system 120 is shown, with which the patient-specific hearing device data and the audiometer parameters are transmitted transcutaneously through the closed skin 57 to the implant-side telemetry unit 110 as described. This is done by a transmitting head 121, which is brought to the (bidirectional) data transmission via the implant and, for example, transfers the data by inductive means. If the battery 60 in the implant housing 56 is a secondary, rechargeable element, the unit 110 may also be a power receiving circuit for implant-side provision of recharging energy. Then the external system 120 with the transmitting head 121 is, for example, a portable, wireless charger. In this case, arrangements may preferably be provided, as they themselves US-A-5,279,292 known or in the EP patent applications 98 121 496.8 and 98 121 498.4 are explained in more detail. Next, a portable remote control unit 65 is shown, with which the patient can set or change essential hearing aid functions.

In Fig. 5 ist ein teilimplantierbares System schematisch veranschaulicht. Dabei ist der implantierbare Teil als Teilsystem 220 dargestellt und der externe, außen am Körper zu tragende Teil als Block 210. Die externe Einheit 210 enthält das Mikrofon 10, eine Signalverarbeitungseinheit 30 und eine Treibereinheit 160, die die erzeugten Signale und Betriebsenergie für den Implantatteil zum Beispiel über eine Sendespule 170 induktiv und transkutan durch die geschlossene Haut 180 an den implantierten Systemteil 220 übermittelt. Diese Übertragungsart entspricht der Übertragung bei bekannten, teilimplantierbaren Cochlea-Implantaten beziehungsweise teilimplantierbaren Hörgeräten (siehe unter anderem US-A-4 741 339 , EP-B-0 572 382 , US-A-5 795 287 ). Die elektronische Einheit 30 des externen Systemteils 210 enthält alle erforderlichen elektronischen Komponenten zur Hörgerätesignalverarbeitung und Erzeugung der Audiometersignale, wie sie zum Beispiel anhand der Figuren 1 bis 3 erläutert sind. Die individuelle Programmierung des externen Systems mit patientenspezifischen Hörgerätedaten und mit Audiometerparametern erfolgt über das Programmiersystem 120, das wie bei konventionellen Hörgeräten üblich in diesem Fall drahtgebunden an die elektronische Einheit 30 gekoppelt wird. Implantatseitig umfaßt das System 220 eine Energie- und Signalempfangssschnittstelle, im dargestellten Fall eine induktive Empfangsspule 190. Das elektronische System 200 enthält alle zur Energieversorgung und Datenregenerierung erforderlichen Komponenten wie Demodulatoren und Treiberschaltungen für den elektromechanischen Wandler 20.In Fig. 5 a partially implantable system is illustrated schematically. In this case, the implantable part is shown as subsystem 220 and the external part to be worn on the outside as block 210. The external unit 210 contains the microphone 10, a signal processing unit 30 and a driver unit 160 which generates the generated signals and operating energy for the implant part Example transmitted via a transmitting coil 170 inductively and transcutaneously through the closed skin 180 to the implanted system part 220. This mode of transmission corresponds to the transmission in known, partially implantable cochlear implants or partially implantable hearing aids (see inter alia US-A-4,741,339 . EP-B-0 572 382 . US-A-5 795 287 ). The electronic unit 30 of the external system part 210 contains all the necessary electronic components for hearing aid signal processing and generation of the audiometer signals, as described, for example, with reference to FIGS FIGS. 1 to 3 are explained. The individual programming of the external system with patient-specific hearing aid data and with audiometer parameters takes place via the programming system 120, which is conventionally coupled to the electronic unit 30 in this case, as in conventional hearing aids. On the implant side, the system 220 comprises a power and signal receiving interface, In the illustrated case, an inductive receiver coil 190. The electronic system 200 contains all components required for power supply and data regeneration, such as demodulators and driver circuits for the electromechanical converter 20.

Claims (23)

  1. Partially or fully implantable hearing system for rehabilitating a pure inner ear hearing disorder or a combined sound conduction and inner ear hearing disorder, with a microphone (10) emitting an audio signal, an electronic signal processing and amplifying unit (40, 50, 80, 140, 141) lying in an audio signal processing electronic hearing system path, an implantable electro-mechanical output convertor (20) and a unit (60) for supplying the implant with power, characterised in that the hearing system is completed by an electronic module (90, 140, 141) which generates audiometry signals for an audiological subjective testing and evaluation of the quality of the coupling of the electro-mechanical output convertor (20) and feeds into the audio signal processing path of the hearing implant.
  2. Hearing system as claimed in claim 1, characterised in that signal parameters for the audiometry function specific to the patient can be adapted to the individual requirements of the patient by means of an electronic unit (100).
  3. Hearing system as claimed in claim 1 or 2, characterised in that the electronic signal processing and amplifying unit has an amplifier (40) connected downstream of the microphone (10), an audiological signal processing stage (50, 140) to which the output signal of the amplifier (40) is applied and a driver amplifier (80) connected upstream of the electro-mechanical output converter (20).
  4. Hearing system as claimed in claim 3, characterised in that the electronic module has a signal generator arrangement (90) for generating the signals needed for the audiometry function and a summing element (70) connected between the signal processing stage (50) and driver amplifier (80), via which both the output signal of the audiological signal processing stage (50) and the output signal of the signal generator arrangement (90) are forwarded to the driver amplifier (80).
  5. Hearing system as claimed in claim 3, characterised in that a digital signal processor (140, 141) is provided as the audiological signal processing stage, which is configured both to process the audio signal and generate the signals needed for the audiometry function and for combining the latter signals with the audio signal.
  6. Hearing system as claimed in claim 5, characterised in that an analogue-to-digital converter (130) is connected upstream of and a digital-to-analogue converter (150) is connected downstream of the signal processor (140, 141).
  7. Hearing system as claimed in claims 3 and 6, characterised in that the digital-to-analogue converter (150) and the driver amplifier (80) are combined in one module.
  8. Hearing system as claimed in one of claims 5 to 7, characterised in that the signal processor (140, 141) has a data memory (S) for storing patient-specific, audiological adaptation parameters and/or parameters for generating the signals for the audiometry function.
  9. Hearing system as claimed in one of the preceding claims, characterised in that at least a part of the signal processing and/or generating stages (40, 50, 80, 90, 130, 140, 150) is controlled by means of a micro-controller (100).
  10. Hearing system as claimed in claim 9, characterised in that the micro-controller (100) has a data memory (S) for storing patient-specific audiological adaptation parameters and/or operating parameters of the signal generator arrangement (90).
  11. Hearing system as claimed in one of claims 5 to 8, characterised in that the signal processor (141) is itself designed to control at least a part of the signal processing and/or generating stages (40, 80, 130, 150).
  12. Hearing system as claimed in claim 10 or claims 8 and 11, characterised in that a telemetry unit (110) is provided as a means of inputting data to the data memory (S).
  13. Hearing system as claimed in claim 12, characterised by an external programming system (120) communicating with the telemetry unit (110) in a wireless or hard-wired arrangement.
  14. Hearing system as claimed in claim 12 or 13, characterised in that the device is of a fully implantable design, the signalling processing and amplifying unit (40, 50, 80, 140, 141) lying in the electronic hearing system path, the electronic module (90, 140, 141) for generating and feeding in the signals needed for the audiometry function and the telemetry unit (110) being accommodated, preferably together with the power supply unit (60), in a hermetically sealed and bio-compatible implant housing (56) serving as the electronic module (31).
  15. Hearing system as claimed in claim 14, characterised in that the electronic module (31) is connected via an implant wire (61) to a microphone (20) which can be subcutaneously implanted in the rear wall of the auditory passage.
  16. Hearing system as claimed in claim 14 or 15, characterised in that the electronic module (31) is connected to the electro-mechanical output converter (20) via an implantable wire (59).
  17. Hearing system as claimed in one of the preceding claims, characterised in that the output convertor (20) can be coupled with an ossicle of the middle ear chain by means of a coupling element (21) in order to transmit the output-end mechanical convertor vibrations.
  18. Hearing system as claimed in one of claims 1 to 16, characterised in that the output converter (20) is designed so that it can be coupled with the ossicle chain or inner ear via an air gap.
  19. Hearing system as claimed in one of claims 14 to 18, characterised by an external system (120) for transcutaneously transmitting patient-specific hearing system and audiometry programme data to the implant-end telemetry unit (110).
  20. Hearing system as claimed in claim 19, characterised in that a secondary, rechargeable element is provided as a power supply unit (60), and the telemetry unit (110) is additionally designed as a power receiving circuit for supplying top-up power to the power supply unit at the implant end and the external system (120) is simultaneously designed as a charging device.
  21. Hearing system as claimed in one of claims 14 to 20, characterised by a portable remote control unit (65) for setting or changing hearing system and audiometry functions.
  22. Hearing system as claimed in one of claims 1 to 11, 17 or 18, characterised in that the system is of a partially implantable design and, in addition to the output convertor (20), one implant part (220) has a power and signal receiver interface (190) as well as an electronic circuit (200) connected between the receiver interface and output convertor (20) with components needed for supplying power and generating data, and an external system part (210) comprises the microphone (10), an electronic module (30) with the signal processing unit (40, 50, 140, 141) lying in the hearing system path and the electronic module (90, 140, 141) for generating and feeding in the signals needed for the audiometry function, a driver unit (160) and a power and signal transmitting interface (170) connected to the output of the driver unit.
  23. Hearing system as claimed in claim 22, characterised by an external system (120) for transmitting patient-specific hearing system and audiometry programming data to the electronic module (30) of the external system part (210).
EP99122698A 1999-04-01 1999-11-15 Implantable hearing system with audiometer Expired - Lifetime EP1041857B1 (en)

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DE19914992A1 (en) 2000-12-07
AU2226700A (en) 2000-10-05
CA2300636A1 (en) 2000-10-01
US6788790B1 (en) 2004-09-07
AU766943B2 (en) 2003-10-23
EP1041857A3 (en) 2006-05-31
EP1041857A2 (en) 2000-10-04
ATE548861T1 (en) 2012-03-15

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