Surgery – Surgically implanted vibratory hearing aid
Reexamination Certificate
2001-04-13
2003-05-20
Scherbel, David A. (Department: 3754)
Surgery
Surgically implanted vibratory hearing aid
C600S379000, C607S057000
Reexamination Certificate
active
06565503
ABSTRACT:
SUMMARY OF THE INVENTION
1. Field of the Invention
This invention relates to an at least partially implantable system for rehabilitation of a hearing disorder which comprises at least one sensor (microphone) for picking up an acoustic signal and converting the acoustic signal into the corresponding electrical signals, an electronic signal processing unit for audio signal processing and amplification, an electrical power supply unit which supplies individual components of the system with current, and an output-side actoric stimulation arrangement.
2. Description of Related Art
The expression “hearing disorder” is defined here as inner ear damage, combined inner ear and middle ear damage, and a temporary or permanent noise impression (tinnitus).
In recent years rehabilitation of sensorineural hearing disorders with partially implantable electronic systems has acquired major importance. In particular, this applies to the group of patients in which hearing has completely failed due to accident, illness or other effects or in which hearing is congenitally non-functional. If, in these cases, only the inner ear (cochlea), and not the neural auditory path which leads to the brain, is affected, the remaining auditory nerve can be stimulated with electrical stimulation signals. Thus, a hearing impression can be produced which can lead to speech comprehension. In these so-called cochlear implants (CI), an array of stimulation electrodes, which is controlled by an electronic system (electronic module) is inserted into the cochlea. This electronic module is encapsulated with a hermetical, biocompatible seal and is surgically embedded in the bony area behind the ear (mastoid). The electronic system contains essentially only decoder and driver circuits for the stimulation electrodes. Acoustic sound reception, conversion of this acoustic signal into electrical signals and their further processing, always takes place externally in a so-called speech processor which is worn outside on the body. The speech processor converts the preprocessed signals into a high frequency carrier signal which, via inductive coupling, is transmitted through the closed skin (transcutaneously) to the implant. The sound-receiving microphone is always located outside of the body and, in most applications, in a housing of a behind-the-ear hearing aid worn on the external ear. The microphone is connected to the speech processor by a cable. Such cochlear implant systems, their components, and the principles of transcutaneous signal transmission are described, by way of example, in published European Patent Application EP 0 200 321 A2 and in U.S. Pat. Nos. 5,070,535, 4,441,210, 5,626,629, 5,545,219, 5,578,084, 5,800,475, 5,957,958 and 6,038,484. Processes of speech processing and coding in cochlear implants are described for example in published European Patent Application EP 0 823 188 A1, in European Patent 0 190 836 A1 and in U.S. Pat. Nos. 5,597,380, 5,271,397, 5,095,904, 5,601,617 and 5,603,726.
In addition to rehabilitation of congenitally deaf persons and those who have lost their hearing using cochlear implants, for some time there have been approaches to offer better rehabilitation than with conventional hearing aids to patients with a sensorineural hearing disorder which cannot be surgically corrected by using partially or totally implantable hearing aids. The principle arises, in most embodiments, in stimulating an ossicle of the middle ear or, directly, the inner ear via mechanical or hydromechanical stimulation and not via the amplified acoustic signal of a conventional hearing aid in which the amplified acoustic signal is supplied to the external auditory canal. The actuator stimulus of these electromechanical systems is accomplished with different physical transducer principles such as, for example, by electromagnetic and piezoelectric systems. The advantage of these devices is seen mainly in the sound quality which is improved compared to conventional hearing aids, and, for totally implanted systems, in the fact that the hearing prosthesis is not visible.
Such partially and fully implantable electromechanical hearing aids are described, for example, by Yanigahara et al. “Implantable Hearing Aid”, Arch Otolaryngol Head Neck Surg-Vol 113, 1987, pp. 869-872; Suzuki et al. “Implantation of Partially Implantable Middle Ear Implant and the Indication”, Advances in Audiology, Vol. 4, 160-166, Karger Basel, 1988; H. P. Zenner et al. “First implantations of a totally implantable electronic hearing system for sensorineural hearing loss”, in HNO Vol. 46, 1998, pp. 844-852; H. Leysieffer et al. “A totally implantable hearing device for the treatment of sensorineural hearing loss: TICA LZ 3001”, HNO Vol. 46, 1998, pp. 853-863; H. P. Zenner et al. “Active electronic hearing implants for patients with conductive and sensorineural hearing loss—a new era of ear surgery”, HNO 45: 749-774; H. P. Zenner et al. “Totally implantable hearing device for sensorineural hearing loss”, The Lancet Vol. 352, No. 9142, page 1751; and are described in numerous patent documents among others in published European Patent Applications EP 0 263 254 A1, EP 0 400 630 A1, and EP 0 499 940 A1, and in U.S. Pat. Nos. 3,557,775, 3,712,962, 3,764,748, 5,411,467, 4,352,960, 4,988,333, 5,015,224, 5,015,225, 5,360,388, 5,772,575, 5,814,095, 5,951,601, 5,977,689 and 5,984,859. Here, the insertion of an electromechanical transducer through an opening in the promontory for direct fluid stimulation in the inner ear is described in U.S. Pat. Nos. 5,772,575, 5,951,601, 5,977,689 and 5,984,859.
Many patients with inner ear damage also suffer from temporary or permanent noise impressions (tinnitus) which cannot be surgically corrected and for which, to date, there are no approved drug treatments. Therefore, so-called tinnitus maskers (International Patent Application Publication WO-A 90/07251, published European Patent Application EP 0 537 385 A1, German Utility Model No. 296 16 956) are known. These devices are small, battery-driven devices which are worn like a hearing aid behind or in the ear and which, by means of artificial sounds which are emitted, for example, via a hearing aid speaker into the auditory canal, psychoacoustically mask the tinnitus and thus reduce the disturbing noise impression, if possible, to below the threshold of perception. The artificial sounds are often narrowband noise (for example, third-band noise). The spectral position and the loudness level of the noise can be adjusted via a programming device to enable adaptation to the individual tinnitus situation as optimally as possible. In addition, the so-called retraining method has been developed recently in which, by combination of a mental training program and presentation of broadband sound (noise) near the auditory threshold, the perceptibility of the tinnitus in quiet conditions is likewise supposed to be largely suppressed (H. Knoer “Tinnitus retraining therapy and hearing acoustics” journal “Hoerakustik” 2/97, pages 26 and 27). These devices are also called “noisers”.
In the two aforementioned methods for hardware treatment of tinnitus, hearing aid-like, technical devices must be carried visibly outside on the body in the area of the ear; these devices stigmatize the wearer and, therefore, are not willingly worn.
U.S. Pat. No. 5,795,287 describes an implantable tinnitus masker with direct drive of the middle ear, for example, via an electromechanical transducer coupled to the ossicular chain. This directly coupled transducer can preferably be a so-called “Floating Mass Transducer” (FMT). This FMT corresponds to the transducer for implantable hearing aids which is described in U.S. Pat. No. 5,624,376.
In commonly owned co-pending U.S. patent applications Ser. Nos. 09/372,172 and 09/468,860, which are hereby incorporated by reference, implantable systems for treatment of tinnitus by masking and/or noiser functions are described, in which the signal-processing electronic path of a partially or totally implantable hearing system is supplemented by corresponding electronic modules
Baumann Joachim W.
Leysieffer Hans
Zenner Hans Peter
Cochlear Limited
Nicolas Frederick C.
Nixon & Peabody LLP
Safran David S.
Scherbel David A.
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