Surgery – Surgically implanted vibratory hearing aid
Reexamination Certificate
2001-08-13
2003-07-15
Isabella, David J. (Department: 3738)
Surgery
Surgically implanted vibratory hearing aid
C623S010000, C607S055000
Reexamination Certificate
active
06592512
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to an at least partially implantable hearing system for rehabilitation of a hearing disorder comprising at least one acoustic sensor for picking up an acoustic signal and converting the acoustic signal into corresponding electrical audio sensor 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 energy, and at least one electromechanical output transducer driven by an electronic driver arrangement of the signal processing unit, wherein the electromechanical output transducer is provided with an active electromechanical element and an output member for stimulating, via a passive coupling element, an ossicle of a middle ear ossicular chain, which chain has a natural capability for vibratory movement.
2. Description of Related Art
Hearing systems are defined here as systems in which the acoustic signal is picked up with at least one sensor which converts the acoustic signal into an electrical signal (microphone function), which is electronically further processed and amplified, and whose output-side signal stimulates the damaged hearing electromechanically.
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).
Electronic measures for rehabilitation of inner ear damage which cannot be cured by surgery have currently achieved great importance. With total failure of the inner ear, cochlear implants with direct electrical stimulation of the remaining auditory nerves are in routine clinical use. For medium to severe inner ear damage, for the first time, fully digital hearing devices are presently being used which open up a new world of electronic audio signal processing and offer expanded possibilities of controlled audiological fine tuning of the hearing devices to the individual inner ear damage. In spite of major improvements of hearing aid hardware achieved in recent years, in conventional hearing aids, there remain basic defects which are caused by the principle of acoustic amplification, i.e. especially by the reconversion of the electronically amplified signals in airborne sound. These defects include aspects such as the visibility of the hearing aids, poor sound quality as a result of electromagnetic transducers (speakers), closed external auditory canal as well as feedback effects with high acoustic gain.
As a result of these fundamental defects, there has long been the desire to move away from conventional hearing aids with acoustic stimulation of the damaged inner ear and to replace them by partially or fully implantable hearing systems with direct mechanical stimulation. Implantable hearing systems differ from conventional hearing aids: the acoustic signal is converted with a proper microphone into an electrical signal and amplified in an electronic signal processing stage; this amplified electrical signal, however, is not sent to an electroacoustic transducer (speaker), but to an implanted electromechanical transducer providing for output-side mechanical vibrations which are sent directly, therefore with direct mechanical contact, to the middle ear or inner ear, or indirectly via an air gap in, for example, electromagnetic converter systems. This principle applies regardless of whether implantation of all necessary system elements is partial or complete and also regardless of whether an individual with pure inner ear impairment with a completely intact middle ear or an individual with combined hearing impairment, in which the middle and inner ear is damaged, is to be rehabilitated. Therefore implantable electromechanical transducers and methods for coupling the mechanical transducer vibrations to the functioning middle ear or directly to the inner ear for rehabilitation of a pure inner ear impairment, or to a remaining ossicle of the middle ear in the case of an artificially or pathologically altered middle ear for taking care of a hearing disorder caused by a disturbance of sound conduction, or for combinations of such disorders, have been described in the recent scientific literature and in many patents.
Useful electromechanical transducer processes include basically all physical transducer principles, such as electromagnetic, electrodynamic, magnetostrictive, dielectric and piezoelectric. Various research groups, in recent years, have focused essentially on two of these processes, namely electromagnetic and piezoelectric processes. A survey can be found in ZENNER and LEYSIEFFER (HNO 10/1997, vol. 45, pp. 749-774).
In the piezoelectric process, direct mechanical coupling of the output-side transducer vibrations to the middle ear ossicle or to the oval window is essential. In the electromagnetic principle, force coupling between the transducer and ossicle, on the one hand, can take place “without contact”, i.e. via an air gap; in this case, only the permanent magnet is caused to vibrate by the transducer being in direct mechanical contact with the middle ear ossicle by permanent fixation. On the other hand, it is possible to implement the transducer entirely in a housing (in this case the coil and the magnet preferably being coupled with the smallest possible air gap) and to transmit the output-side vibrations via a mechanically stiff coupling element with direct contact to the middle ear ossicle (see FREDRICKSON et al.:
Ongoing investigations into an implantable electromagnetic hearing aid for moderate to severe sensorineural hearing loss
; Otolaryngologic Clinics of North America, Vol. 28/1 (1995), pp. 107-121; and Leysieffer et al., HNO 10/97, vol. 45, pp.792-800).
The patent literature contains some of the aforementioned versions of both electromagnetic and also piezoelectric hearing aid transducers: U.S. Pat. No. 3,712,962, EPLEY; U.S. Pat. No. 3,870,832, FREDRICKSON; U.S. Pat. No. 3,882,285, NUNLEY et al.; U.S. Pat. No. 4,850,962, SCHAEFER; U.S. Pat. No. 5,015,224, MANIGLIA; U.S. Pat. No. 5,277,694, LEYSIEFFER et al.; U.S. Pat. No. 5,554,096, BALL; U.S. Pat. No. 5,707,338, ADAMS et al.; U.S. Pat. No. 6,123,660, LEYSIEFFER; U.S. Pat. No. 6,162,169, LEYSIEFFER; International Patent Application Publications WO-A 98/06235, ADAMS et al.; WO-A 98/06238, ADAMS et al.; WO-A 98/06236, KROLL et al.; WO-A 98/06237, BUSHEK et al.
The partially implantable piezoelectric hearing system of the Japanese group of Suzuki and Yanigahara presupposes, for implantation of the transducer, the absence of the middle ear ossicles and a free tympanic cavity to be able to couple the piezo element to the stapes (Yanigahara et al.:
Efficacy of the partially implantable middle ear implant in middle and inner ear disorders
: Adv. Audiol., Vol. 4, Karger Basel (1988), pp. 149-159; Suzuki et al.:
Implantation of partially implantable middle ear implant and the indication
. Adv. Audiol., Vol. 4, Karger Basel (1988), pp. 160-166). Likewise, in the method of implanting a hearing system for inner ear hearing-impaired according to SCHAEFER (U.S. Pat. No. 4,850,962) basically the incus is removed in order to be able to couple a piezoelectric transducer element to the stapes. This also applies to further developments which are based on the SCHAEFER technology and which are described in the above mentioned patents (U.S. Pat. No. 5,707,338, ADAMS et al.; International Patent Application Publications WO-A 98/06235, ADAMS et al.; WO-A 98/06238, ADAMS et al.; WO-A 98/06236, KROLL et al.; WO-A 98/06237, BUSHEK et al.).
The BALL electromagnetic transducer (“Floating Mass Transducer FMT” of U.S. Pat. No. 5,554,096, BALL; U.S. Pat. No. 5,624,376, BALL et al.) is, on the other hand, directly fixed to the long process of the incus when the middle ear is intact. The electromagnetic transducer of the partially implantable system of FREDRICKSON (Fredrickson et al.:
Ongoing investigations into an implantable electromagnetic hearing aid for moderate to severe sensorineural hearing loss
, Otolaryngol
Leysieffer Hans
Stöckert Friedemann
Isabella David J.
Nixon & Peabody LLP
Phonak AG
Safran David S.
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