Surgery – Surgically implanted vibratory hearing aid
Reexamination Certificate
2001-11-21
2003-09-16
Winakur, Eric F. (Department: 3736)
Surgery
Surgically implanted vibratory hearing aid
C600S559000, C073S585000
Reexamination Certificate
active
06620093
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention in general relates to a device and to a method for pre-operatively demonstrating at least partially implantable hearing systems for the rehabilitation of hearing disorders. More particularly, the present invention relates to a device for pre-operatively demonstrating an at least partially implantable hearing system for the rehabilitation of hearing disorders, which device includes an electromechanical transducer adapted for being non-invasively coupled from the side of the external auditory canal to at least approximately the center of the tympanic membrane and thus to the end point of the manubrium mallei for producing mechanical vibrations of the tympanic membrane, and an electronic audio signal generator unit. The present invention further is concerned with a method for pre-operatively demonstrating an at least partially implantable hearing system, which system includes an audio signal processing unit and an electromechanical transducer which is driven by the audio signal processing unit and is adapted for being coupled to a preselected coupling site, particularly to the ossicular chain, for causing mechanical vibrations of the coupling site.
2. Description of Related Art
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. In most embodiments the principle consists in stimulating, via a mechanical or hydromechanical stimulus, an ossicle of the middle ear or directly the inner ear, rather than via an 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 by different physical transducer principles, such as, for example, by electromagnetic and piezoelectric systems. The advantage of these processes is seen mainly in the sound quality which is improved as compared to conventional hearing aids, and, in the case of 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. (Arch Otolaryngol Head Neck, Surg, Vol. 113, August 1987, pp. 869872); Hoke, M. (ed), (Advances in Audiology, Vol. 4, Karger Basel, 1988); H. P. Zenner et al. (HNO 1998, Vol. 46, pp. 844-852; H. Leysieffer et al. (“A totally implantable hearing device for the treatment of sensorineural hearing loss: TICA LZ 3001”, in HNO Vol. 46, 1998, pp. 853-863); and H. P. Zenner et al. (“Totally implantable hearing device for sensorineural hearing loss”, The Lancet, Vol. 352, November 1998, No. 9142, page 1751), as well as in numerous patent documents, among others in U.S. Pat. Nos. 5,360,388; 5,772,575; 5,814,095 and 5,984,859.
Recently, such partially and fully implantable electromechanical hearing aids for the rehabilitation of internal ear damages have been introduced into clinical use. In this connection it turned out to be desirable to demonstrate to the patient to be provided with the implant the improvement of hearing or the sound quality, respectively, to be expected. The known audiological methods which until now merely provide for a stimulation of the hearing by sound transmission through the air or through the human body, do not permit such a demonstration without surgical intervention.
There are approaches for testing the middle ear by direct contact with an electromechanical transducer. In conformity with Zoellner (A. Thullen, “Clinical experiences with the sound probe according to Zoellner”, Medizinal-Markt, Vol. 4, No. 12, December 1956, pages 444 and 445) a sound probe is contacted with the middle ear, particularly invasively during middle ear operations. A device for electromechanical testing of hearing (U.S. Pat. No. 5,833,626) and a device for positioning and fixing of therapeutic, surgical, or diagnostic instruments (U.S. Pat. No. 5,776,144) have been proposed for the pre-operative demonstration of implantable hearing systems and for the psychoacoustical measurement of the auditory threshold in quiet by direct mechanical stimulation of the umbo. Hofmann et al. (German Patent No. 198 21 602) propose a vibration measuring head for evaluation of the movability of the middle ear. The basic embodiment includes a transducer, particularly an electromagnetic transducer, which exclusively is operated in resonance, wherein the movability of vibratorily movable elements of the middle ear structure coupled to the actoric side of the transducer can be evaluated by means of a second measuring coil, because the dampening of the system by the middle ear structure coupled thereto is represented by a variation of the voltage generated by this coil.
In the meantime, the device suggested in U.S. Pat. Nos. 5,776,144 and 5,833,626 was used for clinical examination of test persons having normal hearing. The examination showed in a statistically significant manner that this method is well reproducible and valid, and can be applied without any risk for the safety of the test persons.
However, basically there is the problem, that when using the device and the method for patients with impaired hearing, there is an individually varying audition. The differences particularly reside in spectrally very different courses of the auditory threshold in quiet as well as possibly in a positive recruitment (increase of the steepness of the soundness perception) and a reduced frequency resolution power for above-threshold signals. The known devices and methods scarcely permit successes because an individual compensation of the respective hearing disorder, i.e. an adaptation of the electronic audio signal processing unit driving the electromechanical transducer in the sense of an adaptation of a hearing aid, can not be carried out. This necessarily results in the serious disadvantage of the proposed devices and methods that the pre-operative demonstration never provides the patient with the hearing impression he will encounter later on after implantation and individual adaptation of the implanted hearing system to his individual hearing impairment.
SUMMARY OF THE INVENTION
The primary object of the present invention is to devise a device and a method for pre-operatively demonstrating at least partially implantable hearing systems, which permit a non-invasive testing of the hearing capacity as it will be encountered after implantation and adaptation of an individual hearing system.
In accordance with one aspect of the invention this object is achieved by a demonstration device for pre-operatively demonstrating an at least partially implantable hearing system for the rehabilitation of hearing disorders, said hearing system including an electronic audio signal processing unit, said device comprising:
an electromechanical transducer adapted for being non-invasively coupled from the side of the external auditory canal to at least approximately the center of the tympanic membrane and thus to the end point of the manubrium mallei for producing mechanical vibrations of the tympanic membrane,
an electronic audio signal generator unit, and
an electronic audio signal processing unit connected between the audio signal generator unit and the electromechanical transducer for driving the electromechanical transducer, wherein the audio signal processing unit of the demonstration device corresponds to or simulates the electronic audio signal processing unit of the hearing system intended to be implanted.
By the demonstration device of the present invention the action and the sound impression to be expected upon implantation of the respective hearing system can be demonstrated in a very realistic manner to the patient having a hearing disorder.
Preferably, means are provided
Leysieffer Hans
Waldmann Bernd
Cochlear Limited
Nixon & Peabody LLP
Safran David S.
Veniaminov Nikita R
Winakur Eric F.
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