Surgery – Surgically implanted vibratory hearing aid
Reexamination Certificate
1999-12-21
2002-05-28
Shaver, Kevin (Department: 3736)
Surgery
Surgically implanted vibratory hearing aid
C600S028000, C600S559000, C607S057000, C607S056000, C607S055000, C607S137000
Reexamination Certificate
active
06394947
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to partially or fully implantable hearing aids for rehabilitation of an inner ear hearing disorder, which have a microphone which delivers an audio signal, an electronic signal processing and amplification unit which is located in an audio signal processing electronic hearing aid path, an implantable electromechanical output converter and a unit for supplying power to the hearing aid.
2. Description of Related Art
Partially and fully implantable hearing aids for rehabilitation of inner ear damage with mechanical stimulation of the damaged inner ear have recently been available or will soon be available on the market journal HNO 46:844-852, 10-1998, H. P. Zenner et al., “Initial implantations of a completely implantable electronic hearing system in patients with an inner ear hearing disorder”; journal HNO 46:853-863, 10-1998,. Leysieffer et al., “A completely implantable hearing system for inner ear hearing handicapped: TICA LZ 3001”); U.S. Pat. Nos. 5,277,694; 5,788,711; 5,814,095; 5,554,096; and 5,624,376.
Especially in filly implantable systems is the visibility of the system not an issue, so that in addition to the advantages of high sound quality, the open auditory canal and full suitability for everyday use, high future patient acceptance can be assumed.
Many individuals suffer from intermittent or permanent tinnitus which cannot be cured by surgery and against which there have been no approved drug forms of treatment to date. Therefore, so-called tinnitus maskers are known (published PCT application WO-A-90/07251). They are small, battery-operated devices which are worn like a hearing aid behind or in the ear and they cover (mask) the tinnitus psychoacoustically by artificial sounds which are emitted, for example, via a hearing aid speaker into the auditory canal and which reduce the disturbing tinnitus as far as possible below the threshold of perception. The artificial sounds are often narrowband noise (for example, third octave noise) which in its spectral position and its loudness level can be adjusted via a programming device to enable the maximum possible adaptation to the individual tinnitus situation. Moreover, there has recently been devised the so-called “retraining method” in which the perceptibility of the tinnitus is likewise supposed to be largely suppressed by a combination of a mental training program and presentation of broadband sound (noise) near the auditory threshold. These devices are also called “noisers” journal “Hoerakustik” 2/97, pages 26 and 27).
In the two aforementioned methods, technical devices similar to hearing aids can be visibly carried externally on the body in the area of the ear for treatment of tinnitus using hardware; they stigmatize the wearer and therefore are not willingly worn.
U.S. Pat. No. 5,795,287 discloses an implantable tinnitus masker with a direct driving of the middle ear, for example, via an electromechanical converter which is coupled to the ossicle chain. This directly coupled converter can preferably be a so-called “floating mass transducer” (FMT). This FMT corresponds to the converter for implantable hearing aids which is known from U.S. Pat. No. 5,624,376. U.S. Pat. No. 5,795,287 clearly describe especially the “direct drive” concept: this is defined explicitly as only the types of coupling to the inner ear for purposes of tinnitus masking which are of a mechanical nature, therefore direct mechanical converter couplings to one ossicle of the middle ear, such as, for example, by the FMT converter and also air gap-coupled electromagnetic converters such as is described, for example, in U.S. Pat. No. 5,105,225.
U.S. Pat. No. 5,795,287 describes solely implantable systems which are used for tinnitus masking and which are designed to mask the tinnitus based on direct mechanical stimulation of the inner ear with masking signal forms. But, since, as described above, inner ear noise very often occurs simultaneously with inoperable inner ear damage, for the wearer of the implant known from U.S. Pat. No. 5,795,287, technical and hardware measures must also be taken to rehabilitate the inner ear damage. This is only possible by additional application of a hearing aid of conventional design, i.e. a hearing aid worn outside on the body with acoustic stimulation of the eardrum. Especially here, neither a partially nor a fully implantable system is considered, since these systems, likewise, require mechanical coupling to a suitable middle ear structure for mechanical stimulation of the inner ear; one such simultaneous application of two different implants which must fundamentally deliver their actuator stimulus at the same destination is hardly feasible either surgically or technically; in addition, it entails other major clinical risks.
SUMMARY OF THE INVENTION
A primary object of this invention is to treat more easily and effectively the problems associated with the simultaneous occurrence of inner ear damage and tinnitus while avoiding the above described defects.
Proceeding from a partially or fully implantable hearing aid for rehabilitation of a inner ear hearing disorder with a microphone which delivers an audio signal, with an electronic signal processing and amplification unit which is located in an audio signal-processing electronic hearing aid path, with an implantable electromechanical output converter and with a unit for power supply of the implant, this object is achieved in accordance with the invention by the hearing aid for rehabilitation of tinnitus being provided with an electronic module which generates the signals necessary for tinnitus masking, or for a noiser function, and feeds them into the audio signal processing path of the hearing implant.
The hearing aid of the invention makes it possible, using a single active, at least partially implantable system, to treat not only inner ear damage, but also and at the same time, tinnitus. Stigmatization of the patient by visible external hearing aid parts is kept small in the case of a partially implantable simultaneous therapy system, and it is completed avoided in a fully implantable device. The surgery necessary for at least partial implantation of the combination device and the associated residual risks do not exceed what must be tolerated anyway in an at least partially implantable hearing aid alone or in an at least partially implantable tinnitus masker alone.
As the implantable electromechanical output converter especially a converter as per U.S. Pat. No. 5,277,694 is suitable, i.e. a converter in which one wall of the converter housing is made as a vibratory membrane which together with a piezoelectric ceramic wafer applied to the inside of the membrane represents an electromechanically active heteromorphic composite element.
Another converter design suitable for these purposes is described in the co-pending, commonly owned U.S. patent application Ser. No. 09/275,872. It is a converter arrangement for partially or fully implantable hearing aids for direct mechanical excitation of the middle ear or inner ear, which is provided with a housing which can be fixed at the implantation site with respect to the skull and with a mechanically stiff coupling element which can move relative to the housing, the housing containing an electromechanical converter with which the coupling element can be caused to vibrate; these vibrations are transmitted to the middle ear ossicle or directly to the inner ear after completed implantation of the converter arrangement. The electromechanical converter is made as an electromagnet arrangement which has a component which is fixed relative to the converter housing, especially a ring coil, and a vibratory component, preferably in the form of a permanent magnetic pin which dips into the center opening of the ring coil and which is connected to the coupling element such that the vibrations of the vibratory component are transmitted to the coupling element.
However, a converter of the type described in the co-pending, commonly owned U.S. patent applic
Cochlear Limited
Natnithithadha Navin
Nixon & Peabody LLP
Safran David S.
Shaver Kevin
LandOfFree
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