The middle ear bioelectronic microphone for a totally implantable cochlearhearing device for profound and total hearing loss

Background: A bioelectronic middle ear microphone (BMEM) has been developed in a laboratory bench model and successfully tested in fresh human tempora l bones. A transducer actually has been bench-tested in our laboratory; it was implanted in chronic animal experiments (cats) as well as in humans for a period of 1 year as a driver of a semi-implantable electromagnetic middl e ear hearing device (IDE, FDA approved). This BMEM is the result of the us e of this same electromagnetic transducer used in a reverse mode. The appli cability of the BMEM is for the development of a totally implantable cochle ar implant using the eardrum as a diaphragm that transmits vibrations to a magnet cemented to the ossicles. This BMEM is to be powered by a lithium-io n implantable, rechargeable battery. Materials and Methods: To test the efficacy of this BMEM, the experiment wa s divided into two parts: (1) bench model, and (2) fresh human temporal bon es, using an air-core electromagnetic (EM) coil and a ferrite core EM coil for comparison. Results: In the bench model, the average displacement at 3 kHz was 0.95 mic rons (peak) for 4 V p-p and 1.65 microns (peak) for 10 V p-p. At 5 kHz, the measurements were somewhat higher. In fresh human temporal bones, with sou nd source in the ear canal (60 dB HL and 90 dB HL), the result was better w ith the magnet implanted on the head of the malleus with the incus removed. The ferrite core EM coil with the magnet implanted on the malleus with the incus removed was compared with the air-core EM coil. At 60: dB HL, the fe rrite core EM coil yielded more than four times the amplitude of the EM coi l. At 90 dB HL, the ferrite core EM coil produced more than five limes the amplitude compared with the air-core coil. Conclusion: This BMEM using an EM ferrite coil and a permanent magnet on th e head of the malleus is more efficient when compared with an EM air-core c oil. This BMEM may be applicable to the construction of a totally implantab le cochlear implant Further research is necessary to integrate this BMEM wi th the other components of the design concept of the totally implantable co chlear implant.