title: The middle ear bioelectronic microphone for a totally implantable cochlear hearing device for profound and total hearing loss.
abstract: BACKGROUND
  A bioelectronic middle ear microphone (BMEM) has been developed in a laboratory bench model and successfully tested in fresh human temporal 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 middle ear hearing device (IDE, FDA approved). This BMEM is the result of the use of this same electromagnetic transducer used in a reverse mode. The applicability of the BMEM is for the development of a totally implantable cochlear 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-ion implantable, rechargeable battery.
  
  
  METHODS
  To test the efficacy of this BMEM, the experiment was divided into two parts: (1) bench model, and (2) fresh human temporal bones, 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 microns (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 sound source in the ear canal (60 dB HL and 90 dB HL), the result was better with 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 ferrite core EM coil yielded more than four times the amplitude of the EM coil. At 90 dB HL, the ferrite core EM coil produced more than five times the amplitude compared with the air-core coil.
  
  
  CONCLUSIONS
  This BMEM using an EM ferrite coil and a permanent magnet on the head of the malleus is more efficient when compared with an EM air-core coil. This BMEM may be applicable to the construction of a totally implantable cochlear implant. Further research is necessary to integrate this BMEM with the other components of the design concept of the totally implantable cochlear implant.
authors.affiliation: Department of Otolaryngology-Head & Neck Surgery, Case Western Reserve University School of Medicine, USA.
authors.forename: A J
authors.initials: AJ
authors.lastname: Maniglia
authors.forename: H
authors.initials: H
authors.lastname: Abbass
authors.forename: T
authors.initials: T
authors.lastname: Azar
authors.forename: M
authors.initials: M
authors.lastname: Kane
authors.forename: P
authors.initials: P
authors.lastname: Amantia
authors.forename: S
authors.initials: S
authors.lastname: Garverick
authors.forename: W H
authors.initials: WH
authors.lastname: Ko
authors.forename: W
authors.initials: W
authors.lastname: Frenz
authors.forename: T
authors.initials: T
authors.lastname: Falk
mesh_terms: D000818:Animals; D002415:Cats; D019929:Cochlear Implantation / Q000295:instrumentation*; D003054:Cochlear Implants; D003638:Deafness / Q000175:diagnosis* / Q000601:surgery*; D004195:Disease Models, Animal; D004432:Ear, Middle; D055590:Electromagnetic Phenomena; D005290:Ferric Compounds; D006801:Humans; D011474:Prosthesis Design; D015203:Reproducibility of Results; D014159:Transducers
chemical_list: D005290:Ferric Compounds; C001215:ferrite