title: Human studies of a piezoelectric transducer and a microphone for a totally implantable electronic hearing device.
abstract: OBJECTIVE
  For the surgical treatment of patients with moderate and severe sensorineural hearing loss, the authors have developed a totally implantable hearing device, the totally integrated cochlea amplifier (TICA). To evaluate the effectiveness of transducer and microphone of this device, three separate human studies were conducted.
  
  
  METHODS
  The first study using transducer prototypes involved self experiments in investigators with normal hearing. The second study used the transducer prototypes in patients with hearing loss, and the third study involved the temporary implantation of the final transducer prototype and microphone in patients undergoing otologic surgery.
  
  
  METHODS
  In routine middle ear surgery, transducer prototypes were coupled to the ossicular chain of 28 patients. In addition to the transducer, in 5 patients the microphone was placed beneath the skin of the auditory canal, allowing the skin to cover the microphone membrane completely.
  
  
  RESULTS
  The piezoelectric transducer reached an equivalent sound pressure level of 145 dB SPL < or =10 kHz. The dynamics for music reached 32 dB, which was identical with the results of the preoperative investigations using high-fidelity headsets (33 dB). The low nonlinear distortions of <0.1% and the frequency range of 10 kHz are reflected in the positive evaluation of the sound quality by 84% of the patients involved. When phonetically balanced speech material and music were presented under free field conditions at a sound level of 65 dB SPL, understanding of the phonetically balanced speech material was 100%. Most patients judged the presentations of music as clear and undistorted with all broadband components.
  
  
  CONCLUSIONS
  Data in humans on the performance of the two main components of the TICA implant, the transducer and the microphone, are reported.
authors.affiliation: Department of Otolaryngology, University of Tübingen, Germany.
authors.forename: H P
authors.initials: HP
authors.lastname: Zenner
authors.forename: H
authors.initials: H
authors.lastname: Leysieffer
authors.forename: M
authors.initials: M
authors.lastname: Maassen
authors.forename: R
authors.initials: R
authors.lastname: Lehner
authors.forename: T
authors.initials: T
authors.lastname: Lenarz
authors.forename: J
authors.initials: J
authors.lastname: Baumann
authors.forename: S
authors.initials: S
authors.lastname: Keiner
authors.forename: P K
authors.initials: PK
authors.lastname: Plinkert
authors.forename: J T
authors.initials: JT
authors.lastname: McElveen
mesh_terms: D000669:Amplifiers, Electronic; D001301:Audiometry, Pure-Tone / Q000379:methods; D001307:Auditory Perception / Q000502:physiology; D019929:Cochlear Implantation; D003054:Cochlear Implants; D004582:Electronics, Medical / Q000295:instrumentation*; D004867:Equipment Design; D006319:Hearing Loss, Sensorineural / Q000601:surgery*; D006801:Humans; D013506:Otologic Surgical Procedures / Q000379:methods; D011300:Preoperative Care; D011571:Psychoacoustics; D014159:Transducers