title: The Bonebridge: preclinical evaluation of a new transcutaneously-activated bone anchored hearing device.
abstract: OBJECTIVE
  To assess the functional performance of the Bonebridge (BB, MED-EL), a newly-designed transcutaneous bone conduction implant that allows the skin to remain intact and to compare it with the current clinical model of choice, a percutaneous bone conduction implant (BAHA BP100, Cochlear Bone Anchored Solutions AG).
  
  
  METHODS
  The devices were compared using two methods: (1) Measurements of cochlear promontory acceleration in five cadaver heads: Accelerations of the cochlear promontories on both ipsilateral and contralateral sides were measured using a Laser Doppler system, with free-field sound stimuli of 90 dB SPL in the frequency range of 0.3-10 kHz (2) Measurements of pure-tone sound field thresholds in 5 normally hearing human adult subjects under a condition of simulated hearing loss. For the latter measurements, the devices were applied to the head using a Softband, and measurements were performed in the frequency range of 0.25-8 kHz. Within investigation comparisons (i.e., in cadavers or listeners) and a cross-comparison analysis of the cadaver and human results were done.
  
  
  RESULTS
  Results from the cadaver heads showed that the cochlear promontory acceleration with the BB was higher within 10 dB on the ipsilateral side and lower within 5 dB on the contralateral side than the acceleration with the BAHA, in the frequency range of 0.7-10 kHz. The transcranial attenuation of the acceleration for the BB was greater than for the BAHA within 20 dB. For the sound-field threshold assessments with human subjects, the BB and BAHA showed similar threshold improvements of more than 10 dB HL for the ipsilateral side. For the contralateral side, the threshold improvement with the BB was less than with the BAHA, indicating better separation between ipsilateral and contralateral sides.
  
  
  CONCLUSIONS
  Preclinical results imply that the BB has functional performance similar to the BAHA and could be beneficial to patients suffering with conductive and mixed hearing losses as well as for those with unilateral impairment. Based on these preliminary results, a carefully designed clinical trial with conservative inclusion criteria can be recommended. This article is part of a special issue entitled "MEMRO 2012".
authors: Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Zurich, Frauenkliniksrasse 24, Zurich 8091, Switzerland.
authors: A M
authors: AM
authors: Huber
authors: J H
authors: JH
authors: Sim
authors: Y Z
authors: YZ
authors: Xie
authors: M
authors: M
authors: Chatzimichalis
authors: O
authors: O
authors: Ullrich
authors: C
authors: C
authors: Röösli
mesh_terms: D000328:Adult; D001309:Auditory Threshold; D001844:Bone Conduction; D002102:Cadaver; D003051:Cochlea / Q000033:anatomy & histology; D003054:Cochlear Implants; D005260:Female; D006309:Hearing; D006310:Hearing Aids; D034381:Hearing Loss; D006314:Hearing Loss, Conductive / Q000534:rehabilitation; D046089:Hearing Loss, Mixed Conductive-Sensorineural / Q000534:rehabilitation; D006319:Hearing Loss, Sensorineural / Q000534:rehabilitation; D006320:Hearing Tests; D006801:Humans; D007834:Lasers; D008297:Male; D011474:Prosthesis Design; D013067:Speech Perception; D053441:Suture Anchors; D014159:Transducers