A new implantable middle ear hearing device for mixed hearing loss: A feasibility study in human temporal bones.
OBJECTIVE
To assess the feasibility of a new, active middle ear device in temporal bones (TB).


BACKGROUND
This device is designed for patients with mixed hearing loss subsequent to chronic middle ear infection, surgery, or trauma. This Bell-Vibroplasty is built from a VIBRANT MED-EL Vibrant Soundbridge and a Kurz Bell titanium partial ossicular replacement prosthesis.


METHODS
In three fresh TBs, healthy and reconstructed middle ears were analyzed by means of laser Doppler interferometry. The sound transmission properties of a partial ossicular replacement prosthesis and a passive and an active Bell-Vibroplasty were compared with healthy middle ear function.


RESULTS
The measurements provided reliable results with small standard deviations and good signal-to-noise ratios. The performance levels of the partial ossicular replacement prosthesis and of the passive Bell-Vibroplasty were comparable with that of healthy middle ear function. The activated Bell-Vibroplasty provided linear function and a flat frequency response within the measured frequency range (500 Hz-8 kHz), with peak deviations of less than 10 dB. The maximum output of the Bell-Vibroplasty was equivalent to 125-dB sound pressure level.


CONCLUSIONS
Bell-Vibroplasty is feasible in TBs. Bell-Vibroplasty performance in TBs is sufficient to allow for a clinical trial as a next step.
Huber
Alexander M
AM
Department of Otorhinolaryngology-Head and Neck Surgery, University Hospital of Zurich, Switzerland. alex.huber@usz.ch
Ball
Geoffrey R
GR
Veraguth
Dorothe
D
Dillier
Norbert
N
Bodmer
Daniel
D
Sequeira
Damien
D
D000161:Acoustic Stimulation; D001844:Bone Conduction / Q000502:physiology; D004432:Ear, Middle / Q000033:anatomy & histology* / Q000601:surgery*; D005240:Feasibility Studies; D006310:Hearing Aids; D046089:Hearing Loss, Mixed Conductive-Sensorineural / Q000601:surgery*; D006801:Humans; D013701:Temporal Bone / Q000601:surgery*; D014732:Vibration