A New Stapes-Head Coupler for the Vibrant Soundbridge System

Abstract

Introduction: The Vibrant Soundbridge (MED-EL Medical Electronics, Austria) is an active middle ear implant with a floating mass transducer (FMT) for patients with conductive, sensorineural, or mixed hearing loss. While the FMT is vertically aligned above the stapes head (SH) with the current Vibroplasty Clip coupler (MED-EL Medical Electronics), the new SH coupler was developed to mount the FMT on the inferior side of the stapes and to fit in the reduced middle ear space after canal-wall-down mastoidectomy. Methods: Using 11 human cadaveric temporal bones (TBs), placements of the new SH couplers on the stapes were examined, and effective stimuli to the cochlea were evaluated by measuring piston-like motion of the stapes footplate with a current of 1 mA on the FMT. The results were assessed in comparison with the Vibroplasty Clip coupler. Results: The new SH coupler showed perfect coupling on the stapes in 9 out of 11 TBs. A small gap between the SH and the plate of the connection link part was unavoidable in 2 TBs but had negligible effect on vibrational motion of the stapes. Vibrational motion of the stapes with the new SH coupler was reduced at frequencies above 3 kHz compared to the corresponding motion with the current Vibroplasty Clip coupler, but the relative attenuation over all 11 cadaveric temporal bones was <10 dB. Conclusions: The new SH coupler provides an alternative with more stable fixation when placement of the current Vibroplasty Clip coupler is limited due to insufficient space after canal-wall-down mastoidectomy, while still delivering effective stimuli to the cochlea.