Performance of the round window soft coupler for the backward stimulation of the cochlea in a temporal bone model.

The round window vibroplasty is a feasible option for the treatment of conductive, sensorineural and mixed hearing loss. Although clinical data suggest a satisfying clinical outcome with various coupling methods, the most efficient coupling technique of the floating mass transducer to the round window is still a matter of debate. For this, a soft silicone-made coupler has been developed recently that aims to ease and optimize the stimulation of the round window membrane of this middle ear implant. We performed a temporal bone study evaluating the performance of the soft coupler compared to the coupling with individually shaped cartilage, perichondrium and the titanium round window coupler with loads up to 20 mN at the unaltered and fully exposed round window niche. The stimulation of the cochlea was measured by the volume velocities of the stapes footplate detected by a laser Doppler vibrometer. The coupling method was computed as significant factor with cartilage and perichondrium allowing for the highest volume velocities followed by the soft and titanium coupler. Exposure of the round window niche allowed for higher volume velocities while the applied load did not significantly affect the results. The soft coupler allows for a good contact to the round window membrane and an effective backward stimulation of the cochlea. Clinical data are mandatory to evaluate performance of this novel coupling method in vivo.