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Objective: The objective was to demonstrate the long-term outcomes of patients implanted with the Vibrant Soundbridge (VSB) through coupling of the floating mass transducer (FMT) to the round window (RW).

Methods: This study evaluated the clinical performance (audiological outcomes) and safety (revisions/explantations) of the VSB coupled to the RW. Outcomes were subdivided into short- and long- term examination groups, characterized as follow-up (F/U) periods of less than twelve months (<12 months) vs subjects followed up for more than twelve months (> 12 months). Cumulative survival outcomes were separated for subjects with and without Cholesteatoma.

Results: Preliminary data clearly shows improvement of pure tone audiogram as well as The Freiburger Monosyllabic speech test improved significantly at 65 dB and 80 dB (p<0.0001). The outcomes clearly show the correlation between underlying pathology, hence Cholesteatoma as well as radical cavity presence and revision rate on the subject’s survival rate.

Conclusion: The VSB coupled to the RW is a safe and reliable method for patients with conductive and mixed hearing loss. The hearing improvement was stable. The revision rates were directly related to the underlying pathology of cholesteatoma; thus this special cohort requires additional counselling on potential complications.