Phase III Clinical Trial Results with the Vibrant Soundbridge Implantable Middle Ear Hearing Device: A Prospective Controlled Multicenter Study

TLDR

The study aimed to evaluate the performance of the Vibrant Soundbridge System as a semi‑implantable middle ear hearing device for adults with moderate to severe sensorineural hearing loss. A prospective, single‑subject, repeated‑measures multicenter study enrolled 53 adults, assessing residual hearing, functional gain, speech recognition, acoustic feedback, occlusion, and patient satisfaction with the VSB compared to a fitted acoustic hearing aid. Results showed statistically significant improvements in satisfaction, performance, preference, and functional gain, elimination of occlusion and feedback, comparable aided speech recognition, unchanged residual hearing, confirming the VSB as safe and effective.

Abstract

OBJECTIVES The goal of the study was to evaluate the performance of a semi‐implantable middle ear hearing device (Vibrant Soundbridge System [VSB]; Symphonix Devices, Inc). STUDY DESIGN A prospective, single‐subject, repeated‐measures multicenter study was conducted to determine the safety and efficacy of the VSB using analog and digital external processors. Measures included residual hearing, functional gain, speech recognition, acoustic feedback, occlusion, and patient self‐assessment to determine satisfaction, perceived performance, and device preference compared with an appropriately fit acoustic hearing aid. Fifty‐three adult subjects with moderate to severe sensorineural hearing loss were evaluated at 4 or more intervals after implantation. RESULTS Improvements in satisfaction, performance, and preference were statistically significant with the VSB, as was functional gain across all test frequencies ( P < 0.001). Occlusion and feedback were virtually eliminated. Aided speech recognition was comparable between VSB and the hearing aid. Residual hearing was unchanged. CONCLUSION The VSB is a safe and effective treatment option for adults with moderate to severe sensorineural hearing loss.