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

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.