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.
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.
Authors: Hannes Maier; Uwe Baumann; Wolf-Dieter Baumgartner; Dirk Beutner; Marco D Caversaccio; Thomas Keintzel; Martin Kompis; Thomas Lenarz; Astrid Magele; Torsten Mewes; Alexander Müller; Tobias Rader; Torsten Rahne; Sebastian P Schraven; Burkard Schwab; Georg Mathias Sprinzl; Bernd Strauchmann; Ingo Todt; Thomas Wesarg; Barbara Wollenberg; Stefan K Plontke Journal: Audiol Neurootol Date: 2018-09-07 Impact factor: 1.854