Phase III Clinical Trial Results with the Vibrant Soundbridge Implantable Middle Ear Hearing Device: A Prospective Controlled Multicenter Study
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- Charles M. Luetje
- Otologic Center, Inc Kansas City Missouri
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- Derald Brackman
- House Ear Institute Los Angeles California
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- Thomas J. Balkany
- University of Miami School of Medicine Miami Florida
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- Jennifer Maw
- Hearing Institute for Children and Adults San Jose California
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- R. Stanley Baker
- Otologic Medical Center, Inc Oklahoma City Oklahoma
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- David Kelsall
- Denver Ear Associates Englewood Colorado
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- Douglas Backous
- Virginia Mason Clinic Seattle Washington
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- Richard Miyamoto
- Indiana University School of Medicine Indianapolis Indiana
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- Simon Parisier
- Lenox Hill Hospital New York New York
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- Alexander Arts
- University of Michigan Medical Center Ann Arbor Michigan
説明
<jats:sec><jats:title>OBJECTIVES</jats:title><jats:p>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).</jats:p></jats:sec><jats:sec><jats:title>STUDY DESIGN</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p>Improvements in satisfaction, performance, and preference were statistically significant with the VSB, as was functional gain across all test frequencies (<jats:italic>P</jats:italic> < 0.001). Occlusion and feedback were virtually eliminated. Aided speech recognition was comparable between VSB and the hearing aid. Residual hearing was unchanged.</jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p>The VSB is a safe and effective treatment option for adults with moderate to severe sensorineural hearing loss.</jats:p></jats:sec>
収録刊行物
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- Otolaryngology–Head and Neck Surgery
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Otolaryngology–Head and Neck Surgery 126 (2), 97-107, 2002-02
Wiley
