人工中耳Vibrant Soundbridge®国内臨床治験例

稲垣 洋三, 神崎 晶, 岩崎 聡, 山田 浩之, 渡部 高久, 大石 直樹, 小川 郁

doi:10.5631/jibirin.109.239

We participated in a clinical trial for a hearing aid system in Japan, “Verification of the efficacy and safety of the middle ear implant MVS (Medel Vibrant System) in conductive and mixed hearing loss”. We present a report of a case that we encountered in our department. MVS is a Vibrant Soundbridge^® (VSB) middle ear implant device that is approved and is in wide use in Europe and the United States. It has been shown to have the potential to provide a high level of acoustic clarity and sound quality. Also, as compared to conventional hearing aids, there is no howling and the distortion frequency is lower. An additional advantage is the excellent transient response. The patient was a 33-year-old woman, with a history of bilateral hearing loss from birth, who was under observation whilst wearing a hearing aid. In an attempt to improve her hearing, we admitted her to our hospital. Based on the diagnosis of middle ear malformation and mixed hearing loss on both sides, we performed bilateral tympanoplasty. Since the hearing improvement following this procedure was poor on the right side, we prescribed a hearing aid. However, the patient did not adapt satisfactorily to this device. Four years after the initial diagnosis, we performed VSB middle ear implant surgery using the round window stimulation method, placing the transducer in the round window. The postoperative results were good. The speech inspection noise levels in both ears under a free-field, silent setting were 60 dBHL 85%, and 50 dBHL 100%. Thus, the postoperative course was good, the patient’s satisfaction level improved and no adverse events occurred. VSB is likely to be a useful tool in rescue surgery for refractory middle ear cases. Also, it is useful as a standard rescue procedure in difficult hearing aid cases. In practice, otologic procedures are intended to improve the QOL and meet requirements in both diverse cases and individual patient conditions. Therefore, dissemination of VSB as one of the treatment choices for improving hearing loss is expected in the future.

人工中耳Vibrant Soundbridge<sup>®</sup>国内臨床治験例

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