PubMed

Light-Driven Contact Hearing Aid for Broad-Spectrum Amplification: Safety and Effectiveness Pivotal Study.

PMID：28005723 · 2017

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期刊Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology

年份2017

PMID28005723

摘要

Demonstrate safety and effectiveness of the light-driven contact hearing aid to support FDA clearance. A single-arm, open-label investigational-device clinical trial. Two private-practice and one hospital-based ENT clinics. Forty-three subjects (86 ears) with mild-to-severe bilateral sensorineural hearing impairment. Bilateral amplification delivered via a light-driven contact hearing aid comprising a Tympanic Lens (Lens) with a customized platform to directly drive the umbo and a behind-the-ear

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