PubMed

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

PMID: 28005723 · 2017

B, r, u, c, e, , J, , G, a, n, t, z, ;, , R, o, d, n, e, y, , P, e, r, k, i, n, s, ;, , M, i, c, h, a, e, l, , M, u, r, r, a, y, ;, , S, u, z, a, n, n, e, , C, a, r, r, , L, e, v, y, ;, , S, u, n, i, l, , P, u, r, i, a

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

Ano2017

PMID28005723

Resumo

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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