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

Objective: Demonstrate safety and effectiveness of the light-driven contact hearing aid to support FDA clearance. Study Design: A single-arm, open-label investigational-device clinical trial. Setting: Two private-practice and one hospital-based ENT clinics. Patients: Forty-three subjects (86 ears) with mild-to-severe bilateral sensorineural hearing impairment. Intervention: 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 sound processor (Processor) that encodes sound into light pulses to wirelessly deliver signal and power to the Lens. Main Outcome Measures: The primary safety endpoint was a determination of "no change" (PTA4

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