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

Abstract

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 < 10 dB) in residual unaided hearing at the 120-day measurement interval. The primary efficacy endpoint was improvement in word recognition using NU-6 at the 30-day measurement interval over the baseline unaided case. Secondary efficacy endpoints included functional gain from 2 to 10 kHz and speech-in-noise improvement over the baseline unaided case using both omnidirectional and directional microphones.Results:The results for the 86 ears in the study determined a mean change of −0.40 dB in PTA4, indicating no change in residual hearing (p < 0.0001). There were no serious device- or procedure-related adverse events, or unanticipated adverse events. Word recognition aided with the Earlens improved significantly (p < 0.0001) over the unaided performance, by 35% rationalized arcsine units on average. Mean functional gain was 31 dB across 2 to 10 kHz. The average speech-recognition threshold improvement over the unaided case for the Hearing in Noise Test was 0.75 dB (p = 0.028) and 3.14 dB (p < 0.0001) for the omnidirectional and directional microphone modes, respectively.Conclusion:The safety and effectiveness data supported a de novo 510(k) submission that received clearance from the FDA.