title: Light-Driven Contact Hearing Aid for Broad-Spectrum Amplification: Safety and Effectiveness Pivotal Study.
abstract: 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 sound processor (Processor) that encodes sound into light pulses to wirelessly deliver signal and power to the Lens.
  
  
  
  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.
  
  
  
  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.
  
  
  
  The safety and effectiveness data supported a de novo 510(k) submission that received clearance from the FDA.
authors.affiliation: *University of Iowa, Iowa City, Iowa †Earlens Corporation, Menlo Park ‡Camino ENT, San Jose §Departments of Mechanical Engineering and Otolaryngology-HNS at Stanford University, Palo Alto, California.
authors.forename: Bruce J
authors.initials: BJ
authors.lastname: Gantz
authors.forename: Rodney
authors.initials: R
authors.lastname: Perkins
authors.forename: Michael
authors.initials: M
authors.lastname: Murray
authors.forename: Suzanne Carr
authors.initials: SC
authors.lastname: Levy
authors.forename: Sunil
authors.initials: S
authors.lastname: Puria
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006309:Hearing / Q000502:physiology*; D006310:Hearing Aids / Q000009:adverse effects*; D006312:Hearing Loss, Bilateral / Q000503:physiopathology / Q000534:rehabilitation*; D006319:Hearing Loss, Sensorineural / Q000503:physiopathology / Q000534:rehabilitation*; D006320:Hearing Tests; D006801:Humans; D008297:Male; D008875:Middle Aged; D009622:Noise; D013067:Speech Perception; D016896:Treatment Outcome