Earlens is committed to studying the clinical impact of the Light-Driven Hearing Aid. While Earlens is new to the market, the concept is over a decade old, with the core Earlens technology evolving through continual research and development. Throughout, the Earlens clinical program has strived to prove that the technology is feasible, safe and effective for hearing impaired patients.
In 2013 the first published clinical results1 on the Earlens Light-Driven Hearing Aid demonstrated technical feasibility and patient improvement. The 13 participants enrolled in the feasibility study wore the Tympanic Lens for four months with no evidence of inflammation, perforation, infection, or injury to the ear canal, tympanic membrane, or middle ear. In addition, participants reported that the sound quality with this novel device was extremely good.
Figure 1 The tympanic lens will stay in place without inflaming or damaging tissue.
Earlens initiated a larger study in 2014 to prove safety and effectiveness, enrolling 48 subjects across three clinical sites. These subjects were experienced hearing aid users and ranged from mild to severe sensorineural hearing impairment. The primary goal of safety was met, with no change in hearing thresholds after 120 days of use (p<0.0001). Audiometrically, subjects experienced significant functional gain from 125 to 10,000 Hz, with an average of 30-40 dB functional gain at 6,000 Hz and a maximum of 68 dB at 10,000 Hz.
Word Recognition scores using the Northwestern Auditory Test No.6 (NU-6) revealed statistically significant improvements with the Earlens Light-Driven Hearing Aid. This was further supported by improvements in speech understanding in noise as measured with the standardized HINT-90 Test. The improvement in the aided 120-day HINT-90 scores relative to the baseline unaided scores was on average 3.029 dB. Earlens submitted this data to the FDA in support of its premarket submission, and was granted commercialization of the Earlens Light-Driven Hearing Aid in late 2015. Learn more about the Full Spectrum of Sound.