On September 29, 2015 the FDA announced the clearance of the EarLens Hearing System through the 510(k) De Novo process. That announcement and associated media coverage, including a September 30, 2015 article in The Hearing Review, generated significant interest. In response to the many questions it received following the FDA announcement, the EarLens Corporation recently issued additional information about its new hearing system, which is anticipated to reach the market in 2016.
The company reports that the EarLens Hearing System is the first hearing aid to use light to transmit sound. While traditional acoustic hearing aids do not require clearance from the FDA, the EarLens Hearing System uses a new and unique mechanism of sound transduction. This differentiation prompted the FDA to create a new class of hearing aid, exclusive to the EarLens Hearing System.
The system includes a small, custom lens that is placed on the eardrum by an Ear Nose and Throat (ENT) physician during a regular office visit, says the company. A behind-the-ear processor receives sound and relays it to a widely vented in-ear light tip. The light tip converts sound to light and delivers this light to the lens. The lens then directly activates the natural hearing system. This approach, which is designed to prevent the typical feedback loop that troubles traditional amplification, is intended to allow EarLens to achieve high gain values across a broad bandwidth (125-10,000 Hz).
According to EarLens Corporation, the pivotal trial for the EarLens Hearing System was focused on safety and efficacy. The system was demonstrated to be safe, as there were no significant changes in hearing thresholds. Additional testing proved that the system was effective at providing amplification to subjects, as word recognition scores increased an average of 33% after 30 days. Data also demonstrated good performance of the EarLens Hearing System, as patients experienced a maximum gain of 68 dB at 10,000 Hz.
EarLens Corporation was started by entrepreneur Rodney Perkins, MD, who also founded ReSound Corp. His goal with the EarLens Hearing System was to create a hearing aid technology that delivers natural sound quality to patients. Dr Perkins found that direct activation of the eardrum can produce rich, natural sound. EarLens initiated additional clinical trials in the summer of 2015, and is planning an early 2016 commercial launch of the system in the US through ENT and Audiologist channels.
The company noted that, because the product launch is still months away, updated materials are not yet available. However, the company has provided a link to a YouTube animation of how EarLens works.
Source: EarLens Corporation