|The infrared red light emitted from the processor's probe travels through the ear canal and strikes the EarLens implant, which then vibrates the eardrum, creating the perception of sound.--Courtesy of EarLens|
2014 Fierce 15 member EarLens just obtained an FDA approval of its hearing aid via the rarely used de novo pathway for low- to moderate-risk devices that don't have a substantially equivalent predecessor on the market. So, the approval can be interpreted as proof that the company's technology is truly unique. That's because the so-called Contact Hearing device converts sound to infrared light and then vibrations that are felt by the eardrum and perceived as sound.
EarLens is conducting a third clinical trial to fine-tune the device to its commercial launch, expected in early 2016, with a broad explansion planned for later in the year, the company's senior marketing manager, Brian Vraciu told FierceMedicalDevices in an email.
The Contact Hearing device consists of an external processor that goes behind the ear and an implant, dubbed the EarLens. It is placed on the eardrum in an in-office procedure.
The device has an interesting mechanism of action. First, the processor picks up sound via an attached microphone. Then, the sound travels down a probe that extends from the processor into the ear canal. Next, light is emitted via the probe's laser diode. Finally, a photo receptor on the EarLens captures the light and creates a small current that causes the implant to vibrate, thereby activating the eardrum, explains a video on the EarLens company website.
The FDA says the Contact Hearing Device is different from traditional air (as opposed to light) conduction hearing aids because the implanted component is custom-molded to the patient's eardrum and directly stimulates the eardrum by direct contact, resulting in functional sound amplification.
"For the millions of Americans with hearing impairment, hearing aids can significantly improve regular daily communications, as well as overall quality of life," said Dr. William Maisel, the chief scientist in the FDA's device arm (CDRH). "People with hearing impairment now have a new option that may help improve their hearing by amplifying sounds over a broad spectrum of frequencies."
|EarLens' Contact Hearing Device--Courtesy of EarLens|
The device was approved following a 48-person study, which found that patients using the Contact Hearing Device experienced an average 33% improvement in word recognition. The approval simplifies subsequent approvals of devices deemed substantially equivalent by the agency. The Contact Hearing Device will service as their "predicate" device, enabling use of the simpler 510(k) pathway.
"The Earlens Hearing System is designed to provide a rich sound experience beyond the limitations of traditional amplification. Surveys show that experienced hearing aid users list natural sound quality and reducing feedback as their top unmet needs. Earlens is the first hearing aid that uses light to transmit sound, enabling amplification over a wider range of frequencies for some people with hearing loss. The use of light also means that the Earlens Hearing System is not prone to traditional microphone-speaker feedback loops," Vraciu wrote in the email.
There are 37.5 million adult Americans with some form of hearing loss, according to the NIH's National Institute on Deafness and Other Communication Disorders. Hearing aids are underused, the FDA says; only 16% of hearing loss sufferers aged 20 to 69 use the classes of devices. Among those 70 or older, the rate is 30%.
Other med tech players are also hoping to get their hearing aids past the FDA. They are deploying increasingly complicated methods. Ireland's Neuromod Devices just announced it raised €5.5 million ($6.2 million) in a Series A round to begin U.S. clinical trials of its mutebutton device to treat chronic tinnitus, or ringing in the ears. The mutebutton uses neuromodulation to change the neuroplasticity of the brain in the parts that cause tinnitus.
- read the release from the FDA
- here's more about Neuromod's financing round
Special Report: FierceMedicalDevices' 2014 Fierce 15 - EarLens
Editor's Note: This article has been updated with information provided by EarLens senior marketing manager Brian Vraciu.