FDA www.fda.gov allows the marketing of a new hearing aid referred to as the “EarLens Contact Hearing Device” (CHD) manufactured by EarLens Corporation www.earlenscorp.com of Menlo Park, California. The hearing aid uses a laser diode and direct vibration of the eardrum to amplify sound.
The combination of laser light pulses and a custom-fit device component works by coming in direct contact with the eardrum. The device uses the patient’s own eardrum as a speaker and enables amplification over a wider range of frequencies for some hearing impaired persons.
The EarLens CHD consists of two parts, a Tympanic Membrane Transducer (TMT) which is non-surgically placed deeply into the ear canal on the eardrum, plus a Behind the Ear (BTE) audio processor that sits on the outer ear and connected to an ear tip placed in the ear canal.
The EarLens CHD differs from traditional air conduction hearing aids in several ways. The TMT component is custom molded to the patient’s eardrum and contains a driver mechanism that directly stimulates the eardrum enabling efficient amplification of sound.
Clinical data supporting the safety and effectiveness of the device, includes performing several assessments over a four month period, such as residual hearing stability, improved word recognition, functional amplification gain, and the ability to hear sentences in background noise as compared to listening without any amplifications.
“For the millions of Americans with a hearing impairment, hearing aids can significantly improve regular daily communications, as well as the overall quality of life,” said William Maisel, MD, Deputy Director for Science and Chief Scientist in FDA’s Center for Devices and Radiological Health. “People with hearing impairment now have a new option that may help improve their hearing by amplifying sounds over a broad spectrum of frequencies.”
FDA reviewed the data for the device through the de novo premarket review pathway, which is a regulatory pathway for some low to moderate risk medical devices that are not substantially equivalent to an already legally marketed device.