EarLens said Tuesday it won FDA 510(k) clearance for its laser diode-equipped direct vibration-based contact hearing device for use in adults with mild to severe sensorineural hearing impairment.
The device is designed to directly contact the patient’s eardrum and use it as a speaker and act as an amplifier for a wide range of frequencies, the Menlo Park, Calif.-based company said. It consists of a tympanic membrane transducer placed into the ear canal on the eardrum and a behind-the-ear audio processor.
“For the millions of Americans with hearing impairment, hearing aids can significantly improve regular daily communications, as well as overall quality of life. 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 Center for Devices and Radiological Health chief scientist Dr. William Maisel said in a prepared statement.
The device is the 1st of its kind to use light, emitted from a diode attached to the behind-the-ear audio processor, to transmit sound to the receiver against the patient’s eardrum, the company said.
EarLens said the device was reviewed by the FDA through a de novo pathway, and expects to commercialize the device in 2016.
Last March, EarLens said it raised some $36 million in an equity round for its sound-to-light hearing aid. The company, which is led by a former Abbott Vascular honcho, said 22 unnamed investors participated in the round as of Feb. 24. EarLens hoped to raise a total of $38.8 million, according to a regulatory filing.