FDA approves EarLens Contact Hearing Device to improve hearing impairment- EarLens Corporation

The FDA has allowed marketing of a new hearing aid that 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 that comes in direct contact with the eardrum is designed to use the patient�s own eardrum as a speaker and enables amplification over a wider range of frequencies for some hearing impaired persons.

The EarLens Contact Hearing Device (CHD) from EarLens Corporation, is indicated for use by adults with mild to severe sensorineural hearing impairment.The FDA reviewed the data for the EarLens CHD through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally-marketed device.

Comment: Unlike hearing aids, which are in effect tiny speakers that simply turn up the volume on air conducted sound, the EarLens Contact Hearing Device comprises two components: a light-based Behind The Ear (BTE) sound processor, and a removable, custom-made Tympanic Contact Actuator (TCA) placed at the base of the ear canal. The BTE uses a microphone and a digital signal processor to pick up sound and convert it to infrared light. This non-visible light carries both the power and the sound signal to the TCA, which then converts it into vibrations that are directly applied to the eardrum through a tiny custom contact pad and perceived as sound.