FDA approves marketing of new hearing aid

The U.S. Food and Drug Administration (FDA) on Tuesday allowed marketing of a new hearing aid that uses a laser diode and direct vibration of the eardrum to amplify sound.

The EarLens Contact Hearing Device (CHD) is indicated for use by adults with mild to severe sensorineural hearing impairment.

According to data from the National Institute on Deafness and Other Communication Disorders, 37.5 million American adults 18 and older report some form of hearing loss. Only 30 percent of adults aged 70 and older and 16 percent of adults aged 20 to 69 who could benefit from wearing hearing aids have ever used them.

“For the millions of Americans with hearing impairment, hearing aids can significantly improve regular daily communications, as well as overall quality of life,” William Maisel, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said. “People with hearing impairment now have a new option that may help improve their hearing by amplifying sounds over a broad spectrum of frequencies.”

There are two parts to the EarLens CHD: a tympanic membrane transducer, which is non-surgically placed deeply into the ear canal on the eardrum, and a behind-the-ear audio processor that sits on the outer ear and is connected to an ear tip that is placed in the ear canal.