FDA Clears Novel Hearing Aid EarLens

Megan Brooks

September 30, 2015

The US Food and Drug Administration (FDA) yesterday cleared a new hearing aid that uses a laser diode and direct vibration of the eardrum to amplify sound.

The EarLens Contact Hearing Device (CHD), from the EarLens Corporation of Menlo Park, California, is indicated for use in adults with mild to severe sensorineural hearing impairment.

"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 FDA explains in a news release.

"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," William Maisel, MD, MPH, deputy director for science and chief scientist in the FDA's Center for Devices and Radiological Health, said in the release.

The EarLens CHD has two components: a tympanic membrane transducer (TMT), which is nonsurgically placed deep in the ear canal on the eardrum, and a light-based behind-the-ear sound processor placed at the base of the ear canal.

The behind-the-ear sound processor uses a microphone and a digital signal processor to pick up sound and convert it to infrared light, which carries both the power and the sound signal to the TMT, which then converts it into vibrations that are directly applied to the eardrum through a tiny contact pad and are perceived as sound, the company explains on its website.

"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 (functional gain)," the FDA says.

In testing, after 30 days of using the EarLens CHD, 48 patients with hearing impairment experienced a 33% improvement, on average, in word recognition. They also achieved a clinically significant functional gain of 30.5 dB, on average, in the high-frequency range (2000 - 10,000 Hz), with an average of 30 to 40 dB of functional gain noted at 6000 Hz and above and a maximum of 68 dB at 9000 to 10,000 Hz, "which is not typically achieved with conventional air-conduction hearing aids," the FDA notes.

There were no serious device-related adverse events, although several users experienced abrasions in the ear canal.

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.

According to the National Institute on Deafness and Other Communication Disorders, 37.5 million US adults have some type of hearing loss. However, only 30% of adults aged 70 years and older and 16% adults aged 20 to 69 years who could benefit from wearing hearing aids have ever used them.


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