Marketing for EarLens Laser-Based Hearing Aid Approved by FDA

Marketing for EarLens Laser-Based Hearing Aid Approved by FDA
September 30, 2015

For individuals who are hearing-impaired, there may be a new option to consider.

This week, the U.S. Food and Drug Administration (FDA) announced that it would allow marketing of the EarLens Contact Hearing Device (CHD), 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.

"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 in a written statement. "People with hearing impairment now have a new option that may help improve their hearing by amplifying sounds over a broad spectrum of frequencies."

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, and a behind-the-ear (BTE) audio processor that sits on the outer ear and is connected to an ear tip that is placed in the ear canal. External sound waves received by the BTE processor are converted to electronic signals, digitally processed, amplified and sent to the ear tip, which contains a laser diode. There, the electronic signals of amplified sound are converted to pulses of light. The laser light pulses then shine onto a photodetector in the TMT, which converts the light back into electronic signals, transmitting sound vibrations directly to the eardrum by direct contact.

Studies conducted by Earlens showed that after 30 days of use, the 48 subjects experienced a 33 percent improvement in word recognition in addition to a significant decibel gain.

According to statistics compiled by the National Institute on Deafness and Other Communication Disorders, 37.5 million adults aged 18 and older in America report some form of hearing loss. However, 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.