FDA News Release



FDA Eliminates ‘Physician Waiver’ System in Hearing Aid Dispensing!

 Permits marketing of new laser-based hearing aid with potential for broad sound amplification

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The U.S. Food and Drug Administration today 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) is indicated for use by adults with mild to severe sensorineural hearing impairment.

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.

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


Food and Drug Administration (FDA) will be eliminating the so-called “physician waiver” system which requires consumers first to seek a physician for a medical evaluation or sign a waiver prior to obtaining a hearing aid. Dr Mann is the Clinical Deputy Director (ENT devices branch) at FDA, and made the announcement at today’s “Dissemination Meeting: Hearing Health Care for Adults: Priorities for Improving Access and Affordability” so all consumers have the right to purchase hearing aids with the company of there choice without a doctor or audiologist.