FDA proposes over-the-counter hearing aids for Americans


Mature man at medical examination or checkup in otolaryngologist’s office. Doctor Fitting To Male Patient Hearing Aid.

(Reuters) — The U.S. Food and Drug Administration on Tuesday proposed the creation of a new category of over-the-counter (OTC) hearing aids to be sold directly, without expert assistance, to the millions of Americans in need of the devices.

The proposed rule aims to facilitate innovation and increase competition by lowering the barriers to entry for new hearing aid manufacturers, the agency said.

A hearing aid is a device worn around the ear that makes desired sounds more audible for people with hearing loss. Hearing aid devices include a microphone, amplifier and a miniature loudspeaker to make sounds louder. Traditionally, these devices have been accessible only from licensed hearing aid dispensers or audiologists.

The proposed rule follows instruction in President Joe Biden’s broad competition executive order, which had told the Department of Health and Human Services to “promote the wide availability of low-cost hearing aids,” among many other instructions aimed at a wide variety of industries.

OTC hearing aids will offer a do-it-yourself approach to addressing hearing loss. For example, a smartphone app may be used to guide users on how to self-measure and self-adjust the hearing aid to best fit their ear. Traditional hearing aids require a professionally administered hearing test and technical features that may allow more customized fine-tuning.

The White House had estimated that allowing over-the-counter sales of hearing aids could save people with hearing loss thousands of dollars.

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