The U.S. Food and Drug Administration on Tuesday proposed creation of a new category of over-the-counter (OTC) hearing aids to be sold directly to the millions of Americans in need of the devices, without expert assistance.
The proposed rule aims to facilitate innovation and increase competition by lowering the barriers to entry for new hearing aid manufacturers, the agency said.
The proposed rule follows an 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.
The White House had estimated that allowing over-the-counter sales of hearing aids could save people with hearing loss thousands of dollars.
