FDA Clears Way for Over-the-Counter Hearing Aids

The U.S. Food and Drug Administration (FDA) has announced what it calls a “landmark proposal” to make hearing aids available without a prescription, a long-awaited move aimed at making the devices more affordable and accessible to the millions of Americans living with hearing loss.

The proposed rule comes four years after Congress passed a law requiring the FDA to establish a category of over-the-counter hearing aids. The agency had missed its August 2020 deadline for doing so, citing pandemic-related obstacles. If finalized after a 90-day public commentary period, the agency's updated guidelines will create a new category of devices requiring neither a prescription nor a fitting by an audiologist; they would be sold online and at retail stores for adults with mild to moderate hearing loss.

Currently, those seeking hearing aids generally must visit a health care professional for testing and fitting — a process that can be both costly and lengthy.

“Hearing loss has a profound impact on daily communication, social interaction and the overall health and quality of life for millions of Americans,” Acting FDA Commissioner Janet Woodcock, M.D., said in a statement. “The FDA’s proposed rule represents a significant step toward helping ensure that adults with mild to moderate hearing loss have improved access to more affordable and innovative product options.”

For safety, the proposed rule limits the maximum volume allowed for over-the-counter devices and establishes other performance and design requirements. The devices would not be available to people under the age of 18 or adults with severe hearing loss, who would still need to seek out a prescription.

Approximately 15 percent of U.S. adults (37.5 million) report trouble hearing, according to the National Institute on Deafness and Other Communication Disorders, and fewer than 1 in 3 adults age 70 and older with hearing loss who could benefit from hearing aids have ever used them.

Cost is often cited as a major factor for the disparity: Hearing aids currently cost between $2,000 and $6,000 a pair and aren’t covered by Medicare or most insurance. The proposed rule is expected to lead to lower prices for consumers by lowering barriers to entry for manufacturers.

The only over-the-counter options currently available have been personal sound-amplification products (PSAPs), which increase the volume of all the sounds in a given environment, and which typically cost several hundred dollars a pair.

“Reducing health care costs for everyone in America is a top priority,” Health and Human Services Secretary Xavier Becerra said in a statement. “Today’s move by FDA takes us one step closer to the goal of making hearing aids more accessible and affordable for the tens of millions of people who experience mild to moderate hearing loss.”

Sarah Elizabeth Adler joined aarp.org as a writer in 2018. Her pieces on science, art and culture have appeared in The Atlantic, where she was previously an editorial fellow, California magazine and elsewhere.