FDA proposes rule to offer over-the-counter hearing aids

The Food and Drug Administration (FDA) is proposing a rule to offer a new category of over-the-counter hearing aids in an attempt to boost accessibility and lower costs for the devices for Americans.

The agency announced its proposal on Tuesday that would allow certain hearing aids to be sold directly to the millions of adults who have “perceived mild to moderate” hearing loss, once it is finalized. 

Under the updated rule, these patients could purchase specific air-conduction devices in stores or online without undergoing a medical exam or fitting. Adults with severe hearing loss or children with any hearing loss would still need a prescription. 

Officials expect the proposed regulations to “likely” allow less costly hearing aids to be sold and available to the public, thus increasing competition in the market. For safety, the rule covers specific device performance and design requirements, including a maximum volume limit.

The FDA’s proposal implements the Over-the-Counter Hearing Aid Act, which was signed into law as part of the FDA Reauthorization Act of 2017.

Health and Human Services Secretary Xavier Becerra said in a statement that the move “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.”

Sens. Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa), who introduced the 2017 law, praised the FDA’s proposal as “terrific news” in a joint statement.

“We’ve just cleared a major regulatory hurdle for over-the-counter hearing aids,” the senators said. “Soon, millions of people with mild to moderate hearing loss will finally have lower cost hearing aid options — and more options mean more competition in the market, further driving down the cost for consumers.”

The two senators had sent a letter to the FDA last week, pushing it to follow through with President Biden’s July executive order requesting the agency submit regulations for over-the-counter hearing aids within 120 days. 

About 37.5 million — or 15 percent — American adults say they have hearing issues, but only around one-fifth of people who could be assisted by a hearing aid use one.

Progressives have prioritized expanding Medicare to cover hearing, vision and dental care in Democrats’ budget reconciliation package this year. With a slim majority in the House and Senate, the party has been negotiating with moderates in the hopes of achieving the goal, with Sen. Bernie Sanders (I-Vt.) calling its inclusion in the spending package “not negotiable.”