FDA moves to make over-the-counter hearing aids available to millions

The Food and Drug Administration on Tuesday moved to make hearing aids available to consumers to buy over the counter without a prescription or medical exam, a long-awaited goal for nearly 30 million consumers.

“As early as mid-October, Americans will be able to purchase more affordable hearing aids over the counter at pharmacies and stores across the country,” President Joe Biden said in a statement Tuesday. “This action makes good on my commitment to lower costs for American families, delivering nearly $3,000 in savings to American families for a pair of hearing aids and giving people more choices to improve their health and wellbeing.”

The president called on the FDA to make hearing aids available over the counter last year in his Promoting Competition in the American Economy executive order to help lower costs and increase competition in certain industries.

The devices will be available for individuals 18 and older with mild to moderate hearing loss.

The move comes more than four years after Congress ordered the FDA to craft regulations for over-the-counter devices. The new regulations will create a new category of hearing aids that will supersede state-level regulations requiring patients to visit physicians or audiologists to get prescriptions and fittings.

Health and Human Services Secretary Xavier Becerra said Tuesday that this decision is the fulfillment of a long-term goal.

“Reducing health care costs in America has been a priority of mine since Day One and this rule is expected to help us achieve quality, affordable health care access for millions of Americans in need,” he said. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”

The current price of hearing aids averages more than $5,000 per pair, and they are not typically covered by traditional Medicare or other insurers. Supporters of the new proposal have long argued that over-the-counter models would be a fraction of that cost.

This change is expected to significantly benefit older adults—individuals who are most likely to experience hearing loss and to be on a fixed income—as well as those in poor and rural communities that have fewer audiologists.