FDA allows some hearing aids to be sold over the counter, driving down cost and eliminating prescription need

By mid-October, hearing aids will be available over the counter, just in time for everyone to clearly make out their relatives’ squabbling across the holiday dinner table.

The U.S. Food and Drug Administration on Tuesday finalized a ruling that will make hearing aids available over the counter, much like reading glasses. The move will enable easy access to hearing improvement for those with mild to moderate impairment.

People will be able to buy hearing aids online or at the drugstore without shelling out time and money for a doctor’s appointment, obtaining a prescription, or waiting to be fitted by an audiologist under the new rule, which takes effect in 60 days.

“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” said FDA Commissioner Dr. Robert M. Califf in a statement. “Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online.”

The rule potentially benefits many of the 30 million adults in the U.S., the FDA said. It applies to certain types of air-conduction hearing aids made for people ages 18 and up. Still under prescription are hearing aids for severe impairment, and those intended for people under age 18.

The hope is that it will also bring the price down, and it is thus part of President Biden’s stated attempt to foster competition within industries and thus lower costs.

“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,” Health and Human Services Secretary Xavier Becerra said in the FDA’s statement. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”

Biden had issued an executive order last year telling the FDA to find a way. He said the new ruling could reduce hearing aid costs by a good $3,000.

“When too few companies dominate, American consumers pay higher costs,” Biden said in a statement applauding the ruling. “We’re finally building an economy that works for working families.”