Over-the-Counter Hearing Aids: New FDA Ruling Will Make Devices Cheaper, More Accessible

People with mild to moderate hearing impairments will soon be able to buy hearing aids directly from retailers, thanks to a new rule issued by the U.S. Food and Drug Administration (FDA), and announced Tuesday.

The ruling establishes a new category for over-the-counter hearing aids—which may be purchased from stores or online retailers—with no medical exam, prescription, or fitting adjustment necessary.

In addition to making hearing aids more easily accessible, the new rule will also help lower the cost of hearing aids for the millions of Americans who use them. The rule is set to take effect in mid-October.

"Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions," FDA Commissioner Robert M. Califf, MD, said in a news release. "Establishing this new 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."

An Unmet Need for Millions of Americans

Hearing aids—and the appointments necessary to prescribe them—are costly, making the equipment inaccessible to a large number of Americans. Just one pair of hearing aids can set people back nearly $3,000, President Biden said in a statement on the FDA ruling.

Although an estimated 28 million Americans could benefit from hearing aid use, only one in five of those people actually uses a hearing aid.

"There are a lot of people out there that are not getting hearing aids because of lack of access or affordability," Rebecca Lewis, AuD, an audiologist and audiology director of the Adult & Pediatric Cochlear Implant Program at Pacific Neuroscience Institute at Providence Saint John's Health Center in Santa Monica, California, told Health. "Over-the-counter hearing aids are great in that this will improve access to patients."

The move to make hearing aids easier to access may also lead people to seek out and use them earlier.

"I hope that the class of OTC hearing aids will provide individuals with a safe and affordable option of pursuing hearing health intervention," Meaghan Reed, Au.D., CCC-A, director of clinical audiology at Mass Eye and Ear, told Health. "Creating a class of hearing aids that are available potentially online or in pharmacies that are regulated by the federal government will create an avenue for individuals with hearing difficulties earlier than they might otherwise."

According to Lewis, increased availability and use of hearing aids may also help reduce some of the stigma or ageism that may surround wearing them.

Availability This Fall for Some People

The rule is set to go into effect in about 60 days, according to the FDA—that means OTC hearing aids may be available for purchase in mid-October.

While millions of Americans are expected to benefit from the OTC hearing aids, they won't be available for every person who wants one.

The final ruling only applies to air-conduction hearing aids, which are devices that can be placed behind or inside the ear; bone-conduction hearing aids, which are not part of this ruling, require an implant. To benefit from OTC hearing aids, a person must be at least 18 years old, and have perceived mild to moderate hearing impairment. For those with moderately-severe to profound hearing loss, or people younger than 18 years old, a prescription device is still required.

And while, come October, getting an OTC hearing aid may be as simple as walking into your local pharmacy or going to an online retailer and buying one, experts urge that it's still a good idea to seek the advice of a healthcare provider if you're experiencing hearing loss.

"You want to ensure it's not a treatable hearing loss, like hearing loss due to impacted ear wax," said Lewis.

"Additionally," added Reed, "if individuals notice other symptoms along with hearing difficulties such as dizziness, ringing or fullness in the ears, ear pain, ear infections, or hearing better in one ear than the other, they should seek medical evaluation."

But overall, the move to make some hearing aids available over the counter is a welcome one. "I am looking forward to the opportunities this provides," Reed said, "and the changes to hearing health care that might stem from this."