FDA change ushers in cheaper, easier-to-get hearing aids

Dec 3, 2022, 4:04 PM | Updated: Dec 4, 2022, 6:19 am
Sterling Sheffield, an assistant professor of Speech, Language, and Hearing Sciences at the Univers...

Sterling Sheffield, an assistant professor of Speech, Language, and Hearing Sciences at the University of Florida, holds an over-the-counter hearing aid Wednesday, Nov. 30, 2022, in Gainesville, Fla. OTC hearing aids started hitting the market in October after the FDA approved them for adults with mild-to-moderate hearing loss, and Sheffield has been testing them. (AP Photo/Alan Youngblood)

(AP Photo/Alan Youngblood)

              Sterling Sheffield, an assistant professor of Speech, Language, and Hearing Sciences at the University of Florida, shows prescription hearing aids Wednesday, Nov. 30, 2022, in Gainesville, Fla. OTC hearing aids started hitting the market in October after the FDA approved them for adults with mild-to-moderate hearing loss, and Sheffield has been testing them. (AP Photo/Alan Youngblood)
            
              Sterling Sheffield, an assistant professor of Speech, Language, and Hearing Sciences at the University of Florida, shows an iPhone app that controls a Bose hearing aid Wednesday, Nov. 30, 2022, in Gainesville, Fla. OTC hearing aids started hitting the market in October after the FDA approved them for adults with mild-to-moderate hearing loss, and Sheffield has been testing them. (AP Photo/Alan Youngblood)
            
              Sterling Sheffield, an assistant professor of Speech, Language, and Hearing Sciences at the University of Florida, shows over-the-counter hearing aids Wednesday, Nov. 30, 2022, in Gainesville, Fla. OTC hearing aids started hitting the market in October after the FDA approved them for adults with mild-to-moderate hearing loss, and Sheffield has been testing them. (AP Photo/Alan Youngblood)
            
              Sterling Sheffield, an assistant professor of Speech, Language, and Hearing Sciences at the University of Florida, holds an over-the-counter hearing aid Wednesday, Nov. 30, 2022, in Gainesville, Fla. OTC hearing aids started hitting the market in October after the FDA approved them for adults with mild-to-moderate hearing loss, and Sheffield has been testing them. (AP Photo/Alan Youngblood)

It’s now a lot easier — and cheaper — for many hard-of-hearing Americans to get help.

Hearing aids can now be sold without a prescription from a specialist. Over-the-counter, or OTC, hearing aids started hitting the market in October at prices that can be thousands of dollars lower than prescription hearing aids.

About 30 million people in the United States deal with hearing loss, according to the Food and Drug Administration. But only about 20% of those who could use a hearing aid seek help.

Here’s a closer look:

WHO MIGHT BE HELPED

The FDA approved OTC hearing aids for adults with mild-to-moderate hearing loss. That can include people who have trouble hearing phone calls or who turn up the TV volume loud enough that others complain.

It also can include people who have trouble understanding group conversations in noisy places.

OTC hearing aids aren’t intended for people with deeper hearing loss, which may include those who have trouble hearing louder noises, like power tools and cars. They also aren’t for people who lost their hearing suddenly or in just one ear, according to Sterling Sheffield, an audiologist who teaches at the University of Florida. Those people need to see a doctor.

HEARING TEST

Before over-the-counter, you usually needed to get your hearing tested and buy hearing aids from a specialist. That’s no longer the case.

But it can be hard for people to gauge their own hearing. You can still opt to see a specialist just for that test, which is often covered by insurance, and then buy the aids on your own. Check your coverage before making an appointment.

There also are a number of apps and questionnaires available to determine whether you need help. Some over-the-counter sellers also provide a hearing assessment or online test.

WHO’S SELLING

Several major retailers now offer OTC hearing aids online and on store shelves.

Walgreens drugstores, for example, are selling Lexie Lumen hearing aids nationwide for $799. Walmart offers OTC hearing aids ranging from about $200 to $1,000 per pair. Its health centers will provide hearing tests.

The consumer electronics chain Best Buy has OTC hearing aids available online and in nearly 300 stores. The company also offers an online hearing assessment, and store employees are trained on the stages of hearing loss and how to fit the devices.

Overall, there are more than a dozen manufacturers making different models of OTC hearing aids.

New devices will make up most of the OTC market as it develops, Sheffield said. Some may be hearing aids that previously required a prescription, ones that are only suitable for people with mild to moderate hearing loss.

Shoppers should expect a lot of devices to enter and leave the market, said Catherine Palmer, a hearing expert at the University of Pittsburgh.

“It will be quite a while before this settles down,” she said.

WHAT TO WATCH FOR

Look for an OTC label on the box. Hearing aids approved by the FDA for sale without a prescription are required to be labeled OTC.

That will help you distinguish OTC hearing aids from cheaper devices sometimes labeled sound or hearing amplifiers — called a personal sound amplification product or PSAP. While often marketed to seniors, they are designed to make sounds louder for people with normal hearing in certain environments, like hunting. And amplifiers don’t undergo FDA review.

“People really need to read the descriptions,” said Barbara Kelley, executive director of the Hearing Loss Association of America.

And check the return policy. That’s important because people generally need a few weeks to get used to them, and make sure they work in the situations where they need them most. That may include on the phone or in noisy offices or restaurants.

Does the company selling OTC devices offer instructions or an app to assist with setup, fit and sound adjustments? A specialist could help too, but expect to pay for that office visit, which is rarely covered by insurance.

Sheffield said hearing aids are not complicated, but wearing them also is not as simple as putting on a pair of reading glasses.

“If you’ve never tried or worn hearing aids, then you might need a little bit of help,” he said.

THE COST

Most OTC hearing aids will cost between $500 and $1,500 for a pair, Sheffield said. He noted that some may run up to $3,000.

And it’s not a one-time expense. They may have to be replaced every five years or so.

Hearing specialists say OTC prices could fall further as the market matures. But they already are generally cheaper than their prescription counterparts, which can run more than $5,000.

The bad news is insurance coverage of hearing aids is spotty. Some Medicare Advantage plans offer coverage of devices that need a prescription, but regular Medicare does not. There are discounts out there, including some offered by Medicare Advantage insurer UnitedHealthcare in partnership with AARP.

Shoppers also can pay for the devices with money set aside in health savings accounts or flexible spending accounts.

Don’t try to save money by buying just one hearing aid. People need to have the same level of hearing in both ears so they can figure out where a sound is coming from, according to the American Academy of Audiology.

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Follow Tom Murphy on Twitter: @thpmurphy

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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FDA change ushers in cheaper, easier-to-get hearing aids