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FDA Gives Green Light to Cheaper, Over-the-Counter Hearing Aids

Americans with mild to moderate hearing loss can now buy less expensive hearing aids without a medical exam or fitting

spinner image woman holding her hand to her ear indicating she is trying to hear
Blend Images - JGI/Jamie Grill / Getty Images


The Food and Drug Administration approved a long-awaited rule on Aug. 16 that will give millions of Americans a more affordable and more convenient solution to their hearing loss: over-the-counter hearing aids.

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The new devices — designed for those with mild to moderate hearing loss — are expected to transform the hearing aid market. They will be sold at stores and online without a medical exam, prescription or special fitting by an audiologist.

The approved hearing aids could be available by mid-October, according to the FDA. 

AARP fought for the bipartisan law, written by Sen. Chuck Grassley (R-Iowa) and Sen. Elizabeth Warren (D-Massachusetts), that required the FDA to issue these regulations. 

Hearing Loss for Dummies

Authors Frank Lin and Nicholas Reed at the Johns Hopkins School of Medicine lay out the steps to hearing health, including new advice on just-released over-the-counter hearing aids.

spinner image book cover of a a r p hearing loss for dummies

“Giving people with mild to moderate hearing loss access to affordable hearing aids is an important step to ensure their health and quality of life,” said Nancy LeaMond, AARP’s executive vice president and chief advocacy and engagement officer. “For many Americans, the high cost of prescription hearing aids puts them out of reach, increasing their risk of isolation, depression and other health issues. Today’s rule could help millions.” 

About 15 percent of all U.S. adults — 37.5 million Americans —report trouble hearing, and the percentage rises with age. About a third of people ages 65 to 74 and half of those over age 75 have hearing loss.

Yet about 80 percent of people who would benefit from hearing aids don’t wear them, according to the National Institutes of Health.

While some people may be in denial or too embarrassed to wear hearing aids, the biggest obstacle for many Americans is the hefty price tag. Traditional hearing aids ordered through an audiologist run about $1,000 to $6,000 a pair. Most private insurers and traditional Medicare do not cover the cost. 

The FDA estimates the change will save consumers on average about $2,800 per pair. 

Until now, you could only get a hearing aid through an audiologist or a hearing health specialist, and the cost of the devices was often bundled with the price of the service the specialist provided to fit and program the equipment, including follow-up visits. 

“This is great news for older Americans and anyone having difficulty hearing,” says Andrew Scholnick, government affairs director for AARP. “AARP has fought for years to make hearing aid technologies more affordable and accessible. Now, with the creation of over-the-counter hearing aids, more people have the opportunity to hear better and continue to lead active and engaging lives.”

Under the new rule, people with mild to moderate hearing loss can buy a hearing aid without going through an intermediary, test their own hearing and adjust the device settings themselves, most likely by using an online program or a mobile app.

“One reason that people don’t get hearing aids is access to care — they don’t have access to an audiologist or they don’t know how to get into the system,” says Barbara Kelley, executive director of the Hearing Loss Association of America, a consumer advocacy group. “From our point of view, this provides another entry point for consumers … and we’re very excited about it.”

With the debut of over-the-counter options, Kelley expects some audiologists will start charging à la carte fees for the services they offer, such as helping you choose and order a prescription hearing aid or adjusting one you already have to maximize its effectiveness.

“You may be able to go to them with an over-the-counter device and get help with it,” Kelley says.

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Experts say over-the-counter hearing aids should also lower prices by disrupting the overall hearing aid market, which has been controlled by five major manufacturers.

In addition to dominating the industry’s manufacturing, those five companies own thousands of audiology clinics as well as marketing companies, lobbying firms and subsidiaries that manage health insurance claims related to hearing, says Nicholas Reed, an audiologist, researcher and instructor at Johns Hopkins University Bloomberg School of Public Health in Baltimore.

Reed, coauthor of AARP's Hearing Loss for Dummies, says the new rule will likely make it easier for other companies to enter the market and compete, pushing prices down and encouraging innovation.

“It opens up the market, changes access and lowers the cost,” Reed says. “Honestly, we even may see some crazy technology changes, because now you have a direct link between the consumer and the manufacturer. You may see some big changes related to what a hearing aid looks like.”

Who can use over-the-counter hearing aids?

The over-the-counter hearing aids are not for everyone. They are specifically designed for adults who have perceived “mild to moderate hearing loss,” even if they have not had a hearing test.

According to the National Institute on Deafness and Other Communication Disorders, here are some signs your hearing loss may be mild to moderate:

  • Speech or other sounds seem muffled.
  • You have trouble hearing when you’re in a group, in a noisy area or on the phone, or when you can’t see who is talking.
  • You have to ask others to speak more slowly or clearly, speak louder or repeat what they said.
  • You turn up the volume higher than other people prefer when watching TV or listening to the radio or music.

If you have trouble hearing loud sounds such as noisy appliances or a loud truck driving by, if you struggle to hear conversations in quiet settings, or if your hearing loss is in just in one ear, then your hearing loss is considered more significant than over-the-counter aids are intended to address, experts say.

If that’s the case, you should work with an audiologist or hearing instrument specialist to find a hearing aid that will work for you.

Note: You should see a doctor quickly if you experience sudden hearing loss, pain or discomfort in your ear, severe dizziness with hearing loss, or tinnitus (ringing) in only one ear. Those can be signs you need medical treatment.

Because the effort to allow the devices has been in the works for years, some hearing aid manufacturers have over-the-counter hearing aids ready to go.

Electronics companies may also enter the market. Devices labeled as personal sound amplification products, or PSAPs, will likely rebrand as hearing aids, Reed says. He says his research has found that some PSAPs are excellent products for enhancing hearing, while “a lot of them are absolute garbage and can make hearing worse.”

Any devices that the FDA approves as hearing aids will have to meet strict regulatory standards, Reed adds, so consumers will know they are getting a quality product.

Reed expects the over-the-counter hearing aids to cost $250 to $1,000 or more for a pair — still expensive, but significantly less than the current average of about $4,600 for a pair ordered through an audiologist.

The FDA rules set limits on noise levels, frequency, distortion and insertion depth for the over-the-counter aids, and requires them to include safety information on their labels.

If you’re shopping for a hearing aid, look for one with a generous return policy, a long warranty and a robust smartphone app, Scholnick says.

Hearing linked to health

Kelley of the Hearing Loss Association says she hopes the availability of over-the-counter hearing aids will reduce the stigma related to wearing hearing aids and prompt more Americans to give hearing assistance a try.

Some may start with over-the-counter aids but upgrade to more expensive prescription technology with the help of an audiologist if their hearing loss progresses, Kelley says.

Research shows the ability to hear is tightly linked to overall health. Untreated hearing loss is associated with balance problems, falls, social isolation, loneliness, cardiovascular disease, diabetes and cognitive decline.

“When communication is disrupted, that disrupts human relationships,” Kelley says. “If we can get people to take this step sooner rather than later, to pay attention to their hearing health, that’s a good thing.” 

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