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A 'game-changer' for millions of Americans: You can now buy hearing aids over the counter

(CNN) Pete Couste said it was his wife who first noticed that he was turning up the TV louder than she liked.

"I couldn't hear the words in movies as much anymore," admitted Couste, who lives just outside Washington, DC.

Watching TV isn't Couste's only problem. In his church choir, he can't always hear his part and get the pitch right. It's also affected his work at the Fire Safety Research Institute, a nonprofit that generates safety research. The 61-year-old said he feels less effective judging audio quality when his team makes their life-saving videos for firefighters.

"It is affecting all parts of my life," he said.

He saw an audiologist who said he needed hearing aids, but they would have cost him more than $6,000. "I thought, 'Maybe this can wait,' " Couste said.

That was seven years ago.

The wait may be over for Couste and millions of other Americans. On Monday, for the first time, adults with mild to moderate hearing loss in the US will be able to buy over-the-counter hearing aids. Those who are under 18 or who have severe hearing loss will still need a prescription.

Help for millions

In July, President Joe Biden signed an executive order meant to promote competition; it encouraged the US Food and Drug Administration allow over-the-counter, prescription-free hearing aids, and the FDA announced the long-awaited rule change in August. The move ushers in options that should be cheaper and possibly even better.

Now, instead of getting a prescription and having a custom fitting with a hearing health professional, adults can buy hearing aids directly from a store or online. Some doctors estimate that 90% of the population with hearing loss could benefit from these over-the-counter devices.

Experts say the move is a "game-changer."

"We've been working for years for affordable and accessible hearing health care," said Barbara Kelley, executive director of the Hearing Loss Association of America. "We're really looking forward to Monday."

Couste is certainly not alone in forgoing hearing aids because they were too expensive, Kelley said. Only about 16% of the tens of millions of people with hearing loss use a hearing aid, according to the National Institute on Deafness and Other Communication Disorders.

The number of people with hearing loss is substantial. About 1 in 8 people in the US ages 12 and older has hearing loss in both ears, and the rate increases significantly with age. About a quarter of people 65 to 74 have hearing loss, and that goes up to 50% around age 75.

On average, people spend at least $4,000 out of pocket for devices for both ears, according to a 2020 study published in the medical journal JAMA. Prices can vary: Large retailers may offer a pair for about $1,400, but some can cost as much as $6,000 per ear, depending on the technology.

The FDA rule allowing for over-the-counter hearing aids didn't change how the devices are covered. While private insurers pay for treatment after the loss of a limb or even cover the cost of Viagra, most do not cover hearing aids. Most Medicare plans won't pay for them, either. Only about half of state Medicaid programs do.

More competition, more advances

Until now, five companies have controlled 90% of the global marketplace for hearing aids. That kind of consolidation meant there was little price competition.

With the change, many more companies are expected to enter the market. Experts say that existing manufacturers will also develop lower-cost over-the-counter devices in addition to their current offerings.

The White House said Monday that hearing aids are available or coming soon at Walgreens, CVS, Walmart, Best Buy and Hy-Vee, with some models priced as low as about $200 for a pair.

Sony has a couple of models that pair with an app that lets users personalize settings and find additional support. The CRE-C10 sells for $999.99 and has a battery life for up to 70 hours of continuous use. The CRE-E10 has more of an earbud-like design and a rechargeable battery; it is Bluetooth compatible to stream music or audio. It will be available for $1,299.99 on the Sony website and at Amazon, Best Buy and other retailers.

Bose also teamed up with Lexie Hearing to offer the B1 model for $899 a pair. The B2, for $999, adds a rechargeable battery that works for up to 18 hours. Both models are Bluetooth-enabled, can be tuned by the wearer and pair with a mobile app for support. They'll be sold online, at drugstores and at stores like Best Buy.

Best Buy says that nearly 300 of its stores will offer a "hearing experience," which will include about 10 over-the-counter hearing aids and PSAPs, or personal sound amplification products. Those enhance sound but don't need to meet FDA standards, unlike hearing aids, which have to meet the FDA's high standards for labeling, manufacturing and safety, like other medical devices.

Best Buy is encouraging customers to take a hearing assessment on its website before coming into the store to work with trained associates to pick out a new device.

Why hearing aids matter

Hearing aids aren't just nice to have; they are essential for physical and mental health.

People with hearing loss who do not have hearing aids are more likely to report poor health overall, and they are less likely to leave home or exercise, studies have found.

There's a link between hearing loss and general frailty and an increasing risk of falls, which are the second leading cause of unintentional deaths worldwide, according to the World Health Association.

Several studies have also found an link between hearing loss and poorer mental health and psychosocial health.

Hearing loss can lead to depression, loneliness and isolation -- even dementia.

With hearing aids becoming easier to access, "I have a big smile on my face right now," said Dr. Frank Lin, director of the Cochlear Center for Hearing and Public Health. He has been consulting with the government on this issue for eight years.

Lin said there has been little innovation in this space because of the way the market has been regulated.

"In 1977, because of the technology at the time, the only way for hearing aids to be safe and effective is if they were programmed and fitted and professionally adjusted by a licensed provider," he said. "But the market and that technology has changed dramatically.

"This will allow companies like Samsung, Apple, Google -- companies that are already making innovative earbuds -- they can now enter the market. They really couldn't before."

What to look for

Kelley said that if you plan to buy an OTC hearing aid, make sure to read the return policy. The FDA did not require companies to offer one, as Kelley's group pushed, but any return policy should be listed on the package.

Check how long you have before you can return them, too. Hearing aids are different than glasses; it can take your brain up to four weeks to adjust to hearing in a new way.

Test them in different circumstances over a few weeks to see whether they're the right fit. Do they help in a crowded room, or are they better at work? It's not one size fits all.

Couste said he will check with his insurance company to see whether it will pick up any of the cost of an OTC device. But finally, after all these years, he thinks he'll soon be able to hear better.

"I am looking forward to it," Couste said. "I truly am."