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Hearing aids: Americans can now buy them over the counter






CNN

Pete Couste said it was his wife who first noticed him 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 has also influenced his work at the Fire Safety Research Institute, a non-profit organization that generates safety research. The 61-year-old said he feels less efficient in judging the sound quality when his team makes its life-saving videos for firefighters.

“It affects every part 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 United States will be able to purchase over-the-counter hearing aids. Those under 18 or who have severe hearing loss will still need a prescription.

The US Food and Drug Administration announced the long-awaited rule change in August, ushering in alternatives that should be cheaper and possibly even better.

Now adults can buy hearing aids directly from a store or online instead of getting a prescription and getting a custom fit with a hearing care professional. 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 have worked for years for affordable and accessible hearing health care,” said Barbara Kelley, executive director of the Hearing Loss Association of America. – We are very much 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 significant. About 1 in 8 people in the United States aged 12 and older have hearing loss in both ears, and the rate increases significantly with age. About a quarter of people between 65 and 74 have hearing loss, and this rises to 50% around 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: Major retailers can offer a pair for around $1,400, but some can cost as much as $6,000 per ear, depending on the technology.

The FDA rule allowing over-the-counter hearing aids did not change how the devices are covered. While private insurance companies 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.

So far, five companies have done so controlled 90% of the global hearing aid market place. That kind of consolidation meant that there was little price competition.

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

On Monday, some well-known companies from the audio world will be selling hearing aids.

Sony has a couple of models that pair with an app that lets users customize settings and find extra support. The CRE-C10 retails for $999.99 and has a battery life of 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 per pair. B2, for $999, adds one rechargeable battery that works for up to 18 hours. Both models are Bluetooth enabled, user configurable and paired with a mobile app for support. They will be sold online, in pharmacies and in stores such as Best Buy.

Best Buy says 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. They improve sound but do not have to meet FDA standards, unlike hearing aids, which must meet the FDA’s high standards for labeling, manufacturing and safety, like other medical devices.

Best Buy encourages customers to take a hearing assessment on their website before entering the store to work with trained associates to select a new device.

Hearing aids are not only 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 in general and are less likely to leave the house or exercise, studies have found.

There is a link between hearing loss and general frailty and an increased risk of falling, which is the second leading cause of accidental death worldwide, according to the World Health Association.

Several studies have also found a connection 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 more readily available, “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 matter for eight years.

Lin said there has been little innovation in this area 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 was 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 already make innovative earbuds – to now enter the market. They really couldn’t before.”

Kelley said if you plan to buy an OTC hearing aid, be 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 from 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 if they fit. Do they help in a crowded room, or are they better at work? It is not one size fits all.

Couste said he will check with his insurance company to see if it will absorb some of the cost of an OTC device. But finally, after all these years, he thinks he will soon be able to hear better.

“I’m looking forward to it,” Couste said. “I really am.”



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