Hearing aids: Americans can now buy over the counter


Pete Kuster said it was his wife who first noticed that he had the TV turned on bigger than she liked.

“I don’t hear the lyrics from the movie anymore,” admits Kuster, who lives outside Washington, D.C.

Watching TV isn’t Kuster’s only problem. In his church choir, he couldn’t always hear his part and get the pitch right. It also affected his work at the Fire Safety Institute, a nonprofit that conducts safety research. The 61-year-old said he found it less efficient to judge audio quality when his team produced lifesaving videos for firefighters.

“It has affected every aspect of my life,” he said.

He saw an audiologist who said he needed hearing aids, but they would cost him over $6,000. “I thought, ‘Maybe this can wait,'” Kuster said.

That was seven years ago.

The wait for Kuster and millions of other Americans may be over. Adults with mild to moderate hearing loss in the U.S. will be able to buy over-the-counter hearing aids for the first time on Monday. People under the age of 18 or those with severe hearing loss still need a prescription.

The FDA announced long-awaited rule changes in August that introduced cheaper and possibly better options.

Instead of getting a prescription and having a custom fit with a hearing health professional, adults can now buy hearing aids directly from a store or online. Some doctors estimate that 90 percent of people with hearing loss could benefit from these over-the-counter devices.

Experts say the move is a “game changer”.

“We’ve been working on making hearing care affordable and accessible for years,” said Barbara Kelley, executive director of the American Hearing Loss Association. “We’re really looking forward to Monday.” ”

Couste is certainly not alone in giving up hearing aids because they are too expensive, Kelley said. Of the tens of millions of people with hearing loss, only about 16 percent use hearing aids, according to the National Institute on Deafness and Other Communication Disorders.

The number of people with hearing loss is considerable. About 1 in 8 people in the United States ages 12 and older have hearing loss in both ears, and this rate increases significantly with age. About a quarter of 65- to 74-year-olds have hearing loss, and around 75 the rate is as high as 50%.

According to a 2020 study published in the medical journal JAMA, people on average spend at least $4,000 out of pocket for binaural devices. Prices can vary: Big retailers might offer a pair for around $1,400, but some could cost as much as $6,000 per ear, depending on the technology.

The FDA’s rule allowing over-the-counter hearing aids doesn’t change the way these devices are covered. While private insurers pay for treatment and even Viagra after the loss of a limb, most do not cover hearing aids. Most health insurance plans won’t pay for them either. Only about half of state Medicaid programs do so.

To date, there are five companies Controls 90% of the global hearing aid market. This integration means there is little price competition.

With this change, more companies are expected to enter the market. In addition to existing products, existing manufacturers will develop lower-cost over-the-counter devices, experts say.

On Monday, some familiar companies from the audio space will sell hearing aids.

Sony has several models paired with an app that lets users personalize settings and find extra support. The CRE-C10 costs $999.99 and has up to 70 hours of battery life. The CRE-E10 is more of an in-ear design and a rechargeable battery; it’s compatible with Bluetooth and can stream music or audio. It’ll be on sale for $1,299.99 on Sony’s website, as well as at Amazon, Best Buy, and other retailers.

Bose has also teamed up with Lexie Hearing to offer B1 models for $899 a pair. B2, $999, added a Rechargeable battery for up to 18 hours of working time. Both models are Bluetooth-enabled and can be adjusted by the wearer and paired with a mobile app for support. They’ll be available online, in drugstores, and in stores like Best Buy.

Best Buy said its nearly 300 stores will offer “hearing experiences,” which include about 10 over-the-counter hearing aids and PSAPs, or personal amplification products. Those that enhance sound but don’t need to meet FDA standards, unlike hearing aids, it must meet FDA’s high standards for labeling, manufacturing, and safety, just like any other medical device.

Best Buy is encouraging customers to take a hearing assessment on its website before entering a store to pick up a new device with trained staff.

Hearing aids aren’t just great; they’re vital to physical and mental health.

People with hearing loss without hearing aids were more likely to report poor overall health, and they were less likely to leave home or exercise, the study found.

According to the World Health Association, there is a link between hearing loss and general weakness and an increased risk of falls, which are the second leading cause of unintentional death globally.

Several studies have also found a link between hearing loss and poorer mental and psychosocial well-being.

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

As hearing aids become easier to use, “I now have a big smile on my face,” says Dr. Frank Lin, director of the Cochlear Hearing and Public Health Center. He has been consulting with the government on the issue for eight years.

Because of the way the market is regulated, there has been little innovation in this area, Lin said.

“In 1977, because of the technology at the time, the only way for hearing aids to be safe and effective was to have them programmed, installed and professionally adjusted by a licensed supplier,” he said. “But the market and technology have changed dramatically.

“This will allow companies like Samsung, Apple, Google — companies that are already making innovative earbuds — to now enter the market. They really couldn’t do it before.”

If you’re planning to buy an OTC hearing aid, be sure to read the return policy, Kelley says. As Kelley’s group is pushing, the FDA doesn’t require companies to provide one, but any return policy should be listed on the packaging.

Check how long you have left to return them. Hearing aids are different from glasses; it can take up to 4 weeks for your brain to adapt to hearing in a new way.

Test them in different environments after a few weeks to see if they fit. Are they helping out in a crowded room, or are they doing a better job at work? This is not one size fits all.

Kuster said he will check with his insurance company to see if it will cover the cost of any over-the-counter equipment. But in the end, after so many years, he thinks he’ll be able to hear better soon.

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

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