Hearing aids: Americans can now buy them over the counter


Pete Kust said that his wife first noticed him turning on the TV louder than he liked.

“I couldn’t hear the words in the movies anymore,” admitted Kust, who lives just outside of Washington.

Watching TV isn’t Couste’s only problem. In the church choir, he can’t always hear his role and get the voice right. It also affected his work at the Fire Safety Research Institute, a non-profit organization that produces safety research. The 61-year-old said he felt less effective in judging sound quality when his team produced life-saving videos for firefighters.

“It affects all parts of my life,” she said.

She saw an audiologist who told her she needed hearing aids, but that they would cost her more than $6,000. “I thought, ‘Maybe this can wait,'” Couste said.

That was seven years ago.

For Couste and millions of other Americans, the wait may be over. On Monday, for the first time, adults in the United States with mild to moderate hearing loss will be able to purchase hearing aids without a prescription. Those under 18 or with severe hearing loss will still need a prescription.

The US Food and Drug Administration announced a long-awaited rule change in August, introducing cheaper and possibly even better options.

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

Experts say the move is a “game changer”.

“We have been working for affordable and accessible hearing health for years,” said Barbara Kelley, executive director of the Hearing Loss Association of America. “We’re really looking forward to Monday.”

Kelley said Couste was not alone in giving up hearing aids because they were too expensive. According to the National Institute on Deafness and Other Communication Disorders, only 16% of the tens of millions of people with hearing loss use hearing aids.

There are quite a number of people with hearing loss. About 1 in 8 people age 12 and older in the United States have hearing loss in both ears, and this rate increases significantly with age. About a quarter of people aged 65-74 have hearing loss, rising to 50% around age 75.

On average, people spend at least $4,000 out-of-pocket on 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 insurers will 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 half of state Medicaid programs do.

There are five companies so far controls 90% of the global market for hearing aids. This kind of consolidation meant there was less price competition.

More companies are expected to enter the market with the change. Experts say that existing manufacturers will develop cheaper devices in addition to their current offerings.

On Monday, some familiar companies from the audio world will be selling hearing aids.

Sony has several models that come bundled with software that allows users to customize settings and find additional 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 a more headphone-like design and a rechargeable battery; Bluetooth compatible for streaming music or audio. It will be available on Sony’s website and at Amazon, Best Buy and other retailers for $1,299.99.

Bose also offered the B1 with Lexie Hearing for $899 a pair. B2, for $999, adds a Rechargeable battery that lasts up to 18 hours. Both models are Bluetooth-enabled, user-tunable, and can be paired with a mobile app for support. They will be sold online, in drugstores and at stores like Best Buy.

Best Buy says its nearly 300 stores will offer a “hearing experience” that includes about 10 over-the-counter hearing aids and PSAPs, or personal sound amplification products. These amplify sound, but do not need 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 evaluation on its website before coming into the store to work with trained associates to select a new device.

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

Research shows that people with hearing loss without hearing aids report poorer overall health and are less likely to leave the house or exercise.

According to the World Health Association, hearing loss is associated with general frailty and an increased risk of falls, which are the second leading cause of accidental death worldwide.

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

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

As hearing aids become easier to access, “I have a big smile on my face right now,” said Dr. Frank Lynn. He has been consulting with the government on this issue for eight years.

Lin said there has been little innovation in this space through market regulation.

“In 1977, with the technology at the time, the only way hearing aids were safe and effective was for them to be programmed and fitted and professionally adjusted by a licensed provider,” he said. “But the market and this technology have changed dramatically.

“This will allow companies like Samsung, Apple, Google, which already produce innovative headphones, to enter the market now. 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 said. The FDA did not require the companies to offer one, as Kelley’s group insisted, but any return policy should be listed on the package.

Check how much time you have to return them. Hearing aids are different from glasses; it can take up to four weeks for your brain to adjust to hearing in a new way.

Test them in different conditions for a few weeks to see if they fit properly. Are they helpful in a crowded room or better at work? Not one size fits all.

Couste said he would check with the insurance company to see if an OTC device would pick up any costs. But finally, after all these years, he thinks he might be able to hear better soon.

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

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