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Hearing aids can now be purchased without a prescription in the US.

(CNN) — Pete Couste says his wife was the first to notice that he turned the TV up louder than she liked.

“I didn’t hear words from the movies as much anymore,” admitted Couste, who lives outside Washington, DC.

Watching television is not Couste’s only problem. In his church choir, he can’t always hear his part and get the right pitch. It has also affected his work at the Fire Safety Research Institute, a nonprofit organization that generates safety research. This 61-year-old says he feels less effective in judging audio quality when his team makes their videos to save firefighters’ lives.

“It’s affecting every aspect of my life,” he said.

She went to an audiologist who told her she needed hearing aids, but they would have cost 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. This Monday, for the first time, adults with mild to moderate hearing loss in the US will be able to buy hearing aids without a prescription. Those under the age of 18 or those with severe hearing loss will still need a prescription.

Help for millions of people

The US Food and Drug Administration (FDA) announced the long-awaited rule change in August, opening the way to options that should be cheaper and possibly even better.

Now, instead of getting a prescription and custom fitting from a hearing healthcare professional, adults can purchase 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 “tipping point”.

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

Certainly, Couste isn’t alone in giving up hearing aids because they’re too expensive, Kelley noted. Only 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 considerable. About 1 in 8 people age 12 and older in the US have hearing loss in both ears, and the rate increases significantly with age. About a quarter of people between the ages of 65 and 74 have hearing loss, and this number increases to 50% around the age of 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: Large dealers may offer a pair for around $1,400, but some can go as high as $6,000 per ear, depending on the technology.

The FDA rule allowing the use of hearing aids without a prescription has not changed how these devices are covered. While private insurers pay for treatment after loss of a member or even cover the cost of Viagra, most do not cover hearing aids. Most Medicare plans don’t pay for them either. Only half of state Medicaid programs do.

Until now, five companies controlled 90% of the world market for hearing aids. This type of concentration meant that there was little price competition.

More competition, more progress

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

This Monday, some well-known companies in the audio world will sell hearing aids.

Sony has a couple of models that are paired with an app that allows users to customize settings and find additional help. 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 earphone-like design and a rechargeable battery; It supports Bluetooth to stream music or audio. It will be available for $1,299.99 on Sony’s website and at Amazon, Best Buy and other retailers.

Bose has also teamed up with Lexie Hearing to offer the B1 model for $899 a pair. The B2, for $999, adds a rechargeable battery that runs for up to 18 hours. Both models have Bluetooth, can be adjusted by the user and are paired with a helper mobile app. They will be sold online, in pharmacies and in stores like 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. These products improve sound, but do not have to meet FDA standards, unlike hearing aids, which have to meet strict FDA standards for labeling, manufacturing, and safety, just like other medical devices.

Best Buy encourages customers to take a hearing evaluation on its website before coming into the store to work with qualified personnel to select a new device.

Why are hearing aids important?

Hearing aids are not just a nice thing 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 general health, and are less likely to leave the house or exercise, according to studies.

There is a link between hearing loss and general frailty and increased risk of falls, which are the second leading cause of unintentional deaths worldwide, according to the World Health Organization.

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

Hearing loss can cause depression, loneliness and isolation, and even dementia.

Now that hearing aids are more widely available, “I have a big smile on my face,” said Dr. Frank Lin, director of the Cochlear Center for Hearing and Public Health. He has been advising the Government on this issue for eight years.

Lin says that there has been little innovation in this area due to the way the market has been regulated.

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

“This will allow companies like Samsung, Apple, Google – companies that are already making innovative hearing aids – to be able to enter the market now. They couldn’t before.”

What must be considered?

Kelley said if you’re thinking of buying an over-the-counter 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 must be listed on the package.

Also check how much time you have before you can return them. Hearing aids are different from glasses; It can take up to four weeks for the brain to adjust to a new way of hearing.

Try them out in different circumstances over a few weeks to see if they are right for you. Do they help you 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 cover the cost of an over-the-counter device. But finally, after all these years, he believes that he will soon be able to hear better.

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

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