(CNN) — Pete Couste says it was his wife who first noticed he was turning up the TV louder than she wanted.
“I didn’t hear the words in movies as much anymore,” admitted Couste, who lives just outside of Washington, DC.
Watching TV isn’t Couste’s only problem. In the choir of his church, he does not always manage to hear his part and find the right tone. It also affected his work at the Fire Safety Research Institute, a non-profit organization that generates security research. The 61-year-old said he felt less effective at judging audio quality when his team was making their life-saving videos for firefighters.
“It affects all parts of my life,” he said.
He saw an audiologist who told him he needed hearing aids, but it would have cost him over $6,000. “I thought, ‘Maybe it can wait,'” Couste said.
It 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 with severe hearing loss will still need a prescription.
Help for millions
In July, President Joe Biden signed a Executive Decree intended to promote competition; he encouraged the US Food and Drug Administration to allow over-the-counter and non-prescription hearing aids, and the FDA announced the so anticipated rule change in August. This decision paves the way for options that should be cheaper and maybe even better.
Now, instead of getting a prescription and having a custom fitting with a hearing professional, adults can buy hearing aids directly from a store or online. Some doctors estimate that 90% of the hearing-impaired population 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’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 listening device for the hearing impairedaccording to the National Institute on Deafness and Other Communication Disorders.
The number of deaf people is significant. About 1 in 8 people in the United States age 12 and older have hearing loss in both ears, and the rate increases dramatically with age. About a quarter of people aged 65 to 74 have hearing loss, and this rises to 50% by 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 may vary: Major retailers can offer a pair for around $1,400, but some can cost up to $6,000 per eardepending on the technology.
The FDA rule allowing over-the-counter hearing aids has not changed how devices are covered. While private insurers pay for treatment after limb loss or even cover the cost of Viagra, most don’t cover hearing aids. Most health insurance plans won’t pay for them either. Only about half of state Medicaid programs do.
More competition, more progress
So far, five companies have 90% controlled of the global hearing aid market. This type of consolidation meant that 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 will soon be available at Walgreens, CVS, Walmart, Best Buy and Hy-Vee, with some models priced as low as around $200 for a pair.
sony has a few models that pair with an app that allows users to customize settings and find additional support. The CRE-C10 sells for $999.99 and has a battery life of up to 70 hours of continuous use. The CRE-E10 has more of an earphone-like design and rechargeable battery; it is Bluetooth compatible 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 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 are Bluetooth compatible, can be adjusted by the wearer and associated with a mobile app for assistance. 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 improve sound but do not need to meet FDA standards, unlike hearing aids, which must meet high FDA standards for labeling, manufacturing, and safety, like other medical devices.
Best Buy encourages customers to take a hearing assessment on its website before coming to the store to work with trained associates to choose a new device.
Why hearing aids are important
Hearing aids aren’t just nice to have; they are essential for physical and mental health.
There is a link between hearing loss and general fragility and an increase risk of fallingwhich are the second leading cause of unintentional deaths worldwide, according to the World Health Association.
Several studies have also found a link between hearing loss and poorer mental health and psychosocial health.
With hearing aids becoming more accessible, “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 the government on this issue for eight years.
Lin said there has been little innovation in this space due to the way the market has been regulated.
“In 1977, due to the technology of the day, the only way for hearing aids to be safe and effective was if they were professionally programmed, fitted and adjusted by a licensed provider,” he said. . “But the market and this technology have changed dramatically.
“This will allow companies like Samsung, Apple, Google – companies that already make innovative headphones – to be able to enter the market now. They really couldn’t before.
What to look for
Kelley said if you’re considering buying an over-the-counter hearing aid, be sure to read the return policy. The FDA hasn’t required companies to offer one, as Kelley’s group pushed, but any return policies must be listed on the packaging.
Check how long you have before you can return them as well. Hearing aids are different from glasses; it can take up to four weeks for your brain to adapt to hearing in a new way.
Test them out in different circumstances for a few weeks to see if they work for you. Do they help out in a crowded room or are they better at the job? It is not a one size fits all.
Couste said he will check with his insurance company to see if they will cover some of the cost of an OTC device. But finally, after all these years, he thinks he will soon hear better.
“I can’t wait to be there,” Couste said. “I really am.”
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