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FDA change ushers in cheaper, easier-to-get hearing aids

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It’s now much easier — and cheaper — for many hearing-impaired Americans to get help.

Hearing aids can now be sold without a prescription from a specialist. Over-the-counter, or OTC, hearing aids began hitting the market in October at prices that can be thousands of dollars lower than prescription hearing aids.

About 30 million people in the United States struggle with hearing loss, according to the Food and Drug Administration. But only about 20% of those who could use a hearing aid seek help.

Here is an overview:

Who could be helped

The FDA has approved OTC hearing aids for adults with mild to moderate hearing loss. This can include people who have trouble hearing phone calls or turning up the volume on the TV loud enough to make others complain.

It can also include people who have trouble understanding group conversations in noisy places.

OTC hearing aids are not intended for people with more profound hearing loss, which may include those who have difficulty hearing louder noises, such as power tools and cars. They’re also not intended for people who have lost their hearing suddenly or in one ear, according to Sterling Sheffield, an audiologist who teaches at the University of Florida. These people need to see a doctor.

Hearing test

Before over-the-counter products, you usually had to have your hearing tested and buy hearing aids from a specialist. This is no longer the case.

But it can be difficult for people to assess their own hearing. You can always choose to see a specialist just for this test, which is often covered by insurance, and then buy the aids yourself. Check your coverage before making an appointment.

There are also a number of apps and quizzes available to determine if you need help. Some over-the-counter vendors also offer a hearing assessment or test online.

Who sell

Several major retailers now offer OTC hearing aids online and on store shelves.

Walgreens pharmacies, for example, sell Lexie Lumen hearing aids nationwide for $799. Walmart offers OTC hearing aids ranging from around $200 to $1,000 per pair. Its health centers will provide hearing tests.

Consumer electronics chain Best Buy has OTC hearing aids available online and in nearly 300 stores. The company also offers an online hearing assessment, and store employees are trained in the stages of hearing loss and how to fit the devices.

Overall, there are over a dozen manufacturers making different models of OTC hearing aids.

The new devices will make up the bulk of the OTC market as it develops, Sheffield said. Some may be hearing aids that previously required a prescription, ones that are only suitable for people with mild to moderate hearing loss.

Buyers should expect many devices to enter and exit the market, said Catherine Palmer, a hearing expert at the University of Pittsburgh.

“It will take some time before this stabilizes,” she said.

To monitor

Look for an OTC label on the box. Hearing aids approved by the FDA for sale without a prescription must be labeled OTC.

This will help you distinguish OTC hearing aids from less expensive devices sometimes labeled sound or hearing amplifiers – called Personal Sound Amplification Products or PSAPs. Although they are often marketed to the elderly, they are designed to make sounds louder for people with normal hearing in certain environments, such as hunting. And amplifiers are not subject to FDA review.

“People really need to read descriptions,” said Barbara Kelley, executive director of the Hearing Loss Association of America.

And check the return policy. It’s important because people usually need a few weeks to get used to it and make sure they’re working in the situations where they need it most. This can include on the phone or in noisy offices or restaurants.

Does the company selling OTC devices offer instructions or an app to help with setup, adjustment, and sound adjustments? A specialist could also help you, but expect to pay for this office visit, which is rarely covered by insurance.

Sheffield said hearing aids aren’t complicated, but wearing them isn’t as simple as putting on a pair of reading glasses.

“If you’ve never tried or worn hearing aids, you might need a little help,” he said.

The cost

Most over-the-counter hearing aids will cost between $500 and $1,500 for a pair, Sheffield said. He noted that some can run as high as $3,000.

And it’s not a one-time expense. They may need to be replaced every five years or so.

According to hearing specialists, OTC prices could fall further as the market matures. But they’re already generally cheaper than their prescription counterparts, which can cost upwards of $5,000.

The bad news is that hearing aid insurance coverage is spotty. Some Medicare Advantage plans provide coverage for devices that require a prescription, but not regular Medicare. There are discounts, including some offered by Medicare Advantage insurer UnitedHealthcare in partnership with the nonprofit AARP.

Buyers can also pay for the devices with money set aside in health savings accounts or flexible spending accounts.

Don’t try to save money by buying just one hearing aid. According to the American Academy of Audiology, people must have the same level of hearing in both ears to be able to determine where a sound is coming from.

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