Hearing aids: what you need to know before buying them over the counter

CNN
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The high cost of hearing aids has long been a barrier for many people with hearing problems. Traditional prescription hearing aids cost an average of $2,000 per ear, and many people need two.

But the US Food and Drug Administration’s rule change in August means people with mild to moderate hearing loss will be able to buy these devices online or in stores without a prescription – and at a lower price – starting Monday. .

This means people won’t have to visit a hearing health professional and have a custom fitting, a process that can also be prohibitively expensive.

Tens of millions of people suffer from hearing loss, but only 16% of them use a hearing aid, according to the National Institute on Deafness and Other Communication Disorders.

As FDA Commissioner Dr. Robert Califf said in the agency’s Aug. 16 announcement, « Today’s action will not only help adults who have perceived mild hearing loss to moderate to access more affordable innovative production options, but we expect it will unleash the power of American industry to improve technology in ways that impact the enormous burden of l disability due to hearing loss affecting the world.

Here, Dr. Frank Lin, director of the Cochlear Center for Hearing and Public Health at the Johns Hopkins Bloomberg School of Public Health, and Dr. Lindsay Creed of the American Speech Hearing Association, offer their advice on what to keep in mind. mind when buying over-the-counter hearing aids.

Lin and Creed strongly recommend taking a hearing test before heading to the store. Hearing tests measure a person’s level of sensitivity to sound. Creed said a hearing test could also determine if your hearing loss is caused by a condition that may not require a hearing aid, such as earwax buildup.

“It would be helpful to know exactly what your hearing levels are, because the research really suggests that individuals are not good at accurately determining their levels of hearing loss. Younger people tend to overestimate their degree of hearing loss, while older people tend to underestimate their hearing loss,” Creed said. The test will give you the most accurate results when shopping.

Knowing your hearing number is as important as any other health data, Lin said, such as blood pressure, blood sugar or cholesterol.

There are several options for free or low-cost hearing tests, including hearing centers at stores like Costco or Sam’s Club, and even online tests recommended by audiologists. Stores like Best Buy will offer online hearing screenings.

Many hearing aid manufacturers offer their own tests to help customers with ease of use and accuracy.

Creed recommends looking for tests backed by research and data.

« I always feel like knowledge is power. If you want to start with the most information and then make the most informed decision about which technology is best for you, starting with these professionals is a good idea,” she said.

The test will help you choose the product that best suits your needs.

You’ll be able to find hearing aids on the shelves of drugstores and big box stores, online, and even at tech stores. Walgreens, CVS, Walmart, Best Buy, and Hy-Vee are some of the places customers can expect to find these devices.

But there are a few things to keep in mind when buying.

Creed says a return policy is crucial and advises customers to make sure the product they buy has one. New FDA regulations state that the return policy for over-the-counter hearing aids must be clearly marked on the packaging, but extended return policies vary by store.

Best Buy plans to offer an extended 60-day return policy, for example, while Walgreens gives people 45 days to try products.

Additionally, the FDA recommends checking a product’s warranty and whether it covers maintenance and repairs, as well as whether you can get a ready-to-use pair during repairs.

When shopping for hearing aids, Creed recommends looking for the words « OTC Hearing Aid » on the packaging. This is part of FDA regulations to ensure that people receive an actual hearing aid, rather than another type of device such as a hearing amplifier, designed for recreational use. Hearing amplifiers amplify all sound, but hearing aids are customized to meet a person’s hearing needs.

Hearing aids sold without a prescription will be regulated on October 17, but hearing amplifiers are not regulated. The FDA considers hearing aids to be medical devices, but hearing amplifiers to be consumer electronics. If the product does not say « OTC or Over-the-Counter Hearing Aid » on the main screen, it is not an FDA regulated hearing aid.

« I think fortunately the way the FDA has come up with the language, the regulations are really well thought out, » Lin said. « To provide consumers with the information they will need to make an informed decision while creating the performance characteristics to ensure that a device on the market will actually be reasonably safe and effective. »

Creed urges anyone with questions to contact an audiologist for advice.

Over-the-counter hearing aids will be a great option for thousands of people in the mild to moderate stage of their hearing journey, but for some people with more severe hearing loss, prescription hearing aids are still the ideal solution. only possibility. People under 18 will also need a prescription.

« We anticipate there will be differences in the devices because it would not be profitable for manufacturers to sell their top-tier technology at these prices, » Creed said. « So they’ll likely be comparable to entry-level hearing aids in the prescription market. »

Over-the-counter hearing aids may not have the same maximum volume as a prescription model and may not have the same degrees of customization or customization. OTC devices will also likely be softer in volume and have output levels established by the FDA.

“Because of the way the FDA has put out very well thought out regulations, they’re really the range where it benefits…over 90% of people with hearing loss,” Lin said.

For those with severe hearing loss, Lin and Creed recommend seeing an audiologist, even if just to get a personalized recommendation on which over-the-counter hearing aid to choose. But some will require a more customizable prescription option.

« It’s going to be the wild, wild west for another year or two, and that’s a good thing because I think a lot of people are going to try different kinds of technologies and for malls to see what sticks, what meets the consumers where they are, which has never happened before,” Lin said.

He believes the FDA’s decision to approve hearing aids will lead to increased innovation as big tech companies enter the market.

Lin says audiologists will also begin to change their models, perhaps taking a more hands-on route to guiding patients to the right over-the-counter hearing aids and helping them customize them.

Creed notes that while over-the-counter hearing aids are much cheaper and more accessible than prescription versions, they still aren’t cheap.

« There’s a lot of research going on about using community health workers and to see if they can install more booster-type devices using community health workers, » Creed said, « And so I think there’s still a lot of work to be done in that space.”