What to know about buying hearing aids over the counter as FDA's rule change takes effect

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

But the US Food and Drug Administration's rule change in August means that people with mild to moderate hearing loss will be able to buy these devices online or in stores without a prescription -- and for a lower price -- starting October 17.

That means people won't have to visit a hearing health professional and have a custom fitting, a process that can also be cost-prohibitive.

Tens of millions of people have hearing loss, but only about 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 announcement August 16, "Today's action will not only help adults who have perceived mild to moderate hearing loss gain access to more affordable an innovative production options, but we expect that it will unleash the power of American industry to improve the technology in a way that it will impact the enormous burden of disability from 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 when buying hearing aids over the counter.

Tip 1: Get tested

Both Lin and Creed strongly recommend getting a hearing test before heading to the store. Hearing tests measure a person's level of sensitivity to sound. Creed said that a hearing test might also determine whether your hearing loss is caused by a condition that may not require a hearing aid, such as wax buildup.

"It would be helpful to know exactly what your hearing levels are, because the research really suggests that individuals aren't great at accurately determining their hearing loss levels. Younger individuals tend to overestimate their degree of hearing loss, while older individuals tend to underestimate their hearing loss," Creed said. Getting tested will give you the most accurate results when you shop.

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

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

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

Creed recommends looking for tests that are backed by research and data.

"I always feel like knowledge is power. If you want to start out with the most information and then make the best-informed decision as far as the technology that's most appropriate for you, still starting with those professionals is a good idea," she said.

Getting tested will help you choose the product that best fits your needs.

Tip 2: Know what you're buying

You'll be able to find hearing aids on the shelves of pharmacies and big box stores, online and even in tech stores. Walgreens, Walmart and Best Buy are some of the places where customers can expect to find these devices.

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

Creed says a return policy is crucial and advises customers to make sure whatever product they purchase has one. The new FDA regulation says the return policy on over-the-counter hearing aids must be plainly stated on the packaging, but extended return policies are up to the stores.

Best Buy plans to offer an extended return policy of 60 days, for example, while Walgreens gives people 45 days to try out the 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 loaner pair to use during repairs.

When shopping for hearing aids, Creed recommends looking for the words "OTC Hearing Aid" on the package. This is part of the FDA regulation to make sure people are getting an actual hearing aid, rather than another type of device such as a hearing amplifier, made for recreational use. Hearing amplifiers magnify all sound, but hearing aids are customized to suit a person's hearing needs.

Hearing aids sold over the counter will be regulated on October 17, but hearing amplifiers are unregulated. The FDA considers hearing aids to be medical devices but hearing amplifiers to be consumer electronics. If the product doesn't say "OTC or over-the-counter hearing aid" on the primary display, it is not an FDA-regulated hearing aid.

"I think, fortunately, the way the FDA crafted the language, the regulation is really well thought-out," Lin said. "To basically give consumers information they'll need to make an informed decision while at the same time creating the performance characteristics to guarantee that a device on the market will actually be reasonably safe and effective."

Creed urges anyone with questions contact an audiologist for guidance.

Tip 3: Know the difference between over-the-counter and prescription

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 with more severe hearing loss, prescription hearing aids are still the only option. People under the age of 18 will also need a prescription.

"We do anticipate for there to be some differences in the devices because it would not be cost-effective for manufacturers to sell their high-level technology at these prices," Creed said. "So they're probably going to be comparable to entry-level hearing aids in the prescription market."

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

"Because of how the FDA came out with very well thought-out regulations, they are really the range where it benefits ... 90-plus percent of people out there with hearing loss," Lin said.

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

The future of OTC hearing aids

"It's going to be the wild, wild West for another one or two years, and that's a good thing because I think a lot will be trying different types of technologies and for retail malls to see what sticks, what meets consumers where they are, which has never happened before," Lin said.

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

Lin says audiologists will also start to shift their models, perhaps taking a more hands-on route in guiding patients toward the right over-the-counter hearing aids and aiding them in customization.

Creed notes that although over-the-counter hearing aids are much less expensive and more accessible than prescription versions, they're still not cheap.

"There's a lot of research going on using community health workers and seeing if they can fit more amplifier-type devices using community health workers," Creed said, "And so I think that there's still a lot of work to be done in this space."

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