The FDA change makes hearing aids cheaper, more readily available

For many hard-of-hearing Americans, getting help is now easier – and cheaper.

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 less than prescription hearing aids.

According to the Food and Drug Administration, approximately 30 million people in the United States are dealing with hearing loss. However, only 20% of those who can use a hearing aid seek help.

Let’s take a closer look:


FDA approved OTC hearing aids for adults with mild to moderate hearing loss. This may include people who have trouble hearing phone calls or who turn up the TV volume so much that others complain.

This may include people who have difficulty 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 sounds such as power tools and cars. They also aren’t for people who have lost hearing suddenly or in one ear, according to Sterling Sheffield, an audiologist who teaches at the University of Florida. Those people should consult a doctor.


Before over-the-counter prescriptions, you should usually have your hearing tested and get hearing aids from a professional. Not so anymore.

But it can be difficult for people to measure their own hearing. You can still choose to see a specialist for that test, which is often covered by insurance, and then get the help yourself. Check your coverage before making an appointment.

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


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

For example, Walgreens drugstores nationwide sell Lexie Lumen hearing aids for $799. Walmart offers OTC hearing aids from about $200 to $1,000 a 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 online hearing evaluations, and store employees receive training on the stages of hearing loss and how to fit the devices.

In total, there are more than ten manufacturers producing different models of OTC hearing aids.

According to Sheffield, new devices will make up the majority of the OTC market as they develop. Some may be prescription hearing aids that are only suitable for people with mild to moderate hearing loss.

Catherine Palmer, a hearing specialist at the University of Pittsburgh, says buyers should expect more devices to come and go.

“It will be a long time before this is resolved,” he said.


Look for the OTC label on the box. Hearing aids approved by the FDA for over-the-counter sale require OTC labeling.

This will help distinguish OTC hearing aids from cheaper devices that are sometimes labeled as sound or hearing amplifiers. — called a personal sound amplification product, or PSAP. Although they are often marketed to the elderly, they are designed to produce sounds louder for people with normal hearing in certain environments, such as hunting. Boosters are not FDA reviewed.

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

And check the return policy. This is important because people generally need a few weeks to get used to them and make sure they work in situations where they are needed most. This can be on the phone or in noisy offices or restaurants.

Does the company that sells the OTC devices offer a manual or software to help with installation, compatibility, and sound adjustments? A specialist can also help, but expect to pay for an office visit that is rarely covered by insurance.

Hearing aids aren’t complicated, Sheffield says, but putting them on isn’t as simple as wearing reading glasses.

“If you’ve never tried or worn hearing aids, then you might need some help,” she said.


Most OTC hearing aids will cost between $500 and $1,500 a pair, Sheffield said. He noted that some can earn up to 3000 dollars.

And this is not a one-time cost. They may need to be replaced every five years.

Over-the-counter prices could drop further as the market matures, hearing experts say. But they’re cheaper than their prescription counterparts, which can already sell for more than $5,000.

The bad news is that hearing aid insurance is spotty. Some Medicare Advantage plans cover devices that require a prescription, but regular Medicare does not. There are discounts out there, including those offered by Medicare Advantage insurer UnitedHealthcare in partnership with 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 need to have the same level of hearing in both ears to be able to tell where a sound is coming from.


Follow Tom Murphy on Twitter: @thpmurphy


The Associated Press Department of Health and Science receives support from the Science and Education Media Group of the Howard Hughes Medical Institute. AP is solely responsible for all content.

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