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Hearing aids available over-the-counter starting in October. Here’s what you should know.

About 37.5 million people in the U.S. struggle with hearing loss, yet only 16% use hearing aids. Left untreated, hearing loss can lead to isolation, and conditions like depression, anxiety, low self-esteem, dementia, reduced mobility and falls.

Starting in mid-October, Americans with hearing loss won’t need a prescription or exam to buy hearing aids — they’ll be able to get them over-the-counter at retail and drug stores as well as online.

“We’re hoping that these over-the-counter hearing aids will decrease the stigma of hearing loss,” says Leslie Kilton, deaf and hard of hearing technology specialist at the Deaf Action Center. “It tends to make them very isolated. They tend to stop going out and seeing friends because they just won’t hear, they won’t understand.”

Although hearing loss can impact daily life, people wait an average of 10 years before buying hearing aids, according to Johns Hopkins Medicine. This change will not only make the process of getting help for hearing loss easier, it could lower costs by as much as $3,000 per pair, per federal government estimates.

On Aug. 16, the U.S. Food and Drug Administration established a new category of over-the-counter hearing aids, enabling consumers 18 and older with mild to moderate hearing loss to purchase hearing aids directly from stores or online retailers without a medical exam, prescription or a fitting adjustment by an audiologist. That was after President Joe Biden issued an executive order calling for the FDA to take steps to allow hearing aids to be sold over-the-counter. In 2017, Congress passed bipartisan legislation requiring the FDA to create a category of OTC hearing aids, but it was not fully implemented until now.

“It is designed to assure the safety and effectiveness of OTC hearing aids, while fostering innovation and competition in the hearing aid technology marketplace,” the FDA said in the announcement.

How do I know if an OTC hearing aid will work for my hearing loss?

OTC hearing aids are an alternative to prescription hearing aids, which are only available through hearing health professionals such as audiologists, otolaryngologists and hearing aid specialists. Personal sound amplification products are another type of amplification device you can get without a prescription, though they are meant for hearing sounds in specific situations and are not used for hearing loss.

OTC hearing aids are “intended to help adults with perceived mild to moderate hearing loss,” according to the National Institutes of Health. You may have mild to moderate hearing loss if:

  • Speech or other sounds seem muffled.

  • You have trouble hearing when you’re in a group, in a noisy area, on the phone, or when you can’t see who is talking.

  • You have to ask others to speak more slowly or clearly, to talk louder, or to repeat what they said.

  • You turn up the volume higher than other people prefer when watching TV or listening to the radio or music.

The Dallas Ear Institute says the best way to determine if your hearing loss fits into the recommended range for OTC devices is to schedule a comprehensive hearing exam with an audiologist. They’ll tell you the type and degree of your hearing loss, and determine what kind of intervention is needed. If your audiologist determines that you fall into the mild to moderate range and don’t have an underlying medical condition, then OTC aids may be a good option.

“Some people have conductive hearing loss, some people have neurosensory hearing loss. So you don’t really understand your hearing loss,” Kilton says. “When you go to an audiologist, then you would understand fully.”

Also, stores like Costco and Sam’s Club provide free hearing tests that can help. Alternatively, there are hearing screening tools available online that can help you estimate the degree of your hearing loss, but those won’t determine the type of hearing loss or if other conditions are contributing.

OTC hearing aids are not meant for children, or for adults with severe hearing loss. That may be the case if you have trouble hearing conversations in quiet settings or have trouble hearing loud sounds. Consult a hearing health professional to determine if a prescription hearing aid will help you hear better.

Are OTC hearing aids cheaper?

The National Council on Aging’s survey of hearing aid users found cost was at the forefront of buying decisions. Price was the second-most important factor when customers were deciding which hearing aid to buy, directly behind ease of use.

On average, OTC hearing aids are cheaper than prescription hearing aids. OTC devices range from $600 to $1,600 per pair, while prescription hearing aids cost $2,000 to $7,000. Prices could decrease even further as more manufacturers enter the OTC market.

To use OTC hearing aids, you control the settings yourself. No health care professional must be involved. The American Academy of Audiology
To use OTC hearing aids, you control the settings yourself. No health care professional must be involved. The American Academy of Audiology

How do OTC hearing aids work?

To get prescription hearing aids, a professional fits you and makes adjustments. OTC devices, on the other hand, are designed to be self-fitted and adjusted through a smartphone app, according to the Dallas Ear Institute. They typically work through a Bluetooth connection to your smartphone, where you can fine-tune the volume, settings and pitch.

“Hearing aids in general just amplify sound, but now their technology is so amazing that they have different settings on them,” Kilton said. “On your app, you can block out the noise, you can direct the sound, you can do all kinds of things.”

It may be helpful for an audiologist to perform speech mapping, DEI experts say, since the size and shape of the ear canal can impact the delivery of sound. Those measurements allow the audiologist to find out if the OTC hearing aid is correctly amplifying sound and assist you with self-adjustments. Some brands, like Lively, offer remote evaluations and adjustments by an audiologist.

If you have a problem with the OTC hearing aid, you’ll likely need to work with the manufacturer of the device to get it fixed. If you’re getting feedback from the hearing aids, you’ll need to visit an audiologist to pinpoint whether it needs to be adjusted or there’s debris in the ear canal.

When should I consult with a doctor about my hearing?

Some ear problems require medical intervention. If you have any of the following, the NIH says, see a licensed physician promptly:

  • Fluid, pus, or blood coming out of your ear within the previous 6 months.

  • Pain or discomfort in your ear.

  • A history of excessive ear wax or suspicion that something is in your ear canal.

  • A full or plugged feeling in the ear.

  • Episodes of vertigo (severe dizziness) with hearing loss.

  • Sudden hearing loss, fluctuating hearing loss or quickly worsening hearing loss.

  • Hearing loss that has gotten more and then less severe within the last 6 months.

  • Hearing loss or tinnitus (ringing or buzzing) in one or both ears, or a noticeable difference in how well you can hear in each ear.

  • Better hearing in one ear than the other.

  • Injury to or deformity of the ear.

Should I get OTC or prescription hearing aids?

Both types are regulated as medical devices by the FDA (while PSAPs are not), but OTC hearing aids are less expensive and easier to buy than prescription hearing aids, according to the National Council on Aging.

OTC hearing aids cover only mild to moderate hearing loss, while prescription aids also cover severe and profound hearing loss. On average, OTC devices will cost $1,600 per pair, while prescription devices cost nearly triple, averaging $4,600 a pair.

A hearing exam, prescription and fitting appointment are required for a prescription hearing aid, but none of those steps need to be taken for OTC. And OTC hearing aids can be purchased in stores, online and in some hearing clinics, whereas prescription can only be purchased at hearing clinics.

While more accessible and affordable, you may be giving up a certain level of personalized hearing care by choosing OTC hearing aids, says the NCOA. You cannot get them custom fit for your ear, for one. That may lead to the hearing aids not helping as much as you need them to. Other disadvantages: they offer fewer features and have shorter warranties.

Where can I buy OTC hearing aids?

Direct-to-consumer hearing aids are currently available online from manufacturers like Eargo, Lively and Lexie. Starting Oct. 17, you’ll be able to buy OTC hearing aids both online and in big-box and drug stores where health care devices are sold, such as Best Buy, Walgreens and CVS, the NCOA says. They’ll also be sold at some audiology offices.

The NCOA recommends the Audien hearing aids, which start at $99. For a higher-end version with more features, they recommends brands like Audicus and Lively, costing around $3,398.

Tips for purchasing OTC hearing aids

When shopping for hearing aids, consider your budget, your degree of hearing loss, what you’re hoping hearing aids will help you with, and your lifestyle, the NCOA recommends.

Hearing aids can be the third-largest purchase a person makes in their lifetime, after a house and car, according to Johns Hopkins Medicine.

Here are some tips from the NCOA to help you save money on OTC hearing aids:

  • Look for sales: Most brands sell devices at reduced prices during holidays.

  • Search for discounts and financial assistance: You may be eligible for reduced-price or free hearing aids through organizations like the Hearing Aid Project, American Speech-Language Association and National Institute on Deafness and Communication Disorders. You may be eligible for free hearing aids if you’re a veteran. Some insurance companies give an allowance toward the purchase of hearing aids. If you’re a Medicaid recipient, your program may cover hearing exams and devices. Use NCOA’s Benefits CheckUp tool to see which benefits you’re eligible for.

  • Take advantage of payment plans: Most hearing aid companies offer financing plans. Audicus, for instance, offers a plan called Audicus Plus.

Look for hearing aids that can be returned, Kilton recommends, in case they don’t end up working for you. They may be uncomfortable or a bad fit for your ears. And do some research before going into the store and read online reviews as more people purchase OTC hearing aids. If they go for prices into the thousands, it might be worth sticking to prescription hearing aids, Kilton says.

What factors should I consider when looking for OTC hearing aids?

The Hearing Loss Association of America suggests asking the following questions when purchasing OTC hearing aids:

  • Is there a free trial period, or money back return policy?

  • Does it need a smartphone, app, or computer to install, operate, and customize to my needs?

  • Is it compatible with cellphones, or smartphones?

  • Does it have connectivity via Bluetooth, or telecoil to a smartphone, computer, or listening system?

  • Can the hearing aid’s amplification be adjusted? How do you control feedback?

  • Is it water/sweat resistant?

  • How does it control, reduce, or block out background, or wind noise?

  • How long is the battery life? Can it be recharged?

Using OTC hearing aids

Here’s what you should know when you start using OTC hearing aids:

  • Pay attention to package warnings. If you have pain, sudden hearing changes or dizziness, see a doctor.

  • It may take time to adjust to hearing devices.

  • If the first hearing aid doesn’t work, keep trying until you find the right product for you.

How to support a loved one with hearing loss

There are several ways to make life easier for your friend or family member with hearing loss, Kilton says:

  • Make sure background noise like the TV is off when you’re talking to them.

  • Look at them directly and speak at a moderate pace.

  • Watch out for sunlight or glare that may make it difficult for them to lip read.

  • If they can’t understand what you’re saying, make sure there’s nothing in your mouth and rephrase the sentence. You can also use gestures to help.