New Affordable Over-The-Counter Hearing Aids Are Now Available

New over-the-counter hearing aids are now available without a prescription or medical exam, following a final ruling from the U.S. Food and Drug Administration in August.

These devices will be available online, at pharmacies and in retail stores. Big names like Walgreens, Walmart and Best Buy have already announced plans to carry a selection of products this fall.

The new class of OTC devices — available for adults with perceived mild to moderate hearing loss — will be equipped with the same basic technology as traditional hearing aids but at a fraction of the cost.

Hearing aid devices can cost anywhere from $900 to $4,000 per ear. Many health insurance providers — including traditional Medicare — don’t cover the devices or hearing tests.

The new rule also cuts the red tape plaguing many consumers. Hearing aids are currently only available with a prescription from an audiologist or a hearing health specialist. Multiple appointments are usually required, from consultations to fitting adjustments.

So how are over-the-counter hearing aids different?

Here’s what you need to know.

How Much Will Over-the-Counter Hearing Aids Cost?

Over-the-counter hearing aids are just starting to hit store shelves, so it’s hard to say how much they’ll cost. The White House said it anticipates OTC devices will save Americans as much as $3,000 per pair.

Walgreens announced plans recently to start carrying Lexie Lumen hearing aids in stores nationwide after Oct. 17 for $799.

Consumers will also be able to purchase these hearing aids online through Walgreens Find Care for $39 per month for 24 months ($936 total).

Each pair of hearing aids at Walgreens will also include batteries and accessories as well as a 45-day money-back guarantee.

Walmart also told Reuters it will begin offering over-the-counter hearing aids to adults with mild to moderate hearing impairments without a medical exam after Oct. 17 — but the major retailer declined to say how much they will cost.

Competition from manufacturers is expected to drive prices down on OTC hearing aids. But by how much or how quickly is still anyone’s guess.

Will OTC Hearing Aids Be HSA and FSA Eligible?

You can use a health savings account (HSA) or a flexible spending account (FSA) to purchase OTC hearing aids.

The new category of over-the-counter hearing aids is also expected to qualify.

A health savings account is a tax-advantaged account you and your employer can contribute to that can pay for a long list of eligible medical expenses. An FSA offers similar tax-saving benefits but with different contribution limits and other rules.

Are Over-the-Counter Hearing Aids Right For You?

OTC hearing aids are intended for people 18 or older with mild to moderate hearing loss.

They’re not meant for everyone or every situation, kind of like drugstore reading glasses.

You might be a good candidate for an OTC hearing aid device if you experience the following symptoms, according to the National Institute on Deafness and Other Communication Disorders:

• Speech or other sounds regularly seem muffled.
• Having trouble hearing over background noise.
• Struggling to understand speech in a phone call, on the television, or when you can’t see who is talking.
• Difficulty hearing in noisy environments.
• Trouble hearing loud sounds.
• Regularly asking others to speak more slowly or clearly, to talk louder, or to repeat themselves.
• Getting regular complaints from family or friends that you’ve turned the sound up too loud or aren’t hearing them properly.

If you have severe hearing loss or a specific hearing issue — such as deafness in only one ear — you should consult an audiologist.

Likewise, you should see a doctor right away if you experience dizziness, sudden hearing loss, pain or discomfort in your ear canal as these can be signs of a more serious medical condition.

Visiting a hearing care professional can also be beneficial if you want advice on how to choose the right hearing aid or need help adjusting or repairing your OTC device.

The Hearing Loss Association of America offers this tip sheet to help you decide if OTC hearing aids are right for you. It also includes questions to ask yourself when shopping around for a new device.

How Do You Buy OTC Hearing Aids?

Over-the-counter hearing aids will be advertised and sold in pharmacies, big-box stores, online and through the mail. You won’t need a prescription from a hearing specialist to buy them.

You fit the devices yourself, and you might be able to control and adjust the settings in ways that people with prescription hearing aids cannot.

An automated hearing test may be offered through a smartphone app so you can test your hearing at home.

You’ll probably use a smartphone or computer to install and customize your hearing devices as well.

Companies like Audicus, Bose, Eargo, Jabra, Lexie and Lively are all expected to be big players in the OTC market. Additional manufacturers and devices will also emerge over the next few years.

More consumer guidance on how to buy and use OTC hearing aids is expected in the coming weeks.

The Fight For Affordable Hearing Aids

Lawmakers and advocacy groups like AARP have fought for years to lower the cost of hearing aids and make them more accessible.

Under the current system, audiologists usually buy hearing aids wholesale from manufacturers and then set their own prices.

Five manufacturers control about 90% of the hearing aid market, according to a Senate investigative report released in June. Many policy makers say this lack of competition among prescription devices contributes to higher retail prices.

The actual devices usually account for just a fraction of the total cost. Hearing aids are typically bundled with multiple services, including a hearing exam, fittings, programming and repairs.

The added expense of these professional audiology services is what really drives up the cost for many people, especially older Americans.

Medicare beneficiaries spent an average of $914 out of pocket on hearing services in 2018, according to a report from the nonprofit Kaiser Family Foundation.

Approval for OTC hearing aids has been years in the making.

In 2017, Congress ordered the FDA to craft regulations for over-the-counter devices and the proposal was signed by former president Donald Trump.

Little progress was made after that. In July 2021, President Joe Biden called on the FDA to take action “to promote the wide availability of low-cost hearing aids.”

The FDA reviewed more than 1,000 public comments and tweaked the proposal before approving its final rule Aug. 16, 2022.

Wait, Haven’t OTC Hearing Aids Been Around For a While?

Devices known as personal sound amplification products, or PSAPs, have been on the market for years. The same goes for TV amplifiers, hearing assistive devices and hearing protection devices.

These products help people with normal hearing amplify sounds in specific situations — but they’ve never been approved to help treat hearing loss.

The quality of these consumer electronics also varies widely. Attorneys general in New York, California and Texas have warned consumers about low-quality amplifiers falsely marketed as over-the-counter hearing aids in recent years.

The FDA said it is clamping down on this deceptive advertising.

OTC hearing aids will be regulated as medical devices by the FDA, and must adhere to strict specifications and labeling guidelines.

Rachel Christian is a Certified Educator in Personal Finance and a senior writer for The Penny Hoarder.