People with mild to moderate hearing impairments will soon have access to over-the-counter hearing aids without a prescription or medical exam following an Aug. 16 final ruling from the U.S. Food and Drug Administration.
These devices will be available online, at pharmacies and in retail stores. Big names like Best Buy have already announced plans to carry a selection of products this fall.
The new class of OTC devices — available as soon as mid-October — will be equipped with the same basic technology as traditional hearing aids but at a fraction of the cost, according to government officials.
Hearing aids 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 haven’t hit store shelves yet, so it’s hard to say how much they’ll cost.
Brian Deese, the director of the National Economic Council, said OTC devices could save consumers about $2,876 on average for a pair of hearing aids.
A Harvard Medical School news brief from January 2022 noted that if the long-awaited FDA final ruling took effect, OTC hearing aids could cost “about $600 per pair instead of the average $5,000.”
But realistically, it’s hard to predict the cost right now.
Competition from manufacturers is expected to drive prices down. But by how much or how quickly is still anyone’s guess.
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 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 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.
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 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.
What’s the difference between an HSA and FSA? Learn the pros and cons of both.
Who Can Get Over-the-Counter Hearing Aids?
OTC hearing aids are intended for people 18 or older with a mild to moderate hearing impairment. They’re not meant for everyone or every situation, kind of like drugstore reading glasses.
If you have severe hearing loss or a specific hearing issue — such as deafness in just 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 ears as these can be signs of a more serious medical condition.
Visiting the audiologist can also be beneficial if you want professional advice on how to choose the right hearing aids 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.
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.
While these direct-to-consumer products boost your ability to hear certain sounds in specific situations, they’ve never been approved to help treat hearing loss.
The quality of these products 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.
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 the final ruling Aug. 16, 2022.
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 these devices.
You fit them 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 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.
Rachel Christian is a Certified Educator in Personal Finance and a senior writer for The Penny Hoarder.