People with mild to moderate hearing loss will soon have access to over-the-counter hearing aids without a prescription or medical exam following an August 16 final ruling from the U.S. Food and Drug Administration.
These devices will be available online, in pharmacies and in retail stores. Big names like Best Buy have already announced plans to offer a selection of products this fall.
The new class of OTC devices – available from mid-October – will feature the same core technology as traditional hearing aids, but at a fraction of the cost, government officials say.
Hearing aids can cost between $900 and $4,000 per ear. Many health insurance providers — including traditional health insurance — don’t cover hearing aids or tests.
The new rule also reduces red tape that plagues many consumers. Hearing aids are currently only available with a prescription from an audiologist or hearing health specialist. Several appointments are generally necessary, 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, director of the National Economic Council, said over-the-counter devices could save consumers about $2,876 on average for a pair of hearing aids.
A January 2022 Harvard Medical School newsletter noted that if the FDA’s long-awaited final ruling takes effect, over-the-counter 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 should drive prices down. But by how much or how fast is still an enigma.
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 typically purchase hearing aids in bulk from manufacturers and then set their own prices.
Five manufacturers control about 90% of the hearing aid market, according to a Senate inquiry report released in June. Many policymakers say this lack of competition is contributing to higher retail prices.
The actual devices are usually only a fraction of the total cost. Hearing aids are usually “bundled” with several services, including fittings, programming and repairs.
The added cost 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 by the nonprofit Kaiser Family Foundation.
Will over-the-counter hearing aids be eligible for HSA and FSA?
You can use a Health Savings Account (HSA) or a Flexible Spending Account (FSA) to buy hearing aids.
The new category of over-the-counter hearing aids should also be eligible.
A health savings account is a tax-advantaged account that you and your employer can contribute to and that can pay for a long list of eligible medical expenses. An FSA offers similar tax benefits, but with different contribution limits and other rules.
What is the difference between an HSA and an FSA? Learn the pros and cons of both.
Who can get over-the-counter hearing aids?
OTC hearing aids are intended for people 18 years of age or older with mild to moderate hearing loss. They are not for everyone or for all situations, much like drugstore reading glasses.
If you have severe hearing loss or a specific hearing problem, such as deafness in one ear, you should see an audiologist.
Likewise, you should seek medical attention immediately if you experience dizziness, sudden hearing loss, or pain or discomfort in your ears, as this may be a sign 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 if you need help adjusting or repairing your OTC device.
The Hearing Loss Association of America offers this tip sheet to help you decide if over-the-counter hearing aids are right for you. It also includes questions to ask yourself when shopping for a new device.
Wait, OTC hearing aids haven’t 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 television amplifiers, hearing aids and hearing protectors.
Although these direct-to-consumer products improve your ability to hear certain sounds in specific situations, they have 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 shoddy amplifiers mistakenly marketed as over-the-counter hearing aids in recent years.
The FDA said it is cracking down on this misleading advertising.
Over-the-counter hearing aids will be regulated as medical devices by the FDA and must meet strict specifications and labeling guidelines.
Approval of over-the-counter hearing aids took years to prepare.
In 2017, Congress directed the FDA to develop regulations for over-the-counter devices, and the proposal was signed by former President Donald Trump.
Little progress was made thereafter. 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 refined the proposal before approving the final decision on August 16, 2022.
How to buy OTC hearing aids?
Over-the-counter hearing aids will be advertised and sold in pharmacies, big box stores, online and by mail. You won’t need a prescription from a hearing specialist to buy these devices.
You adjust them yourself, and you may be able to control and adjust the settings in ways that people with prescription hearing aids cannot.
An automated hearing test can be offered through a smartphone app so you can test your hearing at home.
You’ll likely also use a smartphone or computer to set up and customize your devices.
Companies like Audicus, Bose, Eargo, Jabra, Lexie, and Lively are all expected to be big players in the OTC market. Other manufacturers and devices will also appear over the next few years.
More consumer guidance on how to buy and use over-the-counter hearing aids is expected in the coming weeks.
Rachel Christian is a Certified Personal Finance Educator and Senior Writer for The Penny Hoarder.
This was originally published on The Penny Hoarder, a personal finance website that empowers millions of readers across the country to make smart decisions with their money with practical, inspirational advice, and resources on how to to earn, save and manage money.