The U.S. Food and Drug Administration (FDA) approved certain hearing aids for over-the-counter (OTC) sale. The move marks a major shift in accessibility and affordability for people with hearing loss.
As of Monday, Oct. 17, OTC hearing aids are available, which will likely make the market more competitive and ultimately lower the costs for high-priced hearing aids that remain inaccessible to many Americans who need them. Some stores took a stand early and stated they will offer OTC hearing aids as soon as regulation officially allows.
Keep reading to learn how to get OTC hearing aids and how much they will cost.
Over-the-counter hearing aid are available — here's how to get them.
While a variety of stores will offer OTC hearing aids, not all of them will have the products available right when the FDA rule takes place. Some stores will be ready to sell OTC hearing aids immediately while others may need additional time to get products ready for retail.
According to Reuters, Walgreens and Walmart are selling OTC hearing aids as of Oct. 17. Walgreens will have the Lexie Lumen hearing aids available for $799.
Walmart will offer a variety of hearing aids for adults starting at $200. The products will be available on Walmart's website and at its vision centers.
Best Buy (BBY) announced that 300 of its 1,000 U.S. stores will sell 10 different OTC hearing aids. The company offers a variety of OTC products and prices in stores as well as online.
Best Buy category officer Frank Bedo said in a statement, “Our expansion of the hearing collection and new store experience will let customers easily find a hearing loss solution from brands they trust.”
Who will benefit from OTC hearing aids?
On Aug. 16, the FDA announced a historic ruling for hearing aid accessibility. In the ruling, the FDA said it has created a “new category of [OTC] hearing aids, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription, or a fitting adjustment by an audiologist.”
According to the National Institute on Deafness and Other Communication Disorders, 28.8 million U.S. adults could benefit from the use of hearing aids. Of U.S. adults ages 20–69 who could benefit from hearing aids, only 16 percent have ever used them.
On average, hearing aids in the U.S. cost about $3,000 (though many are even more expensive). Health insurance doesn’t cover hearing aids and the cost of the piece itself only becomes more expensive when considering associated medical costs.
By making hearing aids available OTC, the FDA is opening up the window for competition and reducing additional costs associated with getting a hearing aid.
Hearing aids vs. PSAPs: How the new classification changes things.
In addition to making hearing aids available for OTC sale, the FDA segmented hearing aids and Personal Sound Amplification Products (PSAPs) into new products.
People with hearing loss use hearing aids for medical purposes while people with normal hearing may use PSAPs due to personal preference.
Potential outcomes for hearing aids: The ruling is a step in the right direction.
OTC sales open up an industry, and increased competition in a sector can improve products while reducing costs for consumers.
Audiologist Nicholas Reed, of the Department of Epidemiology at Johns Hopkins Bloomberg School of Public Health, told reporters, “We don’t know what these companies might come up with. We may literally see new ways hearing aids work, how they look.”
Plus, people with hearing loss will be able to use tax-advantaged Health Savings Account (HSA) and Flexible Spending Account (FSA) funds to purchase hearing aids.
The move isn't a panacea and won’t help every hard-of-hearing person access the right aids (and it doesn't address care), but it’s a step forward.
Will more stores sell OTC hearing aids?
Other stores haven't announced the upcoming sale of hearing aids yet. The high price tag may keep it out of drug stores such as CVS and Walgreens, but other tech companies may take on the product.
Stores like Costco and Walmart already offered hearing aids by prescription, so they will likely transition to the new OTC model.