As of this week, consumers will be able to buy hearing aids directly off store shelves and at dramatically lower prices as a 2017 federal law finally takes effect. Where for decades it cost thousands of dollars to get a device that could be purchased only with a prescription from an audiologist or other hearing professional, now a new category of over-the-counter aids are selling for hundreds of dollars.
The hearing aid industry has remained largely insulated from price competition because of consolidation among manufacturers, widespread state licensing laws that mandate sales through audiologists or other hearing professionals, and the acquisition of hearing professionals’ practices by device-makers.
Spurred by decades of complaints about the high cost of hearing aids, Congress in 2017 ordered the Food and Drug Administration to set rules that would enable over-the-counter sales, with hopes it would boost competition and lower prices. But the Covid-19 pandemic slowed the FDA effort.
Then last year, in order to lower the price and expand access for all Americans, President Biden issued an Executive Order on Promoting Competition in the American Economy, calling on the Food and Drug Administration (FDA) to make hearing aids available over the counter, without a prescription. The final regulations were announced two months ago. Under the federal rules, the new category of hearing aids bypasses state dispensing laws.
The over-the-counter aids are intended for adults with mild to moderate hearing loss — a market of tens of millions of people, many of whom have until now avoided getting help because devices were so expensive. “From a conceptual point of view, this is huge that this is finally happening,” said Dr. Frank Lin, director of the Cochlear Center for Hearing and Public Health at Johns Hopkins University in Baltimore. He predicts it could take a couple of years for the new market to shake out as manufacturers and retailers get accustomed to selling aids and consumers become familiar with the options.
Hearing care experts say they are pleased to see the lower prices. Lin said he believes prices will fall further as more competitors enter the market in the next two years. Prices and features will vary for the new OTC hearing aids — much as they do for prescription aids. A pair of prescription devices typically sells for $2,000 to $8,000. Some of the technology found in the pricier prescription aids will be available in the cheaper OTC aids.
The OTC aids cost less partly because they do not bundle the services of an audiologist for a hearing evaluation, fitting, and fine-tuning the device. Instead, the new devices are intended to be set up by the consumers themselves, although manufacturers will offer technical assistance through apps and by phone.
Some new companies have entered the market, including Sony. It will sell its lowest-cost, self-fitting OTC hearing aid for $999 at Best Buy and other retailers.
Walmart said it will offer an assortment of OTC hearing aids, including some at $199 to $299 per pair from the South Africa-based company hearX, which also makes Lexie devices. Initially, the devices will be available at Walmart stores in Colorado, Michigan, Missouri, Ohio, Pennsylvania, Tennessee, and Texas. But the company expects to make them available nationwide soon.
Walgreens will offer the Lexie Lumen OTC hearing aid for $799 a pair. CVS will start selling over-the-counter hearing aids on CVS.com, with varying options on model and price point. CVS will also offer hearing aids in select CVS Pharmacy locations beginning in November. The offerings at Walgreens, CVS, Best Buy, and Walmart will also include a Lexie hearing aid developed in partnership with Bose.
Costco, one of the largest sellers of hearing aids dispensed through a hearing professional, would not reveal whether it will offer any over the counter. “There are a lot of products out on the market and there is going to be a need for a lot of education for consumers about what is the difference between devices,” says De Wet Swanepoel, co-founder of hearX.
Some consumers may want to see an audiologist either in person or online to get their hearing tested before buying an OTC aid, Lin said. An audiologist could also recommend which hearing aid is best for their kind of hearing loss. Traditional fee-for-service Medicare and most health insurers cover routine hearing tests. But Medicare and most private insurers don’t cover the cost of hearing aids, although many private Medicare Advantage plans do. Consumers can also take hearing tests online or through an app on their phone or computer, Lin said.
Another factor that could fuel demand for the new devices is that the stigma of wearing a hearing aid is diminishing because people commonly use ear devices to listen to music. More than 37 million American adults have trouble hearing, and only 1 in 4 adults who could benefit from a hearing aid have used one, federal health officials estimate.
Experts recommend looking for OTC hearing aids with generous return policies, exceeding a month. Consumers may want to try a device for a few weeks to see how it works. If one brand doesn’t work, they should try another.
Switching may be necessary, since it’s unclear whether consumers will get in-store help in selecting an aid without an audiologist. Some stores plan to provide assistance. Walmart said it would include information on its website to help people find devices that are right for them.
Consumers should look for devices labeled as “self-fitting” because it shows the companies have proved to the FDA that people can set up these devices themselves about as well as if they had professional help.
The American Academy of Audiology, a professional organization for audiologists, posted information online for consumers about OTC hearing aids, and the Hearing Loss Association of America, a consumer advocacy group, also has online advice.
Barbara Kelley, executive director of the Hearing Loss Association of America, said consumers should take their time looking at new options. “This is all going to be a little confusing,” she said. But the new options, she added, will lead to more people getting help with their hearing. “The benefits outweigh the risks,” she said.
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