Posted by: Phil Halewitz,

Kaiser Health News

Starting Monday, consumers will be able to buy hearing aids directly over the counter and at significantly lower prices as the 2017 federal law finally takes effect.

For decades, it cost thousands of dollars to purchase a device that could only be purchased with a prescription from an audiologist or other hearing care professional. But now a new category of over-the-counter remedies is selling for hundreds of dollars. Walmart says it will sell the hearing aid for just $199.

The over-the-counter aids designed for adults with mild to moderate hearing loss is a market of tens of millions of people, many of whom have until now avoided help because the devices were so expensive.

“From a conceptual point of view, it’s huge that it’s finally happening,” he said Dr. Frank Lynndirector of the Cochlear Center for Hearing and Public Health at Johns Hopkins University in Baltimore.

Lin predicted it could take a few years for the new market to take off, as manufacturers and retailers get used to selling the aids and consumers become familiar with the options.

Hearing aid experts, however, say they are happy to see lower prices. Lin said he believes prices will continue to fall as more competitors enter the market over the next two years.

Prices and features of new OTC hearing aids will vary. A pair of prescription devices typically retails for between $2,000 and $8,000. Some technologies found in more expensive prescription products will be available in cheaper over-the-counter products.

Over-the-counter aids are less expensive in part because they do not include the services of an audiologist for hearing evaluation, fitting, and fine-tuning of the device. Instead, the new devices are designed to be set up by consumers themselves, although manufacturers offer technical support via apps and over the phone.

Some new companies have entered the market, including Sony. It will sell its least expensive prescription hearing aid for $999 at Best Buy and other retailers.

Walmart said it will offer a range of over-the-counter hearing aids, including some priced between $199 and $299 a pair from South African company hearX, which also makes the Lexie devices. The devices will initially be available at Walmart stores in Colorado, Michigan, Missouri, Ohio, Pennsylvania, Tennessee and Texas. But the company expects to make them available across the country soon.

Walgreens offers Lexie Lumen Over-the-counter hearing aids at $799 per pair. Walgreens, CVS, Best Buy and Walmart offerings will also include the Lexie hearing aid, designed in partnership with Bose.

Costco, one of the largest sellers of hearing aids sold through deaf professionals, has not disclosed whether it will sell them over the counter.

De Wet Swanepoel, co-founder of hearX, said his over-the-counter Lexie Lumen hearing aid would allow consumers to program it to suit their needs. Other over-the-counter devices offer pre-programmed settings.

“There are a lot of products on the market,” he said, “and consumers will need to be educated a lot about the differences between the devices.”

Some consumers may want to see an audiologist in person or online to have their hearing tested before buying an over-the-counter aid, Lin said. An audiologist can also recommend which hearing aid is best for their type of hearing loss. Traditional fee-for-service Medicare and most health insurance companies cover routine hearing screenings.

But Medicare and most private insurers do not cover the cost of hearing aids, although many private Medicare Advantage plans do.

Consumers can also have their hearing tested online or through an app on their phone or computer, Lin said.

Another factor that could drive the demand for the new devices is that the stigma of using a hearing aid is decreasing because people usually use headphones to listen to music.

More than 37 million American adults have hearing problems, that’s all 1 in 4 adults Federal health officials estimate that those who could benefit from hearing aids have used them.

The hearing aid industry remains largely insulated from price competition due to consolidation among manufacturers, widespread state licensing laws that require sales through audiologists or other hearing care professionals, and acquisitions of hearing care professionals’ practices by device manufacturers.

Spurred by decades of complaints about the high cost of hearing aids, Congress in 2017 ordered the Food and Drug Administration to establish rules that would allow over-the-counter sales, hoping it would increase competition and lower prices. But the coronavirus pandemic has slowed the FDA’s efforts, and last year President Joe Biden ordered the FDA to develop these regulations.

Final regulation were announced two months ago. Under federal regulations, the new category of hearing aids bypass state issuance laws.

Audiologists, who could lose business, warn that the new category will not help people with severe hearing loss. And excessive sound amplification can damage hearing Sarah Sydlovskypast president of the American Academy of Audiology.

But Nicholas Reed, an audiologist and associate professor at the Johns Hopkins Bloomberg School of Public Health, said the devices are likely less dangerous than listening to music with headphones turned up too high. Regulations require new aids to have a safe maximum sound level to protect consumers’ hearing.

Tom Powers, a hearing aid industry consultant in New Jersey, said the new devices will be clearly labeled as FDA-approved, and consumers should be on the lookout. These differ from inexpensive personal devices that amplify sound but do not address other components of hearing loss, such as distortion.

Reed recommends looking for over-the-counter hearing aids with generous return policies that exceed a month. Consumers can try the device for a few weeks to see how it works. If one brand doesn’t work, they should try another.

The switch may be necessary because it’s unclear whether consumers will receive in-store help choosing an aid without an audiologist, although some stores plan to provide assistance.

Walmart, for example, said it will post information on its website to help people find devices that are right for them.

Reed also said that consumers should look for devices labeled “self-assemble” because that indicates the companies have proven to the FDA that people can set up the devices themselves about as well as if they had professional help.

“If you’re tech-savvy, I say right away,” Reid said, though he added that “there’s nothing wrong with talking to a trained audiologist.”

Nancy M. Williams, president of Auditory Insight, a hearing aid management consulting firm, said she analyzed eight major over-the-counter hearing aid products ranging in price from $499 to $1,299. Some look like in-ear headphones or are almost invisible, and some look like traditional hearing aids that wrap around the ear.

The over-the-counter devices she reviewed mostly have limited or no Bluetooth connectivity, a feature that allows users to configure the devices, and only about half have rechargeable batteries. But all eight allow the user to personalize the devices based on the results of the hearing test.