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Starting Monday, 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 only be purchased 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. Walmart says it will sell a hearing aid for $199.

Over-the-counter aids are intended for adults with mild to moderate hearing loss — a market of millions of people, many of whom have avoided getting help until now because the devices are so expensive.

“From a conceptual standpoint, it’s 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 predicted the new market could take years to shake out as manufacturers and retailers become accustomed to selling the aid and consumers become familiar with alternatives.

Hearing care experts say they’re happy to see lower prices. Lin said he believes prices will drop further over the next two years as more competitors enter the market.

Prices and features will vary for new OTC hearing aids — just as they do for prescription aids. A pair of prescription devices typically sells for between $2,000 and $8,000. Some of the technology found in expensive prescription aids can be found in cheaper OTC aids.

OTC aids cost less in part because they do not bundle the services of an audiologist for hearing evaluation, fitting, and fine-tuning the device. Instead, the new devices are intended to be set up by customers, although manufacturers will provide technical support via apps and phones.

Some other new companies have entered the market including Sony. It will sell its lowest-priced, 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 $199 to $299 per pair from the South Africa-based company HairX, which also makes Lexi devices. Initially, the devices will be available at Walmart stores in Colorado, Michigan, Missouri, Ohio, Pennsylvania, Tennessee and Texas. But the company hopes to make them available nationwide soon.

Walgreens will offer Lexie Lumen OTC hearing aids for $799 per pair. Offerings at Walgreens, CVS, Best Buy and Walmart will include a Lexi hearing aid developed in partnership with Bose.

Costco, one of the largest sellers of hearing aids that are distributed through a hearing professional, would not disclose whether it would offer any over the counter.

De Wet Swanepoel, co-founder of HearX, said its Lexi Lumen OTC hearing aid will allow consumers to program it according to their needs. Other OTC devices will offer pre-programmed settings.

“There are a lot of products on the market and there’s going to be a lot of education for consumers about what the differences are between the devices,” he said.

Some consumers may want to see an audiologist in person or online to have their hearing tested before purchasing an OTC aid, Lynn said. An audiologist can recommend which hearing aids are best for their 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 a hearing test online or through an app on their phone or computer, Lin said.

Another factor that could increase the demand for new devices is that the stigma of wearing hearing aids is decreasing as people usually use ear devices to listen to music.

More than 37 million American adults have hearing loss, and federal health officials estimate that only 1 in 4 people who could benefit from a hearing aid use one.

Consolidation among manufacturers, extensive state licensing laws that mandate sales through audiologists or other hearing professionals, and acquisitions of hearing professionals’ practices by device-makers have left the hearing aid industry largely free of price competition.

Spurred by decades of complaints about the high cost of hearing aids, Congress in 2017 directed the Food and Drug Administration to set rules that would enable over-the-counter sales, hoping it would boost competition and lower prices. But the Covid pandemic slowed FDA efforts, and last year President Joe Biden ordered the FDA to develop those rules. The final regulations were announced two months ago. Under federal rules, the new category of hearing aids bypasses state distribution laws.

Audiologists, who could lose business, warn that the new category will not help people with severe hearing loss. And over-amplified noise can damage hearing, says Sarah Siedlowski, former president of the American Academy of Audiology.

However, Nicholas Reed, an audiologist and assistant professor at the Bloomberg School of Public Health at Johns Hopkins, says the devices are less dangerous than listening to music with earbuds at high volume. Regulations require new aids to have safe maximum audio levels to help 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 look out for that. These differ from affordable personal devices that amplify sound but do not address other components of hearing loss such as distortion.

Reid recommends looking for OTC hearing aids with generous return policies, more than one month. Customers 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 is unclear whether consumers will receive in-store assistance in selecting an aid other than an audiologist. Some stores plan to provide assistance. Walmart said it will include information on its website to help people find the right devices for them.

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

“If you’re tech savvy, I’d say jump right in,” Reid says, though notes “there’s nothing wrong with talking to a trained audiologist.”

Nancy M. Williams, president of Auditory Insight, a hearing health care management consulting firm, said he reviewed eight major OTC hearing aid products, ranging from $499 to $1,299. Some look like earbuds or are almost invisible, while others look like traditional hearing aids that wrap around the ear. Most of the OTC aids he reviewed had limited or no Bluetooth connectivity, a feature that allows users to customize devices, and had only half a rechargeable battery. But all eight allow users to personalize the devices based on their hearing test results.

He recommends that people try at least three OTC aids to see which one works best for them.

The American Academy of Audiology, a professional organization for audiologists, has posted online information for consumers about OTC hearing aids, and the Hearing Loss Association of America, a consumer advocacy group, also has online advice.

Barbara Kelly, executive director of the Hearing Loss Association of America, says consumers should take their time to explore new options. “This is all going to be a little confusing,” he said. But new options, he added, will help more people with their hearing. “The benefits outweigh the risks,” he said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Along with policy analysis and polling, KHN is one of the three main operating programs of the KFF (Kaiser Family Foundation). KFF is a non-profit organization that provides health information to the nation.

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