Hearing aids available over the counter for just $199, without a prescription, as 2017 law goes into effect

From Monday, consumers will be able to shop hearing aids directly from store shelves and at dramatically lower prices as the 2017 federal law finally takes effect.

Whereas 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 sells for hundreds of dollars. Walmart says it will sell the hearing aid for just $199.

The over-the-counter aids they are aimed at adults with mild to moderate hearing loss – 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, this is huge that this is finally happening,” he said dr. Frank Lynn, director of the Cochlear Center for Hearing and Public Health at Johns Hopkins University in Baltimore. He predicts it could take a few years for the new market to shake out as manufacturers and retailers get used to selling the devices and consumers become familiar with the options.

Hearing care professionals say they are pleased to see lower prices. Lin said he believes prices will drop further as more competitors enter the market over the next two years.

Prices and features will vary for new OTC hearing aids — just like prescription aids. A pair of prescription devices typically sells for $2,000 to $8,000. Some of the technologies found in more expensive prescription aids will be available in less expensive OTC aids.

OTC aids cost less 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 intended to be set up by consumers themselves, although manufacturers will offer technical assistance via apps and over the phone.

Some new companies entered the market, including Sony. It will sell its lowest-cost, stand-alone OTC hearing aid for $999 at Best Buy and other retailers.

Walmart said it will offer a range of OTC hearing aids, including some priced from $199 to $299 a pair from South African company hearX, which also makes the 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 Lexie Lumen OTC hearing aid for $799 per pair. Walgreens, CVS, Best Buy and Walmart offerings will also include the Lexie hearing aid developed in partnership with Bose.

Costco, one of the largest sellers of hearing aids prescribed by hearing professionals, would not say whether they would offer them over the counter.

De Wet Swanepoel, co-founder of hearX, said his Lexie 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 it will take a lot of education for consumers on what the difference between the devices is,” he said.

Some consumers may want to visit an audiologist either in person or online to have their hearing tested before purchasing an OTC aid, Lin said. An audiologist may also recommend which hearing aid is best for their type of hearing loss. Traditional fee-for-service Medicare and most health insurances cover routine hearing tests. But Medicare and most private insurers do not cover the cost of hearing aids, although many private Medicare Advantage plans do.

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

Another factor that could drive demand for the new devices is that the stigma of wearing a hearing aid is decreasing as people commonly use in-ear devices to listen to music.

More than 37 million American adults they have hearing problems, that’s all 1 in 4 adults who could benefit from a hearing aid have used it, federal health officials estimate.

The hearing aid industry has remained largely insulated from price competition due to consolidation among manufacturers, widespread state licensing laws mandating sales through audiologists or other hearing professionals, and the acquisition of hearing care 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 set rules to allow over-the-counter sales, with the hope that it would spur competition and lower prices. But the Covid-19 pandemic has slowed the FDA’s efforts, and last year President Joe Biden ordered the FDA to draft those rules. Final regulations published two months ago. Under federal rules, the new category of hearing aids bypass state dispensing laws.

Audiologists, who could lose their jobs, warn that the new category will not help people with severe hearing loss. And excessive volume can damage hearing, they said Sarah Sydlowskipast 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, said the devices are probably 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 consultant to the hearing aid industry in New Jersey, said the new devices will be clearly labeled as FDA-approved and consumers should be on the lookout for that. 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 OTC hearing aids with generous return policies, longer than one month. Consumers may want to try the device for a few weeks to see how it works. If one brand doesn’t work, you should try another.

A replacement may be necessary, as it is unclear whether consumers will receive in-store assistance in selecting aids without 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 consumers should look for devices that are labeled “stand-alone” because that shows the companies have proven to the FDA that people can set up these devices themselves, as well as have professional help.

“If you’re tech-savvy, then I say jump right in,” Reed said, though he noted that “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 she reviewed eight major OTC hearing aid products, ranging from $499 to $1,299. Some look like headphones or are almost invisible, while some look like traditional hearing aids that wrap around the ear. The OTC aids she reviewed generally have limited or no Bluetooth connectivity, a feature that allows users to customize the devices, and only about half have rechargeable batteries. But all eight allow the user to personalize the devices based on hearing test results.

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

The American Academy of Audiology, the professional organization for audiologists, announced online information for consumers on OTC hearing aids, and the American Hearing Loss Association, a consumer advocacy group, has as well online advice.

Barbara Kelley, executive director of the Hearing Loss Association of America, said consumers should take the time to look 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.

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