Starting Monday, consumers will be able to purchase hearing aids directly from store shelves and at significantly lower prices as a 2017 federal law finally goes into effect.
While for decades it cost thousands of dollars to obtain a device that could only be purchased with a prescription from an audiologist or other hearing care professional, a new category of over-the-counter aids is emerging. now sells for hundreds of dollars. Walmart says it will sell a hearing aid for as little as $199.
The over-the-counter aids are aimed at adults with mild to moderate hearing loss – a market of tens of millions of people, many of whom have so far avoided seeking help because the devices were so expensive.
READ MORE: FDA approves over-the-counter hearing aids for mild to moderate hearing problems
“Conceptually, 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 predicts that it may take a few years for the new market to collapse as manufacturers and retailers get used to selling aids and consumers become familiar with the options.
Hearing care professionals say they are happy to see the lower prices. Lin said he believes prices will continue to drop as more competitors enter the market over the next two years.
Prices and features will vary for new over-the-counter hearing aids, just as they do for prescription hearing aids. A pair of prescription devices typically sell for between $2,000 and $8,000. Some of the technology found in the more expensive prescription aids will be available in the less expensive over-the-counter aids.
Over-the-counter aids cost less in part because they don’t bundle the services of an audiologist for a hearing assessment, fitting, and fine-tuning of the device. Instead, the new devices are meant to be set up by consumers themselves, though manufacturers offer technical support through apps and over the phone.
Some new companies have entered the market, including Sony. He will sell his cheapest self-adjusting OTC hearing aid for $999 at Best Buy and other retailers.
Walmart said it will carry an assortment of OTC hearing aids, including some $199 to $299 a pair from South Africa-based 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 plans to make them available nationwide soon.
Costco, one of the biggest sellers of hearing aids dispensed by a hearing aid professional, did not reveal whether it would offer them over the counter.
De Wet Swanepoel, the co-founder of hearX, said his Lexie Lumen OTC hearing aid will allow consumers to program it 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 need for consumer education on the difference 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 over-the-counter aid, Lin said. An audiologist might also recommend which hearing aid is best for their type of hearing loss. Traditional fee-for-service health insurance 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 new devices is that the stigma of wearing a hearing aid is decreasing because people commonly use hearing aids to listen to music.
The hearing aid industry has remained largely insulated from price competition due to consolidation among manufacturers, widespread state licensing laws that mandate sales through audiologists or other healthcare professionals hearing, and the acquisition of the practices of hearing care professionals 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 spur competition and make lower prices. But the covid pandemic has slowed the FDA’s effort, and last year President Joe Biden ordered the FDA to produce these rules. The final settlement were announced two months ago. Under federal rules, the new category of hearing aids bypass state distribution laws.
Audiologists, who could lose business, warn that the new category will not help people with severe hearing loss. And over-amplified sound can damage hearing, said Sarah Sydlowskipast president of the American Academy of Audiology.
However, Nicholas Roseau, an audiologist and assistant professor at Johns Hopkins’ Bloomberg School of Public Health, said the devices are likely less dangerous than listening to music with ear cups that are too high. Regulations require new aids to have safe maximum sound levels to help protect consumers’ hearing.
Tom Powers, a hearing aid industry consultant from New Jersey, said new devices will be clearly labeled as FDA-approved and consumers should keep an eye out for that. These are different 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, exceeding one month. Consumers may want to try a device for a few weeks to see how it performs. If one brand doesn’t work, they should try another.
The change may be necessary, as it is unclear whether consumers will get in-store help choosing an aid without an audiologist. Some stores plan to provide assistance. Walmart said it would include information on its website to help people find the devices that are right for them.
Reed also said consumers should look for devices labeled as “self-adjusting” because it shows the companies have proven to the FDA that people can fit these devices themselves as well as if they had help. from a professional.
“If you’re tech-savvy, then I say give it a go,” Reed said, while noting “there’s nothing wrong with talking to a qualified audiologist.”
Nancy M. Williams, president of Auditory Insight, a hearing care management consulting firm, said she reviewed eight leading over-the-counter hearing aid products, ranging in price from $499 to $1,299. Some look like headphones or are nearly invisible, while others look like traditional hearing aids that wrap around the ear. The OTC aids she reviewed largely 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 customize the devices based on their hearing test results.
She recommends people try at least three over-the-counter aids to see which works best for them.
The American Academy of Audiology, a professional organization of audiologists, has published online information for consumers on over-the-counter hearing aids, and the Hearing Loss Association of America, a consumer advocacy group, has also online advice.
Barbara Kelley, executive director of the Hearing Loss Association of America, said consumers should take their time researching new options. “This is all going to be a little confusing,” she said. But the new options, she added, will allow more people to get 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 polling, KHN is one of the three main operating programs of KFF (Kaiser Family Foundation). KFF is an endowed non-profit organization providing information on health issues to the nation.