Starting Monday, hearing aids will be available to buy over the counter across the U.S.
The major shift in hearing health care is due to a recent rule change by the Food and Drug Administration, which in August cleared the way for the devices to be sold in retail stores without the need for buyers to see a doctor first.
The move is being hailed as a win for those with hearing loss, which afflicts millions of people across the country, but experts say customers need to be cautious about what products they purchase as sales begin.
"I hate to use the words 'buyer beware,' so instead it's 'buyer be educated' about what you're doing, what your needs are," said Kate Carr, president of the Hearing Industries Association, a trade group representing hearing aid manufacturers.
You won't need a prescription or an exam to buy a hearing aid
The new rule applies to products for adults who believe they have mild to moderate hearing impairment.
That could include people who have trouble hearing in groups or on the telephone, who need to turn up the TV volume louder than others and whose friends and family say they regularly don't understand speech or ask others to repeat themselves, according to the nonprofit Hearing Loss Association of America.
The over-the-counter hearing devices won't be suitable for children or people with severe hearing impairment.
Under the new rules, there is no longer a requirement to undergo a medical exam, obtain a prescription or be fitted for a device by an audiologist.
People can still get hearing aids by seeing a doctor first, and experts say there are advantages to this option, such as being professionally fitted for a hearing aid based on your individual needs and having a doctor monitor the progression of your hearing loss.
But HLAA executive director Barbara Kelley says that if the new rules lead more people to buy hearing aids, that's a good thing.
"When someone finds out they have hearing loss, they often wait five to seven years before they get a hearing aid," Kelley told NPR.
"So if this would inspire people or motivate people because they see these hearing aids in the mainstream, that should be more affordable or at a different price point, they might take that first step sooner rather than later," she added.
You'll spend less on OTC hearing aids, but it comes at a cost
In the past, the device itself only accounted for about a third of what a person would spend to get a hearing aid. The rest of the price went toward doctors' appointments and other medical services, and Medicare and health insurance typically doesn't cover the cost of hearing aids.
Now, people with hearing loss could see a major decline in what they can expect to pay for a hearing aid.
The White House estimates that people could see nearly $3,000 in savings when they buy over-the-counter devices.
However, Carr with the HIA said hearing aids obtained through the traditional medical route aren't always so expensive, and that people who buy the devices over the counter will miss out on the advice of medical professionals.
(Sens. Elizabeth Warren and Charles Grassley found in a report earlier this year that the HIA was among the organizations that made "serious attempts to undermine the effectiveness of OTC hearing aids." The HIA now says it supports the FDA's new rule.)
Sales are set to begin soon. According to Reuters, the pharmacy chain Walgreens said it was planning to sell Lexie Lumen hearing aids for $799. Walmart said it would begin selling hearing aids in stores and online starting at $200.
There will be lots of options, so it pays to do your research
The rule change will mean that existing hearing aids as well as new products will be available to buy in stores, pharmacies and online.
Experts are urging customers to do their research. Companies' websites may have more detailed information about their products.
Also, sellers are required to include any details about their return policy — if they have one — on the box. It can take three to four weeks to properly adjust a hearing aid, the HLAA says.
Consumer Reports journalist Catherine Roberts recommends looking at what kind of support the company offers as well. Does it have an online chat option? Can you call by phone and speak to a person? Will that kind of service cost extra?
"This self-fitting process is totally new and very few people are going to be familiar with it," says Roberts. "So, the more you can know that there's somebody who can help you troubleshoot, I think that's going to be some of the value in this early marketplace."
The association also suggests people consider whether the hearing aid requires the use of a smartphone to operate it and whether a battery is rechargeable or long-lasting.
Additionally, consumers should know the difference between hearing aids and personal sound amplification products, or PSAPs, which are currently sold over the counter and intended not for people with hearing loss but rather for those with normal hearing who want to amplify sounds, such as hunters.
If people run into trouble with an OTC device, many audiologists offer consultation services for a fee and may be able to help you troubleshoot.
Watch out for potential scams, too
The new FDA guidelines for over-the-counter hearing aids have set standards for product safety, labeling, volume control and effectiveness.
Phoenix audiologist Cliff Olson says they are long overdue and should help.
"And what I'm hoping is, is that because there's now actual regulation around it, it's going to allow the FDA to go in and actually crack down on the bad actors," he said.
"Whether or not they'll actually do that or not," he added, "is anybody's guess."
