Sometime in mid-October, adults who have what they consider to be mild to moderate hearing loss will be able to start buying hearing aids online or in stores without a checkup or prescription from a medical professional.
For older adults used to being able to pick up a $10 pair of nonprescription reading glasses at the drugstore, that may seem like a no-brainer.
But local hearing experts say the advent of over-the-counter hearing aids, while it stands to benefit a lot of people, also poses some questions and concerns, some of which will take time to work through. They’re already hearing many of those questions from their patients.
“The idea is this will open up a whole host of solutions for people who aren’t really ready to try prescription hearing aids and who are having situational hearing difficulty,” said Ryan McCreery, who runs a hearing aid research lab at Boys Town National Research Hospital and serves on the American Academy of Audiology’s ad hoc committee on over-the-counter hearing aids.
Ashton Johnson, a clinical audiologist with Nebraska Medicine, agreed that certain patients will do well with the devices.
Most people, however, aren’t good at judging their hearing loss, she said. Many think they have a mild to moderate loss but instead have a more significant deficit, which still will require a prescription device. Patients also may have a medical reason for their hearing loss that could be caught by a hearing test and treated earlier.
“It’s a double-edged sword,” she said. “You can see where the huge benefit is going to be. But you can also see where the problems may lie.”
People who have a sudden hearing loss, McCreery said, or a hearing loss that comes with symptoms such as dizziness or ringing in the ears, should see a doctor or an audiologist to make sure they don’t have another medical condition or a buildup of wax in the ear.
The change comes as a result of a new Food and Drug Administration rule that was finalized in mid-August and goes into effect in mid-October. The regulation creates a new class of hearing aids that don’t require a medical exam or a prescription.
The move, mandated by the bipartisan Over-the-Counter Hearing Aid Act signed into law in 2017, is expected to increase competition and eventually lower costs. Among the measure’s sponsors were Sens. Charles Grassley, R-Iowa, and Elizabeth Warren, D-Mass.
McCreery, Boys Town hospital’s vice president of research, said age-related hearing loss generally starts when people reach their mid-50s, although most won’t get a hearing aid until they’re much older, in their 60s or even later.
The FDA estimates that nearly 30 million people could benefit from a hearing aid, although only about one-fifth use them.
The potential consequences of not hearing properly go beyond just not being able to catch some of the dialogue on a favorite TV show. Untreated hearing loss, said Johnson, who has a doctorate in audiology, can lead to cognitive decline, isolation and depression.
“This may increase the access for some people and help with some of the issues hearing loss leads to, which would be really great,” she said.
Currently, cost is an obstacle for prescription devices.
McCreery said the average out-of-pocket cost for prescription hearing aids is about $3,000. The devices are not covered by traditional Medicare, and the over-the-counter devices won’t be, either. Some Medicare Advantage plans and some private insurance plans do cover prescription devices. Hearing tests also may not be covered by Medicare.
Hearing experts aren’t yet sure what the over-the-counter devices will cost. But they predict they will range from very low-cost items like personal sound amplification products that are on the market to devices that come with added features and exceed the cost of prescription hearing aids. Personal sound amplification devices do not undergo Food and Drug Administration review and cannot be marketed as hearing aids.
If the cost of the over-the-counter devices approaches that of prescription hearing aids, Johnson said, patients may be better off paying a little more and getting the fitting that comes with prescription devices.
The over-the-counter devices are not intended for children, McCreery said. Kids require careful fittings to accommodate growth and make sure they don’t have problems in school or suffer delays in speech and language development. The hospital’s hearing professionals work with families of children who need prescription devices to help them connect with funding sources.
Staff in McCreery’s clinic recently saw a patient who came in with a pair of personal amplification devices. The patient’s hearing loss was on the edge of moderate. But hearing tests indicated she could hear better without the devices than with them. She was frustrated because she had spent upward of $700 on the devices.
Ideally, McCreery said, people who suspect a hearing loss will have their hearing tested before they purchase devices. At Boys Town, if a person is found to be a candidate for an over-the-counter device, the staff will let them know. “We want them to have help when they need it,” he said.
In the best-case scenario, people who test as candidates for over-the-counter devices will use them until their hearing loss progresses to the point that they need prescription devices. “That would be a segment of the population that we’re not currently serving,” McCreery said.
Johnson said her clinic has not set a policy on how it will handle over-the-counter devices. But her inclination is to recommend them to patients who aren’t candidates for prescription devices.
If people do purchase over-the-counter devices and aren’t doing well with them, she said, they can get a hearing test to tell them whether they truly are candidates. Clinic staff can do a test to measure the devices’ output in the ear canal.
McCreery and Johnson also said they’re also eager to see what type of trial periods and return policies makers of the over-the-counter devices offer.
Prescription hearing aids, McCreery said, come with trial periods so people can wear them and bring them back if they don’t like them. They also come with replacement policies for lost or damaged devices as well several years of coverage for repairs.
Still, McCreery said he is excited to see what the new devices mean for the technology. Currently, five companies make most of the devices sold in the U.S. and conduct most of the hearing aid research. Leading consumer electronic companies that already are in the sound business, including Apple, Bose and Samsung, are investing in the products.
“There’s a lot of excitement that this could drive innovation in the technology that’s available across the board,” McCreery said.
This report contains material from the Associated Press.
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