By Thomas Goldsmith
In this connected age, a measure of help for people with hearing loss might seem as close as an iPhone, an app and earbuds.
With a coming federal rule change, North Carolinians with mild to moderate hearing loss will be able to buy devices called hearing aids — some for as little as $100 — at drugstore counters and elsewhere.
More affordable hearing devices could be a game changer for many people, as traditional hearing aids can cost as much as several thousand dollars for each ear. And research has found hearing loss to be associated with increasing social isolation and cognitive decline, and even exacerbating dementia and Alzheimer’s disease.
They also could be a problem if they don’t get used properly, and people with hearing loss eschew a more appropriate level of care.
That controversy has been brewing in North Carolina and nationally over the value of these over-the-counter, less expensive pieces of technology, something that’s picked up steam since Congress passed a law in 2017 to create a new category for these devices.
The upshot: neither the smartphone approach nor the use of over-the-counter devices requires the intensive testing, diagnosis and examination by audiologists that come with getting traditional hearing aids. Pieces of tech with that label will for the first time be usable without the advice of these trained health professionals.
Audiologists are trained health professionals – many with doctoral degrees – but are not physicians. They make the case that they’re needed to develop more targeted treatment and to flag conditions that might need attention from an ear, nose and throat doctor, problems such as infections, tumors or ear-drum perforation.
Allison Young, an audiologist at UNC Health, says she often works with people with hearing loss who want to try these newer means for improving their hearing. But if they require medical treatment, she’ll recommend working with a physician.
“I’ll say, ‘Try it if it works for you, if it meets your goals and your needs — then you’re improving your quality of life,’” she said. “‘But if it doesn’t, then you can come back and we can discuss next steps, which would typically be a traditional hearing aid.’”
FDA: Label more devices ‘hearing aids’
It’s the over-the-counter segment that’s causing specific controversy now, as part of the wrap-up of a process that began with the passage of the Over-the-Counter Hearing Aid Act of 2017 to allow sales of devices called hearing aids, but that don’t require audiologist supervision.
Final regulations from the Food and Drug Administration have been delayed by COVID and by objections to the changes. Even in regulation-wary North Carolina, an ad hoc committee set up to comment on the regulations has said the FDA should hang extensive restrictions on the sale and use of over-the-counter devices before allowing them to be called hearing aids.
Among its 13 recommendations to the FDA, the North Carolina task force says that the over-the-counter products should be called “Self-Fit Over-the-Counter Hearing Devices” to distinguish them from traditional hearing aids.
“This will serve to create clear terminology for the benefit of the consumer and mitigate the need to deal with unintended consequences of confusing the consumer with the term ‘hearing aid,’” the report says. “Otherwise, there is the risk consumers, who have a less than optimal experience with this new OTC category if called hearing aids, will deduce hearing aids are ineffective.”
In addition, the North Carolina task force recommends, in part, that:
- Buyers should have to verify in writing that they are 18 or older,
- The level of amplification on the OTC devices should be limited within specific decibel levels,
- Consumers should not decide for themselves that their hearing loss is mild to moderate,
- Outside the box labeling should tell buyers about compatible types of phone and operating systems, user controls for volume and feedback, battery type, and the shape and fitting of the device.
- Warnings on when to stop using the device should include examples such as ear drainage, pain and balance problems.
‘Get someone to seek care early’
The established hierarchy in North Carolina and nationally has put significant muscle into protecting an audiologist’s role in overseeing the use of hearing aids. However, the law is a done deal, passed with the support of presidents Donald J. Trump and Joe Biden, so that various forces with a horse in the race are working to affect the outcome, not to halt the change.
In January, the audiologist industry group American Speech-Language-Hearing Association, called ASHA, asked the FDA to ensure “appropriate access, consumer protection, efficacy, and patient safety grounded in the most robust and up-to-date research from the field.”
A central fact concerns all parties: A large majority of North Carolinians with hearing loss do not use hearing aids — only about 15 percent do, according to the NC Department of Health and Human Services. A statewide shortage of audiologists and ENT physicians in rural areas means that children with hearing loss can escape diagnosis and treatment, even though more state resources may be in place for their care.
Smartphones in the house
Use of one of the nontraditional devices could help, either to correct some hearing loss. Or they could become a stopgap measure as patients begin what is typically a seven-year journey to traditional hearing aids, Young said.
“Hearing loss can be progressive, especially after the age of 65,” said Barbara Kelley, executive director of the national, consumer-focused Hearing Loss Association of America. “If we get someone to seek care early to maintain those important human connections, they most likely will end up in the good care of a hearing health professional.”
These kinds of tech advances and proposed changes in regulation represent a classic tension between institutional authority and innovation: Should established forces control and limit the benefits and cost saving of new directions? Or should changes roll on even when benefits and consequences may not be completely clear?
How do these changes fall out in the real world? That answer can be complicated, in no small part because of the diverse universe of people who are hard of hearing.
Philip Woodward is a Raleigh resident who was diagnosed with severe to profound bilateral hearing loss when he was four and a half. He’s worked with the N.C. Council on Developmental Disabilities and other state agencies that deal with hard of hearing people and wears two behind-the-ear hearing aids, can read lips, and knows American Sign Language.
As someone who identifies as culturally Deaf, he’s open to some of the less formal approaches to improving hearing, though is not disposed to use them himself.
“Nowadays, we use a smartphone for so many different things, and there seems to be an app for everything,” Woodward said in an email exchange. “Smartphones are actually a personal extension of ourselves in some ways, so, if a smartphone offers something that will help a Deaf or a deaf or a Hard of Hearing or a Deafblind or a late deafened person communicate more easily and function better in today’s society, then that is a good thing.”
Academic researchers have in recent years explored the performance of smartphones and apps to help people with mild to moderate hearing loss. More than 60 percent among 68 adults with hearing loss in an early study published in an Italian journal in 2020 assessed their hearing quality as good or excellent when using a smartphone. Researchers found drawbacks in that users had to wear the devices at all times, hold it rather than carry it in clothing, and mostly forgo other uses for the phone.
Louder isn’t always clearer
Allison Young, the UNC audiologist, said that smartphones paired with apps have their uses, but lack the sophistication and finely calibrated functions of hearing aids.
“Right now what’s available would be using things through what we would consider sort of native Apple or Android functions,” Young said. “You can use your smartphone as a microphone that can connect to headphones, whether that’s with the wire or without a wire. You can hold your phone up to someone and the closer your phone is to them the louder their voice sounds to you.
“That can help you hear them in specific situations, but it would require you to use the phone microphone to bring this out into your ears and then the headphones to put it into your ears. I think there are some manipulations with some of the apps to increase bass and treble, but they’re not used to treat hearing loss at present.”
Rochelle Ellis, a speech and language pathologist who works with children in the Wake County school system, emphasizes the importance of an audiogram, a test that charts the specific frequencies where people’s hearing is lacking. Such information is as crucial in dealing with hearing loss as are eye exams when prescribing eyeglasses or contact lenses, Ellis said in an interview.
“When you are having trouble reading, you can buy readers at the drugstore,” she said. “You can’t go in and buy a pair of progressives without a prescription and that’s the way it should be for hearing aids. Hearing is just more complex than that.”
Based on experience with family members who have wrestled with conventional hearing aids, Ellis said she can understand the desire to pick up an over-the-counter device or to use a cell phone instead. But she and others point out a frustrating reality for many who have set out on a path to hear better. Think of a blaring speaker at an outside event like a high school football game.
“Making something louder doesn’t necessarily make it easier to understand,” Ellis said.
Another factor that might lead people to potentially less obtrusive devices: There’s also an element of cultural stigma in hearing loss that’s seen as symbolic of age and infirmity.
“Some adults don’t want other people to notice that they need hearing aids,” Woodward said via email. “Part of it is acceptance and how comfortable they feel accepting it and letting other people know that they are now Hard of Hearing.”
When hearing aids hide in a drawer
Traditional hearing aids have often gotten a bad rap when your older uncle or aging parent can’t get a device to work that’s cost him $3,000 or more, and he simply leaves it unused in a drawer.
“Yes, there are still people who will choose not to use their already purchased technology, and truthfully, we always strive to empower patients to make their own decisions,” Young said. “And sometimes that’s not working with us and that’s perfectly fine. Our expertise is here if they need it.”
If a person’s problem is not being able to hear a spouse at the dinner table, hearing aids could offer an easy way to fix that, according to the traditional network.
“And it could improve your quality of life in a way that is meaningful to you,” Young said.
In tough cases, Ellis said, dogged persistence and repeated fittings and adjustments may be the only solution.
“Number one, go to your audiologist,” she said. “And number two, if you are not happy with results, go back and go back and go back.”
What will come with changes from FDA?
The changes in FDA rules on labeling will likely go into effect later this year. Among the perceived benefits of the change, the agency says people who are able to get lower-cost hearing aids will be more likely to take part in family, business, civic and faith life.
“This could be particularly true for people of color, rural Americans, low-income individuals, and others for whom barriers to hearing aid access may be especially burdensome,” the agency said.
That change should also reinforce consumers’ tendency to opt in to free-market solutions.
“The proposed rule is designed to help increase competition in the market while also ensuring the safety and effectiveness of OTC and prescription hearing aids,” the FDA said.
Far down in the lengthy FDA proposal are somewhat startling statistics on the cost savings that could result for consumers. For the industry, not so much difference: additional costs of one to two million dollars for revising the labeling of existing hearing aids, absorbing the rule’s language and changing standard operating procedures.
But the benefits on the consumer side could amount to as much as $145 million annually.
With the public’s seemingly endless appetite for apps, along with the changes from FDA, people who are hard of hearing will almost certainly keep trying the more easily available alternatives.
Audiologists say the work they share with physicians isn’t in danger of collapsing. Too many people need the help, and some who start in other directions wind up back in treatment spaces.
“We’d recommend meeting with a hearing health care professional or an audiologist at a minimum to see what your hearing is,” Young said. “You should also be aware of a potential insurance benefit that you might have that you didn’t know about, like we have in North Carolina that can pay for hearing aids for certain populations or if you qualify. So knowing about those programs can be a good thing.”
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