Can over-the-counter hearing aids correct usage disparities? Delaware will find out.
Linda Heller walked to the front of the room as attendees filed inside a Newark Senior Center suite. Her voice carried across the bright space where everyone could see her face, and read her lips.
Just over a dozen people met her gaze. Some scratched in their notebooks, some followed live transcription by smartphone, and others looked ahead as a hearing loop amplified her voice to their hearing aids.
This was the first fall circle for their hearing loss support group, and a new topic would fill Heller’s notes as she opened the September meeting. Questions flew from every table.
“Let me just start talking about these new over-the-counter hearing aids,” said the semiretired audiologist and founder of the Hearing Loss Association of Delaware.
In August, the Food and Drug Administration announced it would allow the sale of over-the-counter hearing aids, without a medical examination or doctor's referral by Oct. 17, expanding access for millions of Americans with mild-to-moderate hearing loss.
The historic ruling opens hearing aids to more people who may have never been able to afford them. Devices will be available at the drugstore, some retail stores and online for adults, with no prescription required.
"This rule is expected to help us achieve quality, affordable health care access for millions of Americans in need,” said Health and Human Services Secretary Xavier Becerra in a statement.
Many living with hearing loss celebrate the pivotal step — but Delaware patients, audiologists and advocates alike also caution they still have more questions than answers. The ruling doesn't stretch across all degrees of hearing loss, they say, and can't deliver a one-size-fits-all solution to longstanding disparities.
Roughly 13% of the United States — or 30 million people — 12 years or older live with hearing loss, the National Institute on Deafness and Other Communication Disorders estimates. More than two-thirds of adults 75 and older have a clinically significant hearing impairment, according to data analyzed from National Health and Nutritional Examination Surveys.
Only about 1 in 5 people who could benefit from a hearing aid seek out the device.
A single hearing aid can cost anywhere from $3,000 to $6,000 or more, between device and fitting. Many patients, understandably, might need two. Devices also require updating or replacing as they age. Medicare, Medicaid and other insurance plans often cover diagnostic tests, but will not pay for the technology.
Systemic problems embedded in health care mean people of color and lower-income Americans have less access to a range of hearing loss services. In the few studies that have explored the impact of race or ethnicity on hearing health care, significant disparities present in rates of hearing-aid use between white older adults and people of color.
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Background:FDA allows over-the-counter sales of hearing aids without doctor exam or referral
Overall use rose from 2011 to 2018, 15% to 18.5%, in one national survey. But a different trend stood out: Far fewer Black Americans reported an increase in owning and using hearing aids, and hearing aid ownership actually dropped in the past few years among older adults living at or below poverty.
Now over-the-counter devices worn behind or inside the ear could be available for anywhere from $300 to $1,000. They aim to bridge the gap between existing sound-boosting tech and pricey prescription hearing aids. Customers will be able to use smartphone apps to test and calibrate their amplification needs, alongside other required user-adjusted controls.
Will the low-cost accessibility of over-the-counter devices correct disparities in hearing-aid use?
That’s not so easily answered.
“This is decades of lobbying, collaboration between senators and the hearing aid industry, audiologists and other stakeholders,” said Jaipreet Virdi, a University of Delaware assistant professor and historian of medicine, technology and disability.
“And I think it's literally just the beginning.”
[NOTE: See bottom of story for general over-the-counter hearing aids tip sheet]
Barriers to amplification
Barbara Ward leaned forward as Heller continued translating 100 pages of new regulation into group discussion. The clock clicked past its first hour.
The 69-year-old hopes over-the-counter devices might suit her. Most recently, the cost of new devices was just out of reach.
“I have moderate hearing loss,” the Delaware resident told her group, describing an impairment discovered in middle school. “I'm hoping to upgrade what I'm wearing. This was a donated pair after somebody upgraded and donated it to ENT of Delaware.”
Heller hesitated.
“Over the counter, you don't need any kind of prescription from someone like myself, an audiologist or your doctor or hearing instrument specialist,” she said. “They're trying to open it up so that more people can hear better, sooner.”
Heller — much like the Hearing Industries Association, which represents major hearing aid manufacturers and hearing health professionals nationally — said she still recommends hearing tests to determine your level of hearing loss. Such tests may be covered by insurance. She worries consumers won’t understand what they’re buying or whether it meets their needs.
Hearing loss is unique to every person.
The Centers for Disease Control and Prevention defines mild hearing loss as the inability to hear some soft speech sounds and moderate hearing loss as not being able to hear most speech at a normal level. Hearing loss left unchecked is associated with conditions like depression, anxiety, isolation, poorer cognitive function and heightened risk of dementia.
Audiologists like Gary Marencin would tell you it can be difficult for people to tell on their own whether their condition is mild, moderate, caused by medical condition — or something as simple as ear wax.
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“What has traditionally been the journey when a person starts to have difficulty, they will either just automatically consult an audiologist or sometimes their family doctor, who in turn can help to initiate the process of referring a patient for a hearing evaluation,” said the audiology program manager at ChristianaCare. “Over-the-counters may change how people start that journey a little bit.”
Marencin sees many patients over the age of 60, but his clinic has begun to see more patients in their 40s and 50s. Some patients delay approaching hearing aids, and the Delaware audiologist says some resistance isn't tied to price tags alone.
Experts stack multiple reasons on these low rates of hearing-aid use. Alongside the large financial weight of new devices without the help of insurance, patients also face time-intensive tests and fittings, lack of public awareness, less inclusive research or education about coping with hearing impairment — and stigma.
“It has to be a little bit beyond just purely the financial aspect of it,” Marencin said, noting even countries with hearing aids covered in social medicine programs face usage shortcomings. “You know, people will find, like, eyeglasses to be a fashion statement — but hearing aids haven't reached that point, yet.”
Many hope over-the-counter devices will increase that visibility and help reduce stigma.
"It puts hearing help in the mainstream," Barbara Kelley, executive director of the Hearing Loss Association of America, told USA TODAY. "When people find out they have a hearing loss, it often progresses and they wait five to seven years before they get hearing aids. This could possibly be motivation for people to take a step sooner rather than later."
Some audiologists caution consumers may get frustrated without individualized fittings. It's natural to expect a period of adjustment to new devices. Marencin says only time will tell what devices hit the shelves, as well as how consumers, manufacturers and professionals will adjust overall.
Over-the-counter devices are poised to expand the conversation. There's also speculation they could inject competition and innovation in a sector that hasn't had it while reverberating up the market.
It’s just not the full story.
'Just the beginning’
Carolyn Doerr took notes.
The Newark resident’s grandson was born with severe hearing loss in both ears. A recent pair of hearing aids cost about $7,000, though thankfully the now-17-year-old qualified for financial assistance. Doerr told the Delaware support group she mainly hoped to learn more for her daughter-in-law, Rose, who recently discovered moderate hearing loss in response to medication.
And whether it’s those rock concerts or just aging itself, Doerr is now starting to lose a bit of her own grip on sound.
“For me, it's when somebody is saying something, and I have to ask them to repeat it,” said the 75-year-old. “Not because I didn't hear sound but because I couldn't make out the sound of what they were saying. That’s troublesome.
“Like, what did you say? What is that word? Spell it, please. And then I can tell what it is.”
She plans to investigate new devices coming this month. But it’s hard for her not to note the limits of their impact.
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Jaipreet Virdi would agree.
“My biggest worry is we keep proclaiming over-the-counter hearing aids as consumer choice, something about the marketplace, and not what it actually is — hearing health care,” the University of Delaware researcher said. “We're ignoring the issue of having them covered by insurance.”
Virdi has nearly 98% hearing loss in both ears. These over-the-counter devices wouldn’t be able to help her now or when meningitis caused the loss at 4 years old. Other patients with severe hearing loss also won't directly benefit from the latest measure.
She believes manufacturers should collaborate with deaf users to benefit a wider breadth of customers — from greater device longevity and battery power, to improved aesthetic features and affordable models across all degrees of impairment.
“Over-the-counter hearing aids will possibly make the choice of wearing hearing aids more accessible for people who previously thought they had no choice,” she said.
“But I don't think any kind of radical transformation can actually change unless we think about hearing health care as fundamentally a part of health care."
Kelly Powers is a culture reporter for the How We Live team — covering race, culture and identity for the USA TODAY Network's Atlantic Region. Contact her at kepowers@gannett.com or (484) 466-9121, and follow her on Twitter @kpowers01.
Some tips
What is “mild to moderate” hearing loss?
You may have mild to moderate hearing loss if…
You have trouble understanding conversations in groups, with background noise or when you can’t see who is talking.
You have trouble hearing on the telephone.
You need to turn up the volume of television or radio loud enough for others to complain.
Your friends or family complain that you don’t understand speech and ask them to repeat often.
Over-the-counter may NOT help you if…
You also have trouble hearing conversations in quiet environments.
You also have trouble hearing loud sounds like power tools or motor vehicles.
If you experience these, you should see a hearing care professional.
Questions you should be asking
Is there a free trial period or money back return policy?
Does it need a smartphone, app or computer to install, operate and customize to my needs?
Is it compatible with cellphones or smartphones?
Can the hearing aid’s amplification be adjusted? How do you control feedback?
Is it water/sweat resistant?
How does it control, reduce or block out background, wind noise?
How long is the battery life? Can it be charged?
A word of caution
Pay attention to package warnings. If you have pain, sudden hearing changes or dizziness — see a doctor.
It may take time to adjust to your hearing devices.
If the first hearing aid doesn’t work, keep trying until you find the right product for you.
Source: Hearing Loss Association of America
This article originally appeared on USA TODAY NETWORK: OTC hearing aids to boost access where disparities have long persisted
