Why It’s Still Hard to Get the Right Over-the-Counter Hearing Aid
UCSF researchers say many consumers struggle to navigate the complexity of their options and insurance coverage.
Four years after the Food and Drug Administration (FDA) allowed hearing aids for people with mild-to-moderate hearing loss to be sold in the U.S. over the counter (OTC), UC San Francisco researchers explain in a new JAMA Viewpoint the many hurdles consumers continue to face selecting and buying an appropriate device.
Consumers shopping for an OTC hearing aid have to sort through dozens of products, determine which ones are registered or cleared by the FDA, figure out what insurance will cover, and find expert help to choose and set up a device, according to co-authors Kathryn A. Phillips, PhD, a UCSF professor of health economics and health services research, and Christine K. Cassel, MD, a UCSF professor of medicine.
... We need trustworthy information, professional help when people want it, and coverage policies that reflect the way hearing aids are sold today.”
Christine K. Cassel, MD
They point to extensive interviews conducted by the U.S. Government Accountability Office and other research to support their claims. “Over-the-counter hearing aids have opened the door for many people who might otherwise never have gotten hearing aids,” said Phillips. “But people still have to figure out what to buy, whether they can afford it, and where to get help.”
Products vary widely in price, features, and ease of use, and consumers may have trouble determining whether a device is FDA approved, according to the authors. One study cited in the article, for example, found that only about one-quarter of Amazon OTC hearing aids listings could be verified as FDA approved.
Expert help can be hard to find, too. One in 5 OTC hearing-aid users reported receiving no professional assistance, while just 51% received the full range of services that can include evaluation, device selection, and fitting. Audiology practices have long bundled these services with prescription hearing aids, an approach that does not easily accommodate people who buy devices on their own.
Insurance adds another hurdle. Traditional Medicare does not cover hearing aids, and coverage varies among Medicare Advantage, Medicaid, and commercial insurance plans. Plans that offer coverage may require a prescription or choosing certain vendors.
A policy breakthrough and what came next
Cassel, an expert in geriatrics and health policy who co-chaired a hearing-loss working group for the President’s Council of Advisors on Science and Technology that informed the policy change to allow OTC hearing aids to be sold in the U.S., touts improved access but said it’s time to take the next step.
The policy change has substantially lowered costs. OTC hearing aids are about $500 on average compared with $3,400 for prescription devices, according to data cited by the authors. Among people buying hearing aids for the first time, 70% chose an OTC device.
“Making hearing aids available over the counter removed an important barrier, and that was a major advance,” Cassel said. “Now we need trustworthy information, professional help when people want it, and coverage policies that reflect the way hearing aids are sold today.”
Making access work in practice
Phillips and Cassel suggest several ways to make the system easier to navigate.
Consumers could receive copies of their audiograms and hearing-aid programming information, much as they do for eyeglass prescriptions, so they can choose their own provider.
Audiologists could offer stand-alone consultations to people who buy OTC devices.
Insurers that cover hearing aids could explicitly include OTC products in their plans.
The authors also call for better data on who uses the devices, what people pay, and how well the devices work across diverse populations. Future legislation that expands hearing aid coverage should account for OTC devices as well.
The lessons may extend beyond hearing care, Phillips said, as regulators consider moving other medical products from prescription to over-the-counter status.
“Changing a regulation can create access, but it doesn’t automatically create a system that people can navigate,” she said. “If we want these changes to improve people’s health, we have to pay attention to what happens after the product reaches the shelf.”
Authors: Kathryn A. Phillips, PhD, and Christine K. Cassel, MD, of UCSF.
Funding: The work was supported by the National Human Genome Research Institute (R01-HG011792).
Disclosures: Phillips reported receiving personal fees from the Institute for Clinical and Economic Review evidence review committee and previously consulting for Illumina, Roche, and Danaher outside the submitted work. No other disclosures were reported.