The U.S. Food and Drug Administration finalized a ruling Monday that will make hearing aids available over the counter without a prescription or an appointment.
It’s a game-changer for many disabled people, who say the ruling will benefit millions of Americans with hearing loss. At the same time, the ruling illuminates barriers to hearing aid access that members of the disabled community say still need to be addressed. HuffPost spoke to experts in the field who unpacked the benefits of over-the-counter hearing aids ― and aired some concerns about their rollout.
“I’m thrilled with this leap forward,” Glenda Sims, chief information accessibility officer at the digital accessibility firm Deque, told HuffPost. “People that want to enhance their hearing, or get back to a level of hearing that they had, if they have mild or moderate hearing loss, [and] that couldn’t afford it in the past, are really going to have it much more within their reach when there are some that are going to be available at $200 versus thousands of dollars.”
Tens of millions of Americans experience hearing loss, but only 16% of them use hearing aids, according to the National Institute on Deafness and Other Communication Disorders. Cost is a major factor preventing access to these devices. The average cost of one prescription hearing aid is approximately $2,000, not including the cost of audiology visits for fittings and other services.
Over-the-counter hearing aids are now available at major retailers such as Walgreens and CVS at a significantly lower cost, and are estimated to save consumers $3,000 per pair of hearing aids. Sims said that her best friend had been experiencing hearing loss in one of her ears, but she struggled to afford hearing aids as a single parent on an elementary school teacher’s salary. She ended up paying $2,000 out of pocket for prescription hearing aids.
“She couldn’t pay for it,” Sims said. “It’s riding on credit card debt because she needed it. She can’t hear the ends of the words that the kids are saying to her in class.”
OTC hearing aids can also be beneficial to someone with mild to moderate hearing loss who previously may not have had access to prescriptions. Laura Pratesi, a doctor of audiology who is also hard of hearing, said many patients fall into that category and would benefit from having some technology, but can’t afford or don’t necessarily need prescription hearing aids.
One important point, Pratesi notes, is that OTC hearing aids could allow early adoption of hearing technology. The longer a person lives with hearing loss, the more difficult it can be for them to successfully transition to hearing aids if they so choose. And studies have shown that adults will wait more than a decade after they first experience hearing loss to get fitted for hearing aids, which Pratesi believes is partly linked to stigma.
Sims believes that commercialization of OTC hearing aids, along with more innovation, could destigmatize the devices. Pratesi notes that the advent of Bluetooth technology and AirPods has breathed new life into the hearing health care sphere.
“I’ve had patients that don’t necessarily love the idea of getting hearing aids, but when I tell them, ‘This can connect to your iPhone, this can connect to your Android,’ you’re like, ‘Oh, that’s so cool,’” she said.
One issue professionals see with OTC hearing aids is that consumers may not have the technological savvy to choose the right products. Jaipreet Virdi, a history professor at the University of Delaware, said she believes the FDA’s ruling for OTC hearing aids is a good thing, especially given the cost-saving advantages. However, she’s concerned that not everyone will have the technological know-how to take full advantage.
“It’ll be great that people will go and buy the right hearing aid that’s more affordable for them, but they might not get the full benefit from the products that they would need,” Virdi told HuffPost.
Audiologists can calibrate hearing aids and program them to an individual’s audiological range, as well as provide services such as aural rehab, auditory training, cleaning and software updates, to ensure the user is getting the most out of the device. Still, affording these services along with the cost of prescription hearing aids can be difficult. Sims notes that this is a reason some people may want to get OTC hearing aids rather than prescription ones.
“If I needed [hearing aids] right now … I would go to an audiologist,” Sims said. “They’re going to walk me through step by step, they’re going to know all kinds of things about sound and ears and adjustments.”
“I just spoke from privilege,” she added. “I could afford to do that, instead of doing the research myself. I could also do the research myself and be patient and have a little bit more trial and error. So I think audiologists and doctors are still an important piece of the puzzle. It’s just nice to not force it.”
OTC hearing aids are limited in some ways because they don’t help children or people with profound hearing loss, Pratesi said. For example, Maria Page, 53, said that her hearing loss is too great to be able to benefit from OTC hearing aids.
“Due to my inner ear hearing loss, my very small, in-the-ear-canal hearing aids have a custom fit so that I can wear them all day, every day,” Page told HuffPost. “Will the over-the-counter hearing aids have custom fits? I suspect not, because that would mean additional expense.”
Hearing aids aren’t a one-size-fits-all model, Virdi said. She uses the analogy of getting eyeglasses: Some people, depending on their visual needs, can go to the store and try on different glasses to figure out which ones help them see more clearly. But other people need to get their eyes examined and assessed by an ophthalmologist to determine which prescription lens would work best for them.
Page worries that the FDA’s ruling on OTC hearing aids and the one-size-fits-all mindset will lead some people to jump to the wrong conclusions.
“If anything, this FDA decision will have a negative impact on me, because everyone else will expect that I will be able to easily and somehow more cheaply get hearing aids on a regular basis,” she said. “I will have to explain even harder how that is not the case.”
Pratesi said that since her practice is unbundled ― a cheaper alternative to bundled services ― she can assist people who bring in OTC hearing aids. However, the costs can still be high out of pocket, since audiological services, as well as the actual hearing aids, are not covered by insurance.
“I want audiological care to be affordable and accessible for everybody,” Pratesi said. “If over the counter works for what someone needs, that’s fantastic. If over the counter doesn’t work for what somebody needs, nobody should have to go without audiological care because of cost.”
Pratesi said this barrier to access could be addressed if insurance companies categorized audiologists as limited licensed practitioners rather than as equipment suppliers, and hearing aids as medical devices rather than cosmetic or consumer products. This issue has been heavily debated since the development of the first electric hearing aid 100 years ago, and particularly during congressional hearings starting in the 1960s, Virdi said.
“As long as they’re being promoted as a consumer product, where consumers make the decision about which hearing aid fits their need, and not as a medical device that means it’s covered by insurance … we’re always going to be limited,” she said.
Some states have passed insurance mandates for hearing health care coverage, according to the American Speech-Language-Hearing Association. However, Pratesi notes that federal legislation would help. The Medicare Audiologist Access and Services Act is a federal bill that would require insurance coverage of hearing aids and audiological services. It would also improve access to licensed providers for people who suspect they have hearing loss, by eliminating the medical doctor referrals that are required in order to receive a hearing test.
“If we think about where we’re going in the future, I think we should push more for the devices to be covered by insurance ― and not just the devices, but all associated costs that go along with it,” Virdi said. “I think that’s one thing that I really hope will change.”
Some experts predict that OTC hearing aids will ultimately lead to more innovation and lower costs. Pratesi believes there will be a shift in practices offering more unbundled services, which would also result in lower costs.
OTC hearing aids have also started important conversations about inaccessibility, and how hearing aids, American Sign Language and cochlear implants are all tools to help people with various communication goals, Pratesi said. Still, she doesn’t want change to stop here.
“I’m excited for what this legislation does. But I don’t want people to think that ‘OK, great, we passed OTC and now we’re there.’ We’re not there,” she said. “There’s still more people that need to be helped, there’s still more changes that we need to make so that audiological care is affordable and accessible for everyone.”