The US Food and Drug Administration finalized a ruling Monday that will make Hearing aids are available without a prescription or 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 shines a light on barriers to hearing aid access that members of the disability community say still need to be addressed. HuffPost spoke to experts in the field who broke down the benefits of over-the-counter hearing aids and raised some concerns about their launch.
“I’m thrilled with this leap forward,” Glenda Sims, director of information accessibility at digital accessibility firm Deque, told HuffPost. “People who want to improve their hearing or get back to their hearing level, if they have mild or moderate hearing loss, [and] that they couldn’t afford it in the past, they 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 wear 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 a prescription hearing aid is approximately $2,000, not including the cost of audiology visits for adjustments and other services.
Over-the-counter hearing aids are now available at major retailers such as Walgreens and CVS at significantly lower cost, with consumers estimated to save $3,000 per pair of hearing aids. Sims said her best friend had been experiencing hearing loss in one of her ears, but she struggled to buy hearing aids as a single mother on an elementary school teacher’s salary. She ended up paying $2,000 out of pocket for prescription hearing aids.
“She couldn’t afford it,” Sims said. “It’s based on credit card debt because she needed it. She can’t hear the end of the words the kids say to her in class.”
Over-the-counter hearing aids may also be beneficial for someone with mild to moderate hearing loss who has not previously had access to prescriptions. Laura Pratesi, an audiologist who is also hard of hearing, said many patients fall into that category and would benefit from some technology, but can’t afford or don’t necessarily need prescription hearing aids.
An important point, Pratesi says, is that over-the-counter hearing aids could enable early adoption of hearing technology. The longer a person with hearing loss lives, the more difficult it can be for them to successfully transition to hearing aids if they so choose. Y studies have shown that adults will wait more than a decade after first experiencing hearing loss to be fitted with hearing aids, which Pratesi believes is partly related to stigma.
Sims believes that the marketing of over-the-counter hearing aids, coupled with more innovation, could remove the stigma from the devices. Pratesi points out that the advent of Bluetooth technology and AirPods has breathed new life into the field of hearing health care.
“I’ve had patients who don’t necessarily love the idea of getting hearing aids, but when I say, ‘This can be connected to your iPhone, this can be connected to your Android,’ they’re like, ‘Oh, that’s great.'” , said.
One problem professionals see with over-the-counter 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 thinks the FDA’s decision for over-the-counter hearing aids is a good thing, especially given the cost-saving advantages. However, she worries that not everyone has the technological savvy to make the most of it.
“It will be great for people to go and buy the right hearing aid that is more affordable for them, but they may not get all the benefits of the products that they would need,” Virdi told HuffPost.
Audiologists can calibrate hearing aids and program them for an individual’s audiological range, as well as provide services such as hearing rehabilitation, hearing training, cleaning and software updates, to ensure the wearer gets the most out of the device. Still, paying for these services along with the cost of prescription hearing aids can be difficult. Sims notes that this is one reason some people may want to get over-the-counter hearing aids instead of prescription ones.
“If I needed [hearing aids] right now…I would go to an audiologist,” Sims said. “They will guide me step by step, they will know all kinds of things about sound, ears and adjustments.”
“I only spoke out of privilege,” he 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 more trial and error. So I think audiologists and doctors are still an important piece of the puzzle. It’s good not to force it.”
Over-the-counter 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 her hearing loss is too great to benefit from over-the-counter hearing aids.
“Because of my inner ear hearing loss, my very small in-ear hearing aids have a custom fit so I can wear them all day, every day,” Page told HuffPost. “Will over-the-counter hearing aids have custom settings? 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 buying glasses: Some people, depending on their visual needs, may go to the store and try on different glasses to find out which ones help them see more clearly. But other people need to have their eyes examined and evaluated by an ophthalmologist to determine which prescription lenses work best for them.
Page worries that the FDA’s decision on over-the-counter hearing aids and the “one size fits all” mentality is leading some people to the wrong conclusions.
“If anything, this FDA decision will have a negative impact on me, because everyone else will expect me to be able to get hearing aids easily and cheaply on a regular basis,” he said. “I’ll have to further explain how that’s not the case.”
Pratesi said that since his practice is disaggregated ― a cheaper alternative to bundled services ― can help people who bring over-the-counter hearing aids. However, out-of-pocket costs can still be high, since audiological services, as well as hearing aids, are not covered by insurance.
“I want audiological care to be affordable and accessible to everyone,” Pratesi said. “If OTC products work for what someone needs, that’s great. If over-the-counter medications don’t work for what someone needs, no one should be left without hearing care because of the cost.”
Pratesi said this barrier to access could be addressed if insurance companies classified audiologists as limited-licensed professionals rather than equipment providers, and hearing aids as medical devices rather than cosmetics or consumer products. This topic has been hotly debated since the development of the first electric hearing aid 100 years ago, and particularly during Congressional hearings beginning in the 1960sVirdy said.
“As long as they’re promoted as a consumer product, where consumers make the decision about which hearing aid suits their needs, and not as a medical device, which means it’s covered by insurance… we’ll always be limited,” she said. said.
Some states have passed insurance mandates for hearing health care coverage, depending on the American Speech-Language-Hearing Association. However, Pratesi points out that federal legislation would help. the Medicare Audiologist Services and Access Act is a federal bill that would require insurance coverage for 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 referrals required to receive a hearing test.
“If we think about where we’re going in the future, I think we should push harder for devices to be covered by insurance, and not just the devices, but all the associated costs that go along with them,” Virdi said. “I think that’s something that I really hope will change.”
Some experts predict that over-the-counter hearing aids will ultimately lead to more innovation and lower costs. Pratesi believes there will be a change in practices offering more unbundled services, which would also translate into lower costs.
Over-the-counter hearing aids have also started important conversations about inaccessibility and how hearing aids, American Sign Language and cochlear implants are tools to help people with various communication goals, Pratesi said. Still, she doesn’t want to change to stop here.
“I am excited about what this legislation does. But I don’t want people to think that ‘Okay, great, we passed OTC and now we’re there.’ We are not there,” she said. “There are still more people who need help, there are still more changes we need to make to make hearing care affordable and accessible to everyone.”
