The US Food and Drug Administration issued a decision Monday making hearing aids available for sale over the counter without a prescription or appointment.
This is a game changer for many people with disabilities, as they say the ruling will benefit millions of Americans with hearing loss. At the same time, the ruling highlights barriers to accessing hearing aids that members of the disability community say have yet to be addressed. The HuffPost spoke to experts in the field who have highlighted the benefits of over-the-counter hearing aids — and raised some concerns about their adoption.
“I’m excited about this leap forward,” Glenda Sims, chief information accessibility officer at Deque, a digital accessibility company, told HuffPost. “People who want to improve their hearing or return to a previous level of hearing if they have mild or moderate hearing loss, [and] who couldn’t afford it in the past will really have a lot more within their reach when there are some that will be available for $200 instead of thousands of dollars.”
Ten million Americans suffer from 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 a prescription hearing aid is approximately $2,000, not counting the cost of audiological visits for fittings and other services.
Over-the-counter hearing aids are now available from major retailers like Walgreens and CVS at significantly lower costs, saving consumers an estimated $3,000 per pair of hearing aids. Sims said her best friend had a hearing loss in one of her ears, but she struggled to afford hearing aids as a single parent for 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 takes on credit card debt because she needed it. She can’t hear the ends of the words the kids are saying to her in class.”
OTC hearing aids can also be beneficial for people with mild to moderate hearing loss who may not have previously had access to prescriptions. Laura Pratesi, an audiology doctor who is also hard of hearing, said many patients fall into this category and would benefit from a technology but cannot afford or do not necessarily need prescription hearing aids.
A key point, Pratesi says, is that OTC hearing aids could allow for early adoption of hearing technology. The longer a person lives with hearing loss, the more difficult it can be for them to successfully switch to hearing aids when they so choose. And studies have shown that adults wait more than a decade after first experiencing hearing loss to fit hearing aids, which Pratesi says is partly related to stigma.
Sims believes the 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 hearing aid acoustics.
“I’ve had patients who don’t necessarily like 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 it so cool,’” she said.
One problem professionals see with OTC hearing aids is that consumers may not have the technological know-how to choose the right products. Jaipreet Virdi, a history professor at the University of Delaware, said she believes the FDA’s decision to favor OTC hearing aids is a good thing, especially given the cost-saving benefits. However, she worries that not everyone has the technological know-how to reap the full benefits.
“It will be great that people buy the right hearing aid that is more affordable for them, but they may not get the full benefit of the products they would need,” Virdi told HuffPost.
Audiologists can calibrate and program hearing aids to a person’s audiological range, as well as provide services such as hearing rehabilitation, hearing training, cleaning, and software updates to ensure the user is getting the most out of the device. Still, these services can be difficult to afford along with the cost of prescription hearing aids. Sims notes that this is one reason some people may prefer to buy OTC hearing aids rather than prescription ones.
“If I needed it [hearing aids] now…I would go to a hearing care professional,” Sims said. “They’re going to walk me through step by step, they’re going to know all sorts of things about sound and ears and fittings.”
“I only spoke out of privilege,” she added. “I could afford to do that instead of doing my own research. I could also do my own research and be patient and have a bit more trial and error. So I think audiologists and doctors are still an important piece of the puzzle. It’s just nice not to force it.”
OTC hearing aids are somewhat limited because they don’t help children or people with profound hearing loss, Pratesi said. For example, Maria Page, 53, said her hearing loss was too severe to benefit from OTC hearing aids.
“Because of my sensorineural hearing loss, my very small, in-the-ear-canal hearing aids have a custom fit that allows me to wear them all day, every day,” Page told HuffPost. “Are the over-the-counter hearing aids custom fitted? I assume no, because that would mean more work.”
Hearing aids are not a one-size-fits-all, Virdi said. She uses the analogy of buying glasses: depending on their vision needs, some people can go to the store and try on different glasses to see which ones help them see more clearly. But other people need to have their eyes examined and evaluated by an optometrist to determine which corrective lens is best for them.
Page worries that the FDA ruling on OTC hearing aids and the one-size-fits-all mindset may lead some people to the wrong conclusions.
“If anything, this FDA decision will have a negative impact on me because everyone else will expect that I’ll be able to get hearing aids easily and somehow cheaper on a regular basis,” she said. “I’m going to have to explain even harder why that’s not the case.”
Pratesi said she can help people who bring OTC hearing aids because her practice is unbundled – a cheaper alternative to bundled services. However, the costs can still be high since audiological services and the actual hearing aids are not covered by insurance.
“I want audiology care to be affordable and accessible for everyone,” said Pratesi. “When over-the-counter products work for what someone needs, that’s fantastic. If over-the-counter doesn’t work for what someone needs, nobody should have to sacrifice audiological care for cost reasons.”
Pratesi said this barrier to entry could be addressed if insurance companies classified audiologists as restricted-licensed practitioners rather than equipment suppliers and classified hearing aids as medical devices rather than cosmetic 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 starting in the 1960s, Virdi said.
“As long as they’re advertised as a consumer product, where consumers make the decision about which hearing aid meets their needs, and not as a medical device, which means it’s covered by insurance, we’re always going to be limited,” she said.
According to the American Speech-Language-Hearing Association, some states have enacted health insurance mandates for hearing aids. However, Pratesi notes that federal legislation would help. The Medicare Audiologist Access and Services Act is a federal law that mandates coverage for hearing aids and audiological services. It would also increase access to licensed providers for people who suspect they have a hearing loss by eliminating the medical referrals needed for a hearing test.
“As we think about where we’re going in the future, I think we should be pushing more for insurance to cover the devices — and not just the devices, but all the costs associated with it,” Virdi said. “I think that’s one thing that I really hope will change.”
Some experts predict that OTC hearing aids will eventually lead to more innovation and lower costs. Pratesi believes that there will be a shift in practice to offer more unbundled services, which would also lead to 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 diverse communication goals, Pratesi said. Still, she doesn’t want the change to stop there.
“I am excited to see what this legislation will do. But I don’t want people to think, ‘okay, great, we passed OTC and now we’re there. We’re not there,'” she said. “There are more people who need to be helped, there are more changes we need to make to make audiological care affordable and accessible for all.”