New FDA Proposal is a Big Step Towards Over-the-Counter Exam-Free Hearing Aids
The idea has been tossed around for years: what if hearing aids could be purchased over the counter, without an expensive exam – sort of like reading glasses? According to this recent Washington Post article by reporter Katie Shepherd, that idea has finally taken a big step toward reality, thanks to a just-released proposal by the U.S. Food and Drug Administration. Both Presidents Trump and Biden had been pushing the FDA toward relaxing its rules as a way of driving down costs and improving innovation, and that day is now much closer. But some in the industry worry that making hearing aids cheaper and easier to buy might also cause people to use devices that aren’t right for their condition.
Hearing Aids Without a Hearing Exam
According to the Washington Post report, the seemingly-insurmountable barriers to more affordable, easier-to-access hearing aids may finally be coming down with a proposal from the FDA that would allow consumers to purchase the devices over-the-counter. These devices will represent a whole new category of hearing aids.
Currently, state-level regulations require a prescription or exam by a medical professional for access to hearing aids, but for millions of patients with mild to moderate hearing loss, acquiring the devices could get easier by as soon as next fall. It is a long-awaited change—over four years in the making since Congress first ordered it—and one highly anticipated by consumers nationwide.
High Cost, Lack of Medical Coverage are Barriers to Hearing Aid Use
Despite the benefits—both socially and emotionally—of wearing hearing aids to improve auditory health, many older adults never try them, the article points out. And the most significant barrier is cost.
As the Washington Post reports, traditional hearing aids can easily cost $5,000-plus per pair, and—perhaps surprisingly to some—the costs are usually not covered by typical Medicare plans or other insurers. (Many Medicare Advantage plans do offer some partial coverage.) This means that older adults, many on fixed incomes, can’t afford the purchase or upkeep of hearing aids, along with the required visits to an audiologist. Demographically, audiologists tend to practice in urban areas with a higher population of young, wealthy people, which can be an insurmountable barrier for older adults who live in rural, semi-rural, or less affluent areas.
The proposed change would make over-the-counter devices available at a fraction of the cost of the usual models, and would completely do away with the need for audiologists in all but the most severe and unusual cases.
Most Hearing-Impaired Seniors Never Try Hearing Aids
Hearing loss is not a rare problem among older adults. According to data collected in the National Health Interview Survey, about 38 million adults in the United States self-report hearing loss. Yet ironically, only one in three adults over 70 with hearing loss has ever worn a hearing aid, mostly because of the barriers mentioned above, but also because of denial or embarrassment.
“More than 30 million people suffer from some sort of hearing loss, and hearing is so vital to what we do, your ability to communicate with others is a huge part of your quality of life,” said Massachusetts physician Vinay Rathi, as reported in the Post article. “We’re really denying people that sort of basic right, which is the ability to communicate with others, because of issues related to cost and access to audiologists.”
New Category of Devices Offers Innovation, Access, Affordability
The over-the-counter hearing aids proposal has had a history several years in the making. Bipartisan federal support of this move has been kicked around since 2015, when President Barack Obama’s Council of Advisors on Science and Technology first recommended the category of over-the-counter hearing aids to the FDA. President Trump signed the Over-the-Counter Hearing Aid Act of 2017 and gave the FDA three years to act.
The three years deadline passed us by in 2020, but the FDA received renewed pressure from President Biden when he signed an executive order including a new November 2021 deadline.
The new rules—if enacted according to plan—should increase both innovation and competition in hearing aid manufacturing, and the FDA intends to regulate this shifting landscape to make sure that safety and effectiveness don’t suffer.
Hearing Aid Manufacturers Express Doubts
Despite the support this move has received on both a federal and consumer level, not everyone is jumping for joy over the intended changes, says the Washington Post. Unsurprisingly, the companies who currently dominate hearing aid manufacturing aren’t keen on the idea of increased competition. These firms also caution that hearing problems won’t all disappear overnight because of the newfound accessibility of over-the-counter devices.
For example, Brandon Sawalich, CEO of Starkey, one of the five biggest hearing aid manufacturers, expressed concern that scams and poor-quality devices will flood the market if barriers are lifted. “My only concern with all of this,” he told the Washington Post, “[is] the reputation of hearing aids. It’s the confusion […] that this could bring to [hearing aids and] the role of the hearing professional.”
Despite his concerns and those of others in his field, moves have already been taken to allow less-expensive hearing aids on a case-by-case basis. High-end speaker company Bose, for example, obtained permission from the FDA in 2018 to sell hearing amplification devices as hearing aids, as did other companies who have pushed the rule changes for years. The new regulations would lift the need for this special case-by-case permission, and enable more and more companies to throw their proverbial hats in the ring.
New Devices Are on Their Way – but Not Quite Yet
Officials are making the changes top-priority, but that doesn’t mean they’ll be ready tomorrow. There will be a 90-day public comment period, after which the rule will be finalized in 60 days and then a further 180-day compliance period for companies already manufacturing hearing aid-like devices.
In short: there’s no real timeline from the FDA quite yet, but affordable, accessible hearing aids are much more than just a fantasy. They’re coming fairly soon to a drugstore near you.
Rajiv’s View: Cautious Optimism, but Expect Frustration
We asked Rajiv Nagaich AgingOptions for his view of this important change, and he said it’s good news in some ways – but he worries that many seniors will be disappointed. “My fear is that there will be a lot of frustration before the marketplace gets this right,” Rajiv said. “People are going to be frustrated in trying to get these new appliances to work properly.”
Yes, he acknowledges, present costs are high, but sometimes the expense is worth it. “No matter what people say,” Rajiv adds, “there is a lot of value to getting a professional hearing test to know what frequencies and decibel ranges and so on a person needs to focus on.”
Nevertheless, in spite of that hesitancy, from a consumer’s standpoint, Rajiv expressed cautious optimism. “In many ways, and for some consumers, this is definitely a step in the right direction,” he said.
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(originally reported at www.washingtonpost.com)