In theory, millions of Americans with mild-to-moderate hearing loss should be able to walk into a drug store today, buy devices akin to smartphone earbuds and re-engage with the audible world as they exit the store. That they can’t is another thing to blame on the pandemic.

The Food and Drug Administration, its hands full with the health crisis, missed its August 2020 deadline to propose rules for selling hearing aids over the counter under a 2017 law, according to the National Institutes of Health. President Joe Biden last month signed an executive order nudging the agency to finish draft rules within 120 days. If that happens, it could take about a year for the products to start appearing in drugstores, experts say.

When the FDA eventually does issue final rules, experts hope it will unleash competition among consumer electronics companies for a global market that some estimate should jump 40% to  $11.6 billion by 2028. Currently, only a handful of specialty device makers dominate the hearing aid market.

“These over-the-counter devices should cost $200 to $800. And they’ll be produced by companies like Bose, Samsung and maybe Apple,” said Dr. Justin Golub, an ear specialist at Columbia University Medical Center in New York. “These are the really innovative companies that always compete to drive costs down, constantly innovate and prove value. So we’re pretty excited about this.”

Affects 40 million adults 

Hearing loss is no minor ailment. When you can’t hear well, you’re more prone to slip into depression, feel socially isolated and even be at higher risk for dementia, researchers have found. In the U.S., it’s a widespread problem. About 40 million American adults suffer from some form of hearing loss, according to the National Institutes of Health. 

Yet most insurance — including most forms of Medicaid and traditional Medicare — doesn’t cover hearing aids, which require a prescription. Some people are too embarrassed to wear what’s historically been a clunky design. Fewer than 30% of people who need hearing aids actually wear them, said Dr. Hope Lanter, the head audiologist at healthcare services provider hear.com, even when it seems like everyone these days has a device in their ears compared to even a decade ago. 

Adding “the flashy, sex-appeal version of some of the companies that will put their stamp on these things” will help, Lanter said. “Even though some of our most major manufacturers are out there doing extremely amazing jobs with hearing technologies, we still don’t necessarily have that stamp from some of the bigger players that some people might find to be a little bit more attractive,” she said.

At about a $2,500 out-of-pocket cost on average — high-end devices can run over $8,000 — most adults can’t afford hearing aids. And 14% of adults would be pushed below the federal poverty level if they spent the money, according to one estimate.

Brands like Bose reduce stigma

Less expensive hearing aids by known brands are currently available. Bose sells an $850 hearing design cleared by the FDA for direct-to-consumer online sales in five states — Massachusetts, Montana, North Carolina, South Carolina and Texas — with plans to expand. Apple in 2013 began including Bluetooth software for its iPhone that is compatible with hearing aids and offers other hearing-oriented device features, including dampeners and amplification. Costco, through its Kirkland brand, sells hearing aids for about $1400.

Tech companies are betting that sleeker designs and over-the-counter sales will help eliminate stigmas of ageism and expand the market, said Brian Maguire, who leads Bose Hear.

“Over time, we believe truly, with greater accessibility and more people wearing hearing aids at lower prices, they just become more palatable,” Maguire told CBS MoneyWatch. “Today, they’re viewed almost as a prosthetic as opposed to a desirable consumer object. And we believe that could change.”

Maguire and others point to reading glasses as an example of a similar shift.

“You don’t look at someone who’s wearing glasses or readers the same way you might with a hearing aid,” he said, but believes hearing aids will soon shake that stigma. “We believe that when they become more accessible over time, over the generations, they certainly will,” he said. 

Like reading glasses for vision

Consumers shouldn’t confuse devices called personal sound-amplification products, available from various retailers, with hearing aids. These so-called PSAPs are marketed to people with unimpaired hearing as sound amplifiers in noisy settings like restaurants, according to the Hearing Industries Association, an industry group. They cost up to about $500, and the FDA prohibits retailers from marketing them as hearing aids.

Meanwhile, many people with hearing loss require more sophisticated hearing aids, experts note. Over-the-counter tech — much like reading glasses for vision — won’t address severe hearing loss or specific needs.

“Over-the-counter hearing aids are only going to be for adults with perceived mild to moderate hearing loss — and they will self-diagnose, self-fit,” said Barbara Kelley, executive director of the Hearing Loss Association of America. “For more severe hearing loss, you still have to go through the process and end up in the good care of either an audiologist or a hearing aid specialist.”

For its part, the FDA shares President Biden’s desire to move things along, and has been “working diligently” to draft the new rules amid the pandemic, the agency told CBS MoneyWatch.

“Issuing the proposed rule is a high priority for FDA, and the agency is committed to ensuring proper guardrails are in place to assure that over-the-counter hearing aids will be a safe and effective option for consumers,” the FDA said in a statement.