In 2017, Congress granted the F.D.A. three years to develop standards for safe and effective over-the-counter hearing aids. The agency took five years instead, and the long delay and continued industry opposition made manufacturers skittish about investing, Dr. Lin said.
Pandemic-related shortages and supply chain snafus have not helped.
So far, manufacturers and retailers have said little about new products, prices and distribution. But some details have emerged.
Best Buy, for instance, will open hearing centers in more than 300 stores by late October. Customers will be able to use an online hearing assessment tool and choose from nine over-the-counter brands with help from sales staff members, who will undergo specialized training. Prices will range from $200 to $3,000, the company said.
Sony has announced a partnership with WS Audiology Denmark, one of the big five hearing aid manufacturers, but has not revealed specifics. Bose Corporation and Lexie Hearing will introduce a new self-fitted over-the-counter aid for about $900, well below traditional prices but “still a price point people will think twice about,” Ms. Kelley said.
Prices are likely to fall over time, “like everything else in consumer electronics,” especially as competition increases, Dr. Lin said. For now, many of the available over-the-counter products have already been offered online, but companies are likely to unveil new devices in January at the Consumer Electronics Show in Las Vegas.
The potential market is enormous. Self-perceived mild to moderate hearing loss, the condition that these devices are designed to address, affects about one-quarter of people in their 60s, half of those in their 70s and three-quarters of those over 80.
People with mild to moderate hearing loss may experience problems understanding conversations when they are in groups, when there is background noise and when they are on the phone; they may have to ask others to speak louder or repeat themselves, and turn up the television volume.
Untreated hearing loss can increase the risks of social isolation and depression and contribute to falls. The Lancet Commission on Dementia Prevention, Intervention and Care identified it as the single greatest potentially modifiable risk factor for dementia.
Yet, a 2018 study of Americans over 70 found that although hearing aid use had increased over several years, only 18.5 percent owned and used them, with still lower rates among low-income and Black respondents.
Price has been a major obstacle, although not the only one. Traditional Medicare does not cover hearing aids; Medicare Advantage plans usually include some hearing coverage, yet beneficiaries still wind up paying 79 percent of their costs out of pocket.
Expanding traditional Medicare to include hearing, vision and dental benefits was part of the Biden administration’s Build Back Better Act, which was passed by the House of Representatives last year but scuttled in the Senate.
So the eventual advent of an array of lower-cost hearing aids, available without gatekeepers, presents opportunities for millions of people. Some devices will require smartphones and Bluetooth technology to customize their functions; others will be simpler, with preset amplification options. Most will be rechargeable, largely eliminating the need to fumble with tiny batteries.
“I’m very enthusiastic about this,” said Jan Blustein, a health policy professor at New York University and an author of a recent overview in The Journal of the American Geriatrics Society. “The barriers in the current system are too great. People need access to devices.”
But in these early months, she and other advocates warned, consumers should maintain realistic expectations and proceed with caution. Contrary to the widely used analogy, acquiring hearing aids is not like buying eyeglasses.
Most aging eyes have not suffered any damage; they simply no longer bend light as effectively. Corrective lenses solve the problem and, with the correct prescription, often provide near-perfect vision. But with hearing in older adults, “there’s been damage to the inner ear with age and noise exposure,” Dr. Lin said. “The cells that send sounds to the brain die off and can’t regenerate.”
With the appropriate aids, “your hearing will improve,” Dr. Blustein said. “But don’t expect you’ll go back to the way it was before you developed hearing problems.”
Moreover, finding the right device and adjusting it to the correct “acoustic fit” — boosting whichever frequencies a user needs amplified — may take several tries. “It’s not climbing Mount Everest, but it’s complicated,” said Dr. Blustein, who uses hearing aids. “You really have to persevere.”
That makes return policies important. The F.D.A. disappointed consumer advocates by not mandating them, leaving it to states, manufacturers and retailers to set their own. But the agency did require that return policies be clearly specified on the package. Since a user’s brain can take several weeks to adapt to amplified sound, consumers should look for at least a 30-day return policy.
It remains to be seen how audiologists will adapt. For many, hearing-aid sales have been their primary source of income. How readily will they alter their practices to mainly provide testing, education, counseling and support, while customers purchase devices over the counter?
Some users will feel comfortable self-fitting their new aids using online tools, but others will want guidance on choosing, fitting and learning to live with their devices. They may need help as problems arise, such as ear wax blockage and device repair. And since hearing aids have a three- to five-year life span, Dr. Lin said, users will eventually need to go through the process again, perhaps several times.
Some companies selling directly to consumers, like Eargo, provide extensive support services remotely, but will that satisfy most older buyers? Dr. Lin said he hoped that “a lot of audiologists will see patients, spend time testing and counseling and educating them, and not have to sell them a $4,000 device.”
To help consumers navigate the new terrain, the Hearing Loss Association of America has published a tip sheet. Wirecutter has published a useful guide to over-the-counter hearing aids and updates it frequently. (Wirecutter is a product recommendation service owned by The New York Times Company.) Hearing Tracker, a website published by the audiologist Abram Bailey, will assess over-the-counter devices as well.
Last month, the Johns Hopkins Bloomberg School of Public Health created HearingNumber.org to help people determine their level of hearing loss and learn about treatment options. For now, its assessment tool requires an Apple smartphone or tablet.
But as with almost everything else involved with this expected transformation, that will change in the next few months, Dr. Lin said. Give it a little time.