The Food and Drug Administration (FDA, for its acronym in English) decided Tuesday to allow the sale of hearing aids over the counter and without a prescription to adults, a longed wish of consumers frustrated by expensive tests and devices.
The high cost of hearing aids, which are not covered by basic Medicare, has discouraged millions of Americans with hearing loss from purchasing the devices. Health experts say that untreated hearing loss can contribute to cognitive decline and depression in older people.
Under the new rule, people with mild-to-moderate hearing loss should be able to buy hearing aids online and in retail stores starting in October, without needing to see a doctor for an exam to get a prescription.
The FDA cited studies that estimate that about 30 million Americans experience hearing loss, but only one-fifth of them receive help. The changes could shift the market, which is dominated by a relatively small number of manufacturers, into a larger field with less expensive and perhaps more innovative designs. Current costs for hearing aids, which tend to include visits to an audiologist, range from $1,400. at Costco a approximately $4,700 elsewhere.
“This could fundamentally change the technology,” said Nicholas Reed, an audiologist in the Department of Epidemiology at the Johns Hopkins Bloomberg School of Public Health. “We don’t know what will happen to these companies. We can literally see new ways hearing aids work, how they look.”
The FDA’s final rule takes effect in 60 days. Industry representatives say device makers are largely ready to launch new products, though some may need time to update labeling and packaging or to comply with technical details of the rule.
Dr. Robert Califf, the FDA commissioner, said the move is intended to “unleash the power of American industry” in a way that could have global influence.
“Hearing loss has a profound impact on daily communication, social interaction, and the overall health and quality of life for millions of Americans,” Dr. Califf said during a news conference on Tuesday. “This is a tremendous global problem where I think American ingenuity can make a big difference.”
The White House also hailed the move as a signature achievement for President Biden, who is also expected to sign the Inflation Reduction Act on Tuesday. The change eliminates the requirement to see an audiologist for a hearing exam and fitting, a process rarely covered by insurance.
Federal officials estimated a savings of $2,800 on the cost of a pair of hearing aids. Brian Deese, director of the White House National Economic Council, said making the change was a “top priority” for the president.
“This is going to make a really concrete difference in the lives of millions of Americans,” Mr. Deese said.
Hearing loss is associated with cognitive decline, depression, isolation, and other health problems in older adults. However, barriers to hearing aids include costs not covered by Medicare. There is also the stigma, such as looking “old,” that comes with use.
Appreciation of the importance of acute hearing for adults is also misplaced: A recent survey found that people ages 50 to 80 were twice as likely to plan to take their pet to the vet in the next year than to get their hearing tested.
“It breaks my heart a bit,” said Sarah Sydlowski, associate director for enhancement at the Cleveland Clinic Head and Neck Institute and lead author of the study. “I think our biggest challenge as a profession and as a health care system is making sure people understand that hearing is incredibly important. It deserves your attention, it deserves your action.”
The move has irked some of the nation’s audiologists, the professionals who guide people through the process of choosing the best hearing aid, adjusting settings and getting the right fit. The new move removes a longstanding requirement that consumers start the process of getting a hearing aid with them. But some in the profession see the opportunity.
“The hearing health professional isn’t going to go far,” said Barbara Kelley, executive director of the Hearing Loss Association of America, which represents audiologists and consumers. “The over-the-counter rule opens up a huge new avenue for adults with mild to moderate hearing loss to take that step sooner rather than later. And that’s what really excites us.”
Change has been seeping in for years. In 2016, a proposal for the FDA to approve over-the-counter hearing aids for adults with mild to moderate hearing loss was presented at the National Academies. report. The following year, Senators Chuck Grassley, a Republican from Iowa, and Elizabeth Warren, a Democrat from Massachusetts, introduced a bill allowing the agency to make the change that signed into law.
The process to finalize the regulations has moved slowly since then, with some conflicting over details, such as how the federal rule would interact with state laws on return of hearing aids or warranty policies and how much the devices should amplify sound.
President Biden issued an executive order last July calling for more competition in the economy, including a call for the rule to be published “to promote the wide availability of low-cost hearing aids.”
that rule he left in the fall, followed by a public comment period. The Hearing Industries Association, an industry group, released a 45-page report comment letter warning the FDA about companies that had gone on the market in 2018, after the initial law was passed, selling hearing aids that “were ineffective, of poor quality and, in some cases, dangerous.” The organization offered detailed advice on how to avoid a repeat of the scenario.
“We applaud action to increase access to care for people who are struggling and encourage them to seek out a professional” to help them explore their options and the adjustment process, said Kate Carr, president of the trade group. Other organizations expressed concern that the FDA would be creating a safety problem by allowing new hearing aid manufacturers to make devices that allow users to hear loud sounds.
Senators Warren and Grassley had published a joint report accusing “dominant hearing aid” manufacturers of engaging in an “artificial turf lobbying” effort by inundating the FDA with boilerplate comments directing the agency toward a new generation of hearing aids that would be “less effective, protecting the participation of manufacturers’ existing market and securing their competitive advantage.
“The logic is simple: the less effective an over-the-counter hearing aid is, the more likely it is that consumers will be forced to abandon these options and instead opt for more expensive prescription devices sold by the manufacturers that dominate this line of business. “, the senators’ investigation report said.
The FDA reviewed more than 1,000 comments submitted on the rule and made some changes to the final version released Tuesday. They include the reduction of the maximum sound output of the devices and the revision of the insertion depth limit in the ear canal. The rule also requires hearing aids to have a user-adjustable volume control and simplified wording on the product label.
