The FDA has finally issued a ruling that took years to complete and opens the door to cheaper, more accessible hearing aid devices to be acquired without a prescription or medical exam.
President Biden issued an executive order last July calling for greater competition in the economy, which included a call for the rule “to promote the wide availability of low-cost hearing aids” to be published.
Today, The Food and Drug Administration announced hearing aids will be available without a prescription to adults. Consumers have long been frustrated by expensive exams and devices.
As soon as mid-October, people with mild to moderate hearing loss should be able to buy hearing aids online and in retail stores, without being required to see a doctor for an exam to get a prescription.
The FDA cited studies estimating that about 30 million Americans experience hearing loss, but only about one-fifth of them get help. The changes could upend the market, which is dominated by a relatively small number of manufacturers, and make it a broader field with less costly, and perhaps, more innovative designs. Current costs for hearing aids, which tend to include visits with an audiologist, range from about $1,400 at Costco to roughly $4,700 elsewhere.
“This could fundamentally change technology,” said Nicholas Reed, an audiologist at the Department of Epidemiology at Johns Hopkins Bloomberg School of Public Health. “We don’t know what these companies might come up with. We may literally see new ways hearing aids work, how they look.”
The FDA’s final rule will take effect in 60 days. Device makers are already prepared to launch new products. Updates to the labeling and the packaging to comply with technical details in the rule, may take some delay.
Dr. Robert Califf, the FDA commissioner, tweeted Tuesday that the rule tackles a “critical public health issue” that affects millions.
“Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online,” he said.
A recent survey found that people aged 50 to 80 were twice as likely to plan on taking their pet to the veterinarian in the coming year than to get their hearing checked.
“It breaks my heart a little bit,” said Sarah Sydlowski, associate chief improvement officer of 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 to make sure that people understand that hearing is incredibly important. It deserves their attention; it deserves their action.”
Hearing loss can result in cognitive decline, depression, isolation and other health problems in older adults. Barriers to getting help have included costs that are not covered by Medicare. People are also concerned with appearing “old” when wearing a hearing aid.
Back In 2016, a proposal for the FDA to approve over-the-counter hearing aids for adults with mild to moderate hearing loss came out in a National Academies report. The following year, Senators Chuck Grassley, a Republican of Iowa, and Elizabeth Warren, a Democrat of Massachusetts, introduced a bill enabling the agency to make the change that was signed into law but the process to finalize regulations has moved slowly since then. There was the typical conflict over the details, like how the federal rule would interact with state laws on hearing aid returns, warrantees and policies and how technical concerns regarding just much the devices should amplify sound.
That particular rule came out in the fall of 2016, followed by a period of public comment. The Hearing Industries Association, an widely respected industry group, submitted a 45-page comment letter warning the FDA about companies that had just come on the market in 2018, right after the initial law passed. The report was concerned about 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 scenario.
“We applaud the action to increase access to care for persons who have difficulty and encourage them to seek a professional,” to help navigate their options and the fitting process, said Kate Carr, president of The Hearing Industries Association. Other organizations were concerned that the FDA would be creating a safety issue by allowing new hearing aid makers to make devices that allow users to hear loud sounds.
Senators Warren and Grassley also released a joint report accusing the “dominant hearing aid” makers of engaging in what they called an “astroturf lobbying” effort by flooding the FDA with repetitive comments steering the agency toward a new generation of hearing aids that would be “less effective, protecting manufacturers’ existing market share and locking in their competitive advantage.”
“The logic is simple: The less effective an O.T.C. hearing aid is, the more likely 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’ investigative report said.
The FDA reviewed more than 1,000 comments submitted about the rule and made a handful of changes in the final version released on Tuesday. They include lowering the maximum sound output of the devices and revising the insertion depth limit in the ear canal. The rule also requires that the hearing aids have a user-adjustable volume control and more easily understandable wording on the product labels.