The Food and Drug Administration today moved to make hearing aids available over the counter and without a prescription for adults, after consumers frustrated with a long-sought expensive exams and devices.
In mid-October, consumers with mild to moderate hearing loss should be able to buy hearing aids online and in retail stores, over the counter, without needing to see a doctor for an exam for a prescription.
The FDA, citing studies, estimated that about 30 million Americans experience hearing loss, but only one-fifth of them receive assistance. The changes could lift the market, which is dominated by a relatively small number of manufacturers, and make it a wider sector with less expensive, and perhaps, more innovative designs. The current cost of hearing aids, which includes visits with an audiologist, ranges anywhere from about $1,400 at Costco to $4,700 elsewhere.
“It could fundamentally change technology,” said Nicholas Reid, an audiologist in the department of epidemiology at the Johns Hopkins Bloomberg School of Public Health. “We don’t know what these companies can come up with. We can literally see how hearing aids work, how they look.”
The FDA’s final rule goes into 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 comply with technical details in the regulation.
Dr. Robert Califf, FDA Commissioner, tweeted On Tuesday that rule tackles a “significant public health problem” that affects millions of people.
“Instituting this new regulatory category will give people with mild to moderate hearing loss convenient access to a range of safe, effective and affordable hearing aids from their neighborhood store or online,” he added.
Hearing loss is associated with cognitive decline, depression, isolation and other health problems in older adults. Yet barriers to getting a hearing aid include costs that are not covered by Medicare. There’s also the stigma—such as looking “old”—that comes with use.
Appreciation of the importance of sharp hearing for adults is also off-kilter: A recent survey found that more people aged 50 to 80 plan to take their pet to the vet in the coming year than I was twice as likely to have his hearing examined.
“It breaks my heart a little bit,” said Sarah Sidlowski, MD, associate chief correctional officer at the Cleveland Clinic Head and Neck Institute and lead author of the study. “I think our biggest challenge as a profession and the health care system is to make sure that people understand that hearing is incredibly important. It deserves their attention, it deserves their action.”
Change has been going on for years. In 2016, a National Academies report revealed a proposal by the FDA to approve over-the-counter hearing aids for adults with mild to moderate hearing loss. The following year, Senator Chuck Grassley, a Republican from Iowa, and Elizabeth Warren, a Democrat from Massachusetts, introduced a bill that would enable the agency to make signed changes into law.
Since then the process of finalizing the rules has progressed slowly, with some conflict over details, such as how federal rules will interact with state laws on hearing aid return or warranty policies and how much devices must amplify sound.
President Biden issued an executive order last July calling for more competition in the economy, including a call to publish a rule to “promote the wider availability of low-cost hearing aids.”
That rule came out in the fall, followed by a period of public comment. The Hearing Industries Association, an industry group, submitted a 45-page comment paper warning the FDA about companies that hit the market in 2018, after the initial legislation was passed, for hearing aids. Sales that were “ineffective, of poor quality, and in some cases, dangerous.” The organization provided detailed advice on how to avoid a recurrence scenario.
“We appreciate the action taken to increase access to care for individuals with difficulty and to encourage them to seek a professional,” said Kate Carr, president of the trade group. Other organizations raised concerns that the FDA would create a safety problem by allowing new hearing aid manufacturers to make devices that allow users to hear louder sounds.
Senators Warren and Grassley released a joint report accusing “major hearing aid” manufacturers of being involved in an “astroturf lobbying” effort, with repeated comments to the FDA to move the agency toward a new generation of hearing aids. would be “less effective”. Protecting manufacturers’ existing market share and locking in their competitive advantage.”
,The logic is simple: The less effective an OTC hearing aid, the more likely consumers are to be forced to forgo these options and instead opt for the more expensive, prescription devices sold by the manufacturers that dominate the line. . The report said.
(This story has not been edited by seemayo staff and is published from a rss feed)