FDA clears over-the-counter hearing aids.

The Food and Drug Administration moved Tuesday to make hearing aids available over-the-counter and over-the-counter to adults, a longtime wish of consumers frustrated by expensive tests and devices.

As of mid-October, people with mild to moderate hearing loss will be able to purchase hearing aids online and in retail stores without having to see a doctor for a prescription.

The FDA cites studies that estimate that about 30 million Americans have hearing loss, but only one-fifth of them get help. The changes could upend a market dominated by a relatively small number of manufacturers and make it a wider field with less expensive and perhaps more innovative designs. Hearing aids, which include a visit with an audiologist, range from about $1,400 at Costco to about $4,700 elsewhere.

“This could fundamentally change 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 these companies might come up with. We literally see new ways of how hearing aids work, how they look.

FDA’s final rule will take effect in 60 days. According to industry representatives, device makers are mostly ready to launch new products, although some may need time to update labels and packaging or comply with technical specifications in the regulation.

FDA Commissioner Dr. Robert Califf; He tweeted. On Tuesday, he said the legislation would address a “critical public health issue” affecting millions of people.

“Establishing this new regulatory category will allow people with mild to moderate hearing loss to have access to safe, effective and affordable hearing aids at their local store or online,” he said.

Hearing loss is associated with cognitive decline, depression, isolation and other health problems in older people. However, barriers to hearing aid access include costs not covered by Medicare. Along with the benefits comes the stigma of looking “old”.

Appreciating sharp hearing isn’t easy for adults, either: A recent study found that 50- to 80-year-olds are twice as likely to plan to take their pet to the vet in the next year than to get their hearing checked.

“It breaks my heart a little bit,” said Sarah Sydlowski, MD, chief of the Cleveland Clinic and associate chief research officer of the 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 people realize that hearing is incredibly important. It deserves attention, it deserves action.”

The change has been brewing for years. In the year In 2016, a proposal to 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, Republican of Iowa, and Elizabeth Warren, Democrat of Massachusetts, introduced a bill that would allow the agency to make the signed changes into law.

The process of finalizing regulations has moved slowly since then, with some conflicting over details, such as how the federal regulation interacts with state laws on hearing aid response or warranty policies and how loud the devices should be.

President Biden called for greater competition in the economy last July, which included a call for legislation to “promote broad access to low-cost hearing aids.”

That rule came out in the fall, followed by a public comment period. The Hearing Industries Association, an industry group, filed a 45-page opinion letter warning the FDA about companies that came on the market in 2018 as “ineffective, substandard, and dangerous in some cases.” The organization offered detailed advice on how to avoid recurring cases.

The trade group’s president, Kate Carr, said: “We appreciate the move to increase access to care for people with problems and encourage them to seek a professional.” Other organizations have raised concerns that the FDA is creating a safety issue by allowing new hearing aid makers to make devices that allow users to hear loud sounds.

Senators Warren and Grassley released a joint report accusing “major hearing aid” makers of engaging in “astroturf lobbying” efforts, flooding the FDA with repeated comments that the agency is “ineffective” for new hearing aid manufacturers to protect market share and lock out their competitive advantage.

The logic is simple: the less OTC hearing aid services available, the more 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 report stated.

The FDA reviewed more than 1,000 comments submitted about the rule and made a few changes in the final version released Tuesday. The devices include lowering the maximum sound output and improving the limit of insertion depth in the ear canal. The regulation also requires hearing aids to have a user-adjustable volume control and simple wording on the product label.

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