F.D.A. Clears Path for Over-the-Counter Hearing Aids

The Food and Drug Administration on Tuesday made a move to make hearing aids available over-the-counter without a prescription, a long-standing wish of consumers frustrated by expensive tests and hearing aids.

In mid-October, people with mild to moderate hearing loss will be able to purchase hearing aids online and in retail stores. No need to see a doctor and get a prescription.

The FDA cited a study that estimates that about 30 million Americans experience hearing loss, but only about one-fifth of them receive help.This change could upend a market dominated by a relatively small number of manufacturers into a wider field of lower-cost and perhaps more innovative designs. Starting at around $1,400, which tends to include a specialist visit at Costco To about $4,700 Elsewhere.

“This could fundamentally change the technology,” said Nicholas Reed, an audiologist at the Johns Hopkins Bloomberg School of Public Health’s Department of Epidemiology. We might literally see new ways of how it works and how it looks.”

The FDA’s final rule will take effect in 60 days. Equipment makers are almost ready to launch new products, according to industry representatives, but time may be needed to update labels and packaging and comply with the technical details of regulations. be.

FDA Commissioner Dr. Robert Calif said: murmured Regulations address a “critical public health issue” affecting millions on Tuesday.

“By establishing this new regulatory category, we are enabling people with a perceived mild to moderate hearing loss to have convenient access to a range of safe, effective and affordable hearing aids from their neighborhood store or online. will be,’ he said.

Hearing loss is associated with cognitive decline, depression, isolation, and other health problems in older adults. But barriers to getting hearing assistance include costs not covered by Medicare. There is also the stigma associated with using it, such as looking “old”.

Recognition of the importance of keen hearing is also for adults. Recent research People aged 50 to 80 were twice as likely to be planning to take their pet to the vet next year than to have a hearing test, it found.

Sarah Sidlowski, Associate Chief Improvement Officer at the Cleveland Clinic Head and Neck Institute and lead author of the study, said: “I think our biggest challenge as a profession and as a healthcare system is getting people to understand that hearing is so important. worth it.”

Change has permeated over the years. In 2016, a proposal for the FDA to approve an over-the-counter hearing aid for adults with mild to moderate hearing loss was presented at the National Academy. reportThe following year, Iowa Republican Rep. Chuck Grassley and Massachusetts Democrat Senator Elizabeth Warren introduced legislation that would allow the agency to make the change. sign the law.

Since then, the process of finalizing the regulations has been a slow one, with questions such as how federal regulations will interact with state laws on hearing aid return or warranty policies, how much sound must be amplified by devices, and more. There are some conflicts over the details.

Last July, President Biden issued an executive order calling for greater competition in the economy, including one calling for the publication of rules to “encourage the spread of affordable hearing aids.”

The rules were announced in the fall, followed by a period of public comment.The Hearing Industry Association, an industry association, on page 45 comment letter After the original law was passed, it warned the FDA about companies that hit the market in 2018, selling “ineffective, poor quality, and in some cases dangerous” hearing aids. provided detailed advice on how to avoid

Kate Carr, president of the industry association, said, “We applaud their actions to increase access to care for people in difficulty and encourage them to seek out professionals,” referring to their choices and fitting process. Other organizations fear the FDA could pose a safety hazard by allowing new hearing aid makers to make devices that allow users to hear loud sounds. expressed.

Senators Warren and Grassley released joint report A “dominant hearing aid” manufacturer repeatedly floods the FDA with comments accusing it of engaging in “astroturf lobbying” for their competitive advantage. ”

The logic is simple; The less effective OTC hearing aids are, the more likely consumers will be forced to abandon these options in favor of the more expensive prescription devices sold by the manufacturers that dominate this business segment. said the senator’s report.

The FDA reviewed more than 1,000 comments submitted on the rule and made some changes to the final version released Tuesday. This includes lowering the device’s maximum sound output and correcting the insertion depth limit into the ear canal. The regulation also requires the display of user-adjustable volume controls and simplified language on hearing aid product labels.

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