Hearing aids to finally be sold over the counter, lower prices expected

Health regulators have unveiled their proposal to allow Americans to buy hearing aids without a prescription, a long-awaited move intended to make the devices more accessible to millions of people with hearing problems.

The Food and Drug Administration said the proposed rule would reduce the bureaucracy that currently requires hearing tests and a prescription for people with mild to moderate hearing loss. As part of the plan, the devices could be ordered online or purchased over-the-counter at drugstores and other retail stores.

The move follows years of pressure from medical experts and consumer advocates to make the devices cheaper and easier to obtain.

More than 37 million Americans, or 15% of adults, have hearing problems, according to the FDA, but only about a fifth of people who could benefit from a hearing aid use one.

Cost is a big hurdle. Between the device itself and the hearing aid services, Americans can pay more than $ 5,000 to get a hearing aid. Insurance coverage is very limited and Medicare does not pay for hearing aids, only diagnostic tests.

U.S. officials said on Tuesday that the FDA change, when finalized, is expected to boost competition and lower prices.

“Today we are opening the door to an easier and more affordable process,” Xavier Becerra, Secretary of Health and Human Services, told reporters.

The agency will collect public comments on its proposal for 90 days before finalizing the new rules. FDA officials wouldn’t speculate on when new devices actually hit store shelves.

Consumer electronics companies have been making inexpensive “personal sound amplification” devices for years, but US regulations prevent them from being marketed as hearing aids and they are not subject to the FDA review. Regulators said Tuesday that the new rules would explicitly state that the devices are not alternatives to FDA-approved hearing aids. Companies that improperly market them could face federal sanctions, such as fines or product seizures.

For their part, hearing aid manufacturers have long argued that professional expertise is required to choose the right device and adjust its settings to make it work properly.

Once the FDA rules take effect, traditional manufacturers are expected to start selling models that are cheaper and direct to the consumer. Ultimately, advocates predict that the hearing aid market will resemble eye care, where consumers can choose between drugstore reading glasses or prescription bifocals.

The more flexible regulations would not apply to devices intended for people with severe hearing loss or for children. Additionally, the agency said over-the-counter devices should have volume limits and other measures to help prevent injury.

Companies making over-the-counter hearing aids would generally not be required to conduct studies on people. Instead, they would submit claims to the FDA showing they met its standards for the devices.

Tuesday’s announcement follows prompting from medical committees and Congress, which in 2017 asked the agency to present a plan for over-the-counter hearing aids by August 2020. The agency missed that point. deadline, in part because of the COVID-19 pandemic workload. Additionally, an executive order from President Joe Biden earlier this year set a timeline for the agency to take action no later than mid-November.

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