Matthew Perone Associated Press
Health regulators on Tuesday announced a proposal to allow Americans to buy hearing aids without a prescription. This is a long-awaited move aimed at making the device accessible to millions of people with hearing problems.
The Food and Drug Administration said the proposed rules would reduce bureaucratic formalism, which now requires hearing tests and prescriptions for people with mild to moderate hearing loss. With this plan, you can order your device online or buy it over-the-counter at a pharmacy or other retail store.
The move, under long-standing pressure from medical professionals and consumer advocates, calls for devices to be cheaper and easier to obtain.
According to the FDA, more than 37 million Americans, or 15% of adults, have hearing problems, but only about one-fifth of those who can benefit from hearing aids use hearing aids. ..
Cost is a major obstacle. Between the device itself and the fitting service, Americans can pay more than $ 5,000 to get a hearing aid. Insurance coverage is very limited and Medicare does not cover the cost of hearing aids and only pays for diagnostic tests.
US officials said Tuesday that if the FDA’s changes were finalized, they would promote competition and lower prices.
“Today we open the door to easier and more affordable processes,” Health and Welfare Secretary Xavier Besera told reporters.
The agency will take public comments on the proposal for 90 days before finalizing the new rules. FDA officials did not speculate when the new device would actually hit the shelves.
Consumer electronics companies have been manufacturing low-cost “personal sound amplifier” devices for many years, but US regulations have banned them from being sold as hearing aids and have not been reviewed by the FDA. Regulators said Tuesday that new regulations would make it clear that these devices are not FDA-scrutinized replacements for hearing aids. Companies that sell them improperly may face federal penalties such as fines and foreclosure of products.
Hearing aid manufacturers have long argued that choosing the right device and adjusting the settings to function properly requires specialized expertise.
When FDA regulations come into force, traditional manufacturers are expected to start selling cheaper direct-to-consumer models. Ultimately, proponents predict that the hearing aid market will resemble eye care, and consumers will be able to choose between drugstore reading glasses or prescription bifocals.
Loose regulations do not apply to devices for people with severe deafness or children. The agency also said that off-the-shelf devices require volume limits and other measures to prevent injury.
Companies that manufacture over-the-counter hearing aids usually do not need to do people’s research. Instead, submit an application to the FDA stating that it meets the device’s criteria.
Tuesday’s announcement follows a proposal from the Medical Commission and Congress instructing authorities to plan for over-the-counter hearing aids by August 2020 in 2017. Pandemic. In addition, an executive order by President Joe Biden earlier this year set a schedule for agents to take action by mid-November.
The Associated Press’s Department of Health Sciences is supported by the Department of Science Education at the Howard Hughes Medical Institute. AP is solely responsible for all content.
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