WASHINGTON – Millions of Americans will be able to buy hearing aids without a prescription later this fall, according to a long-awaited rule completed on Tuesday.
The Food and Drug Administration says the new regulation cuts red tape by creating a new class of hearing aids that don’t require a physical exam, prescription and other specialist evaluations. Instead, the devices will be sold online or over-the-counter at pharmacies and other retail stores.
This device is intended for adults with mild to moderate hearing problems. The FDA estimates that nearly 30 million adults could benefit from the use of hearing aids, but currently only about one in five people with hearing problems use them. The FDA first proposed the rule last October. The new rule will go into effect in mid-October.
Biden administration officials highlighted the potential for cost savings.
“Today’s action by the FDA represents an important milestone in making hearing aids more affordable and accessible,” Health and Human Services Secretary Xavier Becerra, said in a statement. .
The move comes after years of pressure from medical professionals and consumer advocates to make the devices cheaper and easier to buy.
Cost is a major obstacle these days. Between the device itself and the assembly services, Americans can pay more than $5,000 for a hearing aid. Coverage is very limited and Medicare does not pay for hearing aids but only for diagnostic tests.
The new over-the-counter status will not apply to more severe hearing loss devices, but will only apply to prescriptions.
Consumer electronics companies have for years produced lower-cost “personal sound amplifiers” devices, but U.S. regulations prohibit them from being marketed as hearing aids and they not reviewed by the FDA. The new rule states that those devices are not alternatives to FDA-approved hearing aids. Companies that inappropriately market them may face penalties, such as fines or product confiscation.
The FDA said it changed several parts of the original proposal in response to public comments, including clarifying how the federal rule would impact state regulations on devices. Hearing Aid.
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Once the federal regulation goes into effect, traditional manufacturers are expected to begin selling cheaper models, directly to consumers. Ultimately, advocates predict the hearing aid market will resemble eye care, where consumers can choose between pharmacy reading glasses or prescription bifocals.
Tuesday’s announcement comes at the urging of health committees and Congress, which in 2017 directed the agency to plan for over-the-counter hearing aids.
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