Las Vegas

FDA proposes rule to offer over-the-counter hearing aids – Las Vegas, Nevada

Las Vegas, Nevada 2021-10-19 12:24:29 –

(Getty Images)

Washington(Hill) – The Food and Drug Administration (FDA) is proposing rules to offer a new category of over-the-counter hearing aids to make devices more accessible and cost-effective for Americans.

agency Announced the proposal On Tuesday, when a particular hearing aid is completed, it will be available for direct sale to millions of adults who experience “mild to moderate” deafness.

Under the updated rules, these patients were able to purchase certain air conduction devices in stores or online without undergoing a medical examination or fitting. Adults with severe deafness or children with deafness still need a prescription.

Authorities Proposed regulations “Probably” means intensifying competition in the market by selling cheaper hearing aids and making them available to the public. For your safety, this rule covers specific device performance and design requirements, including maximum volume limits.

The FDA’s proposal implements the over-the-counter hearing aid law, which was signed as part of the 2017 FDA Reapproval Act.

Secretary of Health and Welfare Xavier Besera In a statement, the move “is one step closer to the goal of making hearing aids more accessible and affordable for tens of millions of people who experience mild to moderate deafness.”

sense. Elizabeth Warren (D-Mass.) And Charles Grassley Introducing the 2017 law (R-Iowa) praised the FDA’s proposal as “great news” in a joint statement.

“We have just cleared the major regulatory hurdles for over-the-counter hearing aids,” said the Senator. “Soon, millions of people with mild to moderate deafness will eventually have access to low-cost hearing aid options. With more options, competition in the market will intensify and consumers The cost is even lower. “

Two senators sent a letter to the FDA last week urging them to follow through. President BidenJuly Executive Order requiring distributors to submit regulations for over-the-counter hearing aids within 120 days.

About 37.5 million American adults, or 15%, say they have hearing problems, but only about one-fifth of those who can get the help of hearing aids have hearing problems.

Progressive has prioritized expanding Medicare to cover hearing, vision and dental care with this year’s Democratic Budget Adjustment Package. The party, which has a majority in the House of Representatives and the Senate, is negotiating with Sen in hopes of achieving its goals. Bernie Sanders (I-Vt.) Including it in the spending package is called “non-negotiable”.

Source link

Back to top button