Via press release from the FDA:
Today, the U.S. Food and Drug Administration issued a landmark proposal intended to improve access to and reduce the cost of hearing aid technology for millions of Americans. The agency proposed a rule to establish a new category of over-the-counter (OTC) hearing aids.
When finalized, the rule would allow hearing aids within this category to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist.
The proposed rule is designed to help increase competition in the market while also ensuring the safety and effectiveness of OTC and prescription hearing aids.
Today’s action follows President Biden’s July Executive Order on Promoting Competition in the American Economy, which called for the FDA to take steps to allow hearing aids to be sold over the counter.
This effort also builds on the Biden-Harris Administration’s goal of expanding access to high-quality health care and lowering medical care costs for the American public.
“Reducing health care costs for everyone in America is a top priority,” said Health and Human Services Secretary Xavier Becerra.
“Today’s move by FDA takes us one step closer to the goal of making hearing aids more accessible and affordable for the tens of millions of people who experience mild to moderate hearing loss.”
President Biden’s executive order on competition is making hearing aids easier to get and more affordable for millions of Americans.https://t.co/cBBDG5jiYe
— The White House (@WhiteHouse) October 19, 2021