Via press release from the FDA:
Today, the U.S. Food and Drug Administration issued a final rule to improve access to hearing aids which may in turn lower costs for millions of Americans.
This action establishes a new category of over-the-counter (OTC) hearing aids, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or a fitting adjustment by an audiologist.
The rule is expected to lower the cost of hearings aids, furthering the Biden-Harris Administration’s goal of expanding access to high-quality health care and lowering health care costs for the American public.
It is designed to assure the safety and effectiveness of OTC hearing aids, while fostering innovation and competition in the hearing aid technology marketplace.
Today’s action follows President Biden’s 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 and set a swift 120-day deadline for action, which the FDA met.
Breaking News: The FDA cleared the way for hearing aids to be sold over the counter without a prescription to adults, a long-awaited wish of millions of consumers frustrated by expensive exams and devices.https://t.co/WPZNwVgGjR
— The New York Times (@nytimes) August 16, 2022
Good news: The FDA has issued a new rule to allow hearing aids to be sold over the counter. pic.twitter.com/3WJLUueEwt
— Vice President Kamala Harris (@VP) August 16, 2022
Today, we took action to establish a new category of over-the-counter hearing aids, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers. https://t.co/xAuSXWYeal pic.twitter.com/6hUYatBKY8
— U.S. FDA (@US_FDA) August 16, 2022