The US_FDA recently announced a landmark proposal which could improve access to and reduce the cost of hearing aids for millions of Americans. Find out more:
to establish a new category of over-the-counter 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.
Approximately 15% of American adults age 18 and over report some trouble hearing. However, despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from a hearing aid use one. The proposed rule aims to address barriers to use, including cost, access, social stigma related to hearing loss, perceived value of the devices or certain state and federal regulations.
The proposed rule implements a key provision of the Over-the-Counter Hearing Aid Act, as enacted in the FDA Reauthorization Act of 2017. President Biden’s Executive Order on Competition included a timeline for action, and the FDA has now issued the proposed rule ahead of that schedule. “Hearing loss has a profound impact on daily communication, social interaction and the overall health and quality of life for millions of Americans,” said Acting FDA Commissioner Janet Woodcock, M.D. “The FDA’s proposed rule represents a significant step toward helping ensure that adults with mild to moderate hearing loss have improved access to more affordable and innovative product options.
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