(Bloomberg Law) -- Nearly 30 million US adults impacted by hearing loss will now have easier access to hearing aids under a final rule from the FDA allowing them to be purchased over the counter.
The action, which finalizes an October 2021 draft rule, would establish a separate medical device category for certain air-conduction hearing aids used among people 18 years old and older with mild to moderate hearing issues. The new rule stems from President Joe Biden‘s sweeping mandate to crack down on monopolistic practices in agriculture, technology, pharmaceuticals, and other industries. Biden’s order instructed the FDA to take actions within 120 days that would allow hearing aids to be sold over the counter.
“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” FDA Commissioner Robert M. Califf said in a statement. “Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to a wide array of safe, effective, and affordable purchasing options from their neighborhood store or online.”
The FDA, along with the final rule, issued guidance differentiating between hearing aids and personal sound amplification products, which help people with normal hearing ability amplify sounds in certain environments.
The 2017 FDA user fee reauthorization included provisions for FDA to conduct rulemaking to establish an over-the-counter category for hearing aids. The bipartisan legislation also called for FDA to establish safety and effectiveness requirements for hearing aids that fall in this category.
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