Adults with mild to moderate hearing impairment will be able to buy hearing aids directly from stores, pharmacy and online retailers as soon as mid- October.
The final rule was issued by the FDA on Tuesday and will take effect in two months. The new category of over-the-counter hearing aids will make them more accessible and affordable for millions of Americans.
The rule only applies to certain air-conduction hearing aids for people over the age of 18 who have mild to moderate hearing impairment. Consumer products that help people with normal hearing amplify sounds are not covered by it.
Hearing loss can make it difficult to communicate and contribute to social isolation. According to the FDA, 30 million Americans could benefit from hearing aids. Only a small percentage of Americans with hearing loss use them.
Hearing aids and exams that aren't covered by basic Medicare have been a problem for many people. The devices alone range from $1,000 to $6,000 per ear, and consumers must spend additional time and money getting examined and fitted by a specialist, even though experts say medical evaluation is not needed.
The new rule is estimated to lower the cost of hearing aids by hundreds or thousands of dollars. Robert Califf said on the call that the FDA is working with manufacturers to make sure the over-the-counter devices are of good quality.
The move will reduce red tape and promote innovation and competition in a highly concentrated marketplace, according to the administration.
The top five hearing aid manufacturers control more than ninety percent of the market, according to an investigative report released by two senators.
The bipartisan Over-the-Counter Hearing Aid Act was introduced by the two senators.
The FDA did not issue the rules that would allow for those devices to be sold directly to consumers. Biden called on the FDA to take action on over-the-counter hearing aids within 120 days of the July 2021.
The FDA made several changes to the final version of the proposed rule after receiving more than 1000 public comments.
Hearing aid manufacturers and their allies launched form letter-writing campaigns that accounted for 40% of all public comments on the proposed rule.
The FDA's announcement was applauded by the senators, who said in a statement that they pressed the FDA to take action every step of the way and fought back against entrenched special interests.
Check out these tips from the Hearing Loss Association of America if you want to buy your own hearing aids.
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