FDA 提出创建新类别的非处方助听器的提案

一旦敲定, 该规则将允许助听器在商店和网上销售给消费者,而无需进行体检或听力学家的验配. It would apply to certain air-conduction hearing aids intended for adults age 18 and older who have mild to moderate hearing loss.

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The Food and Drug Administration issued a proposal Tuesday in an effort to provide over-the-counter hearing aids.

The Food and Drug Administration issued a proposal Tuesday in an effort to provide over-the-counter hearing aids. (iStock)

Hearing aids for severe hearing loss and for people younger than 18 would still require a prescription.

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.

The FDA proposal implements a provision from the Over-the-Counter Hearing Aid Act, which was part of the 2017 FDA Reauthorization Act.

This May 2010 photo shows Zahra Baker, 10, getting a hearing aid at an event at Charlotte Motor Speedway.

This May 2010 photo shows Zahra Baker, 10, getting a hearing aid at an event at Charlotte Motor Speedway. (AP/File)

周围 37.5 million Americans have some trouble hearing, the FDA said. Of that, only one-fifth of people use a hearing aid.

The rule is intended to remove barriers such as costs and the social stigma related to hearing loss, 该机构说.

The rule aims to facilitate innovation and increase competition by lowering the barriers to entry for new hearing aid manufacturers,” 它说.

The Food and Drug Administration issued a proposal Tuesday in an effort to provide over-the-counter hearing aids.

The Food and Drug Administration issued a proposal Tuesday in an effort to provide over-the-counter hearing aids. (iStock)

含义. 伊丽莎白·沃伦(Elizabeth Warren), D-Mass, and Chuck Grassley, R-Iowa., applauded the FDA action, 称呼它 “terrific news.

We’ve just cleared a major regulatory hurdle for over-the-counter hearing aids,” the senators said in a joint statement. “很快, millions of people with mild to moderate hearing loss will finally have lower cost hearing aid options – and more options mean more competition in the market, further driving down the cost for consumers.

Both lawmakers sent the FDA a 信件 last week calling for regulations for over-the-counter hearing aids without delay.

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