FDA Authorizes First Over-The-Counter Hearing Aid Software, Intended To Be Used With Compatible Versions Of The Apple AirPods Pro Headphones
FDA Authorizes First Over-The-Counter Hearing Aid Software, Intended To Be Used With Compatible Versions Of The Apple AirPods Pro Headphones
美國食品和藥品管理局授權首款可在櫃台上購買的助聽器軟件，旨在與兼容版本的蘋果AirPods Pro耳機配合使用。
Today, the U.S. Food and Drug Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple AirPods Pro headphones. Once installed and customized to the user's hearing needs, the Hearing Aid Feature enables compatible versions of the AirPods Pro to serve as an OTC hearing aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment.
今天，美國食品藥品監督管理局批准了第一款非處方（OTC）助聽器軟件設備——助聽器功能，該設備旨在與兼容版本的蘋果 AirPods Pro 耳機配合使用。一旦安裝並根據用戶的聽力需求進行定製，AirPods Pro的兼容版本即可用作非處方助聽器，旨在爲18歲或以上感知輕度至中度聽力障礙的人放大聲音。
"Hearing loss is a significant public health issue impacting millions of Americans," said Michelle Tarver, M.D., Ph.D., acting director...
美國食品藥品管理局設備與放射健康中心代理董...
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