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
美国食品和药品管理局授权首款可在柜台上购买的助听器软件，旨在与兼容版本的苹果AirPods Pro耳机配合使用。
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，美国食品药品监督管理局批准了第一款非处方（OTC）助听器软件设备——助听器功能，该设备旨在与兼容版本的苹果 AirPods Pro 耳机配合使用。一旦安装并根据用户的听力需求进行定制，AirPods Pro的兼容版本即可用作非处方助听器，旨在为18岁或以上感知轻度至中度听力障碍的人放大声音。
"Hearing loss is a significant public health issue impacting millions of Americans," said Michelle Tarver, M.D., Ph.D., acting director...
美国食品药品管理局设备与放射健康中心代理董...
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