Earlier this week, Apple He said that it is AirPods Pro 2 could now be “transformed” into a custom hearing aid through an upcoming software update that would boost specific sounds in real time, including parts of speech or elements within the user’s environment.
New hearing health features will be available this fall to AirPods Pro 2 users in more than 100 countries and regions, Apple said.
Once installed and customized to a user’s hearing needs, the software allows the AirPods Pro versions to function as an over-the-counter hearing aid, designed to amplify sounds for people 18 or older with perceived mild to moderate hearing impairment, the health regulator said.
“Hearing loss is a major public health issue affecting millions of Americans,” said Michelle Tarver, acting director of the FDACenter for Devices and Radiological Health.
More than 30 million American adults report some degree of hearing loss, which can be caused by aging, exposure to loud noises, certain medical conditions and other factors.
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The authorization of a at the counter Hearing aid software improves the availability, accessibility and acceptability of hearing support, Tarver added. In 2022, the health regulator approved the sale of over-the-counter hearing aids that allowed adults with mild to moderate hearing impairment to access hearing aids directly from stores or online retailers without the need for a medical exam, prescription or visit to an audiologist.
Apple’s hearing aid feature, authorized Thursday, is a software-only mobile medical app and is set up using an iOS device such as an iPhone and accessing the user’s hearing levels from iOS’ HealthKit to customize the feature.
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