Apple gets FDA authorization to turn the AirPods Pro into hearing aids

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Apple’s second-generation AirPods Pro pictured in a side profile photo of a woman’s head.
Photo by Chris Welch / The Verge

Just days after Apple announced a new hearing aid feature for the second-generation AirPods Pro, the US Food and Drug Administration (FDA) has authorized the software that powers this functionality. In a press release, the FDA describes Apple’s solution as “the first over-the-counter (OTC) hearing aid software device.”

The feature “was evaluated in a clinical study with 118 subjects with perceived mild to moderate hearing loss,” according to the FDA, and “the results demonstrated that subjects who used the HAF self-fitting strategy achieved similar perceived benefit as subjects who received professional fitting of the same device.”

Enabling the AirPods Pro to double as clinical-grade hearing aids is one of several new features that...

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source https://www.theverge.com/2024/9/12/24242929/apple-airpods-pro-hearing-aids-fda-authorization

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