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“The HAF was evaluated in a clinical study with 118 subjects with perceived mild to moderate hearing loss, at multiple U.S. sites.”

U.S. Food and Drug Administrationfda.gov ↗

The FDA cleared Apple’s Hearing Aid Feature, which turns AirPods Pro into an over-the-counter hearing aid. More than 30 million American adults report hearing loss, and the 2022 OTC rule already dropped the exam, the prescription and the audiologist. In a 118-person study, self-fitting matched professional fitting. The audiologist’s fitting appointment just lost to a software update.