FDA approves first over-the-counter hearing aid software compatible with Apple's AirPods Pro, offering a clinically validated Hearing Test feature and personalized hearing profiles.
The FDA has approved the Hearing Aid mode for AirPods Pro 2, enhancing accessibility for adults with mild to moderate hearing loss. Users will take a five-minute test on their iPhone to determine eligibility, with results stored in the Health app. This approval addresses the high cost and accessibility issues of traditional hearing aids, making the AirPods Pro 2 a more affordable option.
Apple's second-gen AirPods Pro gain FDA approval as first OTC hearing aid device, offering benefits for mild to moderate hearing loss users compared to traditional aids. The AirPods 4 series introduces superior audio quality, new design, and two models with prices starting at Rs 12,900.
The FDA authorized Apple's AirPods Pro 2 as the first over-the-counter hearing aid software, designed for individuals 18+ with mild-to-moderate hearing loss, enhancing accessibility and reducing stigma.
Apple's AirPods Pro 2 to offer hearing aid features, approved by FDA as over-the-counter device for mild to moderate hearing impairment in individuals 18 and older.
The FDA authorized Apple's hearing aid software for second-gen AirPods Pro, making it the first OTC hearing aid software. A clinical study showed self-fitting achieved similar benefits as professional fitting. New features include Hearing Protection mode and a Hearing Test for personalized audio profiles. This could reduce stigma and costs for hearing loss protection, impacting 1.5 billion people globally.
FDA approved 'Hearing Aid Feature' software for Apple AirPods Pro, aiding mild to moderate hearing loss in adults. Apple announced AirPods Pro 2 will transform into over-the-counter hearing aids via a fall software update, expanding access to hearing support.
The FDA authorized the first over-the-counter hearing aid software, customizable for mild to moderate hearing loss in adults, compatible with Apple AirPods Pro. This aims to improve accessibility and convenience for hearing support. The Hearing Aid Feature includes a self-fitting mobile app on iOS, assessed through the FDA's De Novo pathway.
Apple's AirPods Pro 2 to feature FDA-approved hearing aid mode, tested in a clinical study with 118 participants showing mild to moderate hearing loss, providing true benefit without adverse effects.