Apple

FDA grants marketing authorization for AirPods Pro as over-the-counter hearing aids for mild to moderate hearing impairment, using self-fitting software.

FDA approves first OTC hearing aid software device, Hearing Aid Feature (HAF), for use in Apple AirPods Pro. The HAF is self-fitting and can be adjusted by the patient, offering similar benefits to professional fittings. Over 30 million US adults have some hearing loss, and the FDA's decision aims to improve accessibility.

The FDA approved software for Apple's AirPods Pro 2, enabling them to function as over-the-counter hearing aids, allowing users to test and calibrate sound levels via the Apple Health app.

Apple announced iPhone 16 lineup, Apple Watch 10 and Ultra, AirPods updates, and Apple Intelligence at 'Glowtime' event. New features include AI integration, sleep apnea detection, and hearing aid capabilities in AirPods Pro.

Apple's AirPods Pro (2nd Generation) will soon function as a hearing aid, approved by the FDA as the first over-the-counter hearing aid in the US. The feature, a software-based mobile medical application, offers similar benefits to professional hearing aids and will be available in 150 countries this fall.

Apple's Airpods Pro 2 approved by FDA as first over-the-counter hearing aid software, allowing users to test for hearing loss and boost frequencies for mild to moderate hearing issues, enhancing hearing across Apple devices.

Apple AirPods Pro 2 can function as hearing aids with FDA-authorized Hearing Aid Feature (HAF) software, available via iOS 18 by October. This marks the first over-the-counter hearing aid software approval, targeting 30 million Americans with mild to moderate hearing loss. The AirPods Pro 2, priced at $249, aim to reduce stigma and increase accessibility.

FDA approves Apple’s AirPod Pro 2 as a hearing aid, offering amplification at a lower cost ($250) without a prescription, targeting mild to moderate hearing loss.

FDA approves OTC hearing aid software for Apple AirPods, based on study with 118 adults showing comparable performance to professional aids. Also, FDA approves Tremfya for active ulcerative colitis, with 50% of patients achieving clinical remission. Additionally, plozasiran receives FDA breakthrough therapy designation for familial chylomicronemia syndrome.

Apple's AirPods Pro 2 received FDA authorization for a hearing aid feature, allowing users to test hearing and get assisted listening. The feature aims to make hearing support more accessible and affordable, with a price of $249. Apple plans to roll out the feature in over 100 countries.