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The FDA has cleared Apple’s Airpods Pro Hearing Aid Feature (HAF), a software-only medical app designed for use with the AirPods Pro.
With a self-fitting strategy, feature can be adjusted without the need for a hearing professional, and it’s easy to set up compatible AirPods Pro as a hearing aid with an iOS device. Users can access their hearing levels from HealthKit to customize settings such as tone, volume, and balance.
Prior to authorization, a clinical study of 118 individuals with perceived mild to moderate hearing loss took place across the US. The results showed that those who used the feature saw similar benefits to those who had the device fitted by a professional.
Performance for levels of amplification in the ear canal and speech understanding in noisy environments showed comparable results, too. There were no adverse events reported in clinical trials.
The FDA reviewed the AirPods Pro technology as a pathway, a regulatory route for new low- to moderate-risk devices.
A Step Forward for Adults with Hearing Loss
Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, said this was another step for the “availability, accessibility, and acceptability” of support for people with hearing loss.
With over 30 million adults in the US experiencing some degree of hearing loss, this is a significant move forward after the FDA’s OTC Hearing Aid Regulations, established in 2022. These regulations have made it possible for people to buy hearing aids from stores without a medical exam or prescription, but the devices until now have been specialized hardware that can be prohibitively expensive.
Hearing loss can negatively impact not just day-to-day activity, but also your mental health. Studies show that hearing aids can reduce the severity or frequency of depression, cognitive decline, and other health concerns in older adults.
This latest news from the FDA comes just ahead of Apple’s incoming wave of software updates, and means those with hearing loss won’t need to wait long to use their AirPods Pro as an affordable hearing aid.
