Apple’s AirPods Pro 2 Receive FDA’s First-Ever OTC Hearing Aid Approval

Apple’s AirPods Pro 2 Receive FDA’s First-Ever OTC Hearing Aid Approval

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Apple has secured the US Food and Drug Administration’s (FDA) first-ever approval for Bluetooth earbuds to be sold as over-the-counter hearing aids. Beginning this fall, AirPods Pro 2 users with hearing loss can leverage companion software to adaptively amplify sounds from their environment in real time.

During its “Glowtime” event on Monday, Apple debuted a trio of AirPods Pro updates aimed at helping users with their hearing health. One feature, called Hearing Protection, leverages the earbuds’ ear tips and H2 chip to reduce constant or loud noise from the user’s environment: lawnmowers, subway sounds, chatter at the airport, and so on. The next introduces a “scientifically validated Hearing Test feature,” which uses AirPods Pro 2 and the user’s iPhone or iPad to conduct an impromptu hearing check at home. The last, simply called Hearing Aid, allows what was once just an entertainment- or productivity-focused pair of earbuds to function as an assistive device.

To begin using AirPods Pro 2 as a hearing aid, users will take the hearing test. This takes about 5 minutes to complete and, according to Apple, uses a clinical approach called pure-tone audiometry to measure a person’s hearing sensitivity at different audio frequencies. Once the hearing test is over, users will receive a summary of their results, which is saved in the Health app and can be securely shared with health providers for further discussion.

A sample Hearing Test report.

A sample Hearing Test report.
Credit: Apple

Based on a user’s results, the AirPods Pro 2 Hearing Aid feature performs personalized dynamic adjustments that reportedly “boost” the sounds around them in real time. Sumbul Desai, a medical doctor and Apple’s vice president of health, said during Glowtime that these adjustments will apply automatically to music, videos, games, and phone calls experienced through the user’s iPhone or iPad to keep the user both comfortable and safe.

According to a Reuters report, the FDA’s approval of Apple’s Hearing Aid feature is intended for adults with mild to moderate hearing impairment. Apple will roll out the new feature to AirPods Pro 2 users in more than 100 countries this fall.

Apple’s AirPods Pro updates are derived from findings from the Apple Hearing Study. This collaboration with the University of Michigan School of Public Health and the World Health Organization (WHO) focuses on the impact of sound exposure on human hearing. Over the past five years, the Apple Hearing Study has shared insights related to tinnitus, workplace noise, the prevalence of hearing loss, and more.

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