Apple’s AirPods Pro 2 Receive FDA Approval as Hearing Aid

Apple continues to integrate health-related functionalities into its consumer electronics, exemplified by features such as ECG monitoring, blood oxygen measurement, and cycle tracking, which are primarily found on the Apple Watch.

The recent addition of hearing aid capabilities to the AirPods Pro 2 marks a significant expansion of this initiative.

During its annual September event, Apple unveiled the iPhone 16 alongside updates to the Apple Watch and AirPods, highlighting the new feature that allows AirPods Pro 2 to function as hearing aids, thereby enhancing their utility for users.

The AirPods Pro 2 will facilitate hearing assessments by evaluating fit and background noise levels, providing users with immediate feedback on their hearing capabilities. Additionally, the earbuds will offer Hearing Protection to mitigate exposure to excessive environmental noise.

The hearing aid functionalities necessitated approval from the FDA, marking Apple’s introduction of the first software-enabled Hearing Aid feature.

Upon testing your AirPods Pro 2 and identifying mild to moderate hearing loss, users will be directed to the Hearing Aid feature for setup and customization.

This feature utilizes advanced computational audio and the H2 chip to enhance sound clarity, with machine learning continuously optimizing the experience throughout the day.

The FDA has approved for the AirPods Pro 2 to function as a hearing aid.

This development arose when Apple introduced the Hearing Aid feature during a recent event, despite lacking prior regulatory approval from the FDA to classify the AirPods Pro 2 as over-the-counter medical technology.

The announcement positioned the product as a medical device, which raised concerns regarding compliance.

However, leveraging its significant influence, Apple successfully secured expedited authorization from the FDA, allowing the AirPods Pro to be recognized as a “hearing aid software device.”

This marks the inaugural instance in which software has been integrated as a solution alongside an existing device specifically designed for individuals with hearing impairments. The Food and Drug Administration (FDA) reported that it conducted a clinical study involving 118 participants who experienced mild to moderate hearing loss. The study concluded that there were no adverse effects associated with the use of the AirPods software for addressing hearing loss.

The Hearing Aid feature is set to be introduced to AirPods Pro 2 in the upcoming fall season. This development follows an executive order issued by U.S. President Joe Biden in 2022, which enabled the FDA to evaluate over-the-counter hearing aids without the necessity of a prescription. For students with disabilities or parents of children with disabilities, there are numerous beneficial AI tools available for exploration.

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