Apple Receives US FDA Approval to Enable AirPods Pro 2 Hearing Aids Feature

AirPods Pro (2nd Generation) users will soon be able to utilise the company’s truly wireless stereo (TWS) headset as a hearing aid. Apple has just been granted approval by the US Food and Drug Administration (FDA), clearing the path for the feature to be rolled out to customers in the future. The wireless headset will also be updated with support for a new hearing test that can create an audio profile that will be used for the hearing aid feature.

The FDA said on Thursday that the second-generation AirPods Pro will be the first over-the-counter (OTC) hearing aid in the US. It has authorised the use of the hearing aid feature (HAF) which is a “software-only mobile medical application” that works with the AirPods Pro (2nd Generation).

When tested with 118 subjects, the FDA found that subjects using the HAF “achieved similar perceived benefit” as those who were wearing a professional hearing aid. Meanwhile tests also revealed that the levels of sound amplification in the ear canal and speech understanding in noise were also on par with hearing aid equipment.

The FDA issued guidelines for OTC hearing aids in October 2022, with the aim of making hearing aids more accessible. Under these regulations, people with “perceived mild to moderate hearing impairment” will be able to buy OTC hearing aids without a prescription or a medical exam. At the time, it was estimated that the action would reduce the cost of hearing aids by $2,800 (roughly Rs. 2,35,000).

Apple detailed how the AirPods Pro (2nd Generation) would function as a hearing aid at the company’s ‘It’s Glowtime’ launch event. Users will be able to take a hearing test while wearing the wireless headset, and tapping their smartphone screen when they hear a sound during the test. Their responses will help tune the HAF and generate an audio profile that is tailored to their requirements.

The regulator also says that users will be able to access hearing levels via HealthKit (Apple’s repository for health and fitness data collected from its smartphones and wearables) while modifying settings like tone, volume, and balance.

At its hardware launch event on September 9, Apple announced that the new hearing aid functionality would be rolling out to users in 150 countries “this fall” pending FDA approval. Now that the regulator has approved the use of the software-based HAF on the wireless headset, it’s only a matter of time before the feature is rolled out to users in supported regions.