Apple receives FDA clearance to enable AirPods Pro 2 hearing aid feature

AirPods Pro (2nd generation) users will soon be able to use the company’s truly wireless stereo (TWS) headset as a hearing aid. Apple has just received clearance from the U.S. Food and Drug Administration (FDA), clearing the way for the feature to roll out to customers in the future. The wireless headset is also being 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 U.S. It authorized the use of the Hearing Aid Feature (HAF), a “software-only mobile medical application” that works with the AirPods Pro (2nd generation).

In tests involving 118 subjects, the FDA found that subjects using the HAF achieved “similar perceived benefits” to those wearing professional hearing aids. Meanwhile, tests also showed that the levels of sound amplification in the ear canal and speech understanding in noise were also comparable to hearing aid devices.

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

Apple detailed how the AirPods Pro (2nd generation) would function as a hearing aid during the company’s “It’s Glowtime” launch event. Users can take a hearing test while wearing the wireless headset and tap their smartphone’s screen when they hear a sound during the test. Their answers help tune the HAF and generate an audio profile tailored to their needs.

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

During its hardware launch event on September 9, Apple announced that the new hearing aid functionality would be rolling out “this fall” to users in 150 countries, 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 rolls out to users in supported regions.