Apple gets US FDA approval to enable AirPods Pro 2 hearing aid feature

AirPods Pro (2nd generation) users will soon be able to use the company’s True Wireless Stereo (TWS) headset as a hearing aid. Apple recently received approval from the US Food and Drug Administration (FDA), clearing the way for it to introduce this feature 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 Thursday that the second-generation AirPods Pro will be the first over-the-counter (OTC) hearing aids in the US. It has authorized the use of the Hearing Aid Feature (HAF) which is a “software-only mobile medical application” that works with AirPods Pro (2nd generation).

When tested with 118 subjects, the FDA found that subjects using HAFs “achieved similar perceived benefits” as those wearing professional hearing aids. Meanwhile the tests also showed that the level of sound amplification in the ear canal and speech understanding in noise was equivalent to that of a hearing aid device.

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

Apple detailed how the AirPods Pro (2nd generation) will work as a hearing aid at the company’s ‘It’s Glowtime’ launch event. Users will be able to perform a hearing test while wearing a wireless headset, and tap their smartphone screen when they hear a sound during the test. Their responses will help tune the HAF and produce an audio profile that suits their needs.

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

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