FDA approves Apple AirPods Pro hearing aid feature

Apple hosted the iPhone 16 launch event earlier this week and added several new products to its hardware lineup. While the AirPods Pro are due for an upgrade for the time being, the Cupertino giant showcased its new Hearing Aid feature alongside AirPods 4 and Apple Watch Series 10.

Hearing Aid is a first-of-its-kind software-based hearing assistance feature designed to help users with mild to moderate hearing loss. The US Food and Drug Administration (FDA) authorized Apple's software-based hearing aid just days after it was shown to the public at the "Glowtime" event.

The feature allows users to make personalized hearing adjustments and amplifies nearby sounds in real time for better hearing. Michelle Tarver, FDA's acting director of the Center for Devices and Radiological Health, said in a press release:

Today’s marketing authorization of an over-the-counter hearing aid software on a widely used consumer audio product is another step that advances the availability, accessibility and acceptability of hearing support for adults with perceived mild to moderate hearing loss.

Apple notes that hearing loss is a global concern affecting about 1.5 billion people. In the US alone, more than 30 million adults report some degree of hearing loss. Several factors, such as aging, exposure to loud noises, and certain medical conditions, can contribute to hearing loss.

As per the agency, a "clinical study with 118 subjects with perceived mild to moderate hearing loss" was used to evaluate the hearing aid feature (HAF), noting that "no adverse events related to the device were observed in this study."

The results demonstrated that subjects who used the HAF self-fitting strategy achieved similar perceived benefit as subjects who received professional fitting of the same device. Results also showed comparable performance for tests measuring levels of amplification in the ear canal, as well as a measure of speech understanding in noise.

Apple is expected to release Hearing Aid through a software update during the fall season. It will be available for the AirPods Pro 2 paired with an iPhone or iPad running iOS 18/iPadOS 18.

Apple also discussed the Hearing Protection feature that reduces loud noises in the vicinity and a dedicated Hearing Test that allows users to "quickly check their hearing from the comfort of their home in minutes." The company will release these features in over 100 countries and is waiting for approvals from authorities across the globe.