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Apple’s AirPods hearing aid feature receives FDA approval

FDA approval comes after clinical testing of 118 subjects

UPDATE: Less than a week after Apple revealed its plans to bring hearing health tools to its line of personal audio products, the FDA has approved the upcoming use of AirPods Pro 2 as over-the-counter hearing aids. Apple’s announcement last week included talk of of a “first of its kind, software-based” hearing aid feature coming to the second-generation AirPods Pro, which will include the ability to customize the feature with “an audiogram created by a hearing health professional.”

“The HAF (Hearing Aid Feature) was evaluated in a clinical study with 118 subjects with perceived mild to moderate hearing loss, at multiple U.S. sites,” reads the FDA’s press release. “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. No adverse events related to the device were observed in this study.”

The FDA says that, with the introduction of the near feature, the AirPods Pro 2 becomes  “the first over-the-counter (OTC) hearing aid software device.”

 

The following was originally published September 12, 2024: 

Apple has recently released a huge amount of information on its new and upcoming devices, from its smartwatches to its phones. Among the news, the tech giant has revealed it will begin to integrate a range of hearing-health features to its line of AirPods, including one that will turn its earbuds into hearing aids.

The Apple AirPods Pro 2 will be receiving what the company is calling “the world’s first all-in-one hearing health experience.” This includes features like automatic volume limiting, as well as a clinically-approved hearing test. Most interesting, however, is a software-based hearing aid feature.

“This first-of-its-kind software-based Hearing Aid feature brings users the ability to fine-tune their experience at any time, making access to hearing assistance easier than ever at an approachable price point,” says Apple. “Users can also set up the Hearing Aid feature with an audiogram created by a hearing health professional. Both the Hearing Test and Hearing Aid features are grounded in science and were validated through rigorous scientific studies.”

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The hearing health update will be free to AirPod Pro2 owners, and though it is currently awaiting FDA approval, Apple says it plans to launch the update this fall. Additionally, a feature called Media Assist, available with the update, will extend the hearing aid function to media watched with with AirPod Pro 2, as well as phone calls.

“To help provide the best listening experience, Media Assist is an all-new feature that helps boost certain parts of speech on a phone call or instruments within a soundtrack to help an even broader population,” says Apple.

 

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