Apple recently held its annual launch event and announced its new batch of products, including the new AirPods. However, that’s not all there was to the event. Apple also announced that they were updating the AirPods Pro 2 such that it could be used as an OTC hearing aid device. Now they have received the green light from the FDA for it too!
AirPods Pro 2 as OTC Hearing Aid Overview
Initial Announcement
Though Apple’s most popular audio accessory did not receive any hardware updates this year, it did get nifty software updates. These updates would effectively convert the AirPods Pro 2 into an OTC hearing Aid! Apple loves to add health-conscious features to their offerings. They’ve done it with the iPhones, the Apple Watches, and now to AirPods too!
During the launch event, Apple stated AirPods Pro 2 would get three new health features related to hearing loss. Firstly, they would add “Hearing Protection” to prevent users from loud noise exposure. The H2 chip on the earbuds will be constantly reducing the noise 48,000 times per second to achieve this. Secondly, they introduced a clinically validated Hearing Test which users could take in just five minutes. Through this test, you could learn if you have any form of hearing loss.
Lastly, Apple announced that AirPods Pro 2 would have a clinical-grade over-the-counter Hearing Aid feature. This test would help determine the specific kind of sound you will require assistance with, and then boost it accordingly. Furthermore, the audio output for all the apps across all your Apple devices would be automatically adjusted according to your hearing profile.
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FDA Approval
At the moment of the announcement, FDA and other regulators were yet to approve the Hearing Aid Feature on the AirPods Pro 2. Meaning that Apple only received the clinical grading from the private firms they were collaborating with. However, on 12 September 2024 — just days after the announcement of this feature, it received the FDA’s approval. Now, consumers could get the AirPods Pro 2 as an OTC Hearing Aid for themselves!
This is monumental, as HAF is the first-ever hearing aid software authorised by the US regulator. They evaluated this software in a clinical study with 118 subjects with perceived mild to moderate hearing loss in the US. The results showed that using AirPods 2 Pro as an OTC Hearing Aid performs similarly to actual medical equipment. Additionally, no adverse effects were observed in the subjects. FDA also says that the Apple earbuds offer comparable performance in measuring levels of amplification in the ear canal, as well as a measure of speech understanding in noise.
AirPods Pro 2 as OTC Hearing Aid Conclusion
As per Apple’s own study, a large chunk of people are oblivious to the fact that they have hearing loss. And the majority of them do not seek medical attention until it’s already too late. Hence, following the FDA approval, tests for hearing loss will be much more accessible to the general public.
Moreover, as it is a software update, people who already own the Apple earbuds will have access to this feature. And for those who don’t, they will be spending way less fortune on the AirPods Pro 2 than on the actual OTC Hearing Aid. The HAF will be available in over 100+ countries in the coming few months. Lastly, AirPods Pro 2 are only effective for people with mild to moderate hearing loss and not for individuals with severe cases — they will have to seek medical attention.
- Meanwhile, check out our Apple AirPods Pro 2 review video:
