Hearing aid feature is already FDA approved
Apple announced a handful of new products during its "It’s Glowtime" event this month. While the iPhone 16 lineup grabbed most of the attention, the most intriguing announcement came from a different product line. The Cupertino-based company in California revealed that its top-tier earbuds, the AirPods Pro 2, will now double as over-the-counter hearing aids through a software update, which is a feature that has also received FDA approval.
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Apple AirPods Pro 2 (Kurt "CyberGuy" Knutsson)
AirPods become more than just wireless earbuds
During the iPhone 16 event, Apple discussed the new hearing aid capability designed to assist people with mild to moderate hearing loss. At the time, Apple mentioned that the feature was still awaiting FDA approval. However, on Sept. 12, the FDA announced it had cleared the software-based hearing aid technology.
"Hearing loss is a significant public health issue impacting millions of Americans," the FDA’s Michelle Tarver noted in a statement. "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."
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The FDA approved AirPods after rigorous testing
The FDA said it cleared Apple's hearing aid feature after running a clinical study with 118 people in the U.S. who had mild to moderate hearing loss. The study found that users got similar results from the hearing aid software when they "self-fitted" the AirPods, compared to those who had a professional fitting.
"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 added.
When turned on, this feature uses the results from the Hearing Test to give users a clinical-grade hearing aid experience. It makes real-time adjustments, boosting sounds around them based on their environment. Apple also mentioned that users can set up the Hearing Aid feature with an audiogram provided by a hearing health professional for even more personalized settings.
AirPods Pro 2 (Apple) (Kurt "CyberGuy" Knutsson)
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The feature can save people a ton of money
Behind-the-ear hearing aids can range from $1,000 to $6,000, while the Apple AirPods Pro 2 are priced at just $249.89. That's a massive difference, and the AirPods even deliver similar results, as noted by the FDA. This is fantastic news for people with hearing issues, as they can now get effective assistance without breaking the bank.
It's still unclear when Apple will roll out the update to enable the hearing aid feature, but it’s expected to drop sometime this fall. Once available, the feature can be accessed through the settings in iOS 18 when a pair of AirPods Pro 2 are connected. The hearing aid capability will launch in over 100 countries and regions, including the United States, Germany and Japan.
Apple AirPods Pro 2 (Kurt "CyberGuy" Knutsson)
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FDA cautions: OTC hearing aids are not a substitute for professional care
Now, the FDA has one word of caution. Over-the-counter hearing aids are not a replacement for professional medical evaluations or prescription hearing aids. While OTC hearing aids provide increased accessibility for adults with perceived mild to moderate hearing loss, they have limitations and are not suitable for everyone with hearing impairment. The FDA emphasizes that OTC hearing aids are intended only for adults with perceived mild to moderate hearing loss, not for children or those with more severe hearing loss. For individuals with more significant hearing difficulties or complex hearing needs, prescription hearing aids fitted by hearing health professionals remain the recommended option.
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Kurt’s key takeaway
The AirPods Pro 2 already comes packed with handy features like transparency mode, which lets in ambient sound, conversation awareness, noise cancellation and more. Adding the hearing aid feature turns them into an all-in-one package. Since many people already have AirPods in their ears all day, those with hearing loss might feel more comfortable using them compared to traditional hearing aids.
Would you consider using AirPods as a hearing aid if you have mild to moderate hearing loss? Let us know by writing us at Cyberguy.com/Contact.
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Kurt "CyberGuy" Knutsson is an award-winning tech journalist who has a deep love of technology, gear and gadgets that make life better with his contributions for Fox News & FOX Business beginning mornings on "FOX & Friends." Got a tech question? Get Kurt’s free CyberGuy Newsletter, share your voice, a story idea or comment at CyberGuy.com.