In a groundbreaking development for both consumer technology and healthcare, Apple's AirPods Pro 2 have received FDA authorization to function as over-the-counter (OTC) hearing aids. This innovative feature, set to be released as a software update, transforms these popular wireless earbuds into a powerful hearing assistance device for adults with mild to moderate hearing loss.
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| The innovative AirPods Pro 2, now authorized by the FDA as over-the-counter hearing aids, displayed in a modern and sophisticated manner |
A First-of-its-Kind Approval
The U.S. Food and Drug Administration (FDA) has granted Apple the first-ever authorization for an OTC hearing aid software device. This approval allows the AirPods Pro 2 to be used as clinical-grade hearing aids without the need for professional fitting or prescription, marking a significant milestone in accessibility and hearing health.
How It Works
The new Hearing Aid feature will be available through a software update for AirPods Pro 2 users running iOS 18 or iPadOS 18. The process begins with a hearing test conducted on the user's paired iPhone or iPad, or by using an existing audiogram from a hearing health professional. Based on these results, the AirPods Pro 2 will automatically adjust audio output to compensate for the user's specific hearing needs.
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| An interactive smartphone interface prompts users to perform a hearing test, integral to customizing their AirPods Pro 2 hearing aid experience |
Extensive Testing and Validation
Apple's development process involved analyzing 150,000 real-world audiograms and millions of simulations. The FDA's authorization came after a clinical study involving 118 subjects across multiple U.S. sites, which demonstrated that the self-fitting strategy of the AirPods Pro 2 achieved similar perceived benefits to professional fitting.
Accessibility and Affordability
With this new feature, the AirPods Pro 2 become one of the most affordable hearing aid options on the market, priced at $249. This development has the potential to significantly increase access to hearing assistance technology for millions of Americans with hearing impairment.
Customization and Control
Users will have the ability to fine-tune their experience by adjusting tone, volume, and balance settings. The feature will work seamlessly with all audio played through the AirPods Pro 2, including music, movies, and podcasts, in addition to enhancing environmental sounds.
Global Reach
Apple plans to roll out the Hearing Aid feature in over 100 countries and regions, including the United States, Germany, and Japan, pending local regulatory approvals.
This FDA authorization not only validates Apple's approach to hearing health but also represents a significant step forward in the integration of health features into consumer electronics. As the lines between medical devices and consumer products continue to blur, the AirPods Pro 2 stand at the forefront of this exciting convergence.