Apple’s AirPods Pro: Now Approved by FDA as Over-the-Counter Hearing Aids

In a groundbreaking move, the Food and Drug Administration (FDA) has approved software that transforms Apple’s second-generation AirPods Pro into over-the-counter hearing aids. This new feature, available through a software update in the coming weeks, will offer millions of Americans with mild to moderate hearing loss a convenient and affordable hearing assistance solution.

Revolutionizing Hearing Health

The hearing aid feature in the AirPods Pro amplifies specific sounds, such as voices, while minimizing ambient noise. Users can take a hearing test using the Apple Health app, and the AirPods will automatically adjust sound levels based on the test results. This functionality is exclusive to the AirPods Pro 2, which retails for $249.

Apple’s entry into hearing health aligns with the FDA’s broader initiative to make hearing aids more accessible. In 2022, the FDA approved the sale of over-the-counter hearing aids, reducing the need for costly and time-consuming professional fittings. The FDA believes Apple’s innovative approach will encourage more individuals with hearing loss to seek treatment.

FDA-Backed Clinical Success

The FDA’s approval came after a clinical study involving 118 participants with perceived mild to moderate hearing loss. The study found that individuals who used Apple’s self-fitting method, which includes taking a hearing test using the Apple Health app and allowing the AirPods to adjust sound levels based on the test results, experienced benefits similar to those who received a professional fitting. This validation solidifies Apple’s AirPods Pro as a clinical-grade hearing solution, making it the first over-the-counter hearing aid software device.

Hearing Health Features and Accessibility

In addition to the hearing aid functionality, the AirPods Pro will gain other health-oriented features, such as Hearing Protection mode, which safeguards users’ ears in loud environments like concerts. The feature preserves sound quality while protecting against harmful noise levels. Additionally, users can undergo a new hearing test within the Apple Health app, allowing for personalized sound settings.

Apple’s move marks a significant milestone in hearing health. The World Health Organization estimates that approximately 1.5 billion people globally live with hearing loss, and this development could reduce both the stigma and financial barriers associated with traditional hearing aids.

A Game-Changer for Hearing Aid Technology

Apple’s decision to enter the hearing aid market with its popular AirPods Pro offers a new level of convenience, accessibility, and affordability. The FDA’s approval positions the AirPods Pro as a practical alternative for consumers who might otherwise face challenges obtaining hearing aids. By leveraging familiar technology, Apple could reshape the hearing aid landscape for millions of people, potentially disrupting the traditional hearing aid industry and driving innovation.