Apple’s AirPods Pro gains FDA approval over-the-counter hearing aids: Features and benefits

The FDA reviewed Apple’s application under the De Novo classification, a process for novel, low- to moderate-risk devices lacking prior market precedents.

Apple’s AirPods Pro gains FDA approval over-the-counter hearing aids: Features and benefits
Apple’s AirPods Pro gains FDA approval over-the-counter hearing aids: Features and benefits

Apple has unveiled a groundbreaking new feature for its second-generation AirPods Pro, marking a major innovation in personal hearing solutions. The tech giant’s announcement reveals that the AirPods Pro will soon include a hearing aid function, which has now been officially authorised by the US Food and Drug Administration (FDA). This approval makes the AirPods Pro the first over-the-counter (OTC) hearing aid software device to receive FDA clearance.

The FDA’s endorsement comes after a clinical study involving 118 participants with mild to moderate hearing loss. According to the FDA, the results showed that users of the new AirPods Pro feature experienced benefits in comparison to those who received professional fittings for traditional hearing aids. This finding highlights the effectiveness of the AirPods Pro as a viable alternative to conventional hearing aids.

The FDA reviewed Apple’s application under the De Novo classification, a process for novel, low- to moderate-risk devices lacking prior market precedents.

Launching the AirPods 4, Sumbul Desai, M.D., Apple’s Vice President of Health, stated, “With Apple Watch, we continue to offer our users the ability to uncover important health conditions with new sleep apnea notifications. And on AirPods Pro, powerful features put users’ hearing health front and center, bringing new ways to help test for and receive assistance for hearing loss.”

Apple unveiled the highly anticipated AirPods 4 series, marking a major upgrade in its popular wireless earbuds lineup. The new AirPods 4 series brings a range of enhancements, including superior audio quality, a sleek new design, and advanced features. The AirPods 4 feature a newly refined shape for a better fit during extended use. The series includes two models: the standard AirPods 4 and a version with Active Noise Cancellation (ANC), priced at Rs 12,900 and Rs 17,900 respectively.

Get live Share Market updates, Stock Market Quotes, and the latest India News and business news on Financial Express. Download the Financial Express App for the latest finance news.

This article was first uploaded on September twelve, twenty twenty-four, at forty minutes past eleven in the night.
Market Data
Market Data