FDA Approves First OTC Hearing Aid Software

Stock.adobe.com

Over the past two-and-a-half-decades, Apple has slowly been reducing the number of devices and objects that someone needs to carry around with them. Initially, the iPod took away the need for people to carry music players and individual CDs when they traveled. Eventually, the iPod became the iPhone, which combined music players with cell phones. As the iPhone became more advanced, it eventually became able to handle payments, reducing the need for people to carry credit cards. Other items, like airline passes and concert tickets, can also be digitally stored on smart phones.

Now, Apple is adding hearing aids to the list of devices people can stop carrying around. Apple’s latest AirPods Pro can be used as hearing aids when combined with the proper software.¹ FDA has announced that it has approved Hearing Aid Feature for over-the-counter use, making it the first hearing aid software of its kind to be approved by the agency.

In a press release, acting director of FDA’s Center for Devices and Radiological Health Michelle Tarver said, “Hearing loss is a significant public health issue impacting millions of Americans. 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."

In its own press release,² Apple’s senior vice president of hardware engineering John Ternus said, “With AirPods 4, customers can enjoy Active Noise Cancellation and the most advanced audio experience ever in an open-ear design. And with a revolutionary update to the world’s best-selling headphones, AirPods Pro will deliver groundbreaking new capabilities–including Hearing Test and Hearing Aid features–to help more than a billion people affected by hearing loss.”

FDA also issued warning letters to two Chinese nonclinical testing laboratories in response to citations for laboratory oversight failures and animal care violations.³

In a press release, the acting director of the office of product evaluation and quality in the FDA’s Center for Devices and Radiological Health Owen Faris, PhD, said, “The medical device industry must be built and sustained on safety, effectiveness and quality. The FDA will take action to protect patients, consumers and the medical device supply chain from quality failures and violative practices. We strenuously remind industry of their responsibility and accountability for all data included in their submissions, which are required to comply with federal law."

Sources

1. FDA Authorizes First Over-the-Counter Hearing Aid Software. U.S. Food and Drug Administration. September 12, 2024. https://www.prnewswire.com/news-releases/fda-authorizes-first-over-the-counter-hearing-aid-software-302246763.html
2. Apple Introduces AirPods 4 and the World’s First All-In-One Hearing Health Experience with Airpods Pro 2. Apple. September 9, 2024. Accessed September 12, 2024. https://www.apple.com/newsroom/2024/09/apple-introduces-airpods-4-and-a-hearing-health-experience-with-airpods-pro-2/
3. FDA Issues Warning Letters to Two Chinese Firms Regarding Data Quality and Integrity Concerns, Violative Lab Practices. U.S. Food and Drug Administration. September 11, 2024. https://www.prnewswire.com/news-releases/fda-issues-warning-letters-to-two-chinese-firms-regarding-data-quality-and-integrity-concerns-violative-lab-practices-302245503.html