FDA Approves OTC Hearing Aid Software for Enhanced Hearing Health with Apple AirPods Pro

Thursday, 12 September 2024, 17:52

FDA approves OTC hearing aid software for Apple AirPods Pro, transforming hearing health management for many. This innovative feature enhances the listening experience and broadens accessibility for users with mild to moderate hearing loss. Apple continues to lead in health technology, allowing users to take a hearing test and customize their profile easily.
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FDA Approves OTC Hearing Aid Software for Enhanced Hearing Health with Apple AirPods Pro

Innovative Hearing Aid Technology

The U.S. Food and Drug Administration on Thursday approved the first over-the-counter hearing aid software that is compatible with Apple's AirPods Pro. Following this announcement, Apple has unveiled a new Hearing Aid feature and clinically validated Hearing Test feature for compatible AirPods Pro earbuds.

According to Apple, users can take a convenient hearing test in about five minutes from home. The user's personalized hearing profile will be reflected in the AirPods Pro listening experience.

Impact on Hearing Health

“For decades, Apple has led the way in designing products for everyone and supporting users with a broad spectrum of hearing abilities,” said Sarah Herrlinger, Apple’s senior director of Global Accessibility Policy and Initiatives. This innovative feature will significantly impact many by driving awareness around hearing health and empowering individuals with customizable tools.

  • The Hearing Aid feature has been clinically validated in a controlled study.
  • Apple aims to assist millions experiencing hearing loss.
  • Expected release in an upcoming iOS software update.

Public Health Significance

“Hearing loss is a significant public health issue impacting millions of Americans,” stated Dr. Michelle Tarver, acting director of the FDA's Center for Devices and Radiological Health. “Today's approval of an OTC hearing aid software on widely used consumer audio products enhances the availability and accessibility of hearing support for adults with perceived mild to moderate hearing loss.”


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This article was prepared using information from open sources in accordance with the principles of Ethical Policy. The editorial team is not responsible for absolute accuracy, as it relies on data from the sources referenced.


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