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FDA Authorizes OTC Hearing Aid Software Compatible With Apple AirPods
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The Hearing Aid Feature can be customized to the user’s needs by amplifying sounds for individuals 18 years or older who have perceived mild to moderate hearing impairments.
The FDA authorized the first OTC hearing aid software device called Hearing Aid Feature, intended to be used with compatible Apple AirPods Pro. When the software is installed on the AirPods Pro, the Hearing Aid Feature can be customized to the user’s needs by amplifying sounds for individuals 18 years or older who have perceived mild to moderate hearing impairments, according to the FDA.1
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“Hearing loss is a significant public health issue impacting millions of Americans,” Michelle Tarver, MD, PhD, acting director of the FDA's Center for Devices and Radiological Health, said in a news release. “Today’s marketing authorization of an OTC 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.”1
The Hearing Aid Feature is a software-only mobile medical application that can be used with AirPods Pro, which utilizes a self-fitting strategy and allows users to adjust their needs without the assistance of a hearing professional. It is set up using an iOS device, such as the iPhone or iPad, and the hearing levels can be accessed by the iOS HealthKit. The software can help refine volume, tone, and balance after getting set up.1
The software was evaluated in a clinical study with 118 patients who had perceived mild to moderate hearing loss at multiple US sites, demonstrating that those who used the self-fitting strategy achieved similar perceived benefit as those who received professional fitting on the same device. Further, the results also showed that the comparable performance tests that measured amplification in the ear canal and measure of speech understanding noise. There were also no adverse events related to the device observed in the study.1
According to a video at the Apple Keynote event on September 9, the feature will be available sometime in fall 2024.2
“We are adding this groundbreaking capability to help more than 1 billion people living with mild to moderate hearing loss. To give you insight into your hearing health, we’re introducing a clinically validated hearing test with your AirPods Pro and iPhone,” a speaker said in the presentation.2
The check takes approximately 5 minutes that can be done anywhere, including at home. As part of the software, users are played a series of noises at different volumes and frequencies and are instructed to tap the screen when they hear the noise. Based on the test, the AirPods Pro can boost and adjust sounds in real-time, including speech and noises around the user.2
Furthermore, the software features Hearing Protection, which minimizes loud environmental noises to sustain hearing for the user while preserving the sounds of what the user is listening to.2
“We are so excited for these updates coming to AirPods Pro 2 with active Hearing Protection, a clinical grade hearing test, and an easy-to use professional grade hearing aid,” the speaker said. “These features will be available in a software update coming to AirPods Pro 2 and iOS 18 to help make hearing health significantly more approachable for so many people.”2
REFERENCES
1. FDA Authorizes First Over-the-Counter Hearing Aid Software. News release. FDA. September 12, 2024. Accessed September 13, 2024. https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-over-counter-hearing-aid-software
2. Apple. Hearing Aid feature for AirPods Pro 2 | Apple. https://www.youtube.com/watch?v=dOuNLS1elWs. September 9, 2024. Accessed September 13, 2024.
