Apple AirPods Pro 2 to disrupt hearing aids industry in the US as FDA approves clinical-grade features

The US Food and Drug Administration (FDA) has officially approved the clinical-grade hearing aid features for the Apple AirPods Pro 2, which will be available through an upcoming software update. This marks the first time an over-the-counter hearing aid software device has been authorised in the form of a consumer audio product, the FDA confirmed.

The approval follows Apple’s announcement during its “Glowtime” event, where the tech giant unveiled plans to integrate hearing aid capabilities into its popular AirPods Pro 2.

This will allow Apple to disrupt the hearing aids market in the US to a large extent. Most hearing aids in the US cost from $1,000 to $6,000, based on its features and complexities. The AirPods Pro 2 on the other hand, cost $249.

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Breakthrough for over-the-counter hearing aids
The FDA’s clearance of this feature is a significant milestone, as it aims to assist individuals aged 18 and older with mild to moderate hearing impairment. The new feature will be delivered through a software update, which will enhance the AirPods Pro 2’s ability to amplify sounds, making it a practical solution for many users.

The FDA’s acting director of the Center for Devices and Radiological Health, Michelle Tarver, MD, PhD, highlighted the importance of this advancement. She noted that hearing loss is a major public health concern affecting millions of Americans, and this approval represents a step forward in making hearing support more accessible and acceptable.

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The software update will provide users with a more personalised hearing experience, potentially transforming their AirPods Pro 2 into effective hearing aids.

Clinical study supports effectiveness
The approval came after a clinical study involving 118 participants with mild to moderate hearing loss. The study found that the AirPods Pro 2, with the new update, offered similar benefits in self-adjusted settings as those installed by professionals.

This suggests that users will be able to customise their hearing aid features independently using their devices.

According to Apple, the upcoming software update will allow AirPods Pro 2 users to adjust the amplification of specific sounds in real-time, enhancing both speech and environmental noise. This functionality will be available in over 100 countries and regions starting this fall.

The feature is designed to meet the needs of individuals with perceived mild to moderate hearing impairments, in line with the FDA’s new guidelines for over-the-counter hearing aids.

Impact and future availability
The FDA had previously approved the sale of over-the-counter hearing aids in 2022, allowing adults with mild to moderate hearing impairments to purchase these devices directly from retailers without requiring a medical exam or audiologist consultation.

Apple’s new hearing aid feature, which will be a software-only mobile medical application, aligns with these regulations. It will be set up using an iOS device, such as an iPhone, with user hearing levels accessed from the iOS HealthKit to tailor the experience.

Tests have shown that the AirPods Pro 2 will perform well in amplifying sounds within the ear canal and in noisy environments, ensuring users can benefit from improved hearing support. Apple plans to roll out this update to its users by the end of 2024, although the exact timetable has not yet been clarified.