The FDA has authorized the first over-the-counter hearing aid software device, called Hearing Aid Feature, for use with compatible Apple AirPods Pro headphones.
Key Points:
- The Hearing Aid Feature (HAF) enables compatible AirPods Pro to function as over-the-counter (OTC) hearing aids for individuals 18 years or older.
- Users can customize the software to their hearing needs without professional assistance.
- A clinical study demonstrated comparable benefits between self-fitting and professional fitting strategies.
- This authorization aligns with the FDA's 2022 regulations enabling OTC sales of hearing aids without prescriptions.
Clinical Study Details: The FDA's decision was based on a clinical study involving 118 subjects with perceived mild to moderate hearing loss. Key findings include:
- Subjects using the HAF self-fitting strategy achieved similar perceived benefits compared to those receiving professional fitting.
- Comparable performance was observed in tests measuring ear canal amplification levels and speech understanding in noise.
- No device-related adverse events were reported during the study.
Implications for Public Health: More than 30 million American adults report some degree of hearing loss. The FDA's authorization of this software-based hearing aid solution may help increase access to hearing support for adults with perceived mild to moderate hearing loss.
Dr. Michelle Tarver, acting director of the FDA's Center for Devices and Radiological Health, stated, "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."
Technical Details: The HAF is a software-only mobile medical application designed for use with compatible AirPods Pro models. Key features include:
- Setup using an iOS device (iPhone, iPad)
- Utilization of iOS HealthKit data for initial customization
- User-adjustable volume, tone, and balance settings
Regulatory Context: This authorization follows the FDA's October 2022 regulations establishing OTC hearing aid categories. The HAF was reviewed under the FDA's De Novo premarket review pathway for novel, low- to moderate-risk devices.
The FDA granted marketing authorization for the Hearing Aid Feature to Apple Inc. This development aligns with the FDA's strategic priority to advance health equity by expanding access to important healthcare technologies.
