Apple AirPods Pro 2 Approved by FDA for Use as Hearing Aids

The U.S. Food and Drug Administration (FDA) has given the green light for AirPods Pro 2 to function as hearing aids. This approval marks a significant milestone in making hearing support more accessible.

FDA Approval and Significance

The FDA’s authorization of the AirPods Pro Hearing Aid feature marks a groundbreaking moment. This is the first time an over-the-counter hearing aid software device has received such approval. This development is a significant stride for both the organization and the hearing aid industry as a whole.

Clinical Validation and Testing

The FDA’s evaluation involved a clinical study with 118 subjects, all experiencing perceived mild to moderate hearing loss. The study took place at multiple sites across the United States and demonstrated that subjects using the self-fitting strategy of the AirPods Pro 2 achieved similar benefits to those who had professional fittings for the same device.

Technological Innovations and Features

The upcoming software update is set to introduce ‘Hearing Aid’ functionality, a hearing test feature, and hearing protection for the AirPods Pro 2. These additions will be available at no extra cost. Users will be able to customize tone, volume, and balance, offering a highly personalized hearing experience.

Accessibility and Affordability

Once the software update is available, users can conduct a hearing aid test to create a unique hearing profile. The AirPods Pro 2 will then make real-time adjustments to sound to enhance the user’s hearing experience.

Anticipated Release and Global Availability

Countries to receive this update include the United States, Germany, and Japan, among others. This widespread release highlights the global impact and reach of this new feature.

Health Benefits Beyond Hearing Aid Functionality

These features build upon existing functionalities, demonstrating a commitment to advancing audio technology for a wide range of uses.

Expert Opinions and Industry Response

Experts believe this could pave the way for more innovative, consumer-friendly hearing solutions in the future.

Steps to Utilize the New Features

To use the new features, users will need to update their AirPods Pro 2 along with an iPhone or iPad to the latest software versions. The process is user-friendly, ensuring that the benefits are readily accessible to a broad audience.


The FDA’s approval of AirPods Pro 2 as hearing aids represents a major advancement in hearing support technology. This move is poised to improve accessibility and affordability for many individuals, marking a new chapter in audio health innovation.

Source: Techradar

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