FDA Approves AirPods Pro 2 as Over-the-Counter Hearing Aid
Key Insights
Apple's AirPods Pro 2 have received FDA approval as over-the-counter hearing aids, accessible via a software update later this year.
The approval allows AirPods Pro 2 users to enhance real-time sound, improving conversations and environmental awareness without needing traditional hearing aids.
The new feature aligns with the FDA's 2022 decision to allow over-the-counter hearing aids for adults with mild-to-moderate hearing loss (search).
Apple's AirPods Pro 2 have been granted FDA approval to function as over-the-counter (OTC) hearing aids, marking a significant step in accessible hearing assistance. This approval, facilitated through a forthcoming software update, positions the AirPods Pro 2 as a mainstream consumer device authorized for hearing aid functionality, offering new possibilities for individuals with mild-to-moderate hearing loss (search).
The software update, expected to roll out later this year in over 100 countries, will enable AirPods Pro 2 users to enhance real-time sound, improving conversational clarity and environmental awareness. This innovation addresses the needs of millions globally who experience hearing loss (search), providing a solution that bypasses the need for traditional, prescription-based hearing aids.
Enhanced Accessibility and Features
During Apple's 'It's Glowtime' event, the company highlighted the potential of AirPods Pro 2 to be transformed into hearing aids. The FDA's authorization now fully integrates this feature, significantly boosting accessibility for those with hearing impairments. Unlike conventional hearing aids, AirPods Pro 2 will allow users to enhance sounds without requiring a medical examination or consultation with an audiologist.
This development follows the FDA’s 2022 decision to permit over-the-counter hearing aids for adults experiencing mild-to-moderate hearing loss (search). Apple’s new feature is in line with this trend, enabling more people to access hearing assistance directly and conveniently.
Addressing a Global Concern
Apple has acknowledged that hearing loss (search) is a widespread issue, affecting 1.5 billion people worldwide. In response, the company has designed an all-in-one solution focused on preventing, monitoring, and assisting with hearing health. A key feature of the AirPods Pro 2 is Active Hearing Protection, which minimizes exposure to loud environmental noises that can contribute to hearing damage over time. This system operates by default across all listening modes.
To further promote awareness of potential hearing issues, Apple has introduced a self-administered Hearing Test feature that works in conjunction with the AirPods Pro and a compatible iPhone or iPad. This clinically validated test mirrors the standard pure-tone audiometry used in clinical settings.
Users can complete the test in approximately five minutes from their homes and receive a detailed summary of their results. The results, including an audiogram, are stored in the Health app, allowing users to share them with healthcare providers for further consultation.