Apple’s AirPods Pro 2 Gains FDA Approval as Over-the-Counter Hearing Aid

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Apple has achieved a significant milestone in health technology with the FDA’s authorization to transform its AirPods Pro 2 into over-the-counter hearing aids. This groundbreaking feature, set to be released this fall, will be available in over 100 countries and regions, pending local health authority approvals.

The new functionality allows users to conduct a hearing test directly through their iPhone or iPad, which takes approximately five minutes to complete. Based on the results, the AirPods Pro 2 can then amplify specific sounds in real-time, including speech and environmental elements. Users can fine-tune volume and tone settings to suit their individual needs.

This development is particularly significant for the estimated 1.5 billion people worldwide living with some form of hearing loss. Dr. Sumbul Desai, Apple’s vice president of health, emphasized the importance of hearing health, stating, ‘Hearing health is an essential part of our overall wellbeing, yet it can often be overlooked’.

This development is particularly significant for the estimated 1.5 billion people worldwide living with some form of hearing loss.

The FDA’s approval was based on a clinical trial involving 118 individuals with mild to moderate hearing loss. The study found that users who set up the settings themselves ‘achieved a perceived benefit similar to those who received adjustments from a professional on the same device’.

Priced at $249, the AirPods Pro 2 ($199 via Amazon) with this new feature offers a significantly more affordable option compared to traditional clinical-grade hearing aids. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, hailed this as ‘a step forward in making hearing aids more accessible, available, and acceptable’.

While this feature represents a major advancement in accessible hearing technology, experts note that it may not be suitable for those with severe or profound hearing loss. Additionally, traditional hearing aids still offer advantages such as longer battery life.

The introduction of this feature aligns with Apple’s broader health initiatives, which include recent upgrades to the AirPods Pro 2 such as Siri Interactions and Voice Isolation. As the technology continues to evolve, Apple is expected to release new AirPods models with enhanced features in the coming years.

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Apple's AirPods Pro 2, now FDA-approved as over-the-counter hearing aids, will be available in over 100 countries. #hearinghealth #accessiblehearing #appleairpods #airpodspro2 #fdaapproval Share on X