AirPods Pro 2 gain FDA approval as over-the-counter hearing aids

  • The FDA has approved a software update transforming Apple’s AirPods Pro 2 into over-the-counter hearing aids for mild to moderate hearing loss.
  • Users can perform a hearing test via the Apple Health app, with the AirPods automatically adjusting sound levels based on the results.

OUR TAKE
This development marks a significant stride in making assistive hearing technology more accessible and acceptable. By integrating hearing aid features into everyday devices like the AirPods Pro 2, Apple is reducing the stigma associated with hearing aids, particularly among younger users. It’s a practical solution that could improve quality of life for many, though it should complement, not replace, professional care for severe cases.
–Vicky Wu, BTW reporter

What happened

In a move that could redefine the landscape of assistive hearing technology, the US Food and Drug Administration (FDA) has approved a software update that will transform Apple’s latest model of AirPods Pro into over-the-counter hearing aids.

This development, announced on Thursday, means that users with mild to moderate hearing loss will soon be able to utilise their AirPods Pro 2 as hearing aids. Apple stated that the new feature would be rolled out via a software update in the coming weeks. The hearing aid functionality operates by amplifying certain sounds, such as speech, while minimising background noise. Users can conduct a hearing test through the Apple Health application, with the AirPods automatically adjusting sound levels based on the results. Clinical studies involving 118 participants confirmed that the self-setup process provided comparable benefits to those set up professionally. The feature is exclusive to the AirPods Pro 2, retailing at $249.

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Why it’s important

This advancement could significantly benefit Americans with mild to moderate hearing loss, potentially acting as a bridge for those who avoid seeking treatment due to cost, accessibility, or aesthetic concerns.

According to experts, even mild hearing loss can lead to social isolation and a reduced quality of life. With Apple holding a considerable global market share in headphones, the integration of hearing aid features into a familiar device could encourage more individuals to address their hearing issues. Industry analysts suggest that this move by Apple could have a lasting impact on the over-the-counter hearing aid market, appealing especially to younger individuals who might be hesitant to use traditional hearing aids due to stigma.

However, it is noted that these consumer earbuds are not a substitute for professional devices required by those with severe hearing loss, who may still need audiologist consultations for adjustments. This initiative aligns with the FDA’s broader effort to increase the availability and acceptability of hearing support for adults with perceived mild to moderate hearing loss, initiated in October 2022.

Vicky-Wu

Vicky Wu

Vicky is an intern reporter at Blue Tech Wave specialising in AI and Blockchain. She graduated from Dalian University of Foreign Languages. Send tips to v.wu@btw.media.

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