Apple’s latest update to the AirPods Pro 2 has made waves in the health tech space, with the UK now recognising them as certified hearing aids under the Medical Devices Regulations 2002. This marks a major shift in the wearable technology landscape – raising both opportunities and regulatory considerations for the future of consumer health devices.

From Wireless Earbuds to Medical Devices

With Apple’s Conversation Boost and Live Listen features, the AirPods Pro 2 can now function as over-the-counter hearing aids, helping those with mild to moderate hearing loss. While this functionality has been available in the US for some time under FDA regulation, its approval in the UK brings new regulatory challenges under the MHRA’s medical device framework.

This launch signals a growing trend: consumer electronics companies entering the medical space. As more wearable tech integrates health-monitoring capabilities, the lines between consumer devices and regulated medical products continue to blur.

Regulatory Implications: What’s Next?

For the UK, the regulation of health-focused wearables presents key questions:

  • Classification: Will more wearables fall under medical device regulations, requiring greater scrutiny and compliance?
  • Data Protection: As devices collect more personal health data, how will GDPR and MHRA guidelines evolve to ensure patient safety and privacy?
  • Market Impact: How will this affect traditional hearing aid manufacturers, who operate within a stricter regulatory framework?

A Sign of Things to Come

Apple’s move could pave the way for other tech giants to integrate regulated health features into their products, driving more accessible, lower-cost solutions for consumers. However, with this innovation comes regulatory responsibility – ensuring these devices meet stringent safety, efficacy, and data security standards.

As the boundaries between consumer tech and medical devices continue to blur, companies navigating this space must stay ahead of evolving UK and global regulatory requirements.

What do you think? Is wearable tech the future of medical devices, or does regulation need to evolve to keep pace?

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