FDA approves Apple Watch for sleep apnea risk & AirPods Pro as hearing aids
The U.S. Food and Drug Administration (FDA) has granted clearance for a sleep apnea detection feature on select Apple Watch models. The company has also received the go-ahead for its hearing aid technology.
These approvals allows Apple to market the features as a legitimate health tools in the US. While the FDA’s jurisdiction is limited in regional scope, its decisions often influence regulatory bodies in other countries. Nations with similar regulatory frameworks, such as Canada, Australia, and members of the European Union, may look to the FDA’s decision for guidance. This is likely to expedite local approval processes.
A novel way of detecting sleep apnea
The sleep apnea tracking feature will be available on the Apple Watch Series 9, the upcoming Series 10, and the Watch Ultra 2. Apple has confirmed that the Series 10 will hit store shelves this Friday.
Interestingly, the company’s approach to sleep apnea detection diverges from expectations. It doesn’t rely on blood oxygen data, which has been a subject of recent legal challenges. Instead, the feature utilizes accelerometer data to identify breathing disturbances during sleep. This method focuses on subtle wrist movements associated with disrupted breathing patterns, offering a novel solution to sleep monitoring.
Apple states that this should not be used as a diagnostic tool. Instead, the sleep apnea detection feature is meant to prompt users who may be at risk to seek a formal diagnosis from a medical professional.
Useful health features
The introduction of this FDA-cleared feature on the Apple Watch platform could potentially impact millions of users. Sleep apnea, affecting an estimated 1 billion people worldwide, often goes undiagnosed due to its occurrence during sleep. By providing a readily accessible means of risk assessment, Apple’s new feature may encourage more individuals to seek proper medical evaluation and treatment.
As with previous health features, the rollout of sleep apnea detection is likely to be region-dependent. So expect varying availability across different countries.
Also approved is the hearing aid technology. To remind, Apple has expanded the functionality of its AirPods Pro to include hearing aid capabilities. Users can take a brief hearing test using their iPhone and AirPods Pro. This five-minute assessment involves tapping the iPhone screen in response to various tones. Based on the results, the AirPods Pro automatically adjust to the user’s specific hearing needs, effectively functioning as a clinical-grade, over-the-counter hearing aid.
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