What do Canada, France, Spain, China, the UK, Mexico, and over 100 other countries have in common? They all lack access to the latest and best hearing health features of the Apple AirPods Pro 2.
From my home office in Toronto, I discovered this firsthand. After updating my iPhone and AirPods Pro 2 to the latest software, I was excited to see the new hearing protection feature. However, I was disappointed to find that the highly anticipated hearing test and hearing aid options linked to iOS 18.1 were unavailable.
When Apple first unveiled these new capabilities for the AirPods Pro 2, I had a premonition that something like this could occur. Although Apple received FDA clearance and approval from regulators in 103 additional countries, prominent markets have yet to endorse their hearing health claims.
One reason for this delay might be related to resources. In some regions, the FDA’s approval is regarded as robust enough evidence for safety and efficacy, while others prefer to verify product claims through independent assessments, a process that can be time-consuming.
Apple’s strategy complicates the situation further, positioning the AirPods Pro as an over-the-counter (OTC) hearing aid. This classification, meant for individuals with mild to moderate hearing loss, is relatively new in the U.S. since being approved by the FDA in 2022. However, many countries, including Canada, do not recognize this classification as a valid form of a medical device.
In particular, Canadian provinces like Ontario do not legally allow the sale of any hearing aid without a prescription from a certified medical professional.
While Canada is expected to align with the U.S. regarding OTC hearing aids, Health Canada has not provided a timeline or assurance about when this might occur.
Given these regulatory landscapes, it makes sense that Apple has held back the hearing test and hearing aid features in places like Canada. The company cannot present the AirPods Pro as OTC hearing aids if doing so would risk legal issues.
While I typically appreciate this cautious approach—ensuring that regulations verify health claims and minimize risks—I believe people who already own AirPods Pro should be given the chance to use these hearing health features, even on a trial basis. This would be contingent on users understanding that their regulatory bodies have yet to verify or endorse these functionalities.
With this in mind, I had my annual hearing exam on October 22. I see no reason why I couldn’t at least compare my results with Apple’s hearing test.
Unfortunately, that won’t be feasible anytime soon. It’s rumored that individuals in regions without access might bypass restrictions by altering the country linked to their Apple ID, but I can’t endorse that method—doing so could lead to various complications.
