January 17, 2025 — Health Canada has approved Apple’s AirPods Pro Firmware Module and Hearing Aid Feature iPhone App by issuing Class II medical device licences. Together, these features enable Apple AirPods to function as over-the-counter (OTC) hearing aids by providing person-specific amplified sound based on a user-controlled in-app hearing test, with the option to upload an audiogram. Notably, this functionality bypasses the need for involvement from an audiologist. 

While these approvals confirm the devices meet manufacturing standards, Health Canada’s evaluation does not include a rigorous assessment of key functional specifications, including power output. 

Currently, Canada lacks specific federal regulations for OTC hearing aids.  In correspondence with other stakeholders, Medical Devices Directorate staff stated, “Access to medical devices is overseen by the provinces and territories in Canada,” indicating no plans for federal oversight specific to OTC hearing aids.  This regulatory gap highlights the need for rigorous evaluation of functional safety and performance—not just adherence to manufacturing standards. 

Although Health Canada has issued Class II medical device licenses for these features, Apple has not yet fully rolled out the software across all provinces and territories. According to Apple experts, the company is following all legal proceedings and requirements specific to each province and territory. 

SAC will continue to advocate for proper regulatory measures to ensure the quality and safety of OTC hearing aids. We strongly encourage consumers to consult with audiologists to better understand their specific hearing needs and make informed choices about their hearing health. Audiologists are essential in safeguarding hearing health by providing expert assessments, tailored recommendations, and ongoing support.