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Bonnie Cooke speaks on regulation of over-the-counter hearing aids

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Speech-Language & Audiology Canada’s Director of Audiology and Interim Advocacy Lead, Bonnie Cooke, spoke with Catherine Handfield, a reporter at Le Presse, about the regulation of over-the-counter hearing aids, specifically the function of Apple Airpods. Cooke was quoted and provided insight on over-the-counter hearing aids.

SAC supports improved access to hearing care through OTC hearing aids for adults with mild to moderate hearing loss. However, SAC emphasizes the need for strong regulation, clinical support, and public education to ensure their safe and effective use.

Read the article, available only in French, here.

Over-the-Counter Hearing Aids & Equitable Access

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On April 17, SAC submitted feedback to Health Canada’s consultation on the Draft Guidance on Managing Applications for Medical Device Licenses, emphasizing our concerns related to over-the-counter (OTC) hearing aids and the need for appropriate regulatory oversight.

On May 2, we also sent a letter to Mr. Greg Orencsak, the Deputy Minister of Health Canada, highlighting the importance of ensuring public safety, consumer education, and product effectiveness through strong regulatory measures for OTC hearing aids in Canada.

Read Health Canada’s Response

We are currently finalizing a position paper, to be released in July, that highlights the role of audiologists and the government when it comes to OTC hearing aids in Canada. This paper calls for measures to ensure public safety, product quality, and informed consumer access. SAC believes that if implemented properly, OTC hearing aids could help to improve access to hearing healthcare in Canada for some. SAC also believes that audiologists are essential in safeguarding hearing health by providing expert assessments, tailored recommendations, and ongoing support.

Health Canada Approves Apple AirPods Pro Firmware Module upgrades: Implications for Hearing Health

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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.

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