Insights

OTC hearing aids are devices intended for a specific cohort – adults with perceived mild to moderate hearing loss. These devices are generally more affordable, but less advanced than prescription hearing aids. Unlike prescription models, OTC hearing aids are self-fitted and self-adjustable, typically through a smartphone app, without requiring professional fitting by a hearing healthcare provider. Although, professional customization is an option for those who seek additional support.

Prescription hearing aids differ from OTC devices in two key aspects: technology sophistication and fitting parameters. Advanced technology and features, often associated with a higher price point, enable a more tailored physical and psychoacoustic fitting, regardless of age or degree of hearing loss. Additionally, prescription hearing aids must be professionally fitted using best-practice verification methods such as Real Ear Measurement to ensure optimal performance.

In Canada, both OTC and prescription hearing aids are regulated by Health Canada as Class II medical devices, which are considered to carry a moderate level of risk. A medical device license is required for Class II medical devices before they can be sold across Canada. Manufacturers may also need to comply with other federal, provincial or territorial or municipal regulations that apply to their product.

To receive approval, manufacturers must attest that the product meets the safety, effectiveness and quality standards established by the Canadian Medical Devices Regulations; although, none of the standards outline specific details related to hearing devices, including acoustic or amplification requirements. All approved Class II medical devices are monitored by The Medical Devices Directorate (MDD) to ensure ongoing safety and effectiveness. Individuals are encouraged to submit problems or concerns with approved medical devices to Health Canada. This includes concerns with a product’s effectiveness, clarity of instructions, and harm or potential harm.

The HPA does not specifically address OTC hearing aids, or regulate the sale of any devices; however, it provides legislative guidance in several ways.   

In the practice statement for audiologists (section 3(2) of Schedule 28), the HPA states that audiologists provide appropriate devices and treatment for auditory dysfunction. Thus, it is ACSLPA’s position that when audiologists practice in compliance with the HPA and ACSLPA’s Standards of Practice and Code of Ethics, they are permitted to provide and fit OTC hearing aids when appropriate for their clients.    

Under the HPA, providing devices, including OTC hearing aids, to treat auditory dysfunction is not a restricted activity (section 1.3(1)). This means individuals who are not regulated members of a health profession college are not prevented by the HPA from providing OTC hearing aids. However, ‘inserting or removing a device beyond the cartilaginous portion of the ear canal’ or ‘inserting into the ear canal a substance that subsequently solidifies’ are restricted activities that must be performed by regulated health professionals in Alberta (section 1.6 of HPA) and may be performed by audiologists (section 68 of the Health Professions Restricted Activity Regulation). Notably, these restricted activities are not exclusive to registered audiologists. For example, hearing aid practitioners registered with the College of Hearing Aid Practitioners of Alberta (CHAPA) can also perform these restricted activities in Alberta (section 17 of the Health Professions Restricted Activity Regulation).

Finally, the HPA (section 2(d)(j)(k) in Schedule 28) and the Speech-Language Pathologists and Audiologists Profession Regulation (section 18(1)(b)) restrict the use of protected titles including “audiologist”, as well as abbreviations such as “Aud” and “R.Aud”, to audiologists registered with ACSLPA. Individuals who provide devices, such as hearing aids, to treat auditory dysfunction but are not registered with ACSLPA, are prohibited from using these protected titles.

ACSLPA regulates the practice of audiologists on behalf of all Albertans by establishing, maintaining, and enforcing standards for competent, safe, and ethical practice. As part of this mandate, ACSLPA has a role with respect to OTC hearing aids.  

First, ACSLPA is responsible for ensuring there are adequate standards for competent, safe, and ethical practice. The College recognizes the need to adapt to advancements in hearing health and will be establishing an ad hoc committee of regulated audiologists to provide input on whether additional standards and guidance are required for OTC hearing aids. In the meantime, registrants are encouraged to review the following existing key college documents:   

• Standards of Practice – ‘Service Delivery’ (1.1, 1.3)
• Code of Ethics (2.1, 4.2 and 4.3)  

Secondly, ACSLPA will continue to monitor and address concerns related to unregistered individuals who use protected titles or perform restricted activities when selling or fitting OTC hearing aids.   

Finally, it is important to note that ACSLPA does not regulate the availability of OTCs or the technical standards for OTC devices or prescription hearing aids at a provincial level.

ACSLPA’s regulated members play a crucial role in educating and supporting the Alberta public in making informed decisions about hearing healthcare, including the use of OTC hearing aids. By providing accurate, evidence-based information, audiologists and speech-language pathologists can help individuals understand both the benefits and limitations of these devices.   

Key ways registrants can support the public include:  

• Identifying appropriate candidates for OTC hearing aids and advising on potential risks and contraindications.
• Addressing public inquiries as awareness of OTC hearing aids increases, ensuring individuals receive reliable information.
• Recognizing when professional intervention is necessary and referring individuals to a qualified hearing healthcare professional as needed.   

As OTC hearing aids become more available, speech-language pathologists may also encounter questions from clients and the public about their suitability. In such cases, speech-language pathologists should refer individuals to an audiologist when necessary, ensuring they receive comprehensive, professional hearing healthcare. This aligns with ACSLPA’s commitment to public education and high-quality service delivery, as highlighted in the College’s 2022 Insights article on OTC hearing aids. 

• Medical Device Regulations 
• SAC Article
• HearAdvisor (the U.S)
• Database of hearing devices in Quebec 
• Health Canada: About medical devices

If you found this article interesting, all of our Insights publications can be accessed here. If you have questions about these topics, the legislation behind them, or the way ACSLPA functions please email feedback@acslpa.ca or call 780-944-1609 ext. 101.