Non-Prescribed Hearing Aids (NPHAs) are hearing aids, instruments, or devices, purchased or obtained over the counter, online, donated, obtained second-hand, or acquired as a gift. CHCPBC receives questions from the public, Registered Hearing Instrument Practitioners (RHIPs), and Registered Audiologists (RAUDs), about NPHAs.
NPHAs are currently classified as medical devices under Canada’s Food and Drug Act (FDA), and the Medical Devices Regulation, because they are classified as products designed to treat a health condition. Under federal legislation, medical devices are defined as any article, instrument, or apparatus intended to diagnose, treat, manage, or prevent a disease or other health conditions.
Unlike Personal Sound Amplification Products (PSAPs) that are designed for recreational use and only to amplify sound, NPHAs are captured under the (federal) regulatory framework because they are intended to be used by those experiencing hearing loss or to treat a condition.
In addition, health professions are regulated provincially in Canada. In British Columbia, under the Health Professions Act (HPA) and the Speech and Hearing Health Professionals Regulation, only RHIPs are licensed to dispense hearing aids. While RHIPs and RAUDs may both prescribe hearing aids, only RHIPs may sell and fit hearing aids.
In the United States, the passage of the federal Over-the-Counter Hearing Aid Act (2017) created a class of NPHAs (or “Over-the-Counter” (OTC) hearing aids) regulated by the Food and Drug Administration (FDA) that are available directly to consumers without the involvement of a health professional. Since October 17, 2022, FDA-regulated hearing aids have been available to the public in the United States.
In December of 2024, Health Canada approved Apple hearing test and hearing aid features. In addition, the College is aware that some hearing aids under the brand Jinghao, marketed elsewhere as OTC hearing aids, also received Health Canada approval in 2024.
As of March 2025, the Apple features remain inaccessible to Canadian consumers. Apple states that these features are “regulated health features that require approval and will be offered after authorization is received”. The approval process Apple referred to would require regulatory changes at both the federal (the device) and the provincial (the restricted activities) level, and the College has no say and takes no position on the regulation or de-regulation of NPHAs.
See below for an answer to a question about NPHAs and OTC hearing aids, including the Apple hearing health features.
Q: What information should Registered Hearing Instrument Practitioners and Registered Audiologists provide to clients, or members of the public, if asked about access to the Apple AirPods’ hearing health features?
Registrants can inform clients and the public that the Apple features are not yet available in Canada and that decisions are likely required at both levels of government (federal and provincial) before these features will be available to consumers.
In addition, registrants can offer support by informing people about the potential risks and benefits of using this kind of technology to address hearing loss, and when this technology may or may not be suitable. For example:
- This hearing technology is intended for adults 18 and older with perceived mild to moderate hearing loss;
- It is not suitable for treatment of hearing loss in infants and children;
- It may not be suitable for adults, particularly if their hearing problems are more severe or complicated;
- More research is likely required to determine the efficacy of this technology to address hearing problems; and
- It is important to seek guidance from a regulated health professional if a person has a complex medical history associated with their hearing issues, or if a person experiences symptoms such as bothersome tinnitus, dizziness, or ear pain, etc., and/or use of the NPHA/OTC device is not providing benefit.
This is not an exhaustive list. Registrants may decide, in their professional judgement, that additional information is useful to share with the public.
If you have questions, contact CHCPBC through the Contact Form.
