Federal Government Position on OTC Devices
Editor’s Note: Since the early studies of Professor Larry Humes, the idea of mild gain hearing aids that can be used by those adults with only a mild or moderate sensori-neural hearing loss, with no audiological input or verification, has been floated with the introduction of OTC hearing aids. Recent research out of the United States indicates that the OTC version of hearing aids has not made any significant headway into the American market, with a significant number being returned for credit. And OTC hearing aids that appear to have similar sound quality tend to be comparable in price to conventional hearing aids based on the unit price. It is no wonder that the Canadian federal government is hesitant to establish well-defined policies regarding the sale and distribution of OTC hearing aids.
Shared by Brian O’Riordan, Registrar CASLPO
Health Canada is committed to enabling access to safe and effective medical devices in Canada. Health Canada regulates the sale, advertising for sale and importation for sale of medical devices through the Medical Devices Regulations (the Regulations) of the Food and Drugs Act. Under the Regulations, Health Canada ensures that medical devices sold in Canada meet regulatory requirements with respect to safety, effectiveness, and quality. Under the Regulations, medical devices are classified into one of four classes where Class I represents the lowest risk and Class IV the highest. Hearing aids are classified as Class II medical devices, and they require a medical device licence for import or sale in Canada.
The use of and access to medical devices licensed for sale by Health Canada, including hearing aids, fall under the practice of medicine, which is outside of Health Canada’s mandate. While the federal government plays a role in supporting health care by providing funding to the provinces and territories, the provincial and territorial governments have primary jurisdiction in the administration and delivery of health care services. …
Western University Study on Willingness to Participate in Primary Care Teams
Western University is recruiting audiologists and speech-language pathologists across Canada, to participate in a concept mapping study exploring “readiness” to participate in comprehensive, interdisciplinary, primary health care teams. They are targeting recruitment through December and January.
To read the letter of information and signup for the study click here.
For more information please email Grecia (Research Assistant at firstname.lastname@example.org
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