tVNS® E is not currently approved by Health Canada and is not available for direct purchase. However, there are options for researchers and health care professionals to access the device under specific regulatory pathways.
Option 1: Investigational Use for Researchers #
Researchers in Canada may use tVNS® E for investigational purposes, provided they adhere to Canadian research regulations. Please contact us for more details if you are conducting a study involving tVNS®.
Option 2: Special Access Program (SAP) #
Through the Special Access Program (SAP), health care professionals can request access to medical devices that have not yet been approved in Canada for their patients. Special access is considered when:
- Conventional therapies have failed, are unavailable, or are unsuitable for a patient.
- The requesting health care professional is legally entitled to provide health services in their province.
To request access, health care professionals must complete and submit the Special Access Application Form: Application Form for Special Access to Medical Devices
Who Covers the Cost? #
Healthcare funding is regulated at the provincial level. Patients should check with:
- Their health care provider
- Their private insurer
- Their provincial health authority
How Long Does Approval Take? #
Health Canada typically reviews SAP requests within 3 business days. Once approval is granted, we can proceed with shipping the device to Canada. For further information or assistance with the Special Access Program, feel free to contact us.