Yes, tVNS® E is a certified medical device. It is classified as a Class IIa medical device under the European Medical Device Regulation (EU-MDR 2017/745). This means it has undergone rigorous testing for safety, efficacy, and quality, meeting strict regulatory requirements for medical use.
What Does This Certification Mean? #
- Clinically Validated – tVNS® E has been evaluated in multiple clinical studies and is approved for treating specific medical conditions.
- Manufactured to High Standards – The device complies with stringent ISO 13485:2016 quality management system standards for medical device manufacturing.
- Regulatory Oversight – The device has been reviewed and approved by TÜV SÜD, an internationally recognized Notified Body for medical devices in Europe.
What Conditions is tVNS® E Approved to Treat? #
tVNS® E is certified as a class IIa medical device under the EU-MDR and indicated for the treatment of various neurological, psychiatric, and chronic conditions. These include:
- Anxiety
- Atrial Fibrillation
- Autism
- Cognitive Impairment
- Depression
- Epilepsy
- Irritable Bowel Syndrome (IBS)
- Inflammatory Bowel Disease (IBD) (including Crohn’s Disease & Ulcerative Colitis)
- Systemic Sclerosis
- Migraines
- Parkinson’s Disease
- Prader-Willi Syndrome (PWS)
- Sleep Disorders
- Tinnitus
Is tVNS® E Approved Outside of Europe? #
In addition to our EU-MDR certification, our tVNS® E device is approved in Israel, Jordan, Kuwait and Türkiye, among other countries.
tVNS® E is currently not approved by the FDA in the United States or Health Canada. However, health care providers may request access through compassionate use programs (expanded access in the U.S., special access in Canada).
If you have any questions about the regulatory status of tVNS® E in your country, please contact our team.