Yes, tVNS® E is approved for use in children aged 3 years and older under the European Medical Device Regulation (EU-MDR 2017/745) for certain conditions, including epilepsy, autism, and Prader-Willi syndrome. Clinical studies and real-world use have demonstrated that transcutaneous vagus nerve stimulation (tVNS®) is well tolerated in pediatric patients when used appropriately.

Safety and Considerations for Pediatric Use #

• Non-Invasive & Well-Tolerated – Unlike implanted VNS, tVNS® does not require surgery and has minimal side effects.
• Adjustable Stimulation Intensity – The device allows parents or caregivers to adjust the stimulation settings to ensure comfort.
• Daily Use for Best Results – Like with adults, consistent daily use over several weeks is needed to assess effectiveness.

Parental Supervision Is Recommended #

For younger children, it is advised that a parent or caregiver helps apply the electrode and monitors the session to ensure proper placement and adherence to treatment guidelines.

Consult Your Child’s Doctor #

Before starting treatment, we recommend speaking with your pediatrician or specialist to determine if tVNS® is the right option for your child’s specific condition. If you have any concerns or questions about using the device for your child, feel free to contact our support team for further guidance.