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tVNS® – currently the only non-invasive vagus nerve stimulation device approved under the European Medical Device Regulation. Experience an evidence-based, transcutaneous, and mobile therapy option for neurological and psychiatric patients.

Trusted by Leading Institutions Worldwide

Introducing tVNS®

Pioneering the Future of Neuromodulation

With its non-invasive approach, patient-friendly treatments, and minimal side effects, tVNS® offers a new horizon of hope and relief for those living with neurological conditions. Embrace a future where each day holds the promise of greater comfort and enhanced quality of life.

Unmatched research and development

tVNS® is Indicated to Treat the Following Conditions

The tVNS E is currently the only transcutaneous vagus nerve stimulation device approved in Europe according to the new Medical Device Regulation (MDR EU 2017/745). The tVNS® E is explicitly approved for the following indications:

Effect of transcutaneous vagus nerve stimulation on stress-reactive neuroendocrine measures in a sample of persons with temporal lobe epilepsy

A randomized, double-blind crossover study of 20 seizure-free temporal lobe epilepsy patients found that 4 hours of transcutaneous vagus nerve stimulation (tVNS) dampened the natural cortisol decline and reduced salivary flow rate compared to sham stimulation. This suggests modest short-term effects on stress-related biological systems, though subjective stress and tiredness were unchanged.

tVNS® and Epilepsy

After a 20 week treatment period, active tVNS® patients recorded an average 34.2% reduction of seizure frequency.

Transcutaneous Auricular Vagus Nerve Stimulation Differently Modifies Functional Brain Networks of Subjects With Different Epilepsy Types

A 30-subject EEG study found that transcutaneous auricular vagus nerve stimulation (taVNS) modifies functional brain network properties in ways that differ by epilepsy type. Generalized and focal epilepsy groups showed opposite patterns of network reorganization during and after stimulation, suggesting taVNS effects are not uniform across epilepsy types. Local brain network changes were largely diffuse and non-specific.

tVNS® and Epilepsy

After a 20 week treatment period, active tVNS® patients recorded an average 34.2% reduction of seizure frequency.

The potential of invasive and non-invasive vagus nerve stimulation to improve verbal memory performance in epilepsy patients

A crossover study of 15 patients with drug-resistant epilepsy found that neither acute invasive VNS nor taVNS improved verbal memory performance on a word recognition task. However, memory scores improved significantly after 6 weeks of VNS treatment, suggesting sustained, repetitive stimulation at moderate intensity is needed to meaningfully enhance memory function.

tVNS® and Epilepsy

After a 20 week treatment period, active tVNS® patients recorded an average 34.2% reduction of seizure frequency.

Transcutaneous auricular vagus nerve stimulation induces stabilizing modifications in large-scale functional brain networks: towards understanding the effects of taVNS in subjects with epilepsy

A prospective trial of 14 epilepsy patients found that one hour of taVNS produced measurable, often persistent changes in EEG-derived brain network properties, including increased integration, robustness, and stability. Importantly, these network modifications occurred without any negative impact on cognition or behavior, suggesting taVNS may promote a more resilient epileptic brain network.

tVNS® and Epilepsy

After a 20 week treatment period, active tVNS® patients recorded an average 34.2% reduction of seizure frequency.

Feasibility of transcutaneous auricular vagus nerve stimulation in treatment of drug resistant epilepsy: A multicenter prospective study

A multicenter feasibility trial of taVNS in 37 drug-resistant epilepsy patients was terminated early due to poor recruitment and high dropout. Only 59% completed six months and 16% completed the full 18-month follow-up. The findings highlight that patient adherence and device usability are critical barriers to real-world taVNS adoption, independent of clinical efficacy.

tVNS® and Epilepsy

After a 20 week treatment period, active tVNS® patients recorded an average 34.2% reduction of seizure frequency.

Learnings from 30 years of reported efficacy and safety of vagus nerve stimulation (VNS) for epilepsy treatment: A critical review

A comprehensive review of 30 years of VNS literature found that invasive VNS achieves 50% seizure reduction in roughly 45 to 65% of drug-resistant epilepsy patients, with efficacy peaking around 6 months and continuing to improve for up to 2 years. Non-invasive taVNS shows promise but remains limited by small study sizes, inconsistent protocols, and lack of long-term data.

tVNS® and Epilepsy

After a 20 week treatment period, active tVNS® patients recorded an average 34.2% reduction of seizure frequency.

A retrospective study of transcutaneous vagus nerve stimulation for poststroke epilepsy

A retrospective study of 52 post-stroke epilepsy patients found that 4 weeks of taVNS showed no significant improvement in seizure frequency, seizure duration, or quality of life compared to a waiting-list control group. The authors attributed the null findings to a short treatment duration, low stimulation dose, and small sample size.

tVNS® and Epilepsy

After a 20 week treatment period, active tVNS® patients recorded an average 34.2% reduction of seizure frequency.

Transcutaneous Vagus Nerve Stimulation (tVNS) for Treatment of Drug-Resistant Epilepsy: A Randomized, Double-Blind Clinical Trial (cMPsE02)

A double-blind RCT of 76 drug-resistant epilepsy patients comparing 25 Hz taVNS against 1 Hz active control found no statistically significant superiority for the active treatment group overall. However, patients who completed the full 20-week treatment showed a significant 34% seizure reduction, and adherence was high. The authors concluded that larger, longer trials are warranted.

tVNS® and Epilepsy

After a 20 week treatment period, active tVNS® patients recorded an average 34.2% reduction of seizure frequency.

Treatment of chronic migraine with transcutaneous stimulation of the auricular branch of the vagal nerve (auricular t-VNS): a randomized, monocentric clinical trial

A case report of a 17-year-old with longstanding treatment-resistant depression found that 7.5 months of daily home-based taVNS, adjunct to escitalopram, was feasible and well-tolerated, with modest improvements in self-reported and clinician-rated depression scores. The authors note that existing protocols are not yet optimized for adolescents and call for dedicated pediatric research.

tVNS® and Depression

tVNS® led to a reduction of depression-specific HAMD score of a minimum of 2-3 points in adult patients when used in parallel with psychopharmacological and psychotherapy treatments after a period of 9 weeks.

Non-invasive vagus nerve stimulation conditions increased invigoration and wanting in depression

A crossover study of 30 MDD patients and 29 healthy controls found that taVNS boosted effort invigoration during the first session in both groups, with gains persisting into a second session rather than requiring repeated acute stimulation. Patients with MDD showed trial-by-trial increases in both invigoration and reward wanting during taVNS, suggesting the stimulation may facilitate motivational learning that could complement existing depression treatments.

tVNS® and Depression

tVNS® led to a reduction of depression-specific HAMD score of a minimum of 2-3 points in adult patients when used in parallel with psychopharmacological and psychotherapy treatments after a period of 9 weeks.

Transcutaneous Vagal Nerve Stimulation in Treatment-Resistant Depression: A Feasibility Study

A single-arm feasibility study of 20 treatment-resistant depression patients found that 80% achieved the compliance threshold of 4 hours of daily taVNS over 4 weeks. Side effects were mild and mostly local. Significant reductions in depression severity and improvements in cognitive speed were observed, supporting the case for larger randomized trials in this difficult-to-treat population.

tVNS® and Depression

tVNS® led to a reduction of depression-specific HAMD score of a minimum of 2-3 points in adult patients when used in parallel with psychopharmacological and psychotherapy treatments after a period of 9 weeks.

Effects of acute transcutaneous vagus nerve stimulation on emotion recognition in adolescent depression

A randomized crossover trial of 33 depressed and 30 non-depressed adolescents found that acute taVNS did not improve general emotion recognition accuracy but did alter response inhibition on an emotional Go/NoGo task. Notably, taVNS reduced responses to sad stimuli in depressed adolescents while improving overall recognition in controls, suggesting the stimulation may specifically modulate negative-valence processing in adolescent depression.

tVNS® and Depression

tVNS® led to a reduction of depression-specific HAMD score of a minimum of 2-3 points in adult patients when used in parallel with psychopharmacological and psychotherapy treatments after a period of 9 weeks.

Outcomes of transcutaneous nerve stimulation for migraine headaches: a systematic review and meta-analysis

A non-blind case series of five adults with Prader-Willi Syndrome found that four hours of daily taVNS over 12 months produced significant reductions in temper outbursts in four of five participants, with improvements emerging around month nine. Halving the stimulation time to two hours reversed gains in most participants, suggesting sustained high-dose stimulation is necessary to maintain therapeutic effects.

tVNS® and Chronic Migraines

Treatment with tVNS® led to a reduction of 50% of the frequency of days with chronic migraines after a treatment period of 12 weeks.

Treatment of chronic migraine with transcutaneous stimulation of the auricular branch of the vagal nerve (auricular t-VNS): a randomized, monocentric clinical trial

A systematic review and meta-analysis of 14 studies covering 995 patients found that preventive transcutaneous nerve stimulation reduced headache frequency by roughly 3 days per month in both episodic and chronic migraine, with episodic migraine patients also experiencing meaningful reductions in pain severity. The authors concluded that transcutaneous stimulation represents a clinically significant non-pharmacologic migraine prevention option.

tVNS® and Chronic Migraines

Treatment with tVNS® led to a reduction of 50% of the frequency of days with chronic migraines after a treatment period of 12 weeks.

Effects of long-term transcutaneous auricular vagus nerve stimulation on circadian vagal activity in people with Prader-Willi Syndrome: A case-series

A 12-month case series of five Prader-Willi Syndrome patients found that daily taVNS significantly increased heart rate variability and reduced resting heart rate, both indicating enhanced vagal activity. Higher HRV levels predicted fewer emotional outbursts, suggesting taVNS may improve behavioral regulation by targeting autonomic nervous system dysfunction in this population.

tVNS® and Prader-Willi Syndrome

After a treatment period of 12 months, 80% of tVNS® patients recorded a reduction of the mean number of outbursts per day of 50%, compared to the mean number of outbursts per day before treatment.

Vagal Nerve Stimulation in Irritable Bowel Syndrome

An ongoing randomized controlled trial (currently recruiting) based at Maastricht University Medical Center testing 8 weeks of taVNS against sham in irritable bowel syndrome patients. Primary outcomes include symptom reduction, quality of life, anxiety, and depression. The study also aims to determine whether a pre-treatment autonomic and brain imaging “neurosignature” can predict who will respond to taVNS.

tVNS® and Prader-Willi Syndrome

After a treatment period of 12 months, 80% of tVNS® patients recorded a reduction of the mean number of outbursts per day of 50%, compared to the mean number of outbursts per day before treatment.

Transcutaneous vagus nerve stimulation (t-VNS): A novel effective treatment for temper outbursts in adults with Prader-Willi Syndrome indicated by results from a non-blind study

A non-blind case series of five adults with Prader-Willi Syndrome found that four hours of daily taVNS over 12 months produced significant reductions in temper outbursts in four of five participants, with improvements emerging around month nine. Halving the stimulation time to two hours reversed gains in most participants, suggesting sustained high-dose stimulation is necessary to maintain therapeutic effects.

tVNS® and Prader-Willi Syndrome

After a treatment period of 12 months, 80% of tVNS® patients recorded a reduction of the mean number of outbursts per day of 50%, compared to the mean number of outbursts per day before treatment.

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Voices of Healing

tVNS® in the media

tVNS® has already been featured in numerous renowned national and international health, science, and innovation media outlets for its evidence-based approach to non-invasive vagus nerve stimulation. The coverage underscores the growing medical and scientific interest in transcutaneous vagus nerve stimulation and the importance of clinically sound technology certified under the European Medical Device Regulation (MDR) in modern neuromodulation.

Click the publications logo that you would like to see, or scroll below and click on the article you would like to read. 

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Voices of Healing

Real Stories from our tVNS® Patients

Worldwide, more and more patients, researchers, and physicians are having positive experiences with tVNS®. These insights help us continuously improve tVNS® therapy and apply it in a targeted way.

We are proud to help people worldwide

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Patient First Care

What is tVNS® and Why We Lead in Vagus Nerve Stimulation

Navigating treatment options can be overwhelming, especially when conventional therapies fall short. tVNS® offers a non-invasive approach by gently stimulating the vagus nerve through the ear, supporting balance within the nervous system without surgery or medication-related side effects. Approved as a Class IIa medical device under the EU-MDR, it combines safety, simplicity, and scientific rigor.

With over 20 years of experience, we are pioneers in non-invasive vagus nerve stimulation. Backed by robust clinical research and developed and manufactured in Germany, our devices are trusted worldwide by clinicians and researchers for their precision, reliability, and high quality standards.

What Makes Our Device Special?

  • Only Certified Non-Invasive Vagus Nerve Stimulation Device
  • Safety Class: Same Safety Class as Hearing Aids 
  • Most Effective Stimulation Site: Cymba Conchae
  • Electrode: High Quality, Non-Allergenic Titanium-Iridium
  • Stimulation Pattern: 28s Active Stimulation / 32s Pause
  • World Class Support: Our dedicated team is here to help

Our tVNS® device is the only non-invasive VNS device that is approved as a medical device under the EU-MDR.

20+ Years

of experience pioneering the non-invasive vagus nerve stimulation.

100% Innervation

of the vagus nerve is achieved via stimulation of the cymba concha.

Made in Germany

of German precision engineering, trusted by researchers and clinicians worldwide.

Use tVNS® anytime, anywhere

How does treatment with tVNS® work?

Transcutaneous aricular vagus nerve stimulation with the tVNS® E is a systemic therapy. Here, sensory fibers of the vagus nerve in the Cymba Conchae of the auricle (outer ear) are addressed, which send the signal further to the brainstem and the cerebral cortex. From there, the signal travels back into the body’s trunk to almost all organs.  

Stimulation of the afferent branches of the vagus nerve in the ear can therefore influence all major organ systems and thus many different diseases and pathophysiologies. Numerous research projects are currently underway worldwide for conditions such as stroke, ME/CFS, Sleep Disorders, Parkinson’s, Chronic Inflammatory Bowel Diseases or Atrial Fibrillation.

How to set-up and begin using the tVNS® E Device

In this unboxing video, we walk you through the tVNS® device step by step, showing exactly what’s included and how to get started. You’ll see how to set up the device, place the electrode correctly, and begin your first session with confidence. Designed to be intuitive and easy to use at home, this guide helps ensure a smooth start and supports safe, comfortable integration of tVNS® into your daily routine.

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Meet your Expert Team of Dedicated Specialists

Contact our tVNS® experts and receive information on individual tVNS® application.