Recommending tVNS in the UK
This page is intended for UK healthcare professionals. It assumes you have read the practice guide and decided that tVNS is worth trying for a specific patient. It covers the route, not the case for it.
What happens when you recommend it
tVNS is sold in the UK as a supported programme, not a device in a box, and the Instructions for Use require medical supervision. In practice that means three parties: the patient or carer, who runs the device every day; you, who own the clinical decisions; and Anatomical Concepts UK, who handle the fitting, the scheduled contact, the consumables, and the logistics. The programme page describes it from the patient's side. This page describes your part.
Your part is small and specific:
- Confirm the indication and the contraindications. Certified indications are drug-resistant epilepsy, depression, chronic migraine, and Prader-Willi syndrome, in adults aged 18 and over. Contraindications per the IFU: pregnancy; an active implant (pacemaker, defibrillator, implanted VNS, cochlear implant); a cerebral shunt; sore, broken, or diseased skin at the cymba conchae. Cardiac arrhythmia needs your clearance first.
- Keep the medication stable for 6 to 8 weeks before the start and through the evaluation window, so that any change can be attributed.
- Review the diary at the schedule for the indication (weeks 8, 12 and 20 for epilepsy; weeks 4, 8 and 12 for depression and chronic migraine; months 3, 6, 9 and 12 for Prader-Willi syndrome). The patient brings a one-page summary sheet to each appointment.
- Name the outcome at the decision point using the four categories in the practice guide: responder, partial responder, non-responder, adherence non-responder.
Everything else (fitting, titration within the IFU range, routine design, the calls between your reviews, consumables, warranty, vigilance paperwork) is ours.
Three ways in
1. Point the patient to the form
The simplest route. The patient or carer completes the request-a-call form, naming you as the consultant involved. We phone them within three working days for a 20 to 30 minute suitability call, and we write to you when they enrol (see the enrolment letter below). Nobody is asked for money on that call, and no deposit is ever taken on a first conversation.
2. Fill in the form on the patient's behalf
The same form has "a clinician" as an option under who is filling it in. Use it when you would rather start the conversation yourself, or when the patient needs help with it. We will phone whoever you name as the contact.
3. Order on behalf of a service
For an NHS service, a private clinic, or a research group buying for a clinical evaluation, we invoice the organisation on a purchase order and run the programme with a named clinician as the point of contact. Email info@anatomicalconcepts.com with "clinician order" in the subject line and tell us the service, the indication, how many patients, and who the contact is. The research device is a separate product with its own route and is not for clinical use.
Whichever route, the patient's decision point and review schedule are the ones in the table on the programme page.
What we send you, and when
On enrolment: a letter. One page, sent with the patient's consent. It states the device and its regulatory status, the protocol (25 Hz, 200 to 250 microseconds, 30 seconds on and 30 off, 2 to 4 hours daily, left cymba conchae, intensity titrated to a clear non-painful tingling), the review schedule for the indication, our contact details, and a request for your view on suitability. It offers a call. It does not ask you to do anything you were not already going to do.
Before each of your reviews: a summary sheet. The patient brings it. One page: the period covered, adherence as the patient reports it (the manufacturer's Patient App logs sessions on the patient's phone; we never hold that log), diary totals in the format of the diary they keep, side effects noted, and the questions the patient wants to ask you. It is written for the patient to fill in with us on the call before their appointment, so it arrives in their words, not ours.
At the decision point: a decision sheet. The four outcome categories, space for your view and the patient's, and the agreed next step: continue, modify, or stop.
Whenever something is reported to us that is yours. Medication questions, a change in seizure pattern or mood, a new symptom: we route it to you the same day, with the patient's agreement, and we do not advise on it. This is stated to every patient on the first call.
First-fit checklist
We fit by video call, or you can fit in clinic if you prefer. Either way, this is the list.
Before the electrode goes in
- Contraindications confirmed and recorded; arrhythmia cleared if relevant.
- Consultant letter sent and acknowledged, or the patient has told you.
- Baseline diary running (8 weeks for epilepsy where possible, 4 weeks for the others, or the patient's existing diary).
- Medication stable.
- Skin at the cymba conchae intact; for Prader-Willi syndrome, skin picking at the ear checked.
Placement
- Left ear. Cymba conchae, not the tragus and not the lobe. The electrode sits in the concha above the ear canal, held by the silicone rings; it should be secure without pressure.
- Electrode cream on both contact surfaces.
Titration
- Increase in steps until the patient reports a clear tingling. Then one notch back. Comfortable is the target; pain is the ceiling, not the goal.
- Explain that the sensation fades over the first two weeks and that we will reset the intensity at the week 2 call. Under-stimulation later is common and is the usual reason a diary shows nothing.
Routine
- Agree the session slot ("after I clear the plates") and a fallback slot for days that go wrong.
- Ramp: about an hour twice daily in week 1, building to 2 to 4 hours daily by the end of week 2.
- The manufacturer's Patient App paired, if the patient wants it; the device works without it.
Before the call ends
- What a skin break at the site looks like and what to do (stop, let it heal, call us).
- The Yellow Card route, in the back of the printed diary.
- Our number, the next call date, and the date of the next appointment with you.
An individual funding request
There is no NICE guidance on auricular VNS and no commissioning route, so the default in the UK is that the patient pays. Where a clinician believes a patient's circumstances are exceptional, an individual funding request (IFR) to the integrated care board (in England) or the health board (elsewhere in the UK) is the route. We say two honest things about it. First, IFR panels fund on clinical exceptionality, not on evidence alone, so the letter has to show why this patient differs from others with the same condition. Second, we have not yet seen one succeed for this device; if yours does, we would like to know, and we will support it with whatever evidence the panel asks for.
The template below is a starting point. Change anything; delete what does not apply; do not overstate the evidence, because the panel will check it.
Individual funding request: transcutaneous auricular vagus nerve stimulation (tVNS)
Patient: [name, date of birth, NHS number] Requesting clinician: [name, role, service] Date: [date]
Diagnosis. [Condition], diagnosed [year], confirmed by [investigation]. [For epilepsy: drug-resistant epilepsy as defined by the ILAE, having failed [n] adequately trialled anti-seizure medications: list them with doses and duration. Current seizure frequency: [n] per month from the patient's diary over [period].]
Treatments tried and their outcome. [List, with the reason each was stopped or is insufficient.]
Why the standard next step is not available or appropriate. [For epilepsy: resective surgery not viable because [reason]; implanted VNS declined by the patient because [reason], or not offered because [reason], or on a waiting list of [duration].]
The intervention requested. A supported evaluation of transcutaneous auricular vagus nerve stimulation using the tVNS device (tVNS Technologies GmbH), a Class IIa medical device certified under EU MDR 2017/745 with [condition] among its certified indications, supplied and supported in the UK by Anatomical Concepts UK Ltd, the UK Responsible Person registered with the MHRA. The device is non-invasive and reversible. It is used adjunctively; no change to current medication is proposed.
Evidence. In the largest randomised, double-blind trial of auricular tVNS in drug-resistant epilepsy (Yang et al., 2023, n=150), 44.7% of the active group achieved at least a 50% reduction in seizure frequency at 20 weeks against 16.7% on control; a 2016 randomised trial of the predecessor device (Bauer et al., cMPsE02, n=76) showed a significant per-protocol reduction. Two 2025 meta-analyses of the randomised trials found significant reductions in seizure frequency with a pooled responder difference that did not reach significance. An independent triple-blind trial with a one-year primary endpoint (TRAVAST, n=164) is under way in Germany with results expected in 2028. Adverse events in the trials were predominantly mild and local. [For other indications, use the summary on the relevant clinician page.] Full references: tvns-uk.com/clinicians/evidence-library.
Why this patient is exceptional. [The panel's test. Set out what makes this patient's clinical situation, risk, or capacity to benefit different from others with the same condition: for example, seizure-related injury, SUDEP risk factors, employment or care consequences of current seizure frequency, contraindication to or refusal of the surgical alternative.]
Proposed evaluation and stop rule. [n]-week supported evaluation with a seizure [or headache, mood, behaviour] diary against a documented baseline, review at weeks [8, 12 and 20], and a decision at week [20] using a 50% responder criterion. If the criterion is not met with documented adherence, treatment stops and the device is returned. Continuation beyond the evaluation only on documented response.
Cost. Device and starter consumables £3,046.76 including VAT. Consumables thereafter approximately [£] per year. For comparison, implanted VNS costs approximately £20,000 to £50,000 including surgery and follow-up.
Monitoring and safety. Medical supervision by the requesting clinician at the reviews above. Adverse events reported through the MHRA Yellow Card scheme and to the UK Responsible Person.
[Signature]
We can supply the current consumable prices, the regulatory documentation, and a copy of the evidence summary for the panel on request.
What we do not do
For clarity, because clinicians ask:
- We do not give clinical advice to patients. Fit, intensity within the IFU range, and routine are ours; everything else comes to you.
- We do not hold the diary or the session log. The printed diary belongs to the patient; the app log stays on their phone. We hold contact details and brief notes of what was agreed on calls. Our privacy policy has the detail.
- We do not pay clinicians for recommendations, referrals, or reviews, and we do not offer anything that could be read that way.
- We do not supply the research device for clinical use, and we will not reprogramme a therapy device outside the certified protocol.
- We do not yet run CPD-accredited training. A case discussion, a service visit, or a teaching slot for a team are all available through book a demo.
Where to next
Request a call on a patient's behalf
Book a demo or a case discussion
tVNS is a Class IIa medical device manufactured by tVNS Technologies GmbH, Germany. Distributed in the UK by Anatomical Concepts UK Ltd.