Vagus nerve stimulation (implanted and transcutaneous auricular)

1. Introduction

Version followed: implanted VNS as described in the US manufacturer's patient safety information for epilepsy and depression (LivaNova, VNS Therapy), NICE interventional procedures guidance IPG679 (August 2020, which replaced IPG330) and CMS National Coverage Determination 160.18 (version effective 15 February 2019); non-invasive VNS as described in the gammaCore labelling summary and FDA 510(k) records; consumer devices as described in New York Times reporting (May 2026). All regulatory statements were checked in October 2026.

Vagus nerve stimulation (VNS) delivers mild electrical pulses to the vagus nerve, the long cranial nerve that runs from the brainstem through the neck to the heart, lungs and gut. It comes in three quite different forms, and clients often run them together:

Implanted (cervical) VNS: a surgically implanted pulse generator in the left chest connected by a lead to an electrode wrapped round the left vagus nerve in the neck. It is a prescription treatment selected, implanted, programmed and followed up by specialist teams (epilepsy or psychiatry, with a surgeon trained in this device and in carotid sheath surgery). [source: LivaNova depression patient safety information; NICE IPG679]
Non-invasive prescription VNS: hand-held or ear-worn devices applied to the skin of the neck (transcutaneous cervical VNS, e.g. gammaCore) or to the outer ear (transcutaneous auricular VNS, taVNS, which targets the ear branch of the vagus nerve). In the US some are cleared for headache or opioid-withdrawal symptoms; for depression and anxiety they remain mainly a research method. [source: gammaCore FAQ; FDA 510(k) K251246 summary; NYT 2026]
Consumer "vagus" gadgets: neck or ear wearables sold directly to the public with wellness claims (energy, sleep, stress, "balance"); they do not have to show the FDA that they work. [source: NYT 2026]

Core idea of how change happens, as the sources state it: the treating team regards VNS as a long-term add-on that modulates brain activity via the nerve's connections to the brainstem; for epilepsy it aims to reduce seizure frequency (it does not stop all seizures) and for depression it is an adjunctive, long-term treatment for chronic or recurrent depression that has not responded to several treatments. Detailed mechanisms are beyond what the sources describe [uncertain]. The psychotherapist does not deliver VNS; this guide describes the treatment at a factual level and sets out the psychotherapist's role alongside the treating team. No stimulation parameters, settings or placement details are given here, and none should be given to clients.

Cross-reference: paired VNS for upper-limb stroke rehabilitation (Vivistim) is covered in its own entry in the rehabilitation family; it is not repeated here.

2. Framework

2.1 Regulatory and coverage status by jurisdiction (checked October 2026)

United States

Implanted VNS, epilepsy: labelled as add-on therapy to reduce seizure frequency in people aged 4 years and older with partial-onset (focal) seizures that do not respond to antiseizure medicines. [source: LivaNova epilepsy US safety information] Medicare has covered VNS for medically refractory partial-onset seizures, where surgery is not recommended or has failed, since July 1999; other refractory seizure types are non-covered. [source: CMS NCD 160.18] The original FDA approval year for epilepsy (commonly given as 1997) was not confirmed in a source opened [uncertain].
Implanted VNS, depression: FDA premarket approval in 2005 for adjunctive long-term treatment of chronic or recurrent depression in adults (18+) in a major depressive episode who have not responded adequately to four or more antidepressant treatments. [source: LivaNova press release, June 2025; LivaNova depression patient safety information]
Medicare coverage for depression: since 15 February 2019, CMS covers FDA-approved VNS for treatment-resistant depression only under Coverage with Evidence Development, i.e. within a CMS-approved, double-blind, randomised, placebo-controlled trial with at least one year of follow-up. The approved study is RECOVER (LivaNova; NCT03887715; CMS approval 4 September 2019). Trial criteria include: depression for at least two years or at least four episodes; at least four failed adequate treatments; a major depressive episode confirmed on a standard scale at two visits; a stable medication regimen before implantation. Exclusions include current or lifetime psychotic features, schizophrenia or schizoaffective disorder, rapid-cycling bipolar disorder, delirium, dementia or other cognitive disorder, and current suicidal intent. Depression treatment outside an approved study is non-covered. [source: CMS NCD 160.18; CMS CED page] In June 2025 the manufacturer announced it had begun asking CMS to reconsider national coverage for unipolar TRD on the basis of RECOVER publications. [source: LivaNova press release, June 2025] Whether CMS has since opened or decided a reconsideration is not confirmed (the CMS CED page was last modified September 2024) [uncertain]. Private insurer coverage varies and was not reviewed [uncertain].
Non-invasive cervical VNS (gammaCore): prescription-only, FDA-cleared for prevention and acute treatment of migraine (adults and adolescents 12+), adjunctive prevention and acute treatment of episodic cluster headache (adults), and hemicrania continua and paroxysmal hemicrania (adults); effectiveness not established for acute treatment of chronic cluster headache. The manufacturer does not claim it treats depression. [source: gammaCore FAQ]
Transcutaneous auricular devices: several ear-based devices are FDA-cleared, prescription-only, for symptom management of opioid withdrawal in adults alongside standard care under clinical supervision (e.g. Sparrow Ascent, 510(k) K251246, decision 25 August 2025, Class II). [source: FDA 510(k) summary via Innolitics; NYT 2026] No taVNS device was found to be FDA-cleared for depression or anxiety [uncertain: absence not exhaustively checked].
Other implanted vagus devices: reporting notes FDA approvals for stroke recovery (see the Vivistim entry) and, most recently, rheumatoid arthritis. [source: NYT 2026]

United Kingdom (England)

Depression: NICE IPG679 (12 August 2020; replaces IPG330): no major safety concerns but side effects are frequent and well recognised; efficacy evidence is of limited quality, so implanted VNS for treatment-resistant depression should be used only with special arrangements for clinical governance, consent and audit or research. Clinicians must inform their trust's clinical governance leads, give clear written information to support shared decision-making (including NICE's public information), make sure patients understand safety, efficacy and the uncertainties, and audit outcomes for every patient. [source: NICE IPG679]
Epilepsy: in the NICE epilepsies guideline (NG217) the committee made a consensus recommendation to consider VNS for the small population of people with drug-resistant epilepsy assessed as unsuitable for resective surgery. [source: NICE NG217 draft evidence review, November 2021] The final recommendation wording and numbering are not drawn on [uncertain].
UK device marking (UKCA/CE) for each indication is not confirmed [uncertain].

European Union / Germany

An auricular device from tVNS Technologies (Erlangen), "tVNS E", is described by its regional industry network as a class IIa medical device certified under the EU Medical Device Regulation (2017/745), with a wide list of stated indications including depression, anxiety disorders, epilepsy, migraine and sleep disorders. This is the company's own description as relayed by that network (page last modified May 2025), not a regulator's statement; check the device's certificate and intended purpose in EUDAMED or with the notified body [uncertain]. CE certification establishes conformity, not that a treatment is recommended in clinical guidelines [synthesis]. CE status of implanted VNS in the EU is not drawn on [uncertain].

Consumer wellness devices (all jurisdictions)

Lightly regulated; some companies avoid FDA review by making vague wellness claims (energy, sleep, memory) rather than disease claims. Researchers quoted in reporting say there is little or no data that consumer gadgets work, that skin tingling or heart-rate changes are not evidence of vagus nerve effects, and that the main harm is false hope and delayed effective treatment. [source: NYT 2026] Treat these claims as contested and attributed.

2.2 Phases of implanted VNS as the psychotherapist meets them

Descriptive only; the treating team sets the pathway. [source: NICE IPG679; LivaNova safety information; CMS NCD 160.18; ordering and therapist goals are synthesis]

Consideration and referral. Goal: the client understands VNS exists, what it is for and who decides. Typically arises after several failed treatments (depression) or failed or unsuitable epilepsy surgery. Therapist goal: support a referral question to the prescriber or specialist service; no promise of eligibility. Move on when the client wants a specialist opinion.
Specialist assessment and consent. Goal (team): confirm indication, exclusions and suitability; provide written information; obtain informed consent (in England, under NICE special arrangements for depression). Therapist goal: help the client prepare questions, process information and weigh uncertainties. Move on when the team and client decide to proceed, or not.
Implantation. Surgery under general or local anaesthesia: an incision on the left side of the neck, an electrode placed round the left vagus nerve, a lead tunnelled under the skin to a pulse generator in a pocket in the left chest wall. [source: NICE IPG679] Therapist goal: pre-operative anxiety support; continuity of sessions; a crisis plan that covers the peri-operative period.
Adjustment phase. The device is switched on and adjusted by the team with an external wireless programmer over follow-up visits. [source: NICE IPG679] Labelling asks for close observation for clinical worsening and suicidal thoughts or behaviour, especially when medicines, doses or stimulation settings change. [source: LivaNova depression patient safety information] Therapist goal: heightened mood and risk monitoring, side-effect tracking, realistic expectations about gradual response [synthesis].
Long-term maintenance. VNS is a long-term adjunct; other treatments usually continue (whether to change them is the prescriber's decision). Battery replacement is a further minor operation at end of life [source: CMS NCD 160.18 notes replacement]; MRI and other procedures need forward planning. Therapist goal: integrated psychotherapy, relapse prevention, monitoring.
Deactivation or removal (if it happens). The device can be switched off; removal needs another operation and part of the lead may stay in place. [source: LivaNova safety information; NICE IPG679] Therapist goal: support through disappointment, decision-making and transition to other care.

Session count and format for the psychotherapist: no source specifies one. Continue the client's existing psychotherapy; add brief focused sessions around assessment, surgery and the adjustment phase where useful [synthesis].

3. Guiding principles

[source: labelling and NICE as cited; one-line meanings are synthesis]

The treating team owns the device. Practical meaning: never advise on settings, magnet use beyond repeating the team's instructions, or whether to keep, switch off or remove the device; route all such questions to the team.
VNS is an add-on, not a replacement. Labelling describes it as adjunctive and long-term. Practical meaning: keep psychotherapy, medicines and other care in view; never imply VNS ends the need for them.
Uncertainty must be shared honestly. NICE calls efficacy evidence for depression of limited quality and requires written information on uncertainties. Practical meaning: help clients hear both hope and uncertainty without overselling or dismissing.
Watch closely when anything changes. Labelling asks for close observation for worsening and suicidality when medicines or settings change. Practical meaning: ask about recent clinic visits and medication changes each session during adjustment and step up risk review.
Side effects are common, usually physical, often temporary. NICE notes high rates of voice change, cough and breathlessness that generally decrease over time. Practical meaning: normalise, record and pass on; do not interpret physical symptoms as purely psychological.
Some symptoms need prompt medical contact. Swallowing difficulty, breathlessness, new sleep apnoea symptoms, painful or abnormal stimulation, signs of wound infection, and pain or heating during a scan are named in labelling. Practical meaning: know these and direct the client to the team or urgent care.
Implanted-device safety travels with the client. Diathermy is contraindicated; MRI and several procedures need planning. Practical meaning: remind clients to tell every clinician about the implant.
Separate evidence-based devices from wellness gadgets. Practical meaning: respond to consumer "vagus" devices with curiosity and attributed information, never ridicule, and protect access to effective treatment.
Collaborative care with consent. Practical meaning: agree with the client, in writing, what you share with the team and how quickly.
Stay in your scope. Practical meaning: you inform, support and monitor; diagnosis of device problems and eligibility decisions belong to the team.

4. Intervention inventory

Part A describes how the treatment is delivered by the treating team, at a descriptive level from official sources. Part B sets out the psychotherapist's own interventions. No stimulation parameters, settings, programming steps or placement details are included.

Part A. How VNS is delivered (treating team)

A1. Implanted VNS: who delivers it and how

Purpose: long-term adjunctive treatment for drug-resistant focal epilepsy (ages 4+ in US labelling) or chronic or recurrent treatment-resistant depression (adults 18+ in US labelling). [source: LivaNova safety information, epilepsy and depression]
Steps (descriptive): specialist assessment and selection (for depression, by physicians trained in treatment-resistant depression; NICE requires governance notification, written information and audit); implantation by a surgeon trained in the device and in carotid sheath surgery, under general or local anaesthesia, with a left-neck incision, electrode round the left vagus nerve and a pulse generator under the skin of the left chest; later switch-on and adjustment by the team with a wireless programmer; long-term follow-up. [source: NICE IPG679; LivaNova depression patient safety information] Patients are given a magnet that can be used, as the team instructs, to pause stimulation (for example while eating if swallowing is affected) and are asked to carry it and show family or carers how to use it. [source: LivaNova safety information]
Example language (illustrative): "From what the team's leaflet says, it's a small device under the skin of the chest, connected to the nerve in the left side of the neck. They switch it on and adjust it over several visits."
Watch for: the client's understanding that response, if it comes, is expected to be gradual and partial ("does not stop all seizures"; adjunctive for depression) [source: LivaNova epilepsy safety information]; time-to-benefit is not stated in the labelling summaries opened [uncertain].

A2. Official safety information for implanted VNS

Purpose: so the therapist recognises what to pass on and what needs urgent medical contact.
Contraindications (US labelling): prior left vagotomy; short-wave, microwave or therapeutic ultrasound diathermy anywhere on the body, whether the device is on or off (diagnostic ultrasound is not included). [source: LivaNova safety information]
Surgical risks and implant-related effects (depression labelling): incision pain and site reactions, voice change, throat inflammation, swallowing difficulty, numbness, nausea, shortness of breath, headache, neck or chest pain, dizziness, rash, surgical-site infection, vocal cord paralysis, urinary retention. Infection is reported as the most common surgical complication. Removal needs a further operation and part of the lead may be left behind. [source: LivaNova depression patient safety information; LivaNova press release 2025]
Stimulation-related effects: voice change or hoarseness, cough, shortness of breath, neck pain, swallowing difficulty, tingling, throat tightness, pain, nausea, headache, chest pain, palpitations, sleep difficulty, heartburn, muscle tension; epilepsy labelling adds larynx spasm, indigestion, vomiting, poor coordination, reduced touch sensation and muscle twitching during stimulation. NICE notes a high incidence of voice change, cough and breathlessness that generally decreases over time. [source: LivaNova safety information; NICE IPG679]
Warnings: swallowing difficulty may lead to aspiration; breathlessness, especially with asthma or COPD; may cause or worsen obstructive sleep apnoea; device malfunction may cause painful stimulation, nerve damage or loss of therapy; blunt trauma to the neck or chest, or manipulating the device through the skin, may damage the lead or nerve; excessive stimulation from frequent magnet use; heart conditions need medical review; smoking may increase laryngeal irritation; safety in pregnancy not established. [source: LivaNova safety information]
Depression-specific warning: close observation for clinical worsening and suicidal thoughts or behaviour, especially when medicines, doses or stimulation settings change; safety and efficacy not established in, among others, acute suicidal thinking, schizophrenia and related disorders, rapid-cycling bipolar disorder, other brain stimulation, or under 18. NICE lists worsening of mood, including suicidality, among key safety outcomes. [source: LivaNova depression patient safety information; NICE IPG679]
MRI and other procedures: tell the doctor before any MRI; stimulation is turned off for the scan and some cases require removal first; report pain, heating or unusual sensations immediately; the magnet must not go into the scanner room. Tell all medical staff about the implant (radiation therapy, defibrillation, lithotripsy, electrocautery, mammography positioning). Strong electromagnetic sources such as anti-theft gates should be avoided as labelling describes. [source: LivaNova safety information]
Example language (illustrative): "Hoarseness when it's on is one of the common effects the leaflet lists. Trouble swallowing or breathing, though, is something the team says to tell them about straight away."
Watch for: any of the above reported in session; the client minimising symptoms to avoid having the device turned down.

A3. Non-invasive prescription VNS (cervical and auricular)

Purpose: gammaCore for specified headache disorders (prescription only); ear-based devices cleared for opioid withdrawal symptoms in adults under clinical supervision. [source: gammaCore FAQ; FDA 510(k) K251246 summary]
Steps (descriptive): prescribed by a licensed clinician; the person applies a hand-held device to the skin of the neck (gammaCore) or wears an ear-based device as directed by the prescriber and the instructions for use. Self-treatment schedules are not described here. [source: gammaCore FAQ]
Safety (gammaCore summary): contraindicated with active implanted medical devices (e.g. pacemakers, implanted hearing aids) and with simultaneous use of other stimulators or portable electronics; not evaluated in carotid atherosclerosis, metal implants at or near the neck, cervical vagotomy, under 12, pregnancy, or clinically significant blood pressure or heart-rate abnormalities. Most common effects are mild and occur during use (application-site discomfort or redness, muscle twitching, local face, head or neck pain, headache, dizziness, tingling). [source: gammaCore FAQ]
Mental-health use: transcutaneous auricular VNS for depression, anxiety or insomnia is mainly at the research stage; researchers describe preliminary findings and the need for more evidence. [source: NYT 2026] An EU-certified auricular device lists depression and anxiety among its stated indications according to the company description (see 2.1) [uncertain]. No guideline opened recommends taVNS for any mental-health condition [uncertain].
Watch for: clients borrowing or buying a prescription device for a non-cleared use; use alongside an implanted device.

A4. Consumer "vagus" devices and practices

What they are: wearables for the neck or ears sold direct to consumers with wellness claims, often promoted by influencers; also non-electrical advice such as humming and slow breathing. [source: NYT 2026]
Status and claims: not required to show efficacy to the FDA; experts quoted describe them as mostly unproven, possibly largely placebo, and note that sensations at the skin do not show vagus nerve engagement. Serious physical harm was considered unlikely by the experts quoted; the main harm is delaying effective treatment. [source: NYT 2026] Labelling-type cautions for people with implants, heart conditions or pregnancy were not given in that reporting [uncertain]; the gammaCore contraindications above suggest caution in those groups [synthesis].
Watch for: the device being used instead of a recommended treatment, cost burden, and a client with an implanted cardiac or VNS device using another stimulator.

Part B. The psychotherapist's interventions

[All Part B procedures are synthesis built on the official sources cited in Part A, unless otherwise tagged.]

B1. Recognising when to suggest a specialist review

Purpose: to make sure a client who might be a candidate, or whose VNS care needs attention, reaches the right clinician.
When to use: chronic or recurrent depression with many failed treatments; drug-resistant epilepsy with surgery unsuitable or failed; an existing VNS client with new symptoms, mood change or device concerns.
Steps: (1) note treatment history in the client's own words (how many treatments, what happened), without judging adequacy; (2) ask whether their prescriber or neurologist has discussed further options; (3) with consent, write a short referral or liaison note describing the clinical picture and the client's question, not a recommendation for VNS; (4) tell the client that eligibility depends on specialist assessment and, in the US, often on insurance or Medicare coverage rules; (5) follow up at the next session.
Example language (illustrative): "You've told me you've tried a lot of treatments without enough relief. Would it help to ask your psychiatrist what other options exist, including devices? I can write a note setting out what we've noticed in therapy."
Watch for: false hope or pressure from the referral; feeling "written off" when a device is mentioned. Working if: the client takes the question to the prescriber and feels heard.

B2. Psychoeducation

Purpose: to give accurate, attributed information and correct myths, including confusion between implanted, prescription non-invasive and consumer devices.
When to use: at first mention, before assessment, and when clients bring online content.
Steps: (1) ask what they have heard and where; (2) distinguish the three device types (section 1); (3) give the official framing: add-on, long-term, uncertain efficacy for depression per NICE, common voice and throat effects; (4) point to the team's written information and NICE public information rather than your summary; (5) check understanding by asking the client to explain it back.
Example language (illustrative): "There are really three different things called 'vagus nerve stimulation'. The implanted one is surgery done by a specialist team. Ear or neck devices on prescription are cleared for some headache or withdrawal problems. The ones sold online are wellness gadgets with little evidence."
Watch for: information overload in depressed clients; repeat and write down key points. Working if: the client can name what VNS is for and what it is not.

B3. Supporting informed consent and shared decision-making

Purpose: to help the client weigh benefits, risks and uncertainties so that their decision with the team is informed and their own.
When to use: between specialist assessment and decision; again before battery replacement or removal.
Steps: (1) review the written information the team gave (NICE requires it in England); (2) help the client list questions: expected benefit, time frame, side effects, surgery and anaesthesia, what happens to other treatments, MRI implications, cost or coverage, what if it does not help, how removal works; (3) explore values and fears (surgery, a device in the body, hope and disappointment); (4) check capacity concerns (severe depression, cognitive difficulties) and, if present, raise them with the team; do not assess capacity for surgery yourself; (5) respect a decision to decline.
Example language (illustrative): "What would make this worth it for you, and what would make it not worth it? Let's write your questions down for the appointment."
Watch for: hopelessness-driven yes ("nothing else matters") or pressure from family. Working if: the client can state the uncertainty in their own words and the decision feels owned.

B4. Support around implantation

Purpose: to reduce peri-operative distress and keep continuity of care.
When to use: the weeks before and after surgery.
Steps: (1) plan session continuity (remote if needed); (2) prepare for surgery-related anxiety with skills already in use (e.g. paced breathing, grounding, coping statements); (3) update the crisis plan for the peri-operative period; (4) after surgery, ask about pain, wound, voice and swallowing and direct physical concerns to the team; (5) explore body image and feelings about the device and scar.
Example language (illustrative): "How has it been having the device there? Some people feel relieved, some feel strange about it. Both make sense."
Watch for: signs of wound infection, swallowing or breathing difficulty (direct to team or urgent care). Working if: the client copes with surgery without crisis and stays engaged.

B5. Monitoring and passing on side effects and mood changes

Purpose: to support the labelling instruction for close observation, especially during adjustment and after medication or setting changes.
When to use: every session during adjustment; regularly thereafter.
Steps: (1) open each session by asking about recent clinic visits, setting or medication changes; (2) use the validated depression or symptom measure your service already uses (do not reproduce copyrighted items; follow licence terms) and a brief side-effect check (voice, cough, breathing, swallowing, sleep and snoring, pain, palpitations); (3) ask directly about suicidal thoughts and, if relevant, elevated mood, reduced sleep need or racing thoughts; (4) agree in advance with the client and team what you will pass on and how fast: same day for suicidality, marked worsening, possible mania, or swallowing or breathing problems; routine report for mild, stable effects; (5) document.
Example language (illustrative): "Did anything change at the clinic or with your medicines since we last met? Since then, how has your mood been, and have you had any thoughts of harming yourself?"
Watch for: worsening after changes, emergent hypomania (rapid-cycling bipolar disorder is a labelled population where safety is not established) [source: LivaNova depression safety information], new sleep apnoea signs. Working if: changes reach the team promptly and the client sees reporting as normal.

B6. Conversations about adherence, ambivalence and expectations

Purpose: to explore feelings about continuing treatment without advising any change.
When to use: disappointment with slow or partial response; wish to switch the device off; burden of side effects.
Steps: (1) reflect both sides of the ambivalence; (2) review what the team said about time frames and goals; (3) encourage the client to raise the concern with the team; (4) never advise using the magnet, switching off or requesting removal; (5) agree how the client will bring it to the next appointment.
Example language (illustrative): "Part of you wants to keep going and part of you is fed up with the hoarseness. That's an important thing to take to your team; they're the ones who can look at it with you."
Watch for: demoralisation and hopelessness feeding risk. Working if: concerns reach the team and the client feels less alone with them.

B7. Crisis and safety planning

Purpose: to address suicide risk in a population with severe, treatment-resistant depression, where labelling asks for close observation and NICE lists worsening mood, including suicidality, as a key safety outcome. [source: LivaNova depression safety information; NICE IPG679]
When to use: before referral, before surgery, during adjustment, at any disappointment point (non-response, deactivation, removal).
Steps: (1) carry out structured risk assessment as your service's current practice requires; (2) write or update a collaborative safety plan: warning signs, coping steps, people and places, professional and crisis contacts including the VNS team's contact route, and lethal-means counselling (safe storage or removal of means); (3) agree with the client and team who is contacted when; (4) for epilepsy clients, include seizure-related safety the neurology team has advised (labelling notes VNS does not stop all seizures, so activities such as swimming alone and driving remain a concern) [source: LivaNova epilepsy safety information]; (5) review the plan at each phase change.
Example language (illustrative): "Let's update your plan for the weeks around surgery and the first adjustments, including who you'll call if your mood drops."
Watch for: hope collapse if response is slow; current suicidal intent (an exclusion in the Medicare-covered trial) needs urgent attention in its own right [source: CMS NCD 160.18]. Working if: the plan is used and updated.

B8. Integrating psychotherapy before, during and after VNS

Purpose: to keep the evidence-based psychotherapy that suits the client's condition going alongside VNS, and to use any improvement for functional recovery.
When to use: throughout.
Steps: (1) continue the client's current psychotherapy (e.g. behavioural activation, CBT, interpersonal work) with adjusted pace during surgery and adjustment; (2) as energy returns, shift towards activity, roles, relationships and work goals; (3) address illness identity after years of treatment resistance; (4) for epilepsy, address anxiety, stigma and quality-of-life goals in liaison with neurology; (5) build relapse-prevention plans that include early warning signs and when to contact the team.
Example language (illustrative): "If your energy is coming back a bit, what's one thing you've been putting off that we could plan for this week?"
Watch for: attributing all change (or none) to the device; voice changes affecting confidence in speaking-based activities. Working if: functional goals progress.

B9. Supporting the client after treatment changes or ends

Purpose: to support clients through deactivation, removal, battery replacement or a decision not to proceed.
Steps: (1) explore meaning and feelings (grief, relief, failure); (2) remind that removal is a further operation and that part of the lead may remain, as labelling describes, and help prepare questions [source: LivaNova safety information]; (3) review next options with the prescriber; (4) update crisis plan; (5) continue psychotherapy.
Example language (illustrative): "It sounds like a big loss that this didn't do what you hoped. What would help you feel less alone in deciding what comes next?"
Watch for: sharp rise in hopelessness. Working if: the client stays engaged with care.

B10. Device-safety reminders in everyday life

Purpose: to reinforce the team's safety instructions, not to give new ones.
Steps: (1) when the client mentions an upcoming scan, physiotherapy, dental or surgical procedure, remind them to tell staff about the implant and contact the VNS team (MRI planning; diathermy contraindicated); (2) when they mention swallowing, breathing, snoring or painful stimulation, direct them to the team; (3) note that carrying the magnet is part of the team's plan.
Example language (illustrative): "Before the physio appointment, it's worth telling them about the implant. The leaflet says some heat treatments must never be used with it."
Watch for: physiotherapy heat treatments and scans being arranged without the team's knowledge.

B11. Responding to clients using consumer "vagus" devices or practices

Purpose: to respect the client's interest, give balanced information and protect access to effective treatment.
When to use: when a client uses or is considering a consumer wearable, app or influencer programme.
Steps: (1) ask with curiosity what they use, why and what they notice; (2) share attributed information: consumer devices do not have to show they work and researchers quoted in reporting describe the evidence as weak or absent [source: NYT 2026]; (3) separate a calming experience (which may be valuable) from claims about treating depression or anxiety; (4) check whether it is replacing recommended treatment, and the cost; (5) if the client has an implanted VNS, pacemaker or other implanted device, a heart condition or is pregnant, suggest they ask their doctor before using any stimulator (consistent with prescription-device contraindications) [synthesis based on gammaCore FAQ]; (6) offer evidence-based self-regulation skills from their therapy (e.g. paced breathing as a coping skill, not as a claim about vagal effects) [synthesis].
Example language (illustrative): "I'm glad it feels calming. It's worth knowing that these gadgets haven't had to prove they treat anything. Can we make sure it sits alongside, not instead of, the treatment that's helping?"
Watch for: delay of effective treatment, shame if the client feels judged, magical expectations. Working if: the client keeps effective care and makes an informed choice.

B12. Collaborative care and documentation

Purpose: to make shared monitoring reliable.
Steps: (1) get written consent for information sharing with the VNS team, prescriber and GP or primary care; (2) record team contact routes, including out of hours; (3) agree thresholds for urgent versus routine contact (see B5); (4) document reports and responses; (5) contribute, if invited, to outcome audit (NICE requires audit of all patients in England) [source: NICE IPG679].
Example language (illustrative): "Can we agree what I'll share with your VNS team and how quickly, so nothing important falls between us?"
Watch for: fragmented care across neurology, psychiatry and surgery. Working if: reports reach the right clinician on time.

5. Handling problems

[All responses below are synthesis unless tagged; safety facts are from the sources cited.]

Stuck client, slow or no response: normalise that VNS is adjunctive and that NICE describes efficacy evidence as limited; refocus therapy on achievable functional goals; encourage the client to review progress with the team; step up risk monitoring. Do not suggest setting changes.
Resistance to referral ("I'm not having surgery"): respect the choice; explore fears; offer information from the team's leaflet only if the client wants it; continue other care.
Overwhelm by information or decisions: break the decision into questions; use written summaries; involve a trusted person with consent; slow the pace of therapy around surgery.
Non-adherence (missed follow-ups, not carrying the magnet, avoiding MRI planning): explore barriers (transport, cost, depression, embarrassment); encourage contact with the team; never advise on device use.
Wish to switch the device off or remove it: explore ambivalence (B6); route to the team; NICE notes the patient can temporarily deactivate the device before asking a clinician for removal, so ensure the team knows promptly [source: NICE IPG679]; update the crisis plan.
Suicidal crisis or marked worsening after a clinic visit: follow your crisis procedure; contact the treating team the same day; labelling links heightened risk to medication and setting changes [source: LivaNova depression safety information].
Possible mania or hypomania: pass on promptly to the prescriber; safety and efficacy are not established in rapid-cycling bipolar disorder [source: LivaNova depression safety information].
Physical red flags in session (choking or swallowing trouble, breathlessness, chest pain, palpitations, painful stimulation, fever or wound redness): advise immediate contact with the team or urgent care; do not interpret as somatisation.
Voice change and social anxiety: validate; voice change is a common, often lessening side effect [source: NICE IPG679]; work on avoidance and self-consciousness; report persistent or distressing changes.
Sleep problems: distinguish insomnia (a listed effect) from possible new or worse obstructive sleep apnoea (snoring, witnessed pauses, daytime sleepiness), which labelling says VNS can cause or worsen; pass on [source: LivaNova safety information].
Ruptures (client feels the therapist doubts the device, or over-sells it): acknowledge, clarify your role as supportive and neutral, and return decisions to the client and team.
Family conflict about VNS: with consent, offer a joint session focused on information and support; avoid taking sides on the decision.
Coverage and cost barriers (US): acknowledge that Medicare covers VNS for depression only in an approved study and that private coverage varies; help the client ask the team about options [source: CMS NCD 160.18] [uncertain: current reconsideration status].
Client using a consumer device instead of treatment: see B11; focus on keeping effective care.
Client asks you for settings advice or how to use the magnet differently: decline kindly and direct to the team; labelling warns that frequent magnet use can cause excessive stimulation [source: LivaNova epilepsy safety information].
DIY or improvised stimulation: if a client describes building or modifying a stimulator, or using a device in a way not intended, explain that this carries risk, particularly with implanted devices or heart conditions, and encourage medical advice; do not discuss technical details [synthesis].
Epilepsy clients with depression or anxiety: liaise with neurology about mood changes; keep seizure-safety advice from the neurology team in the safety plan.

Sources

Sources:

Further reading (not drawn on) [uncertain]: the full FDA PMA documents and physician's manuals for VNS Therapy; the final NICE NG217 recommendation text; UK and EU device certificates for implanted and auricular VNS; any CMS reconsideration decision after June 2025.

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