If you are asking whether vagus nerve stimulation is approved for depression or anxiety, the short answer is yes for one form of depression and no for anxiety. An implanted VNS system is FDA approved as a long-term add-on treatment for adults with treatment-resistant depression, and in the records named here, no vagus nerve device is FDA approved for anxiety. The sections below give you the approval wording, the numbers from the main studies, how Medicare treats the implant, and what the consumer neck and ear devices are sold as, so you can make your next step with clear facts.
For a closer look at the evidence behind these approval questions, read our complete guide to the vagus nerve and anxiety research.
Quick facts, dated 2026-11-11:
| Device | Status | Condition or use | Exact wording |
|---|---|---|---|
| VNS Therapy System (implanted) | FDA approval, PMA supplement P970003/S50, letter dated July 15, 2005 | Treatment-resistant depression | Add-on long-term use for adults 18 and older with chronic or recurrent depression who have not responded adequately to four or more adequate antidepressant treatments (paraphrased from the letter) |
| VNS Therapy System (implanted) | FDA approval, PMA P970003, decision date July 16, 1997 | Epilepsy | “Stimulator, autonomic nerve, implanted for epilepsy” (generic name on the record) |
| SetPoint System, PMA P240039 | FDA approval, decision date July 30, 2025 | Rheumatoid arthritis | “Vagus nerve stimulator for rheumatoid arthritis” (generic name on the record) |
| Vivistim System, PMA P210007 | FDA approval, decision date August 27, 2021 | Arm impairment after chronic ischemic stroke, during rehabilitation therapy | “Stimulator, autonomic nerve, implanted for stroke rehabilitation” (generic name on the record) |
| gammaCore Sapphire, 510(k) K182369 | 510(k) decision “Substantially Equivalent (SESE)”, November 27, 2018 | Cluster headache and migraine (headache uses only) | “Non-Invasive Vagus Nerve Stimulator – Headache” (regulation name on the record) |
| Vagus nerve devices named in these records | No FDA approval listed | Anxiety | No FDA approval for anxiety appears in the records named here. |
| Truvaga, Pulsetto, Apollo Neuro | Sold by their makers as wellness products | Stress and sleep, as the makers describe them | Pulsetto: “Pulsetto is considered a general wellness device.” Truvaga: “Truvaga devices are considered a wellness product.” |
Is vagus nerve stimulation FDA approved for depression?
Yes, for a specific group of adults. The FDA approval letter for the implanted VNS Therapy System, dated July 15, 2005, approves it as an add-on long-term option for adults aged 18 and older with chronic or recurrent depression who are in a major depressive episode and have not responded adequately to four or more adequate antidepressant treatments. You can read the letter yourself in the FDA approval letter for the VNS Therapy System.
The letter says the device is prescription use only, with use restricted by labeling to trained practitioners, and that it is a surgically implanted pulse generator. The FDA required two post-approval studies: a randomized double-blind comparison of different output currents in 450 new subjects with treatment-resistant depression, followed for at least a year, and an observational registry of 1,000 implanted patients followed to five years. The approval applies to the implanted system only. It is not an approval of any ear-clip, neck or wearable consumer device.
Cleveland Clinic’s VNS page lists the same depression use: adults 18 or older with long-term or recurrent major depression that has not responded to four or more antidepressant treatments. It says surgery to implant the device can be done as an outpatient procedure.
What other FDA decisions exist for vagus nerve devices?
The records named here include three more FDA decisions, each for a different use.
The SetPoint System record (P240039) has a decision date of July 30, 2025. Its approval order covers adults with moderately to severely active rheumatoid arthritis who have not responded well to, lost response to, or could not tolerate one or more biological or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs).
The Vivistim System record (P210007) has a decision date of August 27, 2021. Its approval order covers using the paired system during rehabilitation therapy to stimulate the vagus nerve, with the aim of easing arm and hand motor deficits and improving motor function in people with chronic ischemic stroke and moderate to severe arm impairment. Your stroke rehabilitation team is the group to ask about it.
The gammaCore Sapphire record (K182369) is a headache device. Its indications are adjunctive use for the preventive treatment of cluster headache in adults, acute treatment of pain from episodic cluster headache in adults, and acute treatment of pain from migraine in adults. Those clearances belong to that device only.
What did the RECOVER trial find?
RECOVER is a 12-month randomized trial of implanted VNS for treatment-resistant depression, reported in Brain Stimulation in 2025 (Conway et al., e-published December 18, 2024). It randomized 493 adults with marked treatment-resistant major depression to active VNS or a no-stimulation sham, and 88.4% completed the trial. RECOVER trial abstract
The primary outcome was percent of time in response from months 3 to 12, where response means at least a 50% change on the MADRS depression scale. It did not separate active VNS from sham. Several other measures favored active VNS: percent time in response on the CGI-I (P = 0.004) and on the patient-rated QIDS-SR (P = 0.049). Shortness of breath was more common with active VNS (P = 0.035).
The authors’ conclusion calls VNS “safe and effective.” The missed primary outcome belongs in the same result. A 2026 review in the American Journal of Psychiatry by the same lead author, Conway et al., reports participants who averaged 13.3 lifetime antidepressant treatments and 17.8 years in the current episode. It gives QIDS-C response of 39.6% active vs 30.7% sham, and CGI-I of 53.8% vs 39.8%. The review says the primary outcome did not differentiate the groups.
Does Medicare or insurance cover vagus nerve stimulation?
Medicare covers FDA-approved VNS devices for treatment-resistant depression only inside a trial. The CMS National Coverage Determination 160.18, effective February 15, 2019 (implementation date July 22, 2020), covers them under Coverage with Evidence Development. That means only within a CMS-approved double-blind, randomized, placebo-controlled trial with at least one year of follow-up. VNS for treatment-resistant depression outside such a study is non-covered, and all other depression uses are non-covered nationally. Replacing a device already implanted for this use is allowed.
CMS lists the RECOVER trial (NCT03887715, sponsor LivaNova) with a CMS approval date of 09/04/2019. CMS also sets patient criteria: a history of major depression lasting at least two years or involving at least four episodes, at least four earlier treatments that did not work at adequate dose and length, and medicines held steady for four weeks. Psychosis, rapid-cycling bipolar disorder and current suicidal intent are listed exclusions.
For private insurance, Breakthru Psychiatric Solutions, a Georgia practice that offers VNS, says VNS Therapy “is covered by many insurance plans, though it often takes 6 months for prior authorization approval.” Truvaga’s FAQ says its devices “are considered a wellness product and are not covered by health insurance.” Check your own plan before you schedule anything.
What do studies show for ear stimulation and depression?
Ear stimulation, called transcutaneous auricular VNS (taVNS), is a different device type from the implant. A 2023 meta-analysis in the Journal of Affective Disorders (Tan et al.) searched to November 10, 2022 and included 12 studies with 838 participants. The authors say taVNS reduced Hamilton Depression scale scores. Compared with sham, it gave a higher response rate, and the authors rate the certainty of the evidence as low to very low. Tan et al. 2023 meta-analysis
An earlier 2018 meta-analysis in Medicine (Baltimore) (Wu et al.) pooled 4 studies and 222 people with depression. Versus sham, the 24-item Hamilton Depression score improved by a mean difference of -4.23 (95% CI -7.15 to -1.31). The Self-Rating Anxiety Scale improved by -6.57 (95% CI -9.30 to -3.84). The clinician-rated Hamilton Anxiety scale showed no significant difference (-1.12, 95% CI -2.56 to 0.32, P = .13). The authors report no obvious adverse effects.
Is vagus nerve stimulation approved for anxiety?
No. In the records named here, no vagus nerve device has an FDA approval for anxiety. The NHS describes the usual treatment for generalised anxiety disorder as talking therapies, usually cognitive behavioural therapy (CBT), and usually an SSRI. The National Institute of Mental Health lists psychotherapy, including CBT and acceptance and commitment therapy, and medicines such as SSRIs, SNRIs and anti-anxiety medicines.
The studies below are the anxiety research in these records. Each result belongs to the device and group named in its row.
| Study | Device type | Who was studied | Comparison and length | What it found |
|---|---|---|---|---|
| George et al., Brain Stimulation, 2008 | Implanted VNS, added to stable medicines | 11 adults recruited with treatment-resistant OCD, PTSD or panic disorder; the abstract’s breakdown adds to 10. All had failed several medications and CBT. | Open-label, no sham; 12-week acute phase, with long-term follow-up | 3 acute responders on the Hamilton Anxiety scale (response = 50% or more improvement) at 12 weeks; significant improvement at 14 of 18 quarters in long-term follow-up; 4 patients still on VNS four years after implant, with sustained improvement. The authors say the open data suggest further double-blind studies may be warranted. |
| Ferreira et al., Frontiers in Integrative Neuroscience, 2024 | Transcutaneous auricular VNS (ear) | University students aged 18 to 25 with raised anxiety scores (Beck Anxiety Inventory of 7 or higher), not people with a diagnosed anxiety disorder. The abstract says 42 participants; the statistics use 20. | Double-blind, randomized, sham-controlled; one intervention week, measured before, right after and 2 weeks later | The active group’s Beck Anxiety Inventory fell from an average of 9.3 to 4.1 right after and 5.1 at 2 weeks (p < 0.05). The sham group did not change. Adverse events: none reported. Main outcomes were jaw-muscle activity and pain threshold; the anxiety scale was one measure. |
| Jackowska et al., Biological Psychology, 2025 | Transcutaneous VNS | 70 community adults (28 men), mean age 49.33 | Single-blind randomized trial, four groups (early and late, active and sham); 14 days of use per phase | Active beat sham in the early-phase groups, but not the late-phase groups, for anxiety symptoms and perceived stress. No advantage for depressive symptoms. The authors write that the results “tentatively indicate” population-level benefit for stress vulnerability and anxiety. |
| Lin et al., Psychology, Health & Medicine, 2026 | Transcutaneous auricular VNS (ear) | People with sleep disorders, not anxiety disorders; 14 randomized trials, 11 pooled | Meta-analysis; 7 databases searched to January 10, 2025 | Pooled anxiety-related scale scores improved, SMD -0.53 (95% CI -0.74 to -0.32, p < 0.00001). The authors say the findings “should be considered preliminary.” |
| Lai et al., Heliyon, 2025 (protocol) | Transcutaneous VNS with electrical stimulation | 60 adults with generalized anxiety disorder, as planned | Assessor-participant blinded, randomized, sham-controlled; 8 weeks, as planned | This is a study plan. It reports a design, not a result. The primary outcome is treatment response on the Hamilton Anxiety Rating Scale. |
| Benzouak et al., BJPsych Open, 2025 | Transcutaneous VNS | People with trauma- and stressor-related disorders (PTSD); 7 randomized studies, narrative synthesis | Systematic review; no pooled numbers | The authors conclude that VNS as a treatment for PTSD “is limited and does not meet clinical expectations,” with certainty rated “very low.” Within one included trial, less somatic anxiety on the Hamilton Anxiety scale vs sham. |
| Tsang et al., Journal of Psychiatric Research, 2025 | Wrist or ankle wearable giving silent vibration (Apollo Neuro), not vagus stimulation | 16 Apollo users and 18 matched controls in a 12-week ketamine-assisted therapy program | Non-randomized observational cohort | No significant difference in change in GAD-7 anxiety score (p = 0.572 unadjusted; p = 0.63 with propensity balancing). Both groups’ anxiety scores fell. |
The 2008 study used an implanted system. The Ferreira and Jackowska trials used transcutaneous stimulation. Results from one device type do not carry over to another device or to products sold to consumers.
Where is the vagus nerve, and what does it do?
The vagus nerve is the tenth cranial nerve. CMS describes its parasympathetic outflow as regulating heart rate and gastric acid secretion, and says it carries both sensory and motor information to and from the brain.
Ohio State’s Wexner Medical Center describes the left vagus nerve as running “from the brain stem at the base of the neck down to the chest.” NewYork-Presbyterian’s VNS description says the device sends mild pulses “to the brain via the vagus nerve in the neck.” The Georgia practice Breakthru says the nerve “is connected to areas of the brain associated with controlling mood.”
Do consumer vagus nerve devices help anxiety?
Truvaga, Pulsetto and Apollo Neuro are sold as general wellness products for stress and sleep. The makers describe them that way, and none of the anxiety studies above tested these exact products. The results above belong to the devices that were tested.
| Device | Maker | What the maker says | Regulatory wording on the maker’s pages |
|---|---|---|---|
| Truvaga Plus and Truvaga 350 | Truvaga | The devices access the vagus nerve “via the neck”; stimulation “activates” the nerve “to support a balanced nervous system.” Truvaga says it is intended for use on the neck. | “Truvaga devices are considered a wellness product and are not covered by health insurance.” |
| Pulsetto neckband | Pulsetto | Pulsetto says it is a general wellness device and does not claim to diagnose, treat or prevent any medical condition. | Help center: “The Pulsetto device is FCC-certified.” |
| Nuropod | Parasym | “Scientifically proven to modulate the vagus nerve via precise electrical impulses,” for “adults looking to improve their health and performance.” It is an ear device. | Product page: “Third party certified device.” |
| Nurosym | Nurosym | “Nurosym is a certified device (CE) in Europe.” | CE mark in Europe, as the company describes it. |
| Apollo Neuro | Apollo Neuroscience | A “consumer wellness device” that “is intended to help manage stress, challenging life transitions, and to promote a healthy lifestyle.” Its help articles describe vibration, not electrical current. | “The Apollo Neuro wearable is a consumer wellness device and does not require FDA approval for sale.” |
The Truvaga FAQ and Support pages do not contain an FDA clearance statement or an FDA disclaimer. The Apollo Neuro help articles do not say the wearable stimulates the vagus nerve.
What the Pulsetto-funded study measured
Pulsetto’s website prints a stress study, and its acknowledgements say “Pulsetto Proof of Concept gave funding for the project.” It tested 15 healthy people, each with one stimulation session and one session with no stimulation, on different days. The only outcome was heart rate variability, a heart-rhythm measure, not an anxiety or stress questionnaire. The LF/HF ratio fell by an average 64.5% after stimulation and 6.8% after the no-stimulation session. The page’s abstract says five patients, while its body says 15.
So, does Pulsetto work? The company says it is a general wellness device and does not claim to treat any medical condition. Its own funded study measured heart rhythm in healthy people, not anxiety.
Pulsetto’s help center lists people who should not use it, including people with a heart condition, a history of seizures or fainting, any active electronic implant such as a pacemaker, pregnancy, and broken or damaged skin on the neck. Truvaga’s FAQ says it is not intended for anyone with an active implantable medical device, such as a pacemaker.
What do FDA approved, cleared, wellness, CE and FCC mean?
These words are not interchangeable, so check which one a product uses.
| Term | What it means | Where you see it here |
|---|---|---|
| FDA approved (PMA) | The FDA calls the PMA route “the most stringent type of device marketing application,” based on “sufficient valid scientific evidence” that the device is safe and effective for its intended use. | VNS Therapy for depression, SetPoint, Vivistim |
| FDA cleared (510(k)) | A premarket submission showing a device is substantially equivalent to a device already legally marketed. | gammaCore Sapphire (K182369) |
| General wellness | The FDA’s general wellness policy, dated January 6, 2026, says CDRH does not intend to examine low-risk general wellness products to determine whether they are devices. Its examples include relaxation or stress management and sleep management. | Truvaga, Pulsetto, Apollo Neuro |
| CE | The mark Nurosym describes as its certification in Europe. | Nurosym |
| FCC authorization | The FCC regulates radio frequency devices, which must be authorized “before it can be marketed, imported, or used in the United States.” The FCC page describes this for radio emissions and interference with radio services. | Pulsetto’s “FCC-certified” label |
Pulsetto’s help center says its FCC certification means it “is approved for well-being use.” The FCC page describes that authorization as covering radio-frequency emissions and interference.
Common mix-ups
- gammaCore is not an anxiety or depression device. Its FDA record covers headache uses only.
- Vivistim is not a depression treatment. It is an implanted system for stroke arm impairment, used during rehabilitation therapy.
- Apollo Neuro is not vagus stimulation. Its help articles describe vibration.
- “FCC-certified” is not an FDA approval. It concerns radio emissions.
- “Cleared” and “approved” are different routes. Approval (PMA) is the most stringent route; clearance (510(k)) is a substantial equivalence finding.
Can I stimulate the vagus nerve myself for anxiety?
For anxiety, the NHS points to self-directed options: self-help books or online courses, talking to someone, slow breathing practice, yoga or pilates, regular exercise, enough sleep, a steady diet, cutting back on caffeine, alcohol, cigarettes and drugs, and not avoiding situations that cause anxiety. NHS treatment guide for generalised anxiety disorder For a fuller look at how anxiety and depression connect, read our anxiety-depression connection and coping article.
Questions to settle your next step
- Ask a psychiatrist whether you fit the 2005 FDA wording: an adult with a major depressive episode and no adequate response to four or more adequate antidepressant treatments. Keck Medicine’s VNS program describes the same first step, an evaluation to see whether VNS is the right next step. Ubie’s Doctor’s Note says a psychiatrist and sometimes a neurologist determine eligibility.
- For questions about nerve symptoms, an MRI, or vitamins, ask a primary care clinician or a neurologist. No vitamin is tied to the vagus nerve in the records named here. If you are weighing supplements, read our mental health supplements guide, and ask your primary care clinician first.
- Ask your insurer or Medicare whether VNS for your condition is covered. Medicare covers it for treatment-resistant depression only inside a CMS-approved trial.
- For any consumer device, ask the company which FDA status applies to that exact model, and look for the FDA record number. Check the return terms at checkout before you buy.
- For anxiety, ask your doctor about talking therapy and the medicines the NHS and NIMH describe.
By the Global MH Summit Research Team