If stress, a racing mind or poor sleep has you comparing Truvaga and gammaCore, you are asking a fair question. The short answer: both come from electroCore and both use non-invasive vagus nerve stimulation on the neck, but they are sold for different purposes. gammaCore is the prescription device with FDA-cleared uses for specific headache conditions, while Truvaga is sold as a general wellness product for stress and sleep. Neither device is cleared to treat anxiety, so the right choice depends on the problem you are trying to address.
Since neither device is cleared for anxiety, our guide to what studies show about the vagus nerve and anxiety explains where the evidence is still thin.
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What is the difference between Truvaga and gammaCore?
Truvaga’s footer names electroCore, Inc. as the company behind it, and the FDA 510(k) record for gammaCore Sapphire names Electrocore, Inc. as the applicant. The two products share a maker and a basic technology, but they are sold and cleared differently. Here are the facts as of 2026-11-11.
Quick facts, 2026-11-11
| Feature | Truvaga | gammaCore |
|---|---|---|
| Company | electroCore, Inc. (doing business as Truvaga) | Electrocore, Inc., the applicant named in the FDA 510(k) record |
| Regulatory status | General wellness product; the footer says Truvaga products “have not been evaluated by the US Food and Drug Administration” | FDA 510(k) decision “Substantially Equivalent (SESE)”, dated 11/27/2018 |
| How it is sold | Online, without a prescription, according to Virtual Headache Specialist | Prescription only, according to Innerbody’s Truvaga review |
| Models | Truvaga 350 and Truvaga Plus | gammaCore Sapphire |
| Stated use | Stress, relaxation and sleep. The offer page reads “Feel calmer, think clearer, sleep better.” | Specific headache uses: cluster headache, migraine, hemicrania continua and paroxysmal hemicrania, per Virtual Headache Specialist |
| Session length | Two-minute sessions | Two-minute treatments, per gammacore.com |
| Price | Truvaga 350: $299; Truvaga Plus: $499 | Variable, per Virtual Headache Specialist; see the price section below |
| Product Page | Product Page | Product Page |
Is gammaCore FDA approved?
gammaCore is FDA cleared, and that is a different route from FDA approval. The FDA describes a 510(k) as “a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent” to a legally marketed device. It calls the PMA route “the most stringent type of device marketing application” (FDA device approvals and clearances page). The gammaCore Sapphire record is a 510(k) decided on 11/27/2018, under the regulation “Non-Invasive Vagus Nerve Stimulator – Headache” (FDA 510(k) record for gammaCore Sapphire).
Virtual Headache Specialist, updated October 16, 2026, lists gammaCore’s FDA clearances in order:
- April 2017: acute treatment of cluster headache in adults
- January 2018: acute treatment of migraine in adults
- November 2018: cluster headache prevention
- March 2020: migraine prevention
- February 2021: abortive and preventive migraine treatment in adolescents 12 and older
- September 2021: abortive and preventive treatment of hemicrania continua and paroxysmal hemicrania
Truvaga does not carry these clearances. Innerbody’s Truvaga review says gammaCore also carries a CE mark, which it describes as approval for sale in the European Economic Area for having met “high safety, health, and environmental protection requirements.” CE is a European mark, so it does not tell you anything about FDA status.
Does shared technology mean a shared clearance?
Virtual Headache Specialist article, updated October 16, 2026, says Truvaga “utilizes the same patented technology and frequency as GammaCore.” It also says Truvaga “hasn’t been studied as robustly as GammaCore, nor has it received the same FDA clearances.” Truvaga’s own FAQ describes the two as sharing “the same patented electroCore technology.” Innerbody’s Truvaga review adds that Truvaga’s customer support says the devices share the same maximum operating parameters. Same technology does not mean same clearance.
What do the studies show for each device?
gammaCore. The UHCW gammaCore patient leaflet, updated April 2025 by University Hospitals Coventry and Warwickshire, describes gammaCore as used for primary headache conditions such as cluster headache and migraine in adults. It says a large study found gammaCore helps people with chronic cluster headaches, reducing cluster headaches by 50% on average per week. It also reports that patients needed fewer sumatriptan injections and less oxygen therapy.
Vagus nerve devices as a group. Innerbody’s Truvaga review cites a 2018 systematic review of 51 studies with more than 1,300 human subjects. That review covers tVNS devices as a group, and it describes them as “safe and well tolerated.” Three serious events were judged possibly or probably tVNS-related: one case of heart palpitations, one case of acute vertigo, and one case of a localized skin lesion.
Truvaga’s own claims. The Truvaga offer page says “94% felt calmer in 30 days.” Its blog says numerous clinical studies have demonstrated benefits of non-invasive vagus nerve stimulation across migraines, cluster headaches, sleep disturbances, and symptoms related to stress and mood. These are the maker’s statements, and the blog does not name the studies.
Who should use each, and who should skip it?
Truvaga. Truvaga’s blog says the products are recommended for adults 18 and older. Its FAQ says the devices are intended for use on the neck and that they are not for anyone with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device.
gammaCore. The UHCW leaflet lists these groups: people with an implanted device such as a pacemaker, hearing aid implant or other electronic device; people with narrowed arteries in the neck (carotid atherosclerosis); people who have had surgery to cut the vagus nerve in the neck; children; pregnant women; and people with serious blood pressure or heart rate problems. It also says not to use gammaCore if you have a metal implant (stent, bone plate or bone screw) in or near your neck, or if you are using another device at the same time, such as a TENS unit or portable electronic device.
What are the side effects?
The two sets of side effects overlap. The table lists the ones each source names side by side.
| Side effect | Truvaga (maker’s FAQ) | gammaCore (UHCW leaflet) |
|---|---|---|
| Headache | Mild headache | Headache |
| Dizziness | Mild dizziness | Dizziness |
| Neck or face pain | Localized pain in the face, head or neck, including toothache | Neck pain and throat pain |
Truvaga’s FAQ also lists application site discomfort, irritation or redness, and muscle twitching or contractions. It says that in clinical studies less than 5% of participants had mild side effects. The UHCW leaflet says gammaCore is generally well tolerated and also lists nasopharyngitis (a common cold).
How much do they cost, and how do you buy them?
Truvaga. Truvaga’s site lists Truvaga 350 at $299 and Truvaga Plus at $499 (prices as of November 10, 2026; check the checkout for today’s). Virtual Headache Specialist says these are one-time purchases. Truvaga 350 is good for 350 two-minute sessions. Truvaga Plus is rechargeable, uses a spray as its conductive solution, and is designed for unlimited usage for at least 3 years and 30,000 sessions when used as recommended. Its FAQ says the Truvaga Plus app is free on Apple and Google Play and is essential for managing intensity. Truvaga’s pages list free standard shipping.
gammaCore. Virtual Headache Specialist says gammaCore pricing and promotions are variable and that the company can give more specific costs. Innerbody’s review puts it at several hundred dollars per month and says it is available only by prescription. Virtual Headache Specialist describes 3-month refill RFID cards for continued treatment, and the FDA 510(k) summary for gammaCore lists 10-, 31- and 93-day cards.
Insurance. Virtual Headache Specialist says gammaCore is fully covered by VA health care benefits, and that most FSA and HSA programs cover gammaCore and other neuromodulation devices. For Medicare or any other plan, ask gammaCore and your plan directly before you order.
How do Truvaga refunds and cancellations work?
Truvaga’s returns page describes a 30-day money-back guarantee with these conditions as printed:
- The 30 days begin on the day of delivery, and the policy is “only valid for first-time customers.”
- “Returns are only applicable to Truvaga 350 and Truvaga Plus purchases.” Gel and spray purchases are not eligible for a refund.
- The product must be undamaged and returned in the original packaging with any accessories, with a receipt or proof of purchase.
- You pay the shipping costs, and tracking is recommended.
- Step 2 of the returns page says the product must be returned within 21 days of the request, once Customer Support sends a return authorization number.
Truvaga’s terms add that you must email support@truvaga.com for a Return Merchandise Authorization number before shipping, that returns are subject to a 5% restocking fee, and that refunds are processed within approximately thirty days of Truvaga receiving the product, credited to the original payment method, less the original shipping and handling costs. The terms also say you can cancel an order before the order confirmation email is sent by calling 800-643-2036.
Truvaga’s support hours differ between its pages. The contact page lists 8:00AM to 7:00PM EST, and the support page lists 8:00 a.m. through 8:00 p.m. EST. Call 800-643-2036 to confirm. The contact page also lists a physical address. For gammaCore, ask the company for its return and refund terms before you order.
What if anxiety is the problem?
gammaCore’s clearances cover headache uses, and Truvaga is sold for stress and sleep. For a broader look at anxiety, see our anxiety depression and mood guide. The NHS insomnia guide lists stress, anxiety or depression among the most common causes of insomnia. The MedlinePlus sleep disorders overview says sleep helps your body restore energy and supports learning and memory. If sleep is slipping, our sleep and memory guide covers how poor sleep affects attention. For anxiety or headaches, ask a psychiatrist, psychologist, primary care clinician or neurologist which options fit you.
Common mix-ups
- Same maker, same clearance. The clearances belong to gammaCore only, as listed above.
- Truvaga for migraines. The migraine clearances in the list above are gammaCore’s. Truvaga is sold for stress and sleep.
- Vivistim is the implanted gammaCore. Vivistim is a different system. The Vivistim FDA record (PMA P210007, decided 08/27/2021) describes an implanted vagus nerve stimulator used during rehabilitation therapy in chronic ischemic stroke patients with moderate to severe arm impairment.
- Matching specs means matching approval. Innerbody’s review says Truvaga’s specifications align with those of an FDA-cleared device. Specifications are not a clearance.
Before you decide
Whether Truvaga is worth it depends on the facts that decide it: the price, what you want the device for, and whether the return conditions fit your situation. These are the questions that settle your next step.
- Check today’s prices and return terms on the Product Page for Truvaga, and on the Product Page for gammaCore.
- Ask gammaCore and your insurer or FSA/HSA administrator about coverage before you order.
- Call Truvaga at 800-643-2036 to confirm support hours and whether a purchase qualifies for the 30-day return window.
- If you have a pacemaker or other implant, metal in or near your neck, or a heart or blood pressure condition, ask a primary care clinician or neurologist before using either device.
- For anxiety or sleep trouble, ask a psychiatrist, psychologist or primary care clinician what options fit you.
By the Global MH Summit Research Team
This article is for general information purposes only and does not constitute medical advice. Consult your doctor or qualified healthcare provider before making changes to your health routine.