A Guide to FDA-Cleared Migraine Devices

Imagine living with a disease that within minutes can suddenly turn your day upside down: the world narrows to throbbing pain, nausea, and lights that feel like daggers—another migraine attack stealing your plans, your productivity, and your peace. You’ve tried medications, lifestyle tweaks, and everything your doctor suggested, but the attacks keep coming. What if there was a drug-free, non-invasive way to interrupt that “electrical storm” in your brain before it takes over? FDA-cleared migraine devices offer exactly that—gentle treatment that targets nerves to help prevent, reduce, or stop symptoms, often with minimal side effects and no systemic drugs. Whether you’re seeking a new addition to your migraine treatment toolbox or exploring alternatives after other options fell short, this guide breaks down the leading devices available today. 

What Are Migraine Devices? 

“When I have a migraine attack, it feels like my entire body is short-circuiting,” is how Migraine Meanderings’ community member Aaron describes migraine. This description makes sense if you think of a migraine attack as an electrical storm in the brain. Migraine devices are FDA-cleared and provide neuromodulation, or gentle electrical or magnetic pulses that can help calm the electrical storm in the brain. They target nerves directly, and depending on the device, can prevent, reduce, or even stop migraine symptoms. They can also be used on their own or together with medications. 

How Does Each Device Work?

Several devices are currently available, each targeting a different “gateway” to the brain: 

• Cefaly (eTNS): A small device worn on the forehead. It stimulates the trigeminal nerve, the main highway for migraine pain, by sending tiny electrical pulses through the device. It can be used for both stopping an active migraine attack and daily for prevention in people with migraine with and without aura who are 18 years of age and older. You need a doctor’s prescription for the device, and it is covered by Medicaid and many commercial insurance policies. 

Cefaly does not require a prescription from your doctor or a subscription plan. After purchasing the device, your only cost is to replace the electrodes as needed. Explore the Cefaly device. 

• Nerivio (REN): A discreet wearable for the upper arm controlled by your smartphone. It uses “Remote Electrical Neuromodulation” to trigger the brainstem’s natural mechanism to stop pain. It is approved for people with migraine with or without aura who are 8 years of age and older to prevent and stop migraine attacks, and is also safe for women who are pregnant.

The Nerivio app provides educational content and guided techniques to reduce pain and stress. After purchasing the device, costs will include refills. Explore the Nervio REN here.

• gammaCore (nVNS): A handheld device pressed against the neck with a gel to stimulate the vagus nerve. It’s highly effective for both migraine and cluster headaches. It’s approved to prevent and stop symptoms for people with migraine ages 12 and up. It requires a prescription and is available in 3-, 12-, or 36-month treatments. 

You can use your HSA/FSA account to pay for the device. Once you have the device, you will continue to purchase treatment options. Explore gammaCORE here. 

• Relivion (eCOT-NS): A headset that targets both the trigeminal and occipital nerves at the same time, which can create a “calming” effect. It stimulates 6 nerve branches of the occipital and trigeminal nerves with electric pulses. It is approved to treat acute migraine in adults 18 years of age and older and is controlled by a phone app.

Relivion is available with a prescription, and starts with a 60-day Relivion Therapy Program. At the end of the program, you can purchase the device if you feel it’s right for you. Explore Relivion here.

• eNeura (sTMS) (SAVI Dual): A device held to the back of the head that uses a magnetic pulse to disrupt the electrical wave associated with migraine aura. It delivers low-frequency electromagnetic fields that signal the brain to calm hyperactive nerves. A prescription is needed and it is approved to prevent and stop migraine symptoms in people 12 and older. 

eNeura uses a monthly prescription fee model that includes smart technology to track treatment history and progress. Explore eNeura here. 

• HeadaTerm2 (e-TNS): A device worn on the forehead that uses non-invasive neuronal electrical stimulation technology to prevent and treat migraine, tension, and cluster headache. Impulses on the forehead act on nerves to reduce migraine-related signals, and the device is for people 18 and older. 

HeadaTerm2 does not require a doctor’s prescription and is HSA/FSA eligible. The only expense after purchasing the devices is replacing the electrodes. Explore HeadaTerm2 here.

Do Migraine Devices Actually Work?

We asked members of our migraine community about the effectiveness of these devices. 

“Cefaly is an important part of my migraine toolbox. My two teenage daughters—who both have migraine—also find it really helpful. We find that it helps us to relax during an attack, and when used in combination with medication, can almost always decrease our pain levels, sometimes fully stopping an attack. Because of the way it helps my brain and body relax, I also like to use it on the preventive setting or for low-level headaches that may not warrant using medication. Cefaly has given all three of us a much-needed treatment alternative!” – Jessica

“Discovering the Nerivio REN device has been life-changing. It doesn’t work for every attack, largely because I need to start it within 20 minutes of my earliest symptoms. However, every attack it does stop helps give me back some of my life that I have lost to this disease… and that is priceless! When people ask me about it I tell them that it’s a no-brainer to give it a try. What do you have to lose?!” – Shoshana 

“The Headaterm is definitely my preferred method of dealing with migraine attacks. While it doesn’t work all the time, it’s the method I’ve had the most success with – more than any medicine!” – Reuven

“It’s been interesting learning how to use the HeadaTerm device. The first pulses felt a little jarring, even on the lower setting. However, I have learned to relax while using the device, and it makes a huge difference. I can usually stop a migraine attack, or at least reduce the pain. I use it whenever I have symptoms.” – Lorene 

Is A Medical Device Right For Me? 

Before starting any treatment, talk with your doctor. Although these devices are generally considered safe with limited (if any) side effects, they may impact other chronic conditions. Unfortunately, insurance does not cover these devices, and they can be expensive. The electrodes may irritate skin, and you may not like how the stimulation feels. Because the devices work differently, you may need to try more than one to get the best results. 

On the other hand, most users tolerate these devices very well and can offer pain reduction and prevention without medication. Remember, the key to disrupting the progression of migraine is to treat symptoms quickly and appropriately. Ask your doctor about adding a device to your Migraine Action Plan. 

LET US KNOW! Have you tried a migraine device to stop or prevent attacks? What was your experience – did it help? Which device sounds most appealing to you, and what is the biggest barrier for you in trying a neuromodulation device? 

This article is for educational purposes only and does not replace medical advice from your medical team.