FAQ

You can also browse the topics below to find what you are looking for.

  • About CEFALY
  • How Does CEFALY Work?
  • CeCe App
  • Ordering / Financing
  • CUSTOMER SUPPORT
  • TROUBLESHOOTING
  • INSURANCE

Searching FAQ for ''

No results found

About CEFALY

What is CEFALY?

CEFALY is the first FDA-cleared device of its kind for the treatment of migraine headaches. It is a non-invasive, drug-free approach to help relieve migraine pain and decrease the number of migraine days. In technical terms, it is an external trigeminal nerve stimulator, which is a non-invasive device on the head to stimulate and desensitize the trigeminal nerve.

What makes CEFALY different from other migraine treatment devices?

At CEFALY, we believe that everybody living with migraine deserves access to a drug-free treatment that works. CEFALY is the only FDA-cleared neuromodulation device for migraine that’s available without a prescription.

Most other neuromodulation devices require ongoing prescription refills, replacement, or subscription fees. CEFALY is yours to keep. And it’s designed to last, with a 3-year limited warranty. Your only ongoing cost is replacement electrodes, and each electrode can be used many times. That’s why we believe CEFALY is the simpler, smarter, most affordable choice for treating migraine with neuromodulation.

Who is CEFALY for?

CEFALY is indicated to be used for:

  1. The acute treatment of migraine with or without aura in patients 18 years of age or older.
  2. The preventative treatment of migraine in patients 18 years of age or older.

Who should NOT use CEFALY?

Do not use CEFALY if you:

  1. Have metallic or electronic devices implanted in the head
  2. Are suffering from pain of unknown origin
  3. Have a cardiac pacemaker or an implanted or wearable defibrillator.

Can pregnant women use it?

If you are, could be, or may possibly become pregnant, you should ask your doctor before using CEFALY.

Is CEFALY for people of all ages?

All clinical trials regarding the efficacy and safety of CEFALY have been performed on adults (ages 18-65 years old). There are currently no trial results or data specific to use in individuals under the age of 18 or over the age of 65.

Consult a doctor before use if:

  • You are under 18 years of age.
  • You are over 65 years of age.
  • You are pregnant or may become pregnant.
  • You suspect or know that you have heart problems.
  • You had a recent head injury.
  • You have ever suffered a seizure.
  • You have never been diagnosed with a migraine by a health professional.
  • You have a headache that is different from your usual migraines.
  • You have the worst headache of your life.
  • You have fever or a stiff neck.
  • You have a headache that began after a head injury, exertion, coughing, or bending.
  • You experienced your first headache after the age of 50 years.
  • You have a migraine so severe as to require bed rest.

Are there side effects to using CEFALY?

CEFALY has few side effects, which have been demonstrated through clinical trials to be minor and fully reversible with cessation of device use.

If you experience any serious side effects, or if any side effects persist for more than a few days, stop use of CEFALY and consult your healthcare provider or seek immediate medical attention.

Common

  • Sleepiness - Sleepiness is a common side effect after CEFALY treatments. This means that CEFALY cannot be used when driving, operating machinery, or during any activity that can put you at risk of injury. Approximately 0.5% of subjects reported sleepiness during the session.
  • Headache After a Session - Approximately 0.5% of subjects reported a headache after a session of preventative treatment (Program 2 - PREVENT Treatment).

Uncommon

  • Forehead Skin Redness - At the end of the session, the skin on the forehead under the electrode may occasionally appear blotchy due to increased local blood flow. This redness may persist for several minutes and usually disappears within 15 minutes. Approximately 0.2% of subjects reported reversible forehead skin redness.
  • Nausea - A rare occurrence of nausea during a session of acute treatment (Program 1 - ACUTE Treatment) has been reported.

Rare

  • Forehead Skin Allergy - In rare cases, an allergy to the electrode gel can occur, leading to a temporary rash on the forehead. If this happens, stop using CEFALY and contact your doctor or the manufacturer. The rash will gradually disappear within a few days. An anti-inflammatory cream may help speed up the process. Fewer than 1 in 1000 subjects reported an allergic skin reaction.

I have allodynia. Can I use CEFALY treatments?

Allodynia is a condition involving increased sensitivity to touch, where even normally non-painful stimuli can be perceived as painful. If you experience allodynia, you should discuss these symptoms with your healthcare provider before starting CEFALY treatments. We recommend that individuals with allodynia become familiar with the intensity stabilization function before using the device.

Can I use my CEFALY device on areas besides my forehead?

CEFALY is only designed for the forehead. Do not use the device on your neck, chest, or any other part of your body.

What if I have a skin issue, such as a wound on my forehead?

Do not use CEFALY on open wounds, over swollen, infected, or inflamed areas, or on any skin eruptions. Do not apply it over or close to cancerous lesions.

Can I use CEFALY near electronic monitoring equipment?

Do not use CEFALY in the presence of electronic monitoring equipment (e.g., cardiac monitors, electrocardiogram alarms).

Can the CEFALY device get wet?

Do not get the device wet (for example, do not use it in a bath or shower).

Can I use my CEFALY device while sleeping?

While drowsiness may occur, we do not recommend using the device while sleeping.

Can I drive while using CEFALY?

Do not use CEFALY while driving or operating machinery. Do not use it during any activity that can put you at risk of injury.

Can I take part in normal activities while using CEFALY?

CEFALY is a therapeutic device that should be used while in a relaxed state. For optimal results, pause your usual activities during treatments. We recommend using CEFALY while sitting or reclining, with your head tilted back.

Can I travel/fly with CEFALY?

At the airport, your CEFALY device can go through the x-ray machine and baggage check. Many customers fly with their CEFALY and some even use it during flight. Safe travels!

How Does CEFALY Work?

How does CEFALY work?

The trigeminal nerve—an important nerve involved in migraine pain—is located under the skin of your forehead. The CEFALY device is designed to stimulate the nerve endings of this branch via an electrode placed on the forehead between the eyebrows. Once the electrode is in place, the device magnetically attaches to it and sends small electrical impulses to help desensitize the nerve.

I've just ordered my CEFALY - how do I get started?

Visit our Get Started page here for a quick start guide, helpful videos, tips, and other resources.

Your purchase also includes a free session with a CEFALY Coach who will provide one-on-one assistance so you can achieve the best results.

How do I use the PREVENT treatment mode?

To activate the 20-minute PREVENT program, press your device button twice with a slight pause in between. For CEFALY Enhanced and CEFALY Connected devices, press the button once to see the turquoise light, then press again to see the purple light.

When using the PREVENT program, you will notice:

  • You will hear two beeps indicating your selection.
  • For the CEFALY DUAL, a green indicator light flashes twice (this may take a few seconds).
  • For the CEFALY Enhanced and Connected, there will be two intermittent purple flashes (this may take a few seconds).

For best results, use the 20-minute PREVENT treatment daily.

Am I supposed to use the PREVENT treatment every day?

For effective prevention of future migraine attacks, the PREVENT treatment should be used daily. Occasional or brief use may not be effective—just as a regular workout is needed to build muscle, a daily routine helps desensitize the trigeminal nerve.

When using the 20-minute PREVENT treatment, allow at least two to three months to see results.

How do I use the ACUTE treatment mode?

The 60-minute ACUTE treatment program is intended for use at the onset of a migraine attack and is activated by pressing your device button once. This program is designed to stop or relieve your migraine pain when it first begins. During an ACUTE session, you will observe the following:

  • You will hear a single beep indicating your selection.
  • For the CEFALY DUAL, a green indicator light will flash once (this may take several seconds).
  • For the CEFALY Enhanced and Connected, there will be one intermittent turquoise flash (this may take several seconds).

For best results, start ACUTE therapy at the earliest sign of a migraine. If you experience migraines with aura, begin treatment as soon as the aura appears.

What does it feel like to use CEFALY?

The initial stimulation may feel like a gentle tingling or vibrating. Using CEFALY should never be painful. Although the initial sensation may seem unusual, most users quickly become accustomed to it after a few sessions.

When starting an ACUTE or PREVENT session, the stimulation intensity gradually increases over the first 14 minutes. At first, you may not feel much; then you might experience a tingling (or "pins and needles") sensation, numbness, or even a slight worsening of your headache for a few minutes. At any point during these 14 minutes, you can press the button to stabilize the intensity at a comfortable level.

What if the intensity is too strong for me?

When you're new to CEFALY, avoid using the device at maximum intensity. The goal is to find your sweet spot—a stimulation level that is both comfortable and effective. It should feel like a tingling, prickling, or vibrating sensation that is noticeable but never painful.

During the first 14 minutes of a session, press the button once to stabilize the intensity at your preferred level. If you press it again, the intensity will increase further. If the stimulation becomes too strong, remove CEFALY from the electrode and restart your session.

If you are using the Bluetooth-enabled CEFALY Connected, you can monitor the intensity in real time within the CeCe app.

For more information, see our video on controlling stimulation intensity here.

How do I rapidly increase the treatment intensity?

Rapidly increasing the intensity, or "ramping," is recommended only for experienced users accustomed to higher stimulation levels.

To ramp up the intensity, press and hold the device button at any time during the first 14 minutes of your session. Repeat as needed until the maximum intensity is reached (after 30 consecutive seconds of holding the button). When you release the button, the intensity stabilizes. Watch a video for CEFALY DUAL or for CEFALY Enhanced and Connected.

How long does it take before I start seeing results?

When using the 60-minute ACUTE treatment, you should feel pain relief after a few sessions. For best results, begin ACUTE therapy at the earliest sign of a migraine attack.

For the 20-minute PREVENT treatment, allow at least two to three months to see results. CEFALY works by gradually stimulating and desensitizing the trigeminal nerve, so consistent daily use is essential.

If you notice even modest improvement in the first few weeks, it indicates your migraine is responding to treatment. Continue using CEFALY consistently for fewer and less painful migraine attacks.

Can I reuse my electrodes?

With proper care, electrodes can be reused. The number of uses depends on your skin preparation, storage, and activity level during treatment.

Cleanse and dry your skin before each treatment to ensure the electrode adheres securely to your forehead. Use soap and water (avoid makeup removers, moisturizing cleansers, or alcohol wipes, which may shorten the electrode’s lifespan). After your session, place the electrode back on its plastic backing and store it in the provided resealable bag. Do not leave it exposed, as it may dehydrate.

How do I know when it is time for a new electrode?

Replace the electrode if the gel appears dried out, cracked, or clumped, or if the stimulation feels different or uncomfortable.

How do I manage my electrode subscription account?

Sign into your account and go to the "Manage Subscription" section to change your next shipment date or cancel at any time.

How long will my battery last?

A fully charged battery will last approximately 5-7 hours of treatment, depending on your CEFALY model, the treatment program, and the intensity used.

How do I know when CEFALY needs to be charged?

If the CEFALY DUAL emits a long beep when you press the button, the battery charge is too low.

If the CEFALY Enhanced or CEFALY Connected emits a long beep or shows a yellow LED, the battery charge is too low.

Can I use CEFALY with Botox?

There is no contraindication for using CEFALY with Botox injections. If you are considering both therapies, discuss them with your healthcare provider.

If you already receive Botox injections for chronic migraine, wait 48-72 hours after an injection before using CEFALY.

If you are new to both therapies, we recommend starting one treatment at a time and waiting at least three months before beginning the other.

CeCe App

What is the CeCe Migraine Management app?

CeCe is an intuitive migraine management app that helps you understand your migraine patterns. It allows you to identify triggers, track the evolution of your attacks, recognize trends, monitor treatment effectiveness, and maintain a detailed migraine journal. For more details, visit the CeCe homepage.

If you have a CEFALY Connected device, you can track and log your treatments in CeCe. However, the app is available for anyone living with migraine.

What are the minimum smartphone requirements for the app?

The CeCe app requires iOS 12 or later, or Android 8.1 or later. Bluetooth must be enabled on your smartphone to use the CEFALY Connected with CeCe.

How do I pair CeCe with my CEFALY Connected?

To pair your CeCe app with your CEFALY Connected, ensure you have downloaded the app and that your device is fully charged. Keep your Connected device nearby and ensure your smartphone’s Bluetooth is on.

With the app open, click the button on your Connected device. A dark blue LED should start flashing. If the app isn’t already searching for devices, click “Scan” at the top. A prompt will appear—follow it and enter the 6-digit code from the back of your device when requested. Once connected, you’ll receive a confirmation. For more details, see section 4 of the User Manual.

How do I track my treatment session with CeCe?

Starting an ACUTE or PREVENT session with your CEFALY Connected is the same as with previous devices. To track your treatment in CeCe, ensure your device is paired and connected with the app (this feature works only with the Connected device).

When ready, open the app, ensure your CEFALY and smartphone are connected, and then start an ACUTE treatment (press the device button once) or a PREVENT session (press the button twice with a slight pause). Once started, you’ll see the CEFALY logo pulsate on the homepage—tap it to view your treatment intensity and remaining time.

What is my “sweet spot?”

Your “sweet spot” is the stimulation level that is comfortable, safe, and effective for you. To find it:

  1. Time your first session with a stopwatch to establish a baseline. As the stimulation increases over 14 minutes, note when the sensation becomes too strong.
  2. Stop the session by removing the device (you’ll hear three beeps). If you experience discomfort or pain, removing the device will alleviate the symptoms.
  3. Restart your session and press the button once to stabilize the intensity before it becomes too strong. For example, if you stopped at 6 minutes, press the button at 5 minutes 30 seconds during the restart. That’s your sweet spot!
  4. If you’re using the Bluetooth-enabled CEFALY Connected, you can monitor the intensity in real time within the app.
  5. Over time, as your nerve fibers desensitize, if your current sweet spot feels too mild, try a slightly higher stimulation level. You don’t need full intensity to benefit from treatment.

If you need assistance, watch our videos available in the CeCe app under “Learn More” then “Find Your Sweet Spot.”

How is the information I provide to personalize my experience kept secure?

CEFALY Technology is committed to your privacy and security. To learn more about the data we collect, how we use it, and how we keep it safe, please read our full Privacy Policy.

How do I change my email address or password?

In the app, go to your personal profile and scroll down to the email field to update your address. You can access this through the main menu by selecting “Profile Settings” and then “Personal Profile.”

I have an account with cefaly.com. Will my credentials work for the CeCe app as well?

You will need to create a new account for the CeCe app. For security reasons, your CeCe login is separate from your cefaly.com login.

How do I get my migraine data onto a new smartphone?

You can download the CeCe app on multiple devices and log in with your email address and password. Your information is stored securely in the app.

What is the CEFALY device?

CEFALY is the first FDA-cleared device of its kind for the treatment of migraine headaches. It is a non-invasive, drug-free approach that helps relieve migraine pain and decrease the number of migraine days. Technically, it is an external trigeminal nerve stimulator placed on the forehead to stimulate and desensitize the nerve.

Do I need a CEFALY device to use the CeCe app?

No. The CeCe app is designed for anyone living with migraine, whether or not they use CEFALY.

Do I need the CeCe app to use the CEFALY device?

No! All CEFALY devices can be used without the CeCe app. The CEFALY Connected can be used with the app, but it is not required for treatment.

Do I need to log my migraine attacks as soon as they happen?

This is entirely up to you. During a migraine attack, you may not feel up to using the app. You can log your migraine in real time or later—the app allows you to adjust the date and time of your entry.

How do I change my profile photo?

Go to “Profile Settings” then “Personal Profile” from the main menu. Tap your photo and select a new one from your device’s photo library.

How do I add or change my migraine profile?

Access your migraine profile from the main menu by selecting “Profile Settings” then “Migraine Profile” to manage your log inputs, insights, or notifications.

How do I delete my account?

In the app, go to “Profile Settings” and then “Personal Profile” to find the “Delete Account” button. After deletion, your migraine records will be permanently removed. To resume tracking in the future, simply download the app and create a new account. For any questions, email info@cefaly.us.

Who do I contact with questions?

Please contact us at info@cefaly.us. We'd love to hear from you!

Ordering / Financing

Do I need a prescription?

CEFALY is cleared by the FDA for over-the-counter (OTC) use in the U.S. Globally, CEFALY is available OTC to individuals diagnosed by a physician with migraine.

Is CEFALY covered by health insurance?

CEFALY is actively working with insurance payors to expand coverage for our migraine treatment devices. CEFALY does not currently have contracts with commercial insurance company payors, Medicaid, or Medicare. However, you may be able to submit a claim for potential reimbursement using CEFALY’s HCPCS code: K1016. Coverage and reimbursement depend on your individual insurance provider and plan.

 

Other payment options: If you have an HSA/FSA account, you can use it to purchase the CEFALY device and/or electrodes. (Both are approved HSA/FSA expenses.) We also offer flexible payment plans through Affirm and PayPal Credit — just select your preferred option at checkout.

If you are a veteran, CEFALY is covered through the VA healthcare system. Please visit your VA healthcare provider for more information.

Coverage and reimbursement depend on your individual insurance provider and plan. For more information on how to file a insurance claim for CEFALY, please see the Insurance section of the FAQ.

Questions? Just reach out to our Patient Care team. We’re here to help!

Can I use my HSA or FSA account?

In the U.S., expenses for CEFALY are HSA/FSA approved. Your purchase may be reimbursed through your Health Savings Account or Flexible Spending Account. Please check with your administrator for more details.

What if I’m a veteran?

In the U.S., CEFALY is covered through the VA healthcare system. Visit our For Veterans page or speak with your VA healthcare provider for more information.

Is CEFALY covered by a warranty?

Your CEFALY is protected by a three-year limited warranty from the original purchase date when bought directly from www.cefaly.com or an authorized retailer, provided you register your device on cefaly.com.

This warranty covers defects in manufacture and workmanship when used as directed, but excludes electrodes, charging cables, and accessories. Please retain your invoice or sales receipt as proof of purchase.

This warranty does not cover damage caused by misuse, abuse, contact with liquids, accidents, loss, unauthorized accessories, alterations, improper installation, unauthorized repairs, improper use of electrical supply, drops, lack of maintenance, transportation damage, theft, neglect, vandalism, environmental conditions, or other conditions beyond our control. Learn more about our warranty.

Is there a money-back guarantee?

We stand behind the quality of our products. CEFALY Technology offers a satisfaction guarantee—if you are not satisfied, you may return the product within 90 calendar days of delivery for a refund.

Please note that individual responses to treatment vary. When using the 20-minute PREVENT treatment, allow at least two to three months to see results.

If you have any questions, please contact our Customer Service team. Learn more about our Return Policy.

What financing options are available?

If you prefer to pay over time, we offer two options in the U.S.: PayPal Credit for purchases of $99 or more, and 3-, 6-, or 12-month financing through Affirm (a down payment may be required and terms vary by purchase amount). Affirm loans are made by Cross Riverbank, Member FDIC. Visit affirm.com/help for more details.

Please note that neither PayPal Credit nor Affirm can be used for orders that include an electrode subscription. To finance both your device and subscription, please create separate orders.

What payment options does CEFALY accept?

Globally, we accept credit cards (Visa, Mastercard, or American Express), PayPal, Apple Pay, Microsoft Pay, and Google Pay. In the U.S., we also offer financing through Affirm and PayPal Credit.

How long will it take to receive my order?

In the U.S., the average delivery time is 7 to 14 business days for both devices and electrodes.

Why am I being charged an international fee?

CEFALY Technology is a Belgian company. Some U.S. credit card companies may charge an international or foreign exchange fee, which is collected by your bank—not by CEFALY Technology.

If I’m not home, how can I receive my order?

In the U.S., devices and electrodes are shipped via FedEx; in Canada, devices via UPS and electrodes via Canada Post; in the EU, devices via FedEx or DHL and electrodes via Belgium Post. We recommend using an address where someone will be available to receive your order.

How can I return a CEFALY device not purchased on cefaly.com?

For devices not purchased on cefaly.com, please contact the retailer for their return policy and procedure. We can assist with the three-year limited warranty if you have registered your device.

CUSTOMER SUPPORT

I'm in the US. Who do I contact with questions about my order?

In the U.S., call us at 1.844.475.7100 (9:00 AM to 10:00 PM ET, Monday – Friday, and 10:00 AM to 4:00 PM ET, Saturday - Sunday). You can also email us at info@cefaly.us.

I'm in Canada. Who do I contact with questions about my order?

In Canada, call us at 1.844.475.7100 (9:00 AM to 10:00 PM ET, Monday – Friday, and 10:00 AM to 4:00 PM ET, Saturday - Sunday). You can also email us at cs@cefaly.com.

I'm outside of North America. Who do I contact with questions about my order?

Outside of North America, please email us at info@cefaly.com.

Who do I contact for medical or treatment related questions?

For medical or treatment-related questions, please contact our Medical Affairs team by email. If you are in North America, email NAmedical.cefaly.us; if you are outside North America, email GLmedical@cefaly.com.

What other resources do you have to help me use my CEFALY effectively?

To get started with your new CEFALY device, visit our Get Started page. There you’ll find videos, a quick start guide, helpful articles, and FAQs.

You can also schedule a free session with a CEFALY Coach for one-on-one assistance.

What if I have specific issues or medical questions about the CEFALY device?

If you have specific issues or medical questions about CEFALY, please contact CEFALY Medical Affairs at NAmedical@cefaly.us if you're in North America, or GLmedical@cefaly.com if you're outside North America.

TROUBLESHOOTING

The CEFALY emits one long beep and/or displays a yellow light when the button is pressed.

This indicates that the battery is empty. Please charge your device for at least 4 hours for a full charge.

The CEFALY turned off during my session.

Possible causes:

  • Your electrode may not be adhering well to your forehead.
  • Your CEFALY may not be properly secured to the electrode.
  • The battery charge is too low.

Solutions:

  • Cleanse your skin with soap and water, dry thoroughly, reposition the electrode, reattach the CEFALY, and try again. Ensure the electrode is applied evenly without air pockets.
  • Use a mirror to verify that the magnetic contacts between the device and electrode are properly aligned.
  • Recharge the battery for at least 4 hours.

I cannot feel any stimulation.

Possible causes:

  • The electrode may not be adhering well to your forehead.
  • The CEFALY may not be properly secured to the electrode.
  • You might be desensitized to the lower-strength pulses at the beginning of a session.
  • You may have accidentally pressed the button to stabilize at a low intensity, preventing further increase.

Solutions:

  • Cleanse your skin with soap and water, dry thoroughly, reposition the electrode, reattach the device, and try again.
  • Use a mirror to ensure proper positioning so the magnetic contacts align correctly.
  • Wait 2-3 minutes to allow the intensity to increase naturally as you acclimate to the sensation.
  • If needed, after 4 minutes, press and hold the button to manually ramp up the intensity until it reaches a tolerable level.

The intensity feels too high.

Possible cause:

It takes time to adjust to the sensation of using CEFALY. When new to the device, avoid using it at maximum intensity.

Solution:

Find your sweet spot—a stimulation level that is noticeable but never painful. During the first 14 minutes of a session, press the button once to stabilize the intensity at your preferred level. If you press it again, the intensity will increase further. If the stimulation is too strong, remove the device from the electrode and restart your session.

If using the Bluetooth-enabled CEFALY Connected, you can monitor the intensity in real time within the CeCe app. For more information, see our video on controlling stimulation intensity here.

The intensity feels too low.

Possible cause:

  • You might have become desensitized to the lower-strength pulses at the start of a session.

Solution:

  • Press and hold the device button during the first 14 minutes to ramp up the intensity to your desired level. Release the button to stabilize the intensity at that new level. You can repeat this until the maximum intensity is reached (after 30 consecutive seconds of holding the button). Increase only to a tolerable level.

My skin is reddened when I remove the electrode.

Possible causes:

  • The skin on your forehead may become reddened where the electrode was applied.
  • This may indicate an allergy to the acrylate in the electrode adhesive.

Solutions:

  • The redness is usually harmless and may last a few minutes as blood flow increases in the area.
  • In rare cases, if you experience blistering, burning, itching, or swelling, stop using CEFALY and gently wash the area with soap and water. The rash should fade within a few days and may improve with an anti-inflammatory cream. If the condition persists, consult your healthcare provider and contact CEFALY Technology about hypoallergenic electrodes.

I experience painful headaches, nausea, tooth pain, tinnitus (noise or ringing in the ears), or hyperlacrimation (overproduction of tears) that persist after a session is over.

Possible cause:

  • These symptoms may indicate an uncommon side effect of using CEFALY.

Solution:

  • If you experience any of these symptoms persistently during or after sessions for more than a few weeks, stop using the device and consult your healthcare provider.

My CEFALY does not power on.

Possible causes:

  • The battery may not be sufficiently charged.
  • The electrode may not be adhering well to your forehead.
  • The device may not be properly secured to the electrode.

Solutions:

  • Use the micro-USB cable, charging dock, and adapter (if applicable) to charge your CEFALY for at least 4 hours. For first-time use, ensure the device is fully charged.
  • Cleanse your skin with soap and water, dry thoroughly, reposition the electrode, reattach the device, and try again. Make sure the electrode is evenly applied and the magnetic contacts are aligned.

While the device is running, it suddenly stops with a repeated sound.

The connection between the device and your skin has been lost. Make sure the device has not moved from its position. If it hasn’t, try using a new electrode after cleaning your forehead.

I am experiencing blurry vision during CEFALY treatments, what should I do?

If you experience blurry vision in one or both eyes during treatment, stop the session immediately and contact your healthcare provider. Although this is rarely reported, do not resume treatment until you have consulted a professional. Additionally, contact our medical department at NAmedical@cefaly.us if you’re in North America, or GLmedical@cefaly.com if you’re outside North America.

If I am experiencing a side effect, what should I do?

CEFALY clinical trials have shown that side effects are generally minor and fully reversible. If you experience any side effects, discontinue use and consult your healthcare provider. You may also contact our Medical Affairs team at NAmedical@cefaly.us (North America) or GLmedical@cefaly.com (outside North America) for further guidance.

Can the sensation of the CEFALY device feel less intense over time?

If you use CEFALY regularly, you may eventually perceive the stimulation as less intense. This is normal and does not indicate a defect. Over time, your nerves may become accustomed to the stimulation. For some, this process may take weeks, months, or years, while for others the intensity remains unchanged. If your device has been properly maintained, rest assured it is working as intended.

How do I clean my device?

Clean all sides of your device, power adapter, charging dock, and cable with a soft cloth and an alcohol-based cleaning product. Allow them to dry completely before use. Do not submerge the device or its components in water.

INSURANCE

Is CEFALY covered by health insurance?

CEFALY is actively working with insurance payors to expand coverage for our migraine treatment devices. CEFALY does not currently have contracts with commercial insurance payors, Medicaid, or Medicare. However, you may be able to submit a claim for potential reimbursement using CEFALY’s HCPCS code: K1016. Coverage and reimbursement depend on your individual insurance provider and plan.

Other payment options: If you have an HSA/FSA account, you can use it to purchase the CEFALY device and/or electrodes (both are approved HSA/FSA expenses). We also offer flexible payment plans through Affirm and PayPal Credit — just select your preferred option at checkout.

If you are a veteran, CEFALY is covered through the VA healthcare system. Please visit your VA healthcare provider for more information.

Questions? Just reach out to our Patient Care team. We’re here to help!

Are electrodes covered by health insurance?

We’re currently working with insurers to determine if electrodes can be covered. In the meantime, we recommend paying out of pocket and signing up for auto-delivery, which gives you free shipping and a 5% discount on every electrode order. Learn more and start your subscription

How do I find out if my health insurer covers CEFALY?

The best way to find out is to contact your insurer directly and ask: “Does my plan cover durable medical equipment (DME) under HCPCS Code K1016?”

If the answer is yes, then ask what documents you’ll need to submit a claim, such as a Letter of Medical Necessity from your doctor and the original receipt for your CEFALY purchase.

How do I submit a claim for insurance reimbursement for CEFALY?

It’s important to note that filing an insurance claim for CEFALY may not result in reimbursement. Insurance coverage and reimbursement depend on your individual provider and plan. Here’s the process for submitting a claim:

Step 1: Contact your insurance provider.

Before submitting a claim, call your insurance company and ask:

  • Does my plan cover durable medical equipment (DME) under HCPCS Code K1016?
  • What documents do I need to submit for reimbursement?
  • Do I need a prior authorization?

Step 2: Gather the required documents.

If your insurer covers DME under HCPCS Code K1016, collect the documents you need to file a claim. These may include:

  • Letter of Medical Necessity – A letter from your healthcare provider explaining why CEFALY is essential for your migraine treatment.
  • Insurance claim form – Most insurers have a standard claim form available on their website.
  • Copy of your CEFALY invoice – Your receipt that serves as proof of purchase.
  • HCPCS Code K1016 reference – Include this code in your claim submission.

Step 3: Submit your claim.

  • Send your completed claim form and supporting documents to your insurance provider via mail, fax, or online portal according to their requirements.
  • Keep copies of everything for your records.

Step 4: Follow up.

  • Check with your insurer after 2-4 weeks to confirm they received your claim and ask how long it will take to process.

If your insurer denies your claim, ask for a written explanation and consider appealing the decision with additional documentation.

What if my insurer says they won’t cover CEFALY?

Coverage and reimbursement for CEFALY depend on your individual insurance provider and plan, and are not guaranteed. If your insurer doesn’t cover CEFALY, we offer a few different payment options to make our neuromodulation device accessible to all migraine patients:

  • If you have an HSA/FSA account, you can use it to purchase the CEFALY device and/or electrodes (both are approved HSA/FSA expenses).
  • We also offer flexible payment plans through Affirm and PayPal Credit — just select your preferred option at checkout.

CEFALY offers a 90-day money back guarantee so that you can return the device if you’re not able to get insurance reimbursement or if you don’t see the results you want.

What if my insurer denies my claim for reimbursement for CEFALY?

Coverage and reimbursement for CEFALY depend on your individual insurance provider and plan, and are not guaranteed.

If your health insurer refuses to pay your claim, you have the right to appeal. They must provide a written explanation for the denial and inform you of the dispute process. You have two options:

  • Internal appeal: Ask your insurance company to review its decision. Learn more.
  • External review: You can take your appeal to an independent third party for review. Learn more.

What is CEFALY’s HCPCS Code for insurance reimbursement?

CEFALY has been assigned HCPCS Code K1016. This code is used when submitting healthcare claims to Medicare, Medicaid, and other insurers. However, having an HCPCS code does not guarantee insurance coverage or reimbursement.

Support Icon

Can’t find the answer?

Our team is here to answer your questions about CEFALY.
Reach out to us!

Contact Us

What does the science say?

79%
of patients in one study saw a significant reduction in headache pain after one hour of treatment. (ACME study)
56.4%
of patients in one study said CEFALY resolved their most bothersome symptom. (TEAM study)
38.1%
of CEFALY users in one study saw their migraine days reduced by half — or more — with compliant use. (PREMICE study)