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À propos de CEFALY

Qu'est-ce que le CEFALY ?

CEFALY est le premier appareil accepté par la FDA (« FDA-Cleared ») pour le traitement des migraines. Il s'agit d'une approche non invasive et sans médicament qui aide à soulager la douleur migraineuse et à réduire le nombre de jours avec migraine. 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.

Qu’est-ce qui différencie CEFALY des autres appareils de traitement de la migraine ?

Chez CEFALY, nous pensons que toutes les personnes souffrant de migraine méritent d’avoir accès à un traitement sans médicament qui fonctionne. CEFALY est le seul appareil de neuromodulation pour traiter la migraine approuvé par la FDA et disponible sans ordonnance.

La plupart des autres appareils de neuromodulation nécessitent des renouvellements continus d’ordonnance, des frais de remplacement ou des frais d’abonnement. CEFALY is yours to keep. And it’s designed to last, with a 3-year limited warranty. Votre seul coût permanent est le remplacement des électrodes, et chaque électrode peut être utilisée plusieurs fois. C’est pourquoi nous pensons que CEFALY est le choix le plus simple, le plus intelligent et le plus abordable pour traiter la migraine par neuromodulation.

À qui s'adresse le CEFALY ?

CEFALY est préconisé pour :

  1. Le traitement de crise des migraines avec ou sans aura chez les patients de 18 ans et plus.
  2. Le traitement préventif de la migraine chez les patients de 18 ans et plus.

Qui ne doit PAS utiliser CEFALY ?

N'utilisez pas CEFALY si vous :

  1. Avez un implant métallique ou électronique dans la tête
  2. Are suffering from pain of unknown origin
  3. portez un stimulateur cardiaque, ou un défibrillateur implanté ou portable.

Les femmes enceintes peuvent-elles l'utiliser ?

Si vous êtes, pourriez être ou avez des chances de tomber enceinte, vous devriez demander l'avis de votre médecin avant d'utiliser CEFALY.

Le CEFALY est-il destiné aux personnes de tous âges ?

Tous les essais cliniques concernant l'efficacité et la sécurité du CEFALY ont été réalisés sur des adultes (âgés de 18 à 65 ans). Il n'existe actuellement aucun résultat d'essai ou donnée spécifique concernant des personnes âgées de moins de 18 ans ou de plus de 65 ans.

Consultez un médecin avant l'utilisation si :

  • Vous avez moins de 18 ans.
  • Vous avez plus de 65 ans.
  • Vous êtes enceinte ou projetez de l'être.
  • Vous pensez avoir des problèmes cardiaques ou vous savez que vous en avez.
  • Vous avez récemment souffert d'un traumatisme crânien.
  • Vous avez déjà souffert de troubles convulsifs.
  • N'avez jamais été diagnostiqué(e) comme souffrant de migraine par un professionnel de santé.
  • Souffrez de maux de tête différents de vos migraines habituelles.
  • Souffrez du pire mal de tête de votre vie.
  • Avez de la fièvre ou des raideurs dans le cou.
  • Avez des maux de tête suite à une blessure à la tête, un effort physique, à une quinte de toux ou quand vous vous penchez vers l'avant.
  • Avez souffert de votre prermier mal de tête après l'âge de 50 ans.
  • Souffrez d'une migraine tellement aigüe qu'elle nécessite que vous restiez au lit. 

L'utilisation du CEFALY peut-elle causer des effets secondaires ?

Le CEFALY présente peu d'effets secondaires, dont les essais cliniques ont démontré qu'ils étaient mineurs et entièrement réversibles avec l'arrêt de l'utilisation de l'appareil.

Si vous ressentez des effets secondaires graves, ou si des effets secondaires persistent pendant plusieurs jours, cessez l'utilisation du CEFALY et consultez immédiatement un médecin.

Courants

  • 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).

Inhabituels

  • 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. Environ 0,2 % des sujets ont fait état d'une rougeur réversible sur la peau du front.
  • Nausea - A rare occurrence of nausea during a session of acute treatment (Program 1 - ACUTE Treatment) has been reported.

Rares

  • 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.

Je souffre d’allodynie. Puis-je utiliser CEFALY ?

Allodynia is a condition involving increased sensitivity to touch, where even normally non-painful stimuli can be perceived as painful. Si vous souffrez d'allodynie, vous devez discuter de ces symptômes avec votre professionnel de santé avant de commencer les traitements par CEFALY. We recommend that individuals with allodynia become familiar with the intensity stabilization function before using the device.

Puis-je utiliser mon appareil CEFALY sur des zones autres que mon front ?

CEFALY est uniquement conçu pour une utilisation sur le front. N'utilisez pas l'appareil sur votre cou, votre poitrine ou toute autre partie de votre corps.

Que faire si j'ai un problème de peau, par exemple une blessure au front ?

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.

Puis-je utiliser CEFALY à proximité d'un dispositif de surveillance électronique ?

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

L'appareil CEFALY peut-il être mouillé ?

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

Puis-je utiliser mon appareil CEFALY pendant mon sommeil ?

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

Puis-je conduire en utilisant le 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.

Puis-je continuer mes activités habituelles lors de l'utilisation de CEFALY ?

CEFALY est un dispositif thérapeutique qui doit être utilisé dans un état de relaxation. For optimal results, pause your usual activities during treatments. We recommend using CEFALY while sitting or reclining, with your head tilted back.

Puis-je voyager/prendre l'avion avec 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. Voyagez en toute sécurité !

Comment fonctionne le CEFALY ?

Quel est le principe d'action du CEFALY ?

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.

Je viens de commander mon CEFALY - par où commencer ?

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.

Comment utiliser le mode de traitement de PRÉVENTION ?

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.

Dois-je utiliser le programme PRÉVENTION tous les jours ?

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.

Comment utiliser le mode de traitement de CRISE ?

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.

Que ressent-on en utilisant le CEFALY ?

La stimulation initiale peut se traduire par un léger picotement ou une faible vibration. 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.

Que faire si l'intensité est trop forte pour moi ? 

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.

Comment augmenter rapidement l'intensité du traitement ?

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.

Au bout de combien temps vais-je obtenir des résultats ?

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.

Puis-je réutiliser mes électrodes ?

Avec un entretien approprié, les électrodes peuvent être réutilisées. 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.

Comment savoir à quel moment changer d'électrode ?

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

Comment gérer mon compte d'abonnement aux électrodes ?

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

Combien de temps ma batterie durera-t-elle ?

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

Comment puis-je savoir quand le CEFALY doit être rechargé ?

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.

Puis-je utiliser CEFALY avec du Botox ?

Il n'y a pas de contre-indication à l'utilisation de CEFALY avec des injections de Botox. 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.

Application CeCe

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.

Comment déterminer mon niveau d'intensité idéal ?

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. Il s'agit de votre niveau d'intensité idéal !
  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 est le premier appareil accepté par la FDA (« FDA-Cleared ») pour le traitement des migraines. 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. Écrivez-nous !

Commande/Financement

Ai-je besoin d'une ordonnance ?

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. Veuillez consulter votre professionnel de santé des vétérans pour plus d'informations.

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.

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

Puis-je utiliser mon compte HSA (compte d'épargne santé ou CES) ou mon compte FSA (compte d'épargne santé flexible ou CES) ?

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.

Le CEFALY est-il soumis à garantie ?

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. En savoir plus sur notre garantie.

Existe-t-il une garantie de remboursement ?

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. En savoir plus sur notre Politique de retour.

Quelles sont les options de paiement disponibles ?

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). Les prêts Affirm sont accordés par Cross Riverbank, membre de la FDIC. Visit affirm.com/help for more details.

Veuillez noter que ni un crédit PayPal ni Affirm ne peuvent être utilisés pour les commandes qui incluent un abonnement d'électrodes. To finance both your device and subscription, please create separate orders.

Quelles sont les options de paiement acceptées par CEFALY ?

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.

Combien de temps faudra-t-il pour recevoir ma commande ?

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

Pourquoi me demande-t-on de payer une taxe internationale ?

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.

Si je ne suis pas chez moi, comment puis-je recevoir ma commande ?

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.

Comment retourner un appareil CEFALY non acheté sur 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.

SERVICE CLIENT

Je suis aux États-Unis. Qui dois-je contacter pour toute question concernant ma commande ?

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.

Je suis au Canada. Qui dois-je contacter pour toute question concernant ma commande ?

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.

J'habite en dehors de l'Amérique du Nord. Qui dois-je contacter pour toute question concernant ma commande ?

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

Qui dois-je contacter pour les questions d'ordre médical ou relatives au traitement ?

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.

De quelles autres ressources disposez-vous pour m'aider à utiliser efficacement mon CEFALY ?

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.

Que faire si j'ai des problèmes spécifiques ou des questions médicales concernant l'appareil CEFALY ?

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.

AIDE

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.

Le CEFALY s'est éteint pendant ma séance.

Possible causes:

  • Your electrode may not be adhering well to your forehead.
  • Your CEFALY may not be properly secured to the electrode.
  • La charge de la batterie est trop faible.

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.

Je ne ressens aucune 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.

L'intensité semble trop élevée.

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.

L'intensité semble trop faible.

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.

Ma peau présente des rougeurs lorsque j'enlève l'électrode.

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.

Je ressens des maux de tête douloureux, des nausées, des douleurs dentaires, des acouphènes (bruit ou bourdonnement dans les oreilles) ou un larmoiement excessif (surproduction de larmes) qui persistent après la fin d'une séance.

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.

Mon CEFALY ne se met pas en marche.

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.

Pendant que l'appareil fonctionne, il s'arrête soudainement avec un son répété.

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.

Si je ressens un effet secondaire, que dois-je faire ?

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.

La sensation de l'appareil CEFALY peut-elle être moins intense avec le temps ?

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.

Comment puis-je nettoyer mon appareil ?

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. Veuillez consulter votre professionnel de santé des vétérans pour plus d'informations.

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. Cela peut inclure les comportements suivants :

  • 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.

For more details, please refer to our reimbursement one-pager.

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.

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Que dit la science ?

79 %
des patients d’une étude ont constaté une réduction significative de la douleur des maux de tête après une heure de traitement. (Étude ACME)
56,4 %
des patients d’une étude ont déclaré que le CEFALY avait résolu leur symptôme le plus gênant. (Étude TEAM)
38,1 %
des utilisateurs de CEFALY interrogés dans le cadre d’une étude ont vu leurs jours de migraine réduits de moitié, voire plus, grâce à une utilisation conforme. (Étude PREMICE)