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About CEFALY

What is CEFALY?

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

Who is CEFALY for?

CEFALY DUAL 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 episodic migraine in patients 18 years of age or older.

Who should NOT use CEFALY DUAL?

Do not use CEFALY DUAL if you:

  1. Have implanted metallic or electronic devices in the head
  2. Are suffering from pain of unknown origin or
  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 the Cefaly Dual 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 DUAL has few side effects, which have been demonstrated to be minor and fully reversible with cessation of device usage, through clinical trials.

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

Common

  • Sleepiness - The main side effect is a tendency towards sleepiness. This means that CEFALY DUAL cannot be used when driving, or when operating machinery, or during any activity that can put you at risk of injury. Approximately 0.5% of subjects reported sleepiness during the CEFALY DUAL 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 occassionally appear blotchy. This effect is caused by activation of the skin blood circulation. This redness may persist for several minutes. Usually it disappears within 15 minutes. Approximately 0.2% of subjects reported reversible forehead skin redness.
  • Nausea - Rare occurrence of nausea during a session of acute treatment (Program 1 - ACUTE Treatment) has been reported in the clinical trials.

Rare

  • Forehead Skin Allergy - In rare cases an allergy to the electrode gel can arise. A temporay rash develops on the forehead. If this should occur, stop using CEFALY DUAL and contact your doctor or the manufacturer CEFALY Technology. The skin rash will gradually disappear within a few days. The use of an anti-inflammatory cream can accelerate the disappearance of the rash. Less than 1 out of 1000 subjects reported a skin allergic reaction.

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 any skin erruptions. Do not apply over or close to, cancerous lesions (skin abnormalities that could be cancer).

Will CEFALY interfere with electronic monitoring equipment?

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

Can the CEFALY device get wet?

Do not get device wet (such as use in bath or shower)

Can I used my CEFALY device while sleeping?

While there is not enough evidence to make a definitive claim that drowsiness occurs. The trial was only a very few people and it measured alertness, not drowsiness.

Can I drive while using CEFALY?

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

How Does CEFALY Work?

How does CEFALY work?

Research identifies the Trigeminal nerve as a critical area for migraine pain that can be accessed under the skin of your forehead. The CEFALY device has been specifically designed to make contact with the nerve endings of this branch via an electrode positioned on the forehead between the eyebrows. Once the electrode has been placed on your forehead, the device magnetically secures to the electrode, establishes a connection, and begins to send tiny electrical impulses through the top branch into the Trigeminal nerve.

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

Visit our "Start Treating" page here for a quick start guide, helpful videos, tips and blog articles.

Am I supposed to use the PREVENT treatment program every day?

The PREVENT treatment program is meant for daily preventative treatment and is activated by pressing your device button twice. This is a 20-minute program designed for the preventative treatment of migraines. When using the PREVENT migraine treatment program, you will observe the following:

  • You will hear two beeps to indicate your PREVENT program selection.
  • The CEFALY DUAL green indicator light flashes twice throughout the program to aid in treatment monitoring. It may take several seconds for flashing to begin.

How long does an ACUTE session last?

The ACUTE treatment program is intended for treatment during a migraine attack or at the onset of a migraine and is activated by pressing your device button once.

This is a 60-minute program designed to treat migraine attacks when they begin, to stop or relieve your migraine pain. When using the ACUTE migraine treatment program, you will observe the following:

  • You will hear a single beep to indicate your ACUTE program selection.
  • The CEFALY DUAL green indicator light will flash once throughout the program to aid in treatment monitoring. It may take several seconds for flashing to begin.

What does it feel like to use CEFALY?

The sensation produced by CEFALY is unusual, but most people become accustomed to the stimulation quickly, after a few sessions. It should not hurt and is safe. However, some are more sensitive and may consider the sensation produced by CEFALY to be painful. If this is the case for you, press and release the button during the session when the sensation becomes slightly uncomfortable to limit its intensity. Only 1.25% of patients cannot tolerate the sensation produced by CEFALY and are unable to complete the treatment properly.

What if the intensity is too strong for me?

The sensations experienced while using the CEFALY DUAL are novel to most people and can take some adjustment. To make treatment more enjoyable, we recommend you increase the intensity in small increments of time, over the course of a few weeks. If you feel the intensity is too strong for you, simply press the device button once during a session to stabilize the pulses at a tolerable level for the remainder of the session.

How do I adjust the intensity?

By pressing and holding the button during the first 14 minutes of a session, you can quickly ramp up to a desired intensity level. This can be repeated until the maximum intensity has been reached. Wait at least 10 seconds after you’ve selected your session; then, if you wish to increase the intensity, you can press and hold the button until the intensity reaches your desired strength. When you release the button, the intensity will stabilize and remain constant. Should you press and hold the button again, the intensity will increase again. The maximum intensity is reached after pressing and holding the button for 30 consecutive seconds. Click here to watch a video that shows how to adjust the intensity.

How many uses can I get per electrode?

One electrode with a magnetic connection is used with the CEFALY during each session. With proper care, one regular electrode can be reused for up to 20 sessions (the recommended number of uses for hypoallergenic/blue gel electrodes is 10). Immediately before applying the electrode, the skin on the forehead should always be cleansed and degreased thoroughly with plain soap and water. As long as the electrode adheres well to the skin on the forehead, it can be used. Once the session ends, the electrode should be adhered back onto its clear plastic sheet and stored inside its silver pouch. Tip from other users: If you place the silver pouch inside a sealed plastic bag, you may extend the number of uses per electrode. Do not leave the electrode exposed and unpackaged, especially in a dry place. It will dehydrate and will no longer function as designed. If cared for properly, a few drops of tap water on the electrode gel can gently rehydrate it and help prolong its usage.

How long will it hold a charge?

The battery operating life ranges from 5 to 10 hours of stimulation, depending on the program used for each session.

How do I know when CEFALY needs to be charged?

If the CEFALY emits a long beep when you press the button, this means the battery charge is too low. You must recharge it for at least 5 minutes to be able to use it for one session.

Can I use CEFALY with Botox?

Our recommendation is to wait at least three months after botulinum toxin injection (Botox) to treat with the CEFALY device. This recommendation relates to efficacy only and originates from two factors: mechanisms of action (how each treatment works) and the currently availble clinical trial data.

In simple terms, Botox helps prevent migraine by binding to nerves and temporarily dampening electrical signals in those nerves. The CEFALY PREVENT program, on the other hand, stimulates the trigeminal nerve in order to desensitize it over time.

There is no contraindication for using CEFALY with Botox and CEFALY Technology has not received any reports of side effects or adverse events resulting from the use of both treatments together.

CEFALY Technology also recommends that you consult your doctor before adding new treatments to your migraine relief program and for any further questions you might have.

Ordering / Financing

Do I need a prescription?

Great news! CEFALY no longer requires a prescription. CEFALY DUAL was recently cleared by the FDA for over-the-counter (OTC) use in the U.S. Globally, CEFALY DUAL is available over-the-counter to individuals that have been diagnosed by a physician with migraine.

Now that CEFALY no longer requires a prescription, you can treat migraine pain in a safe and convenient way with this effective treatment.

 

Is it covered by health insurance?

CEFALY is not covered by commercial health insurance at this time. However, CEFALY is HSA/FSA approved, and expenses for CEFALY may be reimbursed through your Health Savings Account (HSA) or Health Flexible Savings Account (FSA). Please consult your HSA or FSA administrator for more information. If you are a Veteran, CEFALY is covered through the VA health care system. Please visit your VA health care provider for more information.

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 (HSA) or Health Flexible Savings Account (FSA). Please consult your HSA or FSA administrator for more information.

What if I’m a Veteran?

In the US, CEFALY is covered through the VA health care system. Please visit our For Veterans page or visit your VA health care provider for more information.

Is CEFALY covered by a warranty?

Your CEFALY DUAL is protected by a three (3) year limited warranty from the original date of purchase when purchased directly from www.cefaly.com or CEFALY US, Inc. This limited warranty ensures your CEFALY DUAL is free of defects in manufacture and workmanship if used in accordance with the instructions provided. Electrodes, charging cables, and other accessories are excluded from this warranty. Please keep your invoice or sales receipt as your Proof of Purchase date.

This limited warranty does not cover damage caused by misuse or abuse; contact with any liquids; accident; loss of device; the attachment of any unauthorized accessory; alteration to the product; improper installation; unauthorized repairs or modifications; improper use of electrical/power supply; dropped product; malfunction or damage of an operating part from failure to provide manufacturer’s recommended maintenance and storage; transportation damage; theft; neglect; vandalism; environmental conditions; loss of use during the period the product is at a repair facility or otherwise awaiting parts or repair; or any other conditions whatsoever that are beyond the control of CEFALY Technology. Learn more about our warranty.

Is there a money-back guarantee?

We stand behind the quality of CEFALY products, and hope you are happy with the device. CEFALY Technology SPRL offers a satisfaction guarantee on the CEFALY device. If you are not satisfied with the product you may return it within 60 calendar days of your product delivery date for a refund (please include your order number with your return). If you are considering a return because you are unhappy with the results, please understand that everyone responds to treatment differently. It may take a few weeks of consistent use, following the directions for use detailed in the user manual, before you feel an improvement. If you have any questions, CEFALY’s Customer Service team is happy to help. Learn more about our Return Policy.

What financing options are available?

If you prefer to pay over time, we offer two ways to finance your purchase in the US. We offer PayPal Credit for purchases of $99 or more, as well as 3, 6 and 12 month financing options through Affirm. With Affirm, a down payment may be required. Subject to eligibility check and approval. Payment options depend on your purchase amount. Estimated payment amount excludes taxes and shipping fees. Actual terms may vary. Affirm loans are made by Cross River Bank, Member FDIC. Visit affirm.com/help for more info.

Please note that neither PayPal Credit or Affirm can be used for orders that include an electrode subscription. If you prefer to finance your CEFALY DUAL device but also want to order an electrode subscription, please create a separate order transaction for your subscription using a credit card as payment method.

What payment options does CEFALY accept?

Globally, we accept credit cards (Visa, Mastercard, or American Express) in addition to PayPal, Apple Pay, Microsoft Pay and Google Pay.

In the U.S., we also offer payment options through Affirm and PayPal Credit.

In the Netherlands, we also accept iDEAL.

 

 

How long will it take to receive my order?

In the US and Canada, the average delivery time is one week for both devices and electrodes. Within Europe, devices deliver within 2 business days, and electrode-only orders normally arrive in 1 to 10 business days. Outside of Europe and North America, devices arrive in 5 business days, and electrode-only orders arrive in 1 to 25 business days, depending on the country.

Why am I being charged an international fee?

CEFALY Technology is a Belgian company and as such, some US credit card companies may charge you an international or foreign exchange fee. This fee is collected by your bank, not CEFALY Technology.

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

In the U.S. CEFALY devices and electrodes are shipped via FedEx. In Canada, devices are shipped via UPS and and electrodes are delivered by Canada Post. Regardless of courier, we recommend choosing a delivery address where you know someone will be available to receive your order (workplace, relative, etc.)

CUSTOMER SUPPORT

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

In the US, you can call us at 1.844.475.7100 9:00 AM to 5:00 PM ET, Monday - Friday. You can also email us anytime at info@cefaly.us

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

In Canada, you can call us at 1.844.475.7100 9:00 AM to 5:00 PM ET, Monday - Friday. You can also email us anytime at cs@cefaly.com

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

You can email us anytime at info@cefaly.com

Who do I contact for medical or treatment related questions?

Please contact Medical Affairs by email. If you reside in North America, please contact NAmedical.cefaly.us. For those who live outside North America, please contact GLmedical@cefaly.com

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

To get set up with your new CEFALY device, visit our Get Started page. You'lll find resources to help you get started using your CEFALY device, including videos showing how to use your device, a quick start guide, helpful articles and Frequently Asked Questions.You can also read about others' journey with migraine and learn new tips in our blog, and we'd love for you to join our social media community.

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

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

How do I clean my device?

Thoroughly clean all sides of your device, power adapter and cable with a soft cloth and an alcohol-based cleaning product that does not contain any solvents. Products that you may already have at home that would work include rubbing alcohol or pre-moistened lens/screen cleaning wipes, or natural cleaning products such as Simple Green, Method or Mrs. Meyer’s products. Be sure to check the label first. DO NOT put your CEFALY device or components in water.

TROUBLESHOOTING

The CEFALY DUAL emits one long beep when the device is pressed.

That means the battery is empty. Please charge your device for at least 5 minutes to complete a full session; ideally, charge for 3+ hours to charge the CEFALY DUAL fully.

The CEFALY DUAL turned off during my session.

Possible Cause:

  • Your electrode is not sticking well to your forehead
  • Your Cefaly Dual is not properly secured to the electrode
  • The battery charge is too low

Solution:

  • Cleanse your skin again with soap and water, and pat dry. Then reposition the electrode, attach the CEFALY DUAL and try powering it on again. To reposition the electrode, start from the center and work your way outward toward each corner, running your fingers several times along the entire surface of the electrode. You want the electrode to be flat and firm against your forehead skin.
  • Use a mirror to make sure your CEFALY DUAL is properly positioned on the electrode. The magnetic contacts on the CEFALY DUAL must be properly secured by the corresponding magnetic contact zone on the electrode for the CEFALY DUAL to work properly. If the electrode is not positioned correctly and is not flat against your forehead, the contacts may not connect properly. To reposition the electrode, start from the center of and work your way outward toward each corner, running your fingers several times along the entire surface of the electrode. You want to the electrodes to be flat and firm against your forehead skin.
  • Recharge the battery for at least 5 minutes to complete a full session; ideally, charge for 3+ hours to charge the CEFALY DUAL fully.

I cannot feel any stimulation.

Possible Cause:

  • Your electrode is not sticking well to your forehead.
  • Your CEFALY DUAL is not properly secured to the electrode.
  • Once accustomed to the sensations experienced while using the CEFALY DUAL you may feel desensitized to its lower-strength pulses at the beginning of a session.
  • You accidentally pressed the device button to stabilize your treatment at a low intensity level, prohibiting it from increasing.

Solution:

  • Cleanse your skin again with soap and water, and pat dry. Then reposition the electrode, attach the CEFALY DUAL and try powering it on again. To reposition the electrode, start from the center and work your way outward toward each corner, running your fingeres several timews along the entire surface of the electrode. You want the electrode to be flat and firm against your forehead skin.
  • Use a mirror to make sure your CEFALY DUAL is properly positioned on the electrode. The magnetic contacts on the CEFALY DUAL must be properly secured by the corresponding magnetic contact zone on the electrode for the CEFALY DUAL to work properly. If the electrode is not positioned correctly and is not flat against your forehead, the contacts may not connect properly. To reposition the electrode, start from the center of and work your way outward toward each corner, running your fingers several times along the surface of the electrode. You want to the electrode to be flat and firm against your forehead skin.
  • Wait 2-3 minutes while using CEFALY DUAL for the intensity to increase. It's possible you are becoming used to the sensation.
  • Wait until at least 4 minutes into your session, then press and hold the device button to manually ramp up the intensity of the session. When you release the device button, the intensity will stabilize at the new level and remain constant. Should you press and hold the device button again, the intensity will increase again. The maximum intensity is reached after pressing and holding the device button for 30 consecutive seconds. You should increase the intensity to a tolerable level, but you should stop before the sensation becomes intolerable or painful.
  • Push the device button once to start the ACUTE program and twice in a row to begin the PREVENT program once the electrode and device are properly positioned on your forehead. If the CEFALY DUAL does not power on, use the micro-USB cable and the adapter to charge it for 3+ hours. If this is your first time using the CEFALY DUAL it must be fully charged. Once your CEFALY DUAL is fully charged, the indicator light will remain turned on. If this is not your first time using your CEFALY DUAL and it is not powering on, charging for 5 minutes shoudl allow it to turn on and get you through a full session.

The intensity feels too high.

Possible Cause:

  • The sensations experienced while using the CEFALY DUAL are novel to most people and can take some adjustment.

Solution:

  • To make treatment more enjoyable, we recommend you increase the intensity in small increments of time, over the course of a few weeks. If you feel the intensity is too strong for you, simply press the device button once during a session to stabilize the pulses at a tolerable level for the remainder of the session.

The intensity feels too low.

Possible Cause:

  • Once You’re accustomed to the sensations experienced while using the CEFALY DUAL you may feel desensitized to its lower-strength pulses at the beginning of a session.

Solution:

  • 10 seconds after you’ve selected your session, you may press and hold the device button to quickly ramp up the intensity to your desired strength. When you release the device button, the intensity will stabilize and remain constant. Should you press and hold the device button again, the intensity will increase again. The maximum intensity is reached after pressing and holding the device button for 30 consecutive seconds. You should increase the intensity to a tolerable level, but you should stop before the sensation becomes intolerable or painful.

My skin is reddened when I remove the electrode

Possible Cause:

  • The skin on the forehead may at times become reddened where the electrode was placed.
  • This may indicate an allergy to the acrylate used in the electrode.

Solution:

  • This redness may last a few minutes or more after your session, and is usually harmless. It indicates the CEFALY DUAL has stimulated blood flow to the area.
  • In rare cases, you may experience an allergy to the acrylate used in the electrode adhesive and a temporary rash may cause. You may experience small blistering, burning, itching, or swelling in the areas where the electrode comes in contact with the skin. If this should happen, stop using the CEFALY DUAL and wash the area with soap and water, gently. The skin rash should gradually disappear within a few days and can be helped along by applying an anti-inflammatory cream.

If your condition does not improve, stop using the CEFALY DUAL and speak with your healthcare provider. Before using your CEFALY DUAL after such an event, contact CEFALY Technology to ask about the alternate 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 may indicate that you are experiencing an uncommon side effect of using the CEFALY DUAL.

Solution:

  • Some users have reported experiencing painful headaches, nausau, tooth pain, tinnitus or hyperlacrimation during and after CEFALY DUAL sessions. If you experience any one or more of these conditions and it (they) persist, both during sessions and while not using CEFALY DUAL, for more than a few weeks, stop use and consult your healthcare provider.

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

The connection between the device and the skin has been lost. Make sure that the device has not moved from its position. If it has not moved, try again with a new electrode after cleaning the forehead skin.

The CEFALY DUAL does not power on.

Possible Cause:

  • The CEFALY DUAL does not have enough charge.
  • Your electrode is not sticking well to your forehead.
  • Your CEFALY DUAL is not properly secured to the electrode.

Solutions:

  • Use the micro-USB cable and the adapter to connect your CEFALY DUAL to a power source for 3+ hours. If this is your first time using the CEFALY DUAL it must be fully charged. Once fully charged, the indicator light will remain turned on.
  • Cleanse your skin again with soap and water, and pat dry. Then reposition the electrode, attach the CEFALY DUAL and try powering it on again. To reposition the electrode, start from the center and work your way outward toward each corner, running your fingers several times along the entire surface of the electrode. You want the electrode to be flat and firm against your forehead skin.
  • Use a mirror to make sure your CEFALY DUAL is properly positioned on the electrode. The magnetic contacts on the CEFALY DUAL must be properly secured by the corresponding magnetic contact zone on the electrode for the CEFALY DUAL to work properly. If the electrode is not positioned correctly and is not flat against your forehead, the contacts may not connect properly. To reposition the electrode, start from the center of and work your way outward toward each corner, running your fingers several times along the entire surface of the electrode. You want to the electrodes to be flat and firm against your forehead skin.

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

CEFALY DUAL clinical trials have shown side effects to be minor and fully reversible, as outlined in our clinical trials. If you are experiencing any of these side effects, discontinue use and contact your medical provider or reach out to our Medical Affairs team at NAmedical@cefaly.us in North America, and GLmedical@cefaly.com outside of North America.
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