CEFALY® ENHANCED
Product Code: CEFALYENHANCED
CEFALY® ENHANCED is the first FDA / TGA cleared medical device of its kind for treatment of migraines and is CE marked. The device uses electric impulses that are delivered to the main branch of the trigeminal nerve to prevent and treat pain in the head area. This method can replace or considerably reduce the consumption of painkilling medication and helps to find a better quality of life.
Introducing CEFALY® ENHANCED for Migraine Treatment
Following evidence gathered over the years, several recent technical advances have been made to the CEFALY® device for migraine relief. We now introduce CEFALY® ENHANCED, a new version which is much more efficient than previous models.
Studies, including a recent ACME study, have demonstrated the efficacy and safety of using the new CEFALY® ENHANCED device. Research findings have found the device an effective acute treatment for migraine attacks to relieve headache pain.
The device contains 2 settings:
- Setting 1: an improved acute mode (now 1 hour per session)
- Setting 2: the existing prevention mode (remains at 20 minutes per session)
The previous 3rd setting (sedative effect) has been removed. Both setting 1 and 2 have the sedative effects, allowing the device to focus on managing migraine pain.
Contents
The set includes:
- CEFALY® ENHANCED
- 3 Reuseable Electrodes
- Resealable Electrode Storage Bag
- Instruction Manual
- Charging Dock & USB Cable
- Storage Case
Each electrode can be used multiple times. Additional packs can be purchased directly from BHR - A pack of 3 for £23.00.
About the device
The device is a neurostimulator. It is applied to the forehead using a self adhesive electrode. The electrode is positioned bilaterally on the upper branches of the trigeminal nerve.
The device uses electrical impulses that are delivered to the main branch of the trigeminal nerve. The impulses from the device help to prevent and treat pain in the head area during a migraine attack.
This preventative treatment method can replace or considerably reduce the consumption of painkilling medication. The device provides the best efficacy rating compared to oral anti-migraine medication.
As a result, the device can help you to find a better quality of life. No serious side effects have been reported from using the device. However, you may experience a slight tingling sensation while the device works.
What is CEFALY®?
CEFALY® is a non-medication device that is used for the prevention and treatment of migraines. The device offers external trigeminal nerve stimulation (e-TNS) for relieving migraine symptoms during an attack, including common symptoms, such as head pain.
The trigeminal nerve is the largest of 12 cranial nerves in the brain. The nerve is found above our eyes and transmits sensory information, such as pain, from the brain to our sinuses, skin, and mucous. The trigeminal nerve is involved in most migraine attacks.
The device uses transcutaneous electrical nerve stimulation to treat migraines. The device uses neurostimulation to send precise micro-impulses to the trigeminal nerve. This helps stimulate nerve endings. This can provide a calming and sedative effect that can reduce migraine attacks.
The device is certified to the ISO medical standard and holds the CE medical mark. The device is FDA approved.
Who can use the CEFALY® device?
The CEFALY® migraine device is for those over 18 years who suffer from frequent or chronic migraine attacks. The device provides an alternative to medication treatments, making it a suitable drug free migraine relief for people with migraines.
Those who experience chronic headaches and migraines may benefit most from the device connected. Those suffering from other types of migraines, such as migraine with aura and menstrual migraine, may also benefit.
If you are unsure whether the device is suitable for you, answer a few questions using our online quiz. Find out if the device is right for you.
Long Term Patient Compliance
Data collected from 14.745 migraine patients using the device between 4 and 19 months reveals long-term compliance of 72.4%. Long-term compliance using the device is much better than oral preventative migraine medication.
Still not sold on this Migraine treatment? Check out these reviews.
60 Day Cooling-Off Period
The device comes with a 60 day cooling period. If you did not see the benefit of using the device within this time, you can return the item to us.
Only products returned in their entirety and in their original packaging can be accepted for return. Items missing will not be refunded.
Upon the return of the item, a refund of £320 will be issued to your payment method. BHR retains £58 to dispose of the product safely. This option applies only to online sales to consumers.
All items are disposed of using the correct disposal procedures. Disposable is in accordance with our Standard Operating Procedures for the environmental disposal of electrical items.
Additional resources
Meet CEFALY® ENHANCED
How to use the CEFALY® ENHANCED
Electrode care and maintenance
Face washing tips
CEFALY® ENHANCED FAQs
When should you not use the CEFALY® ENHANCED device?
The CEFALY® ENHANCED device should not be used if you have a cardiac pacemaker or implanted defibrillator, suffer from pain of an unknown origin, or have an electronic device implanted into the head.
Who can use the CEFALY® ENHANCED device?
The CEFALY® ENHANCED device is designed to treat and prevent migraines, including those suffering from acute migraines and preventative treatment for those with episodic or regular migraines. The device is not suitable for those under 18.
You should only use the device if you have been diagnosed with migraines by a physician or have consulted your GP beforehand. Episodic migraine is classed as having between 1 and 14 migraine headaches per month, alongside other associated symptoms.
What benefit does the CEFALY® ENHANCED device provide?
The device can relieve the pain from a migraine and reduce the monthly number of migraine days.
How should I store the CEFALY® ENHANCED device?
The device can be stored at temperatures between -5 and 35 degrees Celsius in a dry environment. The device should also be used in a dry environment and at room temperature (between 10 and 35 degrees Celsius).
What does FDA cleared mean?
The CEFALY® device is the first FDA-cleared medical device to treat migraines. The FDA is short for the Food and Drug Administration and is responsible for testing the safety and efficacy of various medical and cosmetic products.
An FDA-cleared device has undergone the 510(k) submission and has been reviewed and cleared by the FDA. The 510(k) submission is a premarket submission demonstrating whether a device is safe and effective.
What are the adverse reactions to using the CEFALY® device?
Improper use of the device can lead to injury, severe adverse reactions, or even death. It is crucial to properly use the device to avoid such harm.
- Do not use the device while sleeping.
- Never use the device in a wet environment like the bathroom.
- The device should not be used while operating heavy machinery or driving (you should wait at least 1 hour before doing such activities).
- Do not use the device if you have an implant or ECG fitted.
- Only use the device and electrodes on the forehead.
- Never use the device on damaged, saw, wounded, or swollen skin.
- Avoid using the device if you experience any loss of feeling in your forehead skin until the feeling returns.
Is there any risk of an allergic reaction using the CEFALY® device?
The Cefaly electrodes contain acrylates. If you are allergic to acrylates, contact BHR for an acrylates-free electrode alternative.
What are the side effects of using the CEFALY® ENHANCED device?
The device can produce several side effects.
Common:
- Drowsiness
- Slight headache after a preventative session
Uncommon:
- Redness of the forehead skin
- Nausea
Rare:
- Allergy of the forehead skin
If you experience any side effects for over three weeks, stop using the device and see your healthcare provider.
How long does one session last using the CEFALY® device?
The duration of a session depends on the setting used. The acute setting for use during a migraine attack will last 60 minutes. If the migraine pain does not pass or another migraine attack starts, a second 60-minute session can be used.
The preventative setting for preventing a migraine attack lasts for 20 minutes. The preventive setting should only be used daily, preferably in the evening, although this session can be carried out at any time during the day.
Should you use the CEFALY® daily?
If you use the device to prevent migraine head pains more than three times a month, you should use the preventative setting daily. The acute setting should only be used during a migraine attack and should only be repeated once if the pain does not pass.
What if the intensity of the electrical impulse is too strong?
If the device’s intensity is too strong, you can adjust the intensity by pressing the button on the front of the device. It is recommended to slowly increase the intensity of the device over the course of a few weeks to adjust to the sensation.
How long does it take to charge the CEFALY® device?
The device will require recharging once the battery runs flat. A charging session typically takes up to 3 hours. Make sure the battery is fully charged before reusing the device.
How long does the battery last in the CEFALY® device?
The device can be used for between 5 and 10 hours of stimulation, depending on the setting used. To check the battery, press the button on the front of the device when not in use. The device will emit a long beep to indicate low battery.
Does using the CEFALY® device hurt?
The device uses electrical impulses to prevent and treat head pain during a migraine. You may experience a strange sensation when first using the device, with most people getting used to the feeling after a few sessions.
Some people are more sensitive than others and may find the sensation from the device painful. In this case, you should adjust the intensity of the device. Only 1.25% of patients who tried Cefaly were unable to withstand the sensation and unable to continue using the device.
People with allodynia, an increased sensitivity to touch, may find the sensation from the device painful.
Can pregnant women use the CEFALY® device?
Yes, the device can be used by pregnant women to treat and prevent migraines. The device may be an alternative to replace unsuitable medication for pregnant women.
Can I use the CEFALY® device on holiday?
Yes, you can take the device with you on holiday. The device can pass through X-ray and baggage checks. You can also be used during a flight. Don’t forget to pack enough electrodes, though!
How do I get started using the CEFALY® device?
Most people using the device find it easy to use. Check out this simple 6 step guide on the CEFALY® website to show you how to get started.
Can you reuse a CEFALY® electrode?
Yes, providing you take proper care when using an electrode, it can be reused. The number of times you can reuse an electrode depends on how you store the electrode, skin preparation, and how active you are when using the device.
Before using the device, you should always cleanse and dry the skin using soap and water. Do not use makeup removal and alcohol cleansing wipes on the skin before using the device.
After the end of the session, it is recommended to store the electrodes back in the storage bag, placing the back of the electrode onto the clear plastic backing sheet. If the gel backing dehydrates, add a few drops to rehydrate the gel to prolong the electrode usage.
How should I clean the CEFALY® device?
The device should be cleaned using a soft duster and an alcohol-based cleaning solution. Ensure thorough cleaning of all sides of the device, cable, and power adapter. Never immerse the device in water.
