CEFALY® Enhanced
CEFALY® Enhanced
CEFALY Enhanced is a non-invasive migraine device with two treatment settings: a 60-minute ACUTE setting for use during an attack and a 20-minute PREVENT setting for daily use.
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3 electrodes includedReusable 3-packWorth $69.00
Private health rebatesDepends on yourinsurer and coverCheck your cover
NDIS supportSubject to eligibilityand approvalAsk about support
Most new, unopened items can be returned within 30 days. No money-back trial for treatment results. Returns policy
Description
Description
Drug-free migraine relief and prevention with one clinically proven device.
CEFALY Enhanced uses external trigeminal nerve stimulation to help relieve migraine pain during an attack and reduce migraine frequency through regular preventive treatment.
- 60-minute ACUTE treatment for use during a migraine attack
- 20-minute daily PREVENT treatment
- Drug-free and non-invasive
- TGA-registered
- No prescription required
- Includes three reusable electrodes
- Express shipping from Sydney
- Two-year device warranty
Individual results vary. Read the indications, contraindications and warnings before use.
What's in the box?
What's in the box?
Additional Info
Additional Info
CEFALY Enhanced: device details
CEFALY Enhanced uses external trigeminal nerve stimulation (eTNS) through a self-adhesive forehead electrode. It has two treatment settings:
- ACUTE: a 60-minute session for use during a migraine attack.
- PREVENT: a 20-minute session for daily preventive use.
The rechargeable device connects magnetically to the electrode. The kit includes three reusable electrodes, a resealable electrode bag, a charging dock and USB cable, a storage case and an instruction manual.
Getting started: Watch the setup demonstration and read the care guide. Compare replacement electrode options.
Individual results vary. Read the indications, contraindications and warnings and your user manual before use. For the device specifications, see the manufacturer’s CEFALY Enhanced manual.
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Drug Free Pain Relief
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Clinically Proven
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One Device, Two Settings
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Treatment & Prevention
Drug Free Pain Relief
Clinically Proven
One Device, Two Settings
Treatment & Prevention
How electrical impulses treat migraines
Most headaches and migraines affect the trigeminal nerve. Its superior branch ends at the exit of the eye socket, underneath the skin of the forehead.
CEFALY® delivers small electrical impulses via a self-adhesive electrode placed on the forehead to stimulate the trigeminal nerve. These pulses reduce the frequency and intensity of migraine attacks.
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What is CEFALY?
CEFALY is the first FDA / TGA 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.
How does CEFALY work?
Research identifies the Trigeminal nerve as a center for migraine pain and 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 an electrode has been placed, the device magnetically secures a connection and begins to send tiny electrical impulses through the top branch into the Trigeminal nerve.
How long does a session last?
A session with the ACUTE setting lasts one hour and is used during a migraine attack. The session can be repeated for another 60-minute session if necessary or if another migraine attack occurs. A session with the PREVENT setting lasts 20 minutes. It must be used daily and may be done at any time throughout the day, though an evening session is preferred.
Will it hurt?
The CEFALY device should not hurt and is safe. However, the sensations experienced while using the CEFALY device are novel to most people and can take some adjustment. To make treatment more enjoyable, we recommend you increase 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 button to stabilize the session.
Can I adjust the intensity?
If 10 seconds after you’ve selected your session, you wish to increase the intensity, you can press and hold the button to quickly ramp up the intensity to 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.
Can I get covered by Veteran Affairs/NDIS Provider?
Contact your relevant organisation to check whether funding is available for CEFALY and its accessories. Support is subject to eligibility and approval.
Can I claim back some of the cost on my Private health?
Yes you can depending on your insurer and level of cover. Just call you Private Health Insurance and let them know that Cefaly is classed as a TENS Machine, and we can provide an invoice stating that it is a TENS Machine. List of the Top 10 Australian Private Health Funds and the potential refunds they may offer on your Cefaly purchase
Indications, Contraindications, Precautions & Warnings
CEFALY® Enhanced is the first FDA / TGA cleared medical device of its kind for treatment of migraine.
CEFALY Enhanced is indicated to be used for:
- The acute treatment of migraine with or without aura in patients 18 years of age or older.
- The preventative treatment of episodic migraine in patients 18 years of age or older.
CEFALY Enhanced is for patients diagnosed by a physician with migraine per the indications for use.
Do not use if you:
- Have implanted metallic or electronic devices in the head.
- Are suffering from pain of unknown origin.
- Have a cardiac pacemaker or an implanted or wearable defibrillator.
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.
Warnings
- Do not use CEFALY Enhanced while sleeping.
- Do not use CEFALY Enhanced in a wet environment, such as in the bath or shower.
- Do not use CEFALY Enhanced while driving, operating machinery, or during any activity that requires you to be alert and focused. Wait for 1 hour after each treatment session before resuming any such activity.
- Do not use in the presence of electronic monitoring equipment (e.g., cardiac monitors, electrocardiogram (ECG) alarms).
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The CEFALY Enhanced and electrodes are designed for and should be used only in the forehead region.
- Do not use CEFALY Enhanced in the neck region.
- While CEFALY Enhanced’s design prevents this, do not use CEFALY Enhanced close to the thorax (chest region).
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Use CEFALY Enhanced only on normal, intact and clean skin.
- Do not use over open wounds.
- Do not use over skin eruptions.
- Do not use over swollen, infected or inflamed areas.
- Do not use over, or close to, cancerous lesions or skin abnormalities that could be cancerous.
- Use caution or avoid using CEFALY Enhanced if there has been any loss of feeling in the skin of your forehead or scalp until the normal feeling is resumed.
- Use CEFALY Enhanced only with the electrodes and accessories recommended by CEFALY Technology.
- Keep the CEFALY Enhanced out of the reach of children.
- Strangulation risk due to the length of the charging system cable.
- Suffocation risk in case of swallowing the electrode.
- If you have known allergies to acrylates, contact CEFALY Technology for hypoallergenic electrode alternatives.
Consult your healthcare provider before using the CEFALY Enhanced if you have Medication Overuse Headache, Chronic Tension-Type Headache, or Refractory Migraine, as the safety and effectiveness of the device have not been demonstrated for subjects with such conditions.
If the frequency of your headache is not reduced after 2 or 3 months of daily use of Program 2 (prevention), ask your doctor.
The long-term effects of chronic use of CEFALY Enhanced are unknown.
Migraines may indicate that you have a serious medical condition. You should have them checked by a doctor.
You should check with your doctor if you do not understand or if you are not sure whether any of the above Contraindications or Warnings apply to you or your condition.