The U.S Food and Drug Administration (FDA) has cleared the CEFALY medical device as an over-the-counter (OTC) product for the acute and preventative treatment of migraine headaches in adults 18 years of age and older. CEFALY can be purchased without a prescription at www.cefaly.com.
CEFALY becomes the first dual-purpose, external Trigeminal Nerve Stimulator (eTNS) device for migraine headaches available OTC in the United States. The OTC designation means the FDA has confirmed that CEFALY is safe and effective for use by members of the general public who have been diagnosed with migraine by a physician.
Multiple clinical trials and many years of consumer use have shown that CEFALY DUAL has few side effects, which have been demonstrated to be minor and fully reversible once use of the device ends.
What Does CEFALY DUAL’s OTC Designation Mean for You?
If You Already Have a Prescription for Your CEFALY DUAL:
If you’re currently treating your migraine with CEFALY, you don’t have to do anything. The CEFALY device has not changed now that it’s available over the counter. Continue using your CEFALY device as before, and consult your healthcare provider if you have any questions.
If You’ve Never Used CEFALY DUAL:
Now’s the time to try this clinically proven, drug-free, non-invasive migraine treatment option! The CEFALY device simply connects to an adhesive patented electrode worn on the forehead. It generates a treatment signal that’s transmitted through the electrode to modify pain sensation in the Trigeminal nerve.
CEFALY is a single device with two treatment options: Program 1, a 60-minute ACUTE setting that provides pain relief at the onset of a migraine, and Program 2, a 20-minute PREVENT setting for daily use to help prevent future episodes.
You no longer need a prescription to try CEFALY. Purchase CEFALY online and try it risk-free. If you’re not satisfied with your results, you may return the device within 60 calendar days of your product delivery date for a refund.
How Do I Know CEFALY DUAL Is Right For Me?
CEFALY is intended 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.
If you’ve never been diagnosed with migraine, or you’re not sure what type of migraine you have (episodic, chronic, refractory, etc.), you should consult your healthcare provider before trying CEFALY.
Do not use CEFALY DUAL 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.
How Can I Purchase CEFALY?
You can purchase your CEFALY DUAL migraine treatment kit and replacement electrodes directly from CEFALY Technology online.
Try CEFALY for 90 days, and if you are not satisfied with the product, send it back for a full refund. We’ll even email you a PrePaid FedEx shipping label, so you don’t have to pay for the return shipping.
Although CEFALY is not covered by insurance, consumers can use Health Savings Account (HSA), Flexible Spending Account (FSA) funds or finance their purchase with Affirm for as little as $36 per month upon qualifying. In addition, CEFALY Technology is honored to partner with VA Hospitals across the country to offer United States Veterans access to drug-free, non-invasive migraine treatment fully covered under their VA benefits. Learn more about CEFALY for Veterans at https://www.cefaly.com/veterans-migraine-relief.
If you have any questions about CEFALY, please contact us! Our customer service representatives are ready to answer questions about how CEFALY works and how to get the best results from your treatment.
