Cefaly is approved by the FDA for sale in the US.

Cefaly, a TENS unit specifically developed for the treatment of migraine headaches, was cleared for sale in the US. It was available last year for a short time on Amazon.com, but because it was not yet approved, it was taken off the market. I mentioned in my previous post that TENS units have been in use for muscle and nerve pain for decades. TENS has good proof of efficacy in musculo-skeletal pain, but studies in migraines have been relatively small. Even Cefaly was tested in only 67 migraine patients. So, while it is not definitely proven effective, TENS is safe and is worth a try if usual treatments do not help. Cefaly is easy to use but it is expected to cost around $300. The old-fashioned TENS units are not as convenient to use, but sell for as little as $50. Both Cefaly and regular TENS units require doctor’s prescription, although many websites sell TENS units without one. These devices are usually powered by a 9 volt battery and, unless you have a pacemaker or another electrical device in your body, the risk of side effects is low.