I don't know if the age discrepancy is an error in the press release or if the FDA is taking a conservative stance and only approving it for adults at this time.
Another discrepancy I noticed (which IMO is material) is that the company website claims...
emphasis mine
...while the 67 patient study showed:
For us (migraine patients),
any improvement is good news, but if any claim is/can be brought into question, that casts doubt/raises questions about any/all claims.
I also noted that...
Quote:
The patient satisfaction study showed that a little more than 53 percent of patients were satisfied with Cefaly treatment and willing to buy the device for continued use.
Ibid.
|
So while
about half were satisfied, about half
weren't satisfied (i.e. convinced).
My take on it at this time is... A decent TENS unit can be gotten for <$100, with a lot more versatility than Cefaly @ ~$250-$400. I'm sure the high pricetag is due to patent and the sellers hoping insurance will pick up the tab. From what I know about electronics, a fair/reasonable (and still profitable) price would be more like $25-$40, which I think more people would be willing to take a flyer on, on basically a 50/50 proposition. Many will wait until someone figures out how to use a regular TENS unit for the same effect, or until TENS mfrs. include migraine settings/options on their units (which I'm guessing won't be very long).
Doc