While perusing mental-health related websites, I often see advertisements for a device called the “Fisher Wallace Stimulator”. There are few things that make me angrier than companies that make pseudo-science “medical devices” looking to take advantage of desperate and non-scientifically minded people. This set off my bullshit detector, so I decided to do some reading.

I’m not going to validate their product with a link, but it’s easy enough to look up. As it turns out, it’s a class of device known as CES or Cranio Electro Stimulation

What they tell you in their literature is that their device treats depression and anxiety and improves sleep using “proprietary waveforms to gently stimulate the brain to produce serotonin and other neurochemicals responsible for healthy mood and sleep.” WTF are proprietary waveforms?

They very proudly mention that they’re FDA cleared on their website, prominently and repeatedly. Including in their FAQ where they use it to say that their device is “regulated by the FDA”. Sounds so legit, right?

As it turns out being FDA cleared really only means that they’ve demonstrated that it’s “substantially equivalent” to devices already on the market, it doesn’t imply the sort of endorsement as they seem to infer. In this case, it’s piggybacking on the classification of “depth electrode” which is used for things like monitoring seizures. This really only tells you that based on similar devices, it probably won’t harm you.

They also tout all the “scientific evidence” they have, including ONE double-blind placebo controlled study. . Because of the placebo effect and other biases, double-blind placebo controlled studies are the only studies that carry any weight in the scientific community.

The thing about pseudo-science medical device manufacturers, is that they count on you not reading or understanding their studies. The study they cited (and funded) was a “pilot study” using their device to treat Bipolar II disorder. A pilot study is a small study that really only establishes the basis to do a larger study (which was never done). This study had 16 participants of which only 7 people used the device blinded. This is so small that it only takes a statistical anomaly to give the desired result, and if they didn’t like the results, they could just not have published them.

The study concluded that “In contrast to self-report measures, clinician-rated HAM-D scores showed significant improvement for both active and sham groups whereas the decrease of BDI scores was associated with the active CES treatment only.” Luckily they had multiple metrics to choose from so they could highlight the one that told the story they wanted.

There’s another study that you won’t find on their website.
This study ,while double the size of the Wallace Fisher study, was still very small with 30 participants. It concluded that when comparing a CES device (ie The Fisher Wallace device) and a Sham (ie placebo device) no significant differences were observed.

While Fisher Wallace was only established in 2007, CES devices have been around since 1914, which gives so much time for credible research to have been done, but I strongly suspect that good science would have harmful effects on the marketing of these devices.

While I’m sure there’s some overhead in dealing with regulatory industries, a small aa battery-powered device that emits a small amount of alternating current over three frequencies probably doesn’t cost more than a few dollars to manufacture at scale, so selling these things for $700 is absurd.

Though really these things are a waste of money at any price.

Being a fan of vintage audio, I’m disappointed to see that Avery Fisher’s son (of Fisher Electronic’s fame) is involved in such a lame money grab.