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In all 100,000 units circulating, there has never been a significant adverse reaction. Mostly, the only problem reported has been sensitivity at the skin surface where the sponges contact the skin, effectively cured by moving the sponges a bit for each treatment, or worst case, in my population, using gel electrodes instead of sponges, not an authorized modification, but in the few cases the best solution, and the device had the desired response.
Nothing works for everyone. No antidepressant, no blood pressure pill, no pain killer, never gives 100% of patients the desired or expected benefit, though often produces side effects, especially when the "More is better" approach is tried.
The FW stimulator also is not 100% effective for everyone, though the studies have consistently scored it in the 80% effective range for reducing insomnia, fatigue, anxiety, and depression. Better than any pharmacological approach for the same indications. Since the same chemistry in the brain is involved in chronic pain syndromes, it has been beneficial to that population as well, though anything that challenges Big Pharma is going to hit major resistance at the FDA level, since this first well thought out technology, the first successful "electroceutical" rather than "pharmaceutical" approach to these conditions, was rallied by every lobbyist representing companies currently supplying the sedatives, antidepressants, anti-anxiety medications would truly feel a dent in their widespread monopoly over these common problems. This is my experience not only with the Fisher Wallace device, but in getting FDA approval for very safe devices in other areas of medicine totally unrelated to the CES (Cranial Electrostimulation) devices.
Over and above the FW guarantee for refund, our office offers a nearly infinite guarantee of support and when beyond the time interval for the FW refund, even as far as a year or more, we've supported repair, refund, and additional training. In 20+ years of using and prescribing for permanent issue these devices, I'm aware of only two utter failures, refunded readily 100% and put to use as clinical trial machines to decide if a purchase is worthy, of course using fresh wires, electrode cups and batteries.
The cautionary announcement recently broadcase to all users and prescribers related to incorrectly installing the batteries to create an overheating situation has never been seen in my office or any of my patients. Before releasing any device for home use, my patients receive several sessions of training, including that they confirm immediately, before even closing the battery compartment cover, that the "green light" is flashing in the normal way, and if not, how to troubleshoot the problem, since incorrect battery installation is the most common cause, but rarely a defective battery, incorrect placement of the battery, internal breakage of the internal electronics (twice in 20 years!), is the cause. If in doubt, their unit is replaced at my expense, even after a year or two of use, and if that unit is easily repaired, its put to use as a trial stimulator after going through routine testing to assure the original 4 part microcurrent waveform is correctly delivered. But even in "seizure prone" patients, we've never had a problem using this approach. After practicing 35 years+ in my specialty, prescribing the FW100 and for years, its predecessor, I can honestly say this technology has helped countless patients for whom nothing else was effective.
Reading the grim reports in the "complaints" websites, like BBB and Ripoff or Reddit, none of the cited problems has been our experience, since we bulk purchase units and issue them out of our office to patients that stand to benefit from this approach. The bibliography in peer reviewed literature reveals hundreds of worldwide articles surrounding the use of this device and of CES in general in a multitude of settings for a wide range of individual problems.
I do not represent Fisher Wallace, nor have I any corporate interest, not a shareholder, my relationship has been simply someone trained in treating the conditions it's been effective against. There are several CES devices on the market now, some appear promising, others we've tried to integrate into the clinic but the response using them falls well short of what we observe directly, treating these problems. The FW units are in a separate class, the percentage of satisfied patients reporting "Very good" or "Excellent" response (on a scale 0-5, with 5 being Excellent and Zero meaning "No benefit"), has been around 80%, which is far better than pharmaceutical or physical /interactive approaches for the same issues.
Interestingly, since it takes several weeks of twice daily use to assess one's clinical response, the two units returned for refund to our office, on inspection, suggested the device was used only a few times rather than the twice daily x 6 weeks trial, in both cases from patients that were already skeptical of the approach, more interested in "more pills, stronger pills" than giving an authentic trial to the electroceutical.
This is only our personal experience with the device and the response observed, we have no administrative, monetary, or any other relationship to the manufacturer and do not represent any right of input or comments related to others' experience with the FW company or its affiliates. Our opinions and reported experience with the device are strictly our own. There are multiple "Lay literature" articles in venues as diverse as "Elle" magazine or "The Wall Street Journal" or Scientific American, dating back from current content to similar approaches 40 years ago. It is erroneous to state "There is no evidence these devices have a scientifically researched basis that they work", when any simple search will pull up dozens and dozens of citations in US and International literature. Just one clinic's opinion, but this technology has changed lives when all prior approaches failed.

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Replies to "In all 100,000 units circulating, there has never been a significant adverse reaction. Mostly, the only..."

Sorry, noticed a typo......lobbyists rallied (against) this first electroceutical. (Not "for") as the sentence incorrectly implied.