Buyer beware I'm suspicious of a type of device I'm seeing frequently on crowdfunding sites, and in this article, I'll tell you why you should be too. I like to keep up with the products popping up on crowdfunding sites. I used to read a daily email from Indiegogo every morning. It contained descriptions of popular crowdfunded gadgets on its site. (I've since switched to receiving a weekly email,) One of the trends I identified is the many crowdfunded devices that are based on TENS technology and are marketed for specific kinds of pain and even for weight loss. In most cases, the makers don't disclose that these devices are based on TENS technology (or that they may even be no more than a TENS device in a pretty pink casing). Before we get into what a TENS device is, here are a few reasons I'm suspicious of these crowdfunded devices:
What is a TENS device? "TENS" stands for transcutaneous electrical nerve stimulation. A TENS device sends an electrical pulse to a pad that you stick to your skin wherever on your body you want to administer the pulse. You might feel a sensation of buzzing or heat where you put the pad. In theory TENS devices help alleviate pain by generating an electrical pulse that disrupts your nerves' pain signals on their journey to brain. TENS devices have been studied for all sorts of other uses as well. But do they work? Consulting the Cochrane Collaboration is a good way to find out. Cochrane's mission is to audit and summarize scientific studies in order to help people make more informed healthcare choices. Cochrane has reported on many uses of TENS devices. Examples include alleviating neck pain, fibromyalgia, and dementia. In most cases, Cochrane has concluded that the evidence is insufficient to determine whether TENS devices have any effect. But if you want to try a TENS device for yourself, I wouldn't discourage you from buying one for $35 and giving it a try. If it doesn't work, you'd only be out $35. However, I would encourage you to think twice about spending more on a crowdfunded device. How to spot a potential TENS-based device To spot a potential TENS-based device on a crowdfunding website, determine if the device has pads that attach to the skin, with wires that go from the pads to an electronic controller. Not all TENS-based devices look like that, but most do. The PAT device The Livia device Also read the explanation of how the device is claimed to function. If the device is used for nerve stimulation or delivers an electrical pulse to the body, it may be a TENS-based device. Lastly try to determine how quickly and in what way the device acquired FDA clearance. A TENS-based device will receive quick FDA clearance because all a company has to prove is that its device is substantially equivalent to other devices on the market (in this case, a TENS device). Write the company to ask if it obtained FDA clearance via the FDA's 510(k) program, which allows substantially equivalent devices to obtain more rapid clearance. If the device obtained FDA clearance that way, it's essentially a TENS device because, if it were substantially different from a TENS device, the FDA wouldn't grant it 510(k) clearance and would put it through the more rigorous approval process required for a brand-new technology. I strongly advise you against crowdfunding a medical device that has not received FDA approval. Not only is it illegal for a company to take orders for such a device, but if a product is truly a new technology, it might not make it through the rigorous FDA approval process, which can take years, and you might never get your money back if the company goes bankrupt. Examples of suspected devices The are some examples of crowdfunded devices that I believe are TENS-based devices:
Livia Priced at $153 is the Livia device, marketed for alleviating the pain of menstrual cramps, In a VOX interview, the company's founder, Chen Nachum, "explained that the key to the device is TENS." However, on Facebook, a company representative said the Livia device isn't a TENS device and that it is "far more effective" than a TENS device. So is it or isn't it a TENS device, Livia? And where's your evidence that it's "far more effective"? Not only has Livia not performed a comparative study that proves its device is more effective than a TENS device, but the Livia device is also a low-frequency TENS device. High-frequency TENS devices may be effective at easing the pain of menstrual cramps, but there's no evidence to suggest that low-frequency ones may be effective. MODIUS Priced at $499, the MODIUS device is supposed to stimulate the vestibular nerve, which in theory could stimulate weight loss. Is the MODIUS device a TENS device? This is the company's response to that question on its website: While these devices have many things in common, the properties of the electrical pulses that Modius delivers are very different from that of a TENS. We would in no way recommend using a TENS (Transcutaneous Electrical Nerve Stimulation) device for vestibular nerve stimulation. First of all, electrical pulses are electrical pulses. They can vary in strength or frequency (most TENS units give you the option to adjust the pulse), but unless MODIUS has discovered a new type of electricity on Earth, the "properties" of the MODIUS device's electrical pulses can be no different from the "properties" of a TENS device's. Second, the company's next sentence makes me laugh. Of course MODIUS would in no way recommend that you use another device. That wouldn't exactly be a smart business move on the company's part, now, would it? Aside from the steep price point and the company's dubious answer to the question of whether the device is a TENS device, what bothers me most about this product is the lack of transparency around the so-called scientific evidence. The company has a section called The Science on its website, but it lacks any links to published, peer-reviewed journal articles. Was the evidence published or peer reviewed? How large were the studies the company mentions? For all we know, the studies included 30 people. How were the studies performed? Was the methodology sound? (If it wasn't, that completely negates the results.) And lastly, we don't know the long-term effects of prolonged vestibular nerve stimulation on a large population, but I can find no place on the website where the company mentions that this new weight-loss methodology may have negative side effects that we haven't discovered yet. PAT Of all the devices I listed, I give a little more credit to the PAT device for pain relief—but just a little. First of all, the description of the device mentions and even explains TENS technology, so good for the company for being transparent. Then the company explains that its device uses MENS technology (microcurrent electrical nerve stimulation) instead of TENS technology. The company also has peer-reviewed articles in the Research section on its website (so bravo in that regard). Unfortunately the research isn't very helpful if you'd like to know how MENS stacks up against TENS and if the PAT device might be worth the $95. At this time, there are no comparative studies of TENS versus MENS on the website, and in a quick web search, I didn't find any such studies. So making an informed decision about purchasing the PAT device would still be difficult for a consumer. And the marketing of this device is as over-the-top as the marketing of similar devices. It's apparently "revolutionary," "life changing," and "mimics your body’s natural current to alleviate your pain." To that last claim, I say in theory, people. In theory.
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