Some Brain Stimulation Wearables Make False Claims. Alpha-Stim is Backed by Science and the FDA

By now, you’ve likely heard the term “wearable technology.” It’s a booming trend in the health and wellness industry, with devices claiming to do everything from improving your sleep to correcting your posture to relieving your pain. More recently, brain stimulation wearables have hit the market as well. Their claims are exciting – less stress, better focus, enhanced creativity, improved mood – but are they backed by science? And more importantly, are these devices safe and effective?

It is the duty of the FDA to protect consumers from dangerous products. You’ll often see a disclaimer on supplements alerting you to a health claim that “has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.” The FDA also monitors medical devices, issuing recalls for dangerous products and gathering information on adverse effects. In short, the FDA exists to safeguard consumers from false claims and ill effects that might otherwise be ignored or understated by manufacturers who care only about profits.

FDA disclaimer

This FDA disclaimer appears on products that have not been proven to be safe and effective.

But some manufacturers are finding loopholes. According to a recent article in STAT, some companies are pushing the envelope with their claims. They might mention a condition in their marketing materials without explicitly saying their product can impact it.” These companies are taking “a cavalier approach [to] how far they can make particular claims before they jump into a pool of transgression,” says James Giordano, a neurologist and neuroethicist at Georgetown University Medical Center. “It’s the wink-wink, nudge-nudge marketing approach.”

Nine of the brain-stimulating medical devices analyzed by neurologists for a recent paper made claims about specific health conditions such as PTSD, ALS, and chronic pain. Says Judy Illes, a neurologist and neuroethics professor at the University of British Columbia, They really are reaching to a population of people that may be vulnerable, such as people [who have] depression, anxiety, or attention disorders.” These people are suffering, and want desperately to find relief – so much so that they may disregard the lack of FDA approval or supporting research in the hopes of feeling better.

A woman uses Alpha-Stim earclips

Alpha-Stim is not only fast, safe, and effective, but it is FDA cleared.

Alpha-Stim® is one cranial electrotherapy stimulation (CES) device that is, in fact, both effective and FDA cleared. It is clinically proven to be a fast, safe, and effective treatment for insomnia and pain. Alpha-Stim has no need for marketing magic tricks or legal loopholes – its effectiveness is backed by more than 100 clinical research studies.

And this is what sets Alpha-Stim apart from the rest. As the STAT article reveals, “marketing materials for just eight of the 41 devices examined included a link to a relevant, peer-reviewed research paper. Of the rest, 29 had links to general research or explanations of scientific concepts that weren’t specific to their products.”

Vague research citations are not enough; one link to a single relevant paper is insufficient. Alpha-Stim has been proven time and time again over nearly four decades to elicit indisputably positive results. It is trusted and relied upon by both practitioners and patients; civilians and Service Members. Alpha-Stim is a key part of the U.S. Navy Pain Management Program and the alternative medicine center at William Beaumont Army Medical Center, and is available at more than half of the nation’s VAs.

No one should experiment with unregulated brain stimulators; no one should bargain-shop for this type of product. Marketing professionals are skilled at appealing to vulnerable consumers – they know how to make an ineffective and unproven product seem like the answer to all of your problems. But Alpha-Stim is backed by 38 years of research and boasts an excellent safety profile. It is FDA cleared and backs up its claims with evidence.

Don’t let fancy marketing sweep you away. You have only one brain in this lifetime – why subject it to treatments and devices that have not been proven safe and effective?

About Alpha-Stim

Alpha-Stim® is an FDA cleared, handheld medical device that has been proven time and again to effectively treat acute, post traumatic, and chronic pain, as well as insomnia. Alpha-Stim uses cranial electrotherapy stimulation (CES), delivered through a patented waveform via two earclip electrodes, to treat insomnia. Microcurrent electrical therapy (MET) delivers pain relief directly to the source of discomfort via two handheld Smart Probes.

The safety and effectiveness of Alpha-Stim is backed by over 100 independent clinical research studies. Unlike with medications, there is no risk of addiction or lasting side effects.

Alpha-Stim is available by prescription in the United States and over-the-counter in other countries. Get started today!