The FDA has given a regulatory green light to the first device that reduces opioid withdrawal symptoms.
The NSS-2 Bridge from Innovative Health Solutions, a Versailles, Indiana firm, is stuck to the skin behind the ear and relies on four electrodes that are attached around the ear. The electrodes are used to deliver electric current to a set of occipital and cranial nerves (V, VII, IX, and X), hopefully helping addicts to avoid agitation, insomnia, and other symptoms of kicking opioids. The same device was approved by the FDA three years ago for use in acupuncture and the current approval went under the de novo review process intended for uniquely new low to moderate risk technologies.
The FDA based its decision on a study involving 73 patients with an average clinical opiate withdrawal scale (COWS) score of 20.1.