FDA approves wearable device for opioid withdrawal symptom treatment device

By Dave Muoio
02:29 pm

Credit: FDA.gov

DyAnsys, a medical device company specializing in the autonomic nervous system, announced this week that it has received FDA approval for a wearable auricular neurostimulation device designed to treat symptoms of opioid withdrawal.

The device, called Drug Relief, is now available to providers in the US, and is distributed in the EU by the DyAnsys’ European branch.

"This device offers hope to those who are suffering from opioid addiction," DyAnsys CEO Srini Nageshwar said in a statement. "We are in a full-blown crisis and we need non-narcotic options and alternatives like this that can make a significant difference for individual patients and their families.”

Drug Relief is a non-addictive treatment intended to be worn over a period of 120 hours. The device is worn on the head with needles inserted at three specific points around the ear to facilitate electrical stimulation, according to the 510(k) application. The treatment allows wearers to comfortably receive the non-addictive treatment and, according to DyAnsys, experience a reduction in drug withdrawal symptoms within 30 to 60 minutes of beginning the treatment.

Designed to assist in detoxification, the first step in addiction rehabilitation, Drug Relief “allows for a minimized use of opioid agonist treatment and in some cases may eliminate it,” according to DyAnsys’ website.

DyAnsys’ device is much like Innovative Health Solutions’ NSS-2 Bridge, another stimulation device that was initially cleared in 2014 for acupuncture but last year was also granted marketing authorization as an aid for opioid withdrawal symptoms through the de novo premarket review pathway.

With the US’ opioid epidemic showing few signs of abating, the FDA has been on the lookout for more digital alternatives to addictive drug treatments. Just a few weeks ago, for instance, the agency announced an innovation challenge that tasks developers to build new devices, tests, apps, and other technologies that address opioid misuse.

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