- Federal regulators have approved an mHealth wearable that fits around the ear and is designed to help people going through opioid withdrawal.
The U.S. Food and Drug Administration’s 510(k) premarket approval of the Drug Relief aural neurostimulator, developed by DyAnsys, puts two similar mobile health devices on the US market for patients dealing with opioid addictions and their care teams. Last November, the FDA granted de novo premarket review approval to the NSS-2 Bridge, developed by Innovative Health Solutions.
Like the NSS-2 Bridge, the Drug Relief wearable is a percutaneous electrical nerve field stimulator, emitting electrical pulses through tiny needles into the nerves around the ear to provide relief from symptoms associated with opioid withdrawal, including cravings, anxiety, agitation and depression.
The device can be worn up to five days at a time, and company officials report that symptoms have eased within an hour of wearing the device.
According to company officials, the device eases the process of detoxification, the first step in a drug rehabilitation program, by easing symptoms while opioids are cleared from the patient's system. It’s often used during the first stages of withdrawal, and is a necessary first step before beginning medication-assisted therapy.
"This device offers hope to those who are suffering from opioid addiction," Srini Nageshwar, chief executive officer of the California-based company, said in a press release. "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."
The FDA’s action marks a continuing effort to bring opioid addiction treatments to market that focus on digital therapeutics, rather than the prescription of medications.
It also illustrates the attention paid to the nation’s opioid abuse epidemic. Congress is contemplating dozens of bills aimed at tackling this epidemic through improved healthcare technology, including telehealth and telemedicine.