NSS-2 Bridge Device Approved By FDA To Reduce Opioid Withdrawal Symptoms
A device indicated for the treatment of opioid withdrawal symptoms, called the NSS-2 Bridge, has been approved by the Food & Drug Administration. The device, a percutaneous nerve field stimulator, is meant to reduce withdrawal symptoms during opioid addiction recovery, according to manufacturer Innovative Health Solutions.
The battery-powered device, also known as the “Bridge,” is about the size of a half-dollar and is placed behind the person’s ear using double-sided tape. Three electrodes connected to the Bridge by wires are placed on and around the ear, and the device then sends electrical impulses to the cranial nerve. In fact, the Bridge looks a lot like a large hearing aid.
FDA Commissioner Scott Gottlieb announced in the approval in a press release, noting features of the device and why it was approved. Gottlieb said that the FDA was prepared to discover new ways of battling the ongoing opioid crisis. He stated that better medications and innovative new devices would need to be developed, in addition to new approaches to pain management that do not cause addiction.
According to the press release, the device was approved based on the findings of research that included more than 70 patients. That study, however, did not include a control group. Critics of the device and the study say that you can’t say for sure that it works without also testing a placebo device in the research.
The Bridge is meant to be used during the acute stage of opioid withdrawal, which most often lasts less than seven days. Patients can use the device for five days for the mitigation of common withdrawal symptoms such as upset stomach, sweating, agitation, sleep disturbances, and joint pain.
It cannot be used with pacemakers, psoriasis, or hemophilia, and will be available by prescription only.
~ G. Nathalee Serrels, M.A., Psychology