Question: I read in the newspaper that a jail in Virginia is using a “FDA-cleared” device that serves as a nerve stimulator worn around the ear that sends electrical impulses into one's brain to reduce opioid withdrawal symptoms. I note that the BJA/NIC withdrawal guidelines don’t mention this. What does the research reveal on the use of such devices?
Answer: The device you read about is a Masimo “Bridge” device. While it is approved by the FDA as a device for withdrawal symptoms, it is not approved for withdrawal management. There are only a few studies that evaluated Bridge devices. Dr. Jacques Chelly and colleagues at the University of Pittsburgh investigated the utility of Masimo Bridge®, an auricular field nerve stimulator, in reducing postoperative opioid requirements in patients undergoing kidney donor surgery. They found that use of Bridge was associated with significant reductions in opioid use at 24 hours and pain at 24 and 48 hours after surgery, concluding that Bridge “may represent a complementary approach to minimize the postoperative requirement for opioid.” (Monroe AL, Planinsic RM, Tevar A, Chelly JE. Auricular field nerve stimulation using the NSS-2 Bridge® device as an alternative to opioids following kidney donor surgery. J Pain Relief. 2021. 10:365)
Another study of only 16 adult patients eighteen or older divided into two groups found the mean Clinical Opioid Withdrawal Scale (COWS) decreased from 17.125 to 5.75 at 30 minutes for those on Bridge compared to a reduction of 16.25 to 12.875 at 30 minutes for those without Bridge..(Matta, C. et al. (April 2023). Prospective study of Masimo NSS-2 Bridge: as a non-pharmacological treatment for acute opioid withdrawal symptoms, Pain Management Nursing, 24 (2), 338-239).
The FDA standards for approval of medications is different than that for FDA clearances of “devices.”
For opioid withdrawal management, we recommend you look at the BJA/NIV guidelines, https://www.cossup.org/Content/Documents/JailResources/Guidelines_for_Managing_Substance_Withdrawal_in_Jails_6-6-23_508.pdf.
Incidentally, the jail that Masimo identified as the first in the nation using its device for opioid withdrawal reported in May that a 34-year-old woman died six days after being admitted. The sheriff confirmed she was wearing a Masimo Bridge device prior to her death. It was removed the day before she died. A spokesperson from the company told the media that it will be investigating the death.