FDA clears electronic earpiece to block opioid withdrawal symptoms

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wearable device claiming to block the pain of opioid withdrawal has been cleared by the Food and Drug Administration under an expedited review process for medical devices. However, patient safety advocates note that the device has limited evidence for its effectiveness.

The NSS-2 Bridge is a device that attaches to the ear and transmits small electrical pulses through four cranial nerves. It’s marketed by Indiana-based Innovative Health Solutions, and was cleared to treat chronic and acute pain in 2014. IHS can now market the device as one that reduces symptoms of opioid withdrawal including nausea, anxiety, and aches.

Since 2014, doctors from Alaska to Florida have begun using the device off-label for people addicted to opioids. Patients were being charged between $600 and $1,500 out of pocket to have it included as part of a detox process within treatment programs. Doctors have said the device helps those patients avoid relapsing before starting a treatment regimen of monthly naltrexone shots.

“Given the scope of the epidemic of opioid addiction, we need to find innovative new ways to help those currently addicted live lives of sobriety with the assistance of medically assisted treatment,” FDA Commissioner Scott Gottlieb said in a statement. “There are three approved drugs for helping treat opioid addiction. While we continue to pursue better medicines for the treatment of opioid use disorder, we also need to look to devices that can assist in this therapy.”

Evidence for the Bridge, though, remains limited, and it has never been tested in a controlled clinical trial. In its approval, the FDA cited a study of 73 patients that showed that 88 percent had “successfully transitioned” to medication-assisted treatment after having the device attached to their ear for five days.

“We don’t know how often [the Bridge] works, and what’s going to happen to patients for whom it doesn’t work,” Jack Mitchell, former director of the FDA’s Office of Scientific Investigations, previously told STAT. “That’s going to be tough to tell without any comparative trials. You just don’t know.”

Dr. Lance Dodes, a retired professor at Harvard Medical School who has written several books about addiction, had previously reviewed the study for STAT that was submitted to the FDA. He told STAT that “if they’d been more patient, done the pilot, then a full study with a control group, we’d have results.

“This pilot study by itself doesn’t prove efficacy,” he said.

One of the co-authors of the study, Dr. Arturo Taca, an addiction doctor who pioneered the device’s use, has a financial incentive to promote the device. Taca has a patent pending for a treatment program that includes the Bridge and naltrexone; the manufacturer of the latter, Alkermes, has paid him at least $164,000 for consulting, meals, travel, and speaking engagements since 2013. Taca did not immediately respond to request for comment on the approval.

The Bridge is the latest device to pass through FDA’s expedited review process for devices that are judged low-to-moderate risk.

Brian Carrico, the president of Innovative Health Solutions, previously told STAT he’s begun to talk with Indiana University Health about a possible controlled study.

“I’ve never seen it not work for an opioid patient,” Carrico previously told STAT. “For us to sit on this technology, from a humanity standpoint, is incredibly irresponsible.”