FDA Clears Electronic Earpiece to Block Opioid Withdrawal Symptoms

A 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. […]

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.” […]

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