FDA Approves Medical Device to Treat Addiction Withdrawal Symptoms

In mid-November, the US Food and Drug Administration (FDA) granted approval to an electric stimulation device for people to use to help reduce opioid withdrawal symptoms. Called the NSS-2 Bridge, it is a short-term medical device that was originally designed as an adjunct to acupuncture for pain relief.

The hope is that with the NSS-2 Bridge, people who are addicted to opioids will be better equipped to get through the often-painful withdrawal phase, so they can pursue longer-term addiction treatment, such as methadone, naltrexone, or buprenorphine. It is often the pain and misery of withdrawal from opiates that keep people using them and prevents access to medication-assisted addiction treatment, which requires that users first clear their systems of opioids.

How Does the NSS-2 Bridge Device Work?

The NSS-2 Bridge device looks similar to a hearing aid. Users attach it behind their ear with two-sided tape. The device has a battery-powered chip that transmits electrical impulses through three electrodes that are connected to the device by tiny wire. The electrodes are placed on and around the ear.

The electrical impulses emitted by the device are designed to stimulate certain cranial nerves associated with relief of pain. In fact, the device was first marketed as a way to cope with pain. Patients wear the device for up to five days, which covers the worst of the physical withdrawal phase of detox.

What Do Proponents Say About It?

Supporters of the NSS-2 Bridge say that it has been shown to significantly reduce patient scores on the Clinical Opiate Withdrawal Scale, indicating that withdrawal symptoms are less severe. In the study of the device, the average self-reported score prior to using it was 20.1. Within 30 minutes of using the device, scores dropped an average of 31 percent. Overall, of the 73 patients participating in the study, 64 were able to make the transition to medication-assisted addiction treatment after five days. Some still had to take medications for lingering nausea and vomiting, but for the most part, users said their withdrawal periods were much more manageable when they wore the device.

What Do Critics Say About It?

The main criticism of the device is that it has not undergone randomized, controlled trials, where patients are randomly assigned to receive either an actual device or a fake device that looks identical but does not actually do anything. This type of study is designed to tease out placebo effects and give researchers a clearer picture of whether the device itself is easing opioid withdrawal symptoms.

The company that makes the devices sells them for around $600, but there are reports of drug treatment programs charging much more for them. Therefore, some addiction treatment specialists are skeptical about patients paying a high price for a device that has not undergone the type of clinical trials necessary to lock down whether or not it actually works.

The reason the FDA granted approval without there having been randomized controlled trials is that the bar for approval of medical devices (which the NSS-2 Bridge is considered) is lower than that for approval of drugs. It is considered a low-risk device, meaning that whether or not it actually works, there is minimal risk to the person using it.

Addiction treatment is essential for recovery from opioid addiction, and the withdrawal phase of detox is often difficult for patients. Though only one study of the NSS-2 Bridge has been completed, it showed promising results. More will be known about its true effectiveness only after randomized, controlled studies of the device are conducted. If you are struggling with opioid addiction, we encourage you to contact us at any time. Addiction treatment is effective and can help you get your life back. We want to help.