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The over-the-counter device can be used during sleep.
Waltham, Mass.-based NeuroMetrix Inc. has begun the full commercial launch of Quell, an over-the-counter chronic pain relief device. This wearable device uses NeuroMetrix’s non-invasive nerve stimulation technology to provide drug-free chronic pain relief. It is designed for people with painful diabetic neuropathy, sciatica, osteoarthritis and fibromyalgia, among other conditions. “There are an estimated 100 million people living with chronic pain in the U.S., and many are not experiencing adequate relief with currently available treatment options or want to avoid opioid medications that may incur added risk and side effects,” said Paul Christo, M.D., pain specialist and host of the nationally syndicated radio show Aches and Gains. “I am excited by the possibilities non-medication options like wearable transcutaneous electrical nerve stimulation (TENS) devices can provide people living with chronic pain, particularly because they do not carry a risk of opioid dependence and side effects, and do not require invasive surgeries.” Worn just below the knee, Quell is designed to calibrate automatically for every user, determining the ideal therapeutic intensity of electrical nerve stimulation to provide optimal pain relief. Quell triggers a central inhibition effect that “turns down the volume” of pain signals by stimulating the sensory nerves, which causes the brain to release endogenous opioids that ultimately reduce pain signal transmission. Quell provides widespread pain relief and is more than twice as strong as ordinary TENS devices, which typically provide only localized pain relief. A recent study conducted by the National Sleep Foundation found that nearly one in four people living with chronic pain reported having poor or very poor sleep quality. Limitations of traditional transcutaneous nerve stimulation devices leave chronic pain sufferers without relief at night; Quell is the only FDA cleared device of its kind approved for use while sleeping. A built-in accelerometer detects when a person is sleeping and then automatically adjusts the level of therapy so it will not disturb their sleep. Quell received 510(k) U.S. Food and Drug Administration (FDA) clearance in July 2014 for chronic pain relief and use during nighttime sleep without a prescription. The FDA submission for Quell was based on its predecessor, Sensus, which has provided over 2.5 million hours of therapy to chronic pain sufferers throughout the United States. Quell does not have any side effects, but users may experience mild skin irritation after prolonged use. NeuroMetrix develops wearable medical technology and point-of-care tests that help patients and physicians better manage chronic pain, nerve diseases and sleep disorders.
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