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FDA Approves Sensus Pain Management Device for Over-the-counter Use

Updated: 8/14/21 8:00 amPublished: 7/20/14

Neurometrix Sensus

On July 9, NeuroMetrix announced that the FDA had granted clearance for over-the-counter use of the Sensus pain management system for diabetic peripheral neuropathy (DPN). The Sensus device uses transcutaneous electric nerve stimulation (TENS) to relieve the pain and numbness often experienced with DPN – a common complication that will affect an estimated 60-70% of all people with diabetes at some point in their lifetime.  In a statement, the company says that it expects a commercial launch of the over-the-counter Sensus sometime in 2015.

NeuroMetrix CEO Dr. Shai Gozani offered some exciting updates about what to expect: Generally speaking, there’s more flexibility in the design of over-the-counter devices than their prescription counterparts, and new features for the over-the-counter Sensus will include Bluetooth capability, interactivity with a smartphone that can help users optimize their pain relief, a more fashionable color scheme, and high-end materials similar to those used for sports bands, such as the Fitbit. Many people may be willing to give the Sensus a try, especially now that a doctor’s visit is not required to try out the device. While the Sensus is not the only TENS device available over the counter, it is designed specifically to combat DPN pain and its FDA clearance means it is the only approved device for this purpose; other devices are targeted to help with soreness or muscle ache. The over-the-counter price is likely to be around $400, similar to its prescription counterpart.

The first-generation Sensus was approved back in August 2012, and NeuroMetrix has steadily expanded treatment options for users since then. The FDA expanded its approval in 2013 to allow for the use of Sensus during sleep – a big step forward, given that most TENS devices can’t be used during sleep because of concerns with electrodes – and NeuroMetrix launched its second-generation Sensus in April. This newer, sleeker version is 20% thinner than the original and ties in with NeuroMetrix’s commitment to providing a discrete, easy-to-use treatment option for people looking for relief from DPN. –ARW

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