Tivic Health, based outside of San Francisco, won FDA clearance for its ClearUP device for treating allergy-related sinus pain. ClearUP is used to deliver electric current to the nose, the user sliding the device along the outside of the nasal passages while therapy is administered. The device delivers only a small electric current using a proprietary signal pattern that has shown to be effective in clinical practice.
There’s only one button to push and the device can deliver three levels of therapy intensity, depending on the patient’s needs. It only takes about five minutes to use the device and it helps the user to go through the treatment points accurately.
The ClearUP should be available for purchase toward the middle of this year and is expected to cost $149.
Here’s a bit about the study that led to the clearance, according to Tivic Health:
As part of its FDA submission, Tivic Health conducted a double-blind, randomized control trial with 71 patients with sinuspain, to evaluate the effect of microcurrent waveforms on sinus pain. In this pivotal trial, it was demonstrated that after one treatment with ClearUP, three out of four users achieved sinus pain relief (74 percent). In addition, 82 percent of those who used ClearUP preferred it over their current treatment(s). The results of this trial, conducted in May 2018 at a top-tier U.S. research science center, were presented at the American Rhinologic Society Annual Meeting in October 2018.
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