FDA Approves Clearup Sinus Pain Relief For Congestion For Co
The U.S. FDA has expanded the indication for use of ClearUP Sinus Pain Relief to include congestion from allergies, the flu, and the common cold. This is in addition to FDA clearance for treating allergy-related sinus pain caused by seasonal and year-round allergies. A small handheld device, ClearUP is a non-invasive and drug-free treatment that uses gentle microcurrent to relieve sinus and nasal congestion and allergy-related sinus pain.

Clinical studies showed that ClearUP was effective in treating moderate to severe congestion. Study subjects with moderate to severe congestion reported on average 35% reduction in congestion symptoms 10 minutes after a ClearUP treatment and this was significantly greater than placebo. After four weeks of regular use, subjects reported an average 44% reduction in congestion symptoms.

"We are proud to be the first and look forward to reaching millions without drugs or chemicals," says Tivic Health CEO. Microcurrent for congestion relief was never before granted by the FDA. As the bioelectronics industry continues to invest in both basic science and clinical research, these devices will become more effective.

ClearUP stimulates the trigeminal nerve, which is responsible for sensing pain and pressure of the face. It also stimulates sympathetic fibers, which can induce vasoconstriction and reduced swelling. Together, it provides rapid relief of sinus pain and congestion without the side effects of drugs used for these symptoms. "This is a game-changing new product," says Subinoy Das, MD, chief medical officer at Tivic Health.