First-in-Class OTC Bioelectronic Device for Sinus Pain Gets FDA-Cleared
A double-blind, randomized controlled trial evaluated the effect of microcurrent waveforms on sinus pain.
Tivic Health Systems announced that ClearUP Sinus Pain Relief has been cleared by the Food and Drug Administration (FDA) for the treatment of sinus pain due to allergic rhinitis in adults aged ≥18 years.
ClearUP Sinus Pain Relief is a first-in-class bioelectronic treatment that offers a non-invasive and nonpharmacologic option to relieve sinus pain caused by allergies such as dust, mold, pollens, and pet dander. The handheld device measures the user's skin properties to target the optimal treatment points. As the user glides the device along the outer nasal passage (cheek, nose, and brow bone), gentle microcurrent waveforms stimulate the nerves under the skin to relieve sinus pain. Each 5-minute treatment can be personalized at 3 intensity levels and can be used up to 4 times a day.
A double-blind, randomized controlled trial (N=71) evaluated the effect of microcurrent waveforms on sinus pain. The data showed 3 out of 4 users (74%) experienced sinus pain relief after 1 use and 82% of users preferred ClearUP over their current treatment(s).
"For the many patients suffering from allergy-related sinus pain, we now have an effective treatment option that does not involve pills, a spray or nasal flush, surgery or opioids. ClearUP is an important new option that is drug-free, side-effect free and non-invasive," added Subinoy Das, MD, FACS, FARS, CEO and Medical Director for the US Institute for Advanced Sinus Care and Research; and a member of Tivic Health's Medical Advisory Board.
The ClearUP device will be available over-the-counter (OTC) by mid-2019.
For more information visit TivicHealth.com.