Tivic Health Systems has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its ClearUP sinus pain relief device.
ClearUP is an over-the-counter (OTC) device designed to treat sinus pain associated with allergic rhinitis (hay fever).
ClearUP bioelectronic treatment is a non-invasive and drug-free option to alleviate sinus pain caused by different environmental allergies such as dust, mold, pollens and pet dander.
According to the company, the new device uses moderate microcurrent waveforms to provide sinus pain relief to the 40 to 60 million Americans who suffer from allergic rhinitis.
The device is provided with an advanced technology to measure the user’s exclusive skin properties to target the optimal treatment points.
ClearUP is a small handheld device that can easily glide along the outside of the nasal passages such as the cheek, nose and brow bone to provide low current electrical waveforms, which stimulate the nerves under the skin to alleviate sinus pain.
Under FDA submission, the company carried out a double-blind and randomized control study to assess the effect of microcurrent waveforms on sinus pain.
The study showed that three out of four users achieved sinus pain relief with ClearUP device, said the company.
ClearUP’s one-button control is said to provide three intensity levels to personalize treatment and better meet the requirements of the individual.
The company is planning to provide ClearUP sinus pain relief device at over-the-counter without a prescription by mid-2019.
Tivic Health CEO Jennifer Ernst said: “In line with our corporate vision to create accessible, cutting-edge solutions for chronic conditions, we are very pleased to bring to market a next generation microcurrent device that will help transform treatment for the common allergy sufferer.
“ClearUP’s FDA clearance marks a major milestone for Tivic Health and puts us on the map as an innovative leader in the field of bioelectronics and neuromodulation.”
Tivic Health Systems is a bioelectronic device firm engaged in the development of microcurrent therapy solutions for chronic diseases and conditions.