The Food and Drug Administration (FDA) has expanded the approval of ClearUp® Sinus Pain Relief to include congestion from allergies, the flu, and the common cold in individuals 18 years of age and older. The bioelectronic device was previously approved for treating sinus pain due to allergic rhinitis.

ClearUP Sinus Pain Relief is a handheld device that 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. Each 5-minute treatment can be personalized at 3 intensity levels and can be used up to 4 times a day.

“Bioelectronic devices stimulate the body to produce factors that it very tightly regulates,” said Subinoy Das, MD, chief medical officer at Tivic Health and CEO and Medical Director, US Institute for Advanced Sinus Care and Research. “In the case of ClearUP, it stimulates the trigeminal nerve, which is responsible for sensing pain and pressure of the face, and also sympathetic fibers of the autonomic nervous system, which can induce vasoconstriction and reduced swelling.”

The expanded approval was based on data from a single-arm, prospective interventional study (ClinicalTrials.gov: NCT03888274) that enrolled 30 patients with moderate facial pain attributed to sinonasal disease. Results showed that treatment with ClearUp significantly reduced moderate sinus pain for up to 6 hours (P <.0001).


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Moreover, daily treatment over 4 weeks was associated with a significant reduction in moderate pain and congestion (-43.3%; P <.0001). Findings also showed that the magnitude of nasal congestion relief with ClearUp was reported to be comparable to or greater than that seen with over-the-counter medications.  

As for safety, the most commonly reported side effects included mild transient erythema, headache, and eyelid twitch.

The ClearUP device is available without a prescription and retails for $149.

References

  1. FDA expands indication of use for Tivic Health’s ClearUP Sinus Pain Relief to include congestion for common cold, flu and allergies. [press release]. San Francisco, CA: Tivic Health Systems Inc; March 24, 2021.
  2. Goldsobel AB, Prabhakar N, Gurfein BT. Prospective trial examining safety and efficacy of microcurrent stimulation for the treatment of sinus pain and congestion. [Published online November 20, 2019]. Bioelectronic Medicine. doi.org/10.1186/s42234-019-0035-x.