OTC device for hay fever pain relief receives 510(k) clearance

Tivic Health Systems’ ClearUP Sinus Pain Relief uses low current electrical waves to stimulate nerves beneath the skin.
By Dave Muoio
02:04 pm

The FDA has granted 510(k) clearance to an over-the-counter handheld electronic device for treating hay fever sinus pains, according to an announcement from its manufacturer.

Tivic Health Systems’ ClearUP Sinus Pain Relief device is non-invasive and does not rely on a pharmacological component. Instead, the single-button device is run along the skin of the user's cheek, nose and brow, where it delivers a low electrical current to stimulate nerves below the skin.

Tivic Health’s regulatory submission was supported by a double-blind, randomized control trial that enrolled 71 adult sinus pain patients. According to the company, a single treatment with the device reduced sinus pain among 74 percent of the participants, and 82 percent said they preferred it over their current treatment.

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Tivic Health plans to have ClearUP commercially available later this year.

What’s the impact

Hay fever, or allergic rhinitis, affects millions in the US, and is primarily treated using antihistamines. ClearUP would provide these patients with another over-the-counter option that is rechargeable for continued use, and does not include the side effects of antihistamines.

"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,” Dr. Subinoy Das, CEO and and medical director for the US Institute for Advanced Sinus Care and Research, and a member of Tivic Health's medical advisory board, said in a statement. “ClearUP is an important new option that is drug-free, side-effect free and non-invasive.”

What’s the trend

By and large, digital health has generally focused on tools that help those affected avoid conditions in which their allergies may be aggravated, such those included in the One Medical app or in Propeller Health’s respiratory health forecasting services. Other approaches have included telemedicine consultations with allergy specialists through direct-to-consumer services like PlushCare.

On the record

“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," Jennifer Ernst, CEO of Tivic Health, said in a statement. “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.”


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