The U.S. Food and Drug Administration has approved the Sonu Band, an artificial intelligence-enabled, wearable medical device for at-home treatment of moderate-to-severe nasal congestion in pediatric patients aged 12 and up.

This expanded approval makes Sonu the first FDA-approved, drug-free solution for nasal congestion due to allergic and nonallergic rhinitis in children ages 12 years and older. The Sonu uses acoustic resonant sound waves that gently vibrate the nasal cavity to provide personalized relief for nasal congestion by helping to reduce swelling, open nasal passages, and drain healthy mucus.

Clinical data show that over 80 percent of Sonu patients reported improvement in their nasal symptoms in 15 minutes or less. The Sonu app creates a digital map of the sinuses using scans of the patient's face from a smartphone and calculates their optimal resonant frequencies. Following the one-time scan, the patient places the Sonu Band around their head and turns it on.

"Sonu offers a promising new option for children struggling with chronic nasal congestion," Alan Greene, M.D., adjunct professor of pediatrics at Stanford University in California and principal investigator for Sonu, said in a statement. "As a noninvasive, drug-free solution, it addresses a significant need among families looking for safe, effective alternatives to traditional therapies, particularly those involving steroids or medications with side effects."

Approval of the Sonu Band was granted to SoundHealth.