FDA Approves Sonu Band for Non-Drug Treatment of Pediatric Nasal Congestion

The U.S. Food and Drug Administration (FDA) has granted approval for the Sonu Band, a cutting-edge wearable device that leverages artificial intelligence to treat moderate-to-severe nasal congestion in children aged 12 and older at home. This innovative solution marks a significant milestone as the first FDA-approved, drug-free treatment for nasal congestion caused by allergic or nonallergic rhinitis in this age group.

The Sonu Band utilizes acoustic resonant sound waves that gently vibrate the nasal cavity, delivering personalized relief by reducing swelling, opening nasal passages, and aiding mucus drainage. Clinical studies reveal that over 80% of users experience symptom improvement within just 15 minutes of use. The device pairs with a smartphone app, which creates a face scan to map the sinuses and determine the ideal resonant frequencies. After a one-time scan, users simply wear the Sonu Band around their head and activate it.

Dr. Alan Greene, an adjunct professor of pediatrics at Stanford University and principal investigator for the Sonu project, expressed that Sonu offers a promising alternative for children suffering from chronic nasal congestion. He emphasized that as a noninvasive, drug-free option, it addresses a critical need for safe and effective remedies that steer clear of medications with potential side effects, such as steroids.

The approval was granted to SoundHealth, the company behind the device. The development of the Sonu Band responds to the demand for gentle, nonpharmacologic treatments suitable for young patients, providing relief without medication-related risks.

For additional details, see the full report at Medical Xpress.