SAN FRANCISCO – SoundHealth has received U.S. Food and Drug Administration (FDA) approval for pediatric use of its innovative SONU Band, making it the first wearable, drug-free device cleared for treating nasal congestion and allergies in children aged 12 and older. The approval marks a significant milestone in offering safe, non-pharmaceutical alternatives for young patients suffering from allergic and non-allergic rhinitis.
The SONU Band, which had already been authorized for adult use, is now the first FDA De Novo cleared, AI-enabled wearable medical device for children with moderate to severe nasal congestion. Designed for home use, SONU provides personalized, non-invasive therapy using acoustic vibrational energy to reduce nasal swelling and clear congestion without the side effects commonly associated with decongestants or steroid sprays.
Dr. Alan Greene, Adjunct Professor of Pediatrics at Stanford University and Principal Investigator on the SONU study, praised the device as a much-needed solution for families seeking safer treatment options. “SONU offers a promising new option for children struggling with chronic nasal congestion. As a non-invasive, 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,” Greene said.
According to SoundHealth, more than 80 percent of patients using SONU have reported improvement in nasal symptoms. The therapy works by using an AI-powered smartphone app that scans the user’s face and maps the sinuses to determine optimal resonant frequencies. These tailored sound waves are then delivered through the SONU Band, which gently vibrates the nasal cavity to promote drainage, reduce inflammation, and open blocked passages. Relief is typically achieved in 15 minutes or less.
Dr. Paramesh Gopi, founder and CEO of SoundHealth, emphasized the company’s broader mission to transform respiratory health. “Nasal congestion and allergies don’t have to be life-altering,” he said. “Our team of scientists, engineers, and medical professionals has truly revolutionized respiratory health with AI-powered sound therapy. We are thrilled to now be able to offer relief from congestion to children and will continue to work toward helping people breathe better.”
The SONU Band is now positioned as a breakthrough in pediatric respiratory care, offering a new, side-effect-free alternative for millions of children living with chronic nasal conditions.
