FDA Approves Drug-Free AI-Powered Wearable for Nasal Congestion for Kids

What You Should Know: 

– SoundHealth, a medical technology company leveraging artificial intelligence and medical science, recently announced it has received U.S. Food and Drug Administration (FDA) approval for pediatric use of its SONU Band. 

– The AI-enabled wearable device is now cleared as the first FDA-approved, drug-free solution for treating moderate to severe nasal congestion due to allergic and non-allergic rhinitis in children aged 12 and up, offering a safe alternative to traditional pharmaceutical treatments.

– The SONU Band, previously FDA De Novo authorized for adults, uses personalized sound wave therapy to provide relief from nasal congestion and allergy symptoms, often in 15 minutes or less, without the side effects commonly associated with medications.

How the AI-Powered SONU Band Works: Personalized Sound Therapy

The expanded FDA approval addresses a significant need for effective, non-pharmaceutical options for young people suffering from chronic nasal issues. The SONU Band system is designed to be easy, convenient, and pleasant for patients to use. It employs SoundHealth’s proprietary AI technology through the SONU app. The app uses a smartphone to scan the patient’s face, creating a digital map of their sinuses and calculating their optimal resonant frequencies. Following this one-time scan, the patient places the SONU Band around their head; when activated, the band delivers these precisely tailored frequencies.

The underlying science involves acoustic vibrational energy. The band produces resonant sound waves that gently vibrate the nasal cavity. These micro-vibrations are designed to help reduce swelling, open nasal passages, and promote the drainage of healthy mucus. Research has shown that acoustic vibration, similar to humming, can decrease symptoms of nasal congestion, potentially by modulating autonomic inputs to the nasal mucosa or through nitric oxide activity, which may exert a decongestant and anti-inflammatory effect.

Clinically Proven Efficacy and Rapid Relief

Clinical evidence has shown the SONU Band to be fast-acting and effective, with over 80 percent of patients reporting an improvement in their nasal symptoms. SoundHealth states that SONU is the only FDA-approved device demonstrated to be equivalent to or better than the leading nasal steroid spray in calming symptoms of allergies, inflammation, and congestion.

“Nasal congestion and allergies don’t have to be life-altering,” said Dr. Paramesh Gopi, founder and CEO of SoundHealth, who started the company partly due to his personal journey with lifelong allergies. “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”. Dr. Gopi developed the SONU Band in collaboration with Stanford Physicians Peter Hwang and Bryant Lin.