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

by Jasmine Pennic 06/04/2025

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

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