SONU Band by SoundHealth Receives Pediatric FDA Approval
SoundHealth, a medical technology company harnessing the power of artificial intelligence and medical science to improve patient outcomes, announced it received United States Food and Drug Administration (FDA) approval for pediatric use of its groundbreaking SONU Band. SONU is the world’s first FDA De Novo authorized, AI-enabled, wearable medical device for at-home treatment of moderate to severe nasal congestion due to allergic and non-allergic rhinitis. This expanded approval makes SONU the first FDA-approved, drug-free solution for nasal congestion and allergies in children ages 12 and up, providing a safe alternative to pharmaceutical treatments.
First Ever Large-Scale Study Linking Nasal Anatomy to Allergy Symptoms, Unveiled at Leading Allergy, Asthma and Immunology Conference
A groundbreaking study, presented at the Western Allergy Conference 2025, is the first large-scale investigation to examine how nasal anatomy influences upper airway allergies using real-world data from thousands of patients. This large-scale study is the first of its kind to leverage computational fluid dynamics (CFD) modeling with real-world patient data, marking a paradigm shift in allergy research and advancing personalized, precision medicine.
Acoustic Resonance Therapy Offers Promising Treatment for Chronic Insomnia
A groundbreaking study from researchers at Stanford Medicine and SoundHealth presents a new, non-invasive therapy for chronic insomnia using customized binaural spatial audio delivered via an acoustic resonance therapy (ART) headband. Chronic insomnia, which affects 10% to 15% of the adult population, often leads to reduced quality of life and is associated with multiple health risks, including cardiovascular disease and depression.
