June 4, 2025 By Joshua Fitch, Senior Editor
The FDA has approved an expanded pediatric indication for the SONU Band (SoundHealth) for at-home treatment of moderate-to-severe nasal congestion because of allergic and non-allergic rhinitis in individuals aged 12 years and older.1
According to an announcement from SoundHealth, the expanded approval makes the FDA De Novo authorized, AI-enabled device the first FDA-approved, drug-free solution for nasal congestion and allergies.
Read more about how this AI-enabled, wearable device FDA-approved, drug-free solution for nasal congestion and allergies helps children ages 12 and up here.