FDA approves pediatric indication for SONU wearable device to treat nasal congestion

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.