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FDA Approves Sonu Band for Drug-Free Treatment of Pediatric Nasal Congestion

  • On June 11, 2025, the U.S. FDA authorized the Sonu Band, an AI-powered wearable designed to help children aged 12 and older manage moderate to severe nasal congestion from home.
  • This approval follows the need for drug-free, noninvasive options to treat nasal congestion caused by allergic and nonallergic rhinitis in pediatric patients.
  • The Sonu Band uses acoustic resonant sound waves personalized by a smartphone app that maps the sinuses and calculates optimal frequencies to relieve symptoms.
  • More than four out of five patients experienced relief from nasal symptoms within 15 minutes, and Dr. Alan Greene highlighted Sonu as a promising, noninvasive treatment option.
  • This expanded approval establishes Sonu as the first FDA-approved, drug-free device addressing pediatric nasal congestion, offering families a safe alternative to steroid medications.
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FDA Approves Sonu Band for Drug-Free Treatment of Pediatric Nasal Congestion

TUESDAY, June 10, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved the Sonu Band, an artificial intelligence-enabled, wearable medical device for at-home treatment of moderate-to-severe nasal congestion in pediatric patients aged 12 and up.

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Medical Xpress broke the news in on Tuesday, June 10, 2025.
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