Medical Professionals Reference (MPR)FDA Clears Wearable Device to Treat Nasal Congestion in Children

The FDA has expanded clearance for Sonu, an AI-enabled wearable device, to include pediatric patients aged 12 and older for treating moderate to severe nasal congestion. This decision was based on a nonrandomized, single-arm interventional study assessing safety and efficacy in adolescents.

⚕️ Key Clinical Considerations ⚕️

• Device Mechanism: Sonu uses acoustic vibrational energy via a headband with bone conduction transducers to relieve sinonasal congestion in under 15 minutes.
• Study Design: Included 31 participants aged 12–21 with moderate to severe nasal congestion; no control group was used.
• Efficacy Outcomes: Mean TNSS change was -2.74 overall; nasal congestion subscore improved by -0.76 across both age cohorts.
• Safety Profile: No adverse events were reported during the 2-week treatment period, supporting a favorable safety profile.
• Patient Selection: Participants had persistent symptoms for ≥1 month and a TNSS nasal congestion subscore ≥2 at baseline.

🎯 Clinical Practice Impact 🎯

• Patient Communication: Offers a non-drug, non-invasive option for families seeking alternatives to antihistamines or corticosteroids.
• Practice Integration: Can be recommended as an adjunct or alternative therapy for pediatric rhinitis, especially in medication-intolerant patients.
• Risk Management: Minimal safety concerns; however, long-term data and comparative studies are lacking.
• Action Items: Clinicians should assess patient eligibility (age ≥12, symptom severity) and educate on proper device use and expectations.
• Resource Implications: At $299 retail, cost may be a barrier for some families; insurance coverage is not mentioned.

More in Pediatric Allergies