Safety and Effectiveness of Sonu for Pediatric Nasal Congestion

Safety and Effectiveness of Sonu Acoustic Resonance Therapy for the Treatment of Pediatric Patients With Moderate to Severe Nasal Congestion.

To demonstrate the safety and effectiveness of Sonu for the treatment of pediatric patients with moderate to severe nasal congestion.

Inclusion Criteria:

• Pediatric subjects between the ages of 12 to 21 years
• Present with symptoms of nasal congestion for 1 month or more prior to treatment
• Have a 24 hour reflective nasal congestion subscore of the TNSS of 2 or more on a 0 to 3 scale at the time of screening

Exclusion Criteria:

• Head, nasal or sinus surgery within 3 months
• Sinus infection diagnosed within the last month, or rhinitis medicamentosa
• Documented history of nasal polyposis or mass
• Pregnancy