Sonu

Sonu is a non-invasive, over-the-counter device for relieving moderate to severe nasal congestion due to allergic and non-allergic rhinitis in individuals aged 12 and older. It uses acoustic resonance therapy delivered through bone-conduction transducers in an adjustable headband, controlled via a smartphone app.

The device has identical design, dimensions, materials, and technological characteristics to its predicate device. The primary difference is expansion of the intended patient population from adults only to include pediatric patients aged 12-21 years old.

Software development and testing were executed in compliance with IEC 62304, FDA's Content of Premarket Submissions for Device Software Functions guidance, FDA's Cybersecurity in Medical Devices guidance, and FDA's Applying Human Factors and Usability Engineering to Medical Devices guidance.

The subject device is substantially equivalent because it is the same physical device with identical design and technological characteristics as the predicate, and clinical testing in 31 pediatric subjects (aged 12-21) demonstrated equivalent safety and effectiveness without raising new issues. The expansion to pediatric use is supported by clinical data showing similar efficacy metrics and no adverse events, establishing that the population difference does not create new safety or effectiveness concerns.