Sonu, a groundbreaking acoustic resonance therapy device, is now available over-the-counter (OTC) for treating moderate to severe nasal congestion caused by allergic and nonallergic rhinitis. Cleared by the Food and Drug Administration (FDA) in 2023, this innovative, AI-enabled wearable is designed for at-home use by adults aged 22 and older.
The Sonu device utilizes acoustic vibration energy delivered through a sound-emitting headband, worn around the forehead. It features two bone conduction transducers that target the sinonasal cavities to alleviate congestion. The device is paired with a smartphone app that scans the user’s face to determine their optimal resonant frequencies, ensuring a personalized treatment experience.
The efficacy of Sonu was demonstrated in the SCORE trial (ClinicalTrials.gov Identifier: NCT05821842), which involved 52 patients suffering from significant nasal congestion due to rhinitis. Participants were randomized to use Sonu or a sham device for 15 minutes twice daily over two weeks. Results showed a statistically significant improvement in nasal congestion scores with Sonu compared to the sham device. Moreover, Sonu achieved an 80.8% treatment responder rate compared to 46.2% for the sham group.
No device-related adverse events were reported. With its FDA approval and promising clinical results, Sonu offers a new, drug-free approach to managing nasal congestion, potentially transforming the lives of many individuals struggling with rhinitis.
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Article written by Diana Ernst
24/06/2024
Source:
MPR
https://www.empr.com/home/news/fda-cleared-device-delivers-acoustic-resonance-therapy-to-treat-nasal-congestion/