SoundHealth Gains First-of-its-Kind FDA Approval for Paediatric Use of AI-Powered SONU Band

SoundHealth has received approval from the United States Food and Drug Administration (FDA) for paediatric use of its SONU Band. The recent approval permits the use of the device for children aged 12 and older to help manage moderate to severe nasal congestion resulting from both allergic and non-allergic rhinitis.

The SONU Band stands out as the first wearable medical device of its kind, powered by AI, to receive FDA De Novo authorization. It provides a drug-free option for treating nasal congestion and is intended for safe use at home.

The expanded approval now makes SONU the only FDA-cleared, non-pharmaceutical solution available for children suffering from nasal congestion and allergies.

Clinical results have shown that the SONU Band is both fast-acting and effective, with more than 80 per cent of users reporting noticeable improvement in their nasal symptoms. 

Unlike conventional treatments, SONU does not rely on medication and avoids the side effects often associated with pharmaceutical options.

The device functions using proprietary AI technology developed by SoundHealth. Patients begin by using a smartphone app to scan their face, which generates a digital model of their sinus structure and identifies their unique resonant frequencies. After this assessment, users place the SONU Band around their head, allowing the device to emit sound frequencies specifically customized to their sinus configuration.

Once this initial scan is completed, users wear the SONU Band around the head. The device then delivers sound frequencies tailored to the individual's sinus profile.

Relief is typically achieved in 15 minutes or less, and the SONU Band has been found to be as effective as or better than leading nasal steroid sprays. With this new approval, SoundHealth is expanding access to a safe, non-invasive option for managing respiratory symptoms, especially in younger patients.