FDA Approves Nasal Congestion Wearable for Pediatric Patients

It scans the patient's face using a smartphone and creates a digital map of their sinuses.

Sonu By Soundhealth
SoundHealth

SoundHealth received FDA approval for pediatric use of its SONU Band, an AI-enabled wearable medical device for at-home treatment of moderate to severe nasal congestion due to allergic and non-allergic rhinitis.

This expanded approval makes SONU the first FDA-approved, drug-free solution for nasal congestion and allergies in children ages 12 and up.

Using SoundHealth’s proprietary AI technology, the SONU app scans the patient's face using a smartphone and creates a digital map of their sinuses, calculating their optimal resonant frequencies. Following the initial one-time scan, the patient  places the SONU Band around their head, turns it on and the band delivers frequencies tailored to the patient based on the app’s calculations.

The science behind SONU:

  • SONU uses acoustic vibrational energy to provide personalized relief for nasal congestion. The band produces resonant sound waves that gently vibrate the nasal cavity. These micro vibrations help reduce swelling, open nasal passages and drain healthy mucus.
  • Acoustic vibration associated with humming has been shown to decrease symptoms of nasal congestion, possibly through modulation of autonomic inputs to the nasal mucosa or through nitric oxide activity, which may in turn exert a decongestant and anti-inflammatory effect on the nasal passages.
  • Using personalized, relaxing sound waves, SONU provides relief of nasal symptoms in 15 minutes or less.
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