SoundHealth’s SONU Band Earns Pediatric FDA Approval

SoundHealth has obtained U.S. Food and Drug Administration (FDA) approval for pediatric use of its SONU Band, an artificial intelligence (AI)-based wearable device for home treatment of moderate to severe nasal congestion due to allergic and non-allergic rhinitis.

This expanded FDA nod makes SONU the first FDA-approved, drug-free treatment for nasal congestion and allergies in children aged 12 and up. The device first earned FDA approval for adults 22 years and older in July 2024.

The company said that over 80% of SONU patients report improvement in nasal symptoms. It represents a new category of safe, rapid relief therapies for nasal congestion and spares the side effects commonly related to other treatments.

Leveraging SoundHealth’s AI tech, the SONU app scans the face with a smartphone and creates a digital map of the sinuses, calculating optimal resonant frequencies. After the one-time scan, the patient places the band around their head, and once turned on, the band delivers frequencies tailored to the patient based on the app’s calculations.

The resonant sound waves gently vibrate the nasal cavity, helping to reduce swelling. That way, nasal passages can open and drain healthy mucus.

Dr. Alan Greene, Adjunct Professor of Pediatrics, Stanford University; and Principal Investigator said that SONU is a promising new option for children struggling with chronic nasal congestion.

As a non-invasive, drug-free solution, it addresses a significant need among families looking for safe, effective alternatives to traditional therapies—particularly those involving steroids or medications with side effects,” Dr. Greene told the press.

SoundHealth said SONU is also the only FDA-approved device equal to or better than the leading nasal spray to calm down symptoms of allergies, inflammation, and congestion.

“Nasal congestion and allergies don’t have to be life-altering,” said Dr. Paramesh Gopi, founder and CEO of SoundHealth. “Our team of scientists, engineers and medical professionals has truly revolutionized respiratory health with AI-powered sound therapy. We are thrilled to now be able to offer relief from congestion to children and will continue to work toward helping people breathe better.”

In January, the company released SONUCheck, a vocal analysis feature in the SONU app that uses voice as a noninvasive biomarker to measure nasal patency. It features a unique machine learning approach that quantifies nasal breathing in real time and provides a personalized score in the SONU app.