SONU Band by SoundHealth Receives Pediatric FDA Approval
SAN FRANCISCO, June 11, 2025--(BUSINESS WIRE)--SoundHealth, a medical technology company harnessing the power of artificial intelligence and medical science to improve patient outcomes, announced it received United States Food and Drug Administration (FDA) approval for pediatric use of its groundbreaking SONU Band. SONU is the world's first FDA De Novo authorized, 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, providing a safe alternative to pharmaceutical treatments.
"SONU offers 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," said Dr. Alan Greene, Adjunct Professor of Pediatrics, Stanford University; Principal Investigator.
Clinically proven to be fast-acting and effective, over 80 percent of SONU patients reported improvement in their nasal symptoms. SONU represents a brand-new category of safe and rapid relief therapies for nasal congestion and spares patients from the side effects commonly associated with other treatment options.
"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."
SONU is easy, convenient and pleasant to use for patients. 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 simply 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.
SONU is the only FDA-approved device equivalent to or better than the leading nasal steroid spray, calming down symptoms of allergies, inflammation and congestion. For more information, please visit https://soundhealth.life/.
About SoundHealth
SoundHealth is a medical technology company that harnesses the power of artificial intelligence and medical science to improve respiratory and mental health. The SoundHealth team consists of experienced medical professionals, data scientists and engineers who are passionate about improving healthcare. Visit https://soundhealth.life.
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