SONU Band by SoundHealth Receives Pediatric FDA Approval
SoundHealth has developed the world's first FDA-approved, wearable device for children 12 and up that offers a drug-free, safe solution for treating nasal congestion and allergies.
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'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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In 2017, the FDA issued a warning against using injectable silicone for body contouring, citing possible side effects such as "ongoing pain and serious injuries, such as scarring, tissue death, and permanent disfigurement; if the silicone migrates beyond the injection site, it could cause an embolism (blockage of a blood vessel), stroke, infections and death." FDA Commissioner Scott Gottlieb, M.D. said, "We have significant concerns with unsafe injectable silicone that's being marketed for body contouring by unlicensed providers. We've seen serious adverse events result from products, which are sometimes industrial-grade silicone, being used for these unapproved medical purposes." Several years after getting illegal silicone butt injections, K. Michelle had to have four surgeries and two blood transfusions to remove them. She told People, "[The injector] wasn't a doctor — it was black market, it was these 'hydrogel' injections — that's what they were being called. When I found out my favorite rapper did it, that's when I decided, 'I'm getting it done.'" Five years later, she started experiencing pain in her legs and back, migraines, fatigue, and other unexplainable symptoms. Eventually, her doctors found out that the silicone was spreading down her legs, so one suggested she get liposuction. She said, "He thought that you could go and suck it out, but it spread it. It's definitely a new procedure, so he didn't know... I went on tour about a week and a half later … but after a few performances, I was rushed to the emergency room." Removing the affected tissue required three additional surgeries. She said, "I had these lumps, and I was very disfigured." She planned to get reconstructive surgery. According to Beverly Hills-based plastic surgeon Dr. J. Timothy Katzen, cosmetic hydrogel injections aren't FDA-approved, and he recommends removing them before symptoms develop. 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