SAN FRANCISCO– SoundHealth, Inc. (“SoundHealth”), a medical technology company harnessing the power of artificial intelligence and medical science to improve patient outcomes, today introduced SONU. SONU is the world’s first FDA De Novo authorized, AI-enabled, wearable medical device for the treatment of moderate to severe nasal congestion due to allergic and non-allergic rhinitis for at-home use by individuals 22 years of age and older. SONU provides a new non-pharmaceutical treatment option for patients and clinicians. The United States Food and Drug Administration (FDA) issued a De Novo classification for the SONU product, which includes the SONU device and the SONU app.
In parallel with the official launch of SONU, SoundHealth received $7 million of seed-round funding. SoundHealth will use the funds to enhance the commercialization and marketing of SONU and to seek regulatory authorization for additional indications for pediatric use and insomnia. Moai Capital and J4 Ventures led the round with additional funding from TeleSoft Partners, Tau Ventures, TechU Ventures and Rhythm Venture Capital. Peter Moran, an early-stage investor in digital health and wellness companies, a former long-time managing partner at DCM Ventures, and a seed investor in SoundHealth, will join the SoundHealth board of directors. The investor syndicate has a long track record of successful investments in groundbreaking solutions from both enterprise and health tech startups.
“We are delighted to announce the close of our seed-round investment — the proceeds of which will be used for product launch and advancing our pipeline of indications for the SONU device. Our groundbreaking technology provides the first FDA authorized, non-pharmaceutical medical device treatment option for nasal congestion due to allergic and non-allergic rhinitis. SoundHealth’s mission is to provide personalized, intelligent wearables to help people breathe and sleep better!” said Dr. Paramesh Gopi, founder and CEO, SoundHealth.
“SONU is using the latest medical science to provide a game-changing and liberating alternative treatment for nasal congestion. Investors are increasingly looking for high-efficacy solutions to many maladies without the side effects of pharmaceutical approaches. I look forward to working with SoundHealth’s tenured team in helping many people find relief from nasal congestion with this simple yet powerful, non-invasive device without the side effects often associated with pharmaceuticals,” said Moran.
“We were especially struck by how quick and easy SONU can bring relief to allergies, without using a drug. Future applications could include helping with sleep and stress,” said Amit Garg, managing partner of Tau Ventures.
SONU is an AI-enabled patented drug-free medical device that uses acoustic vibrational energy to provide personalized relief for nasal congestion. 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.
Yogic breathing exercises that incorporate humming have been practiced for centuries and have recently been demonstrated clinically to reduce symptoms of chronic sinusitis including nasal congestion.
“SONU’s vibroacoustic therapy offers an innovative drug-free treatment option for my patients suffering from allergic and non-allergic nasal congestion. The prospect of replacing medications with a scientifically proven non-invasive therapy is truly exciting,” said Dr. Cecelia Damask, DO, FAOCO-HNS, FAAOA, a physician at Orlando and Lake Mary ENT & Allergy, board-member-at-large for the American Osteopathic Colleges of Ophthalmology and Otolaryngology-Head and Neck Surgery (AOCOO-HNS), coordinator of education for the American Academy of Otolaryngic Allergy (AAOA), chair-elect of the Allergy, Asthma, and Immunology Committee for the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) and assistant professor in the Department of Otolaryngology at the University of Central Florida College of Medicine.
“SONU is a really interesting technology. It’s based on the really old understanding that when we hum or sing or whistle, our sinuses open, and we also feel very relaxed. The vibration relaxes the sympathetic and parasympathetic parts of our autonomic nervous system; it opens our sinuses with resonance, improves the flow of mucus in the nose and promotes ciliary action. SONU was designed based on what we know about vibrations and acoustic resonance, without any medications, and the patient can do whatever else they want while using the SONU band. We’ve waited a long time in our field for a product that can help manage nasal congestion, sinus pressure and tension in the head and neck in such an elegant way, so that the whole experience is wonderful for our patients. It’s a very good alternative to the other options of medications, allergy management, surgery and office procedures. So, I’m excited to add SONU to the toolkit for patients with nasal congestion,” said Dr. Jacob Johnson, MD, president, San Francisco Audiology, ENT specialist, San Francisco Otolaryngology Medical Group, and associate clinical professor, University of California, San Francisco.
SONU is easy, convenient and pleasant to use for patients. Using SoundHealth’s proprietary AI technology, the SONU app scans their face using a smartphone, creates a digital map of their sinuses and calculates 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 SONU band delivers frequencies tailored to the patient based on the app’s calculations. Symptom relief begins in minutes. Patients do not need to change their activities while using SONU. They can enjoy SONU anytime at home just for 15 minutes twice a day, for example, while online, brushing their teeth, drinking their morning coffee, exercising or watching TV.
The SONU band produces resonant sound waves that gently vibrate the nasal cavity. These micro vibrations are so small they may not even be noticeable, and they stimulate nasal nerves, which may result in vasoconstriction, which reduces swelling and opens nasal passages; sonication, which dilutes accumulated dense mucus; and mucociliary clearance, which drains healthy mucus. 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 pharmaceutical treatment options.
