The over-the-counter device is FDA De Novo-authorized for at-home use to treat nasal congestion due to allergic and non-allergic rhinitis.

Summary: SoundHealth Inc has launched Sonu, an FDA De Novo-authorized AI-enabled wearable device to treat moderate to severe nasal congestion from allergic and non-allergic rhinitis in individuals aged 22 and older. The device provides a non-pharmaceutical option using acoustic vibrational energy for personalized relief. With $7 million in seed funding from investors, SoundHealth aims to commercialize Sonu and expand its indications to include pediatric use and insomnia. Clinical trials have shown its efficacy and safety, making it a promising alternative to traditional treatments.

Key Takeaways:

Product Launch: An FDA De Novo-authorized, AI-enabled wearable device named Sonu has been launched to treat moderate to severe nasal congestion due to allergic and non-allergic rhinitis in individuals aged 22 and older.
Funding and Expansion: The launch was accompanied by $7 million in seed funding, led by Moai Capital and J4 Ventures, that will be used to enhance the commercialization of Sonu and seek regulatory approval for additional indications, including pediatric use and insomnia.
Clinical Impact: Sonu utilizes acoustic vibrational energy for personalized relief, offering a non-pharmaceutical treatment option. Clinical trials and expert endorsements highlight its potential as a safe and effective alternative to traditional medications for nasal congestion.

SoundHealth Inc has launched Sonu, a US Food and Drug Administration (FDA) De Novo-authorized, artificial intelligence (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 FDA issued the De Novo classification for the Sonu product, which includes the Sonu device and the Sonu app, last December.

Seed Funding for Marketing and Expanded Indications

In parallel with the official launch of Sonu, SoundHealth received $7 million of seed-round funding that it will use 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 record of investments in 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,” says Paramesh Gopi, PhD, founder and CEO of SoundHealth, in a release.

Acoustic Resonance Therapy for Nasal Congestion

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.

A SoundHealth-sponsored clinical trial of acoustic resonance therapy, published in the International Forum of Allergy & Rhinology, found that the therapy is a safe and effective non-pharmacologic alternative for the treatment of nasal congestion.

In addition to co-authoring the article, SoundHealth founder and head of research, Peter Hwang, MD, FARS, participated in a panel, “Acoustic Energy and Vibration Therapy of the Sinonasal Cavity,” on July 12 at the American Rhinologic Society’s 13 th Annual Summer Sinus Symposium. Attendees learned the principles, practical applications, devices, and techniques of optimizing treatment for rhinitis using acoustic energy and vibration therapy.

“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,” says 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, coordinator of education for the American Academy of Otolaryngic Allergy, chair-elect of the Allergy, Asthma, and Immunology Committee for the American Academy of Otolaryngology-Head and Neck Surgery, and assistant professor in the Department of Otolaryngology at the University of Central Florida College of Medicine, in a release.

Sonu was designed based on what’s known about vibrations and acoustic resonance, without any medications, and the patient continue daily activities 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,” says Jacob Johnson, MD, president of San Francisco Audiology, ENT specialist at San Francisco Otolaryngology Medical Group, and associate clinical professor at the University of California, San Francisco.

AI for Personalized Therapy

Using SoundHealth’s proprietary AI technology, the Sonu app scans a patient’s 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 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, according to SoundHealth. Patients do not need to change their activities while using Sonu.

The Sonu band produces resonant sound waves that 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.