SoundHealth Unveils FDA-Cleared, AI Wearable for Nasal Congestion

SoundHealth has introduced SONU, a newly U.S. Food and Drug Administration (FDA) de novo authorized, artificial intelligence (AI)-enabled, wearable device to treat moderate to severe nasal congestion due to rhinitis at home in patients 22 and older.

SONU leverages acoustic vibrational energy for personalized relief from nasal congestion. Acoustic vibration related to humming has been demonstrated to decrease nasal congestion symptoms, potentially via modulation of autonomic inputs to the nasal mucosa or through nitric oxide activity. This, in turn, may cause a decongestant and anti-inflammatory effect on the nasal passages.

The SONU app scans the face using a smartphone, then creates a digital map of the sinuses and calculates optimal resonant frequencies. After the one-time scan, the SONU band is placed around the head. Once powered on, the SONU band delivers frequencies tailored to the patient based on the app’s calculations.

The resonant sound waves gently vibrate the nasal cavity and are so small they might not be noticeable, SoundHealth said. Stimulating the nasal nerves can cause vasoconstriction, reducing swelling and opening nasal passages. It can also produce sonication, which dilutes accumulated dense mucus, and mucociliary clearance, which drains healthy mucus.

According to the company, relief of symptoms begins in minutes and patients don’t need to change activities while using SONU. Using the device at home requires 15 minutes, twice a day.

SoundHealth also revealed it has received $7 million in seed-round funding, which it will use to boost SONU’s commercialization and marketing efforts. The company will also seek regulatory authotization and further indications for pediatric use and insomnia.

“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.