Q&A: Wearable device uses acoustic resonance to treat nasal congestion

Key takeaways:

• SONU is an at-home nonpharmaceutical treatment that uses acoustic resonance therapy.
• The device operates as a headband that connects to an app.

SoundHealth Inc. has launched SONU, the world’s first FDA-authorized, AI-enabled, over-the-counter, wearable medical device for the treatment of moderate to severe nasal congestion, according to a company press release.

The product is approved for adults aged 22 years and older for congestion due to allergic or nonallergic rhinitis. The FDA has issued a de novo classification, which gives marketing ability to devices deemed low to moderate risk, for both the SONU device and the corresponding app.

Healio spoke with Bryant Lin, MD, MEng, SoundHealth founder and head of clinical affairs and product design, about the launch.

Healio: What are the current treatments for rhinitis, and what are their limitations?

Lin: Current treatments for rhinitis include saline irrigation, allergy pills, steroids and sprays. Saline irrigation doesn’t need a prescription, but it is bulky/cumbersome and unpleasant to use, and it doesn’t address the underlying cause of symptoms. Allergy pills have variable success and require ongoing pill use. Steroid sprays also have variable success and require ongoing use, and they can have unpleasant side effects. Decongestant sprays such as Afrin (oxymetazoline hydrochloride, Bayer) contain vasoconstricting meds that can work great for single use but can very quickly cause rebound congestion (rhinitis medicamentosa) when used regularly.

Healio: What is acoustic resonance therapy, and how does it work?

Lin: It’s a treatment that uses sound vibrations to stimulate increased mucus clearance from the sinonasal structures and particularly to help with symptoms of congestion from allergic and nonallergic rhinitis. The exact mechanism is still being understood but there are a variety of ways this is thought to work, from the ground-level effects such as vasoconstriction and improved mucociliary clearance to more high-level mechanisms we suspect are regulated by the sphenopalatine ganglion.

Healio: What is the SONU, and how do patients use it?

Lin: It’s a headband, combined with an app, which uses acoustic resonance to treat rhinitis in patients. 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 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.

Healio: Would physicians need any kind of training before they use it?

Lin: No. SONU is equally usable by the lay public and physicians. The app walks the user through first-time use as it pairs to the individual user.

Healio: You published a study last year comparing SONU’s effectiveness vs. a sham device. How did it perform?

Lin: The study showed that SONU effected a significantly greater mean change in the nasal congestion sub-score compared to a sham treatment. SONU reached an 80.8% improvement.

Healio: Did it have a favorable safety profile?

Lin: Yes. No major side effects were reported.

Healio: How do these results compare with other current rhinitis treatments?

Lin: The effect size for acoustic resonance therapy (ART) in our study compares favorably with that of nasal corticosteroid sprays as reported in randomized, placebo-controlled trials for allergic rhinitis.

Healio: Does ART/SONU have any other advantages compared with other rhinitis treatments?

Lin: It frees patients from dependence on pills and sprays. It integrates with their daily activities. (They can wear it in the morning while getting ready and in the evening while winding down.) And patients tell us it is relaxing to use. SONU also offers personalized therapy tailored to the user’s unique sinus anatomy. And it works!

Healio: What is the next step in its development?

Lin: SoundHealth has a full therapeutic roadmap for personalized medicine. Over the next 12 months, we plan to address pediatric nasal congestion — giving clinicians the first nonpharmaceutical clinically proven option that is as effective as steroid treatments with no side effects. Secondly, we are planning to move personalized vibro-acoustic treatment into the sleep market. We’ve already published preliminary results in terms of how continuous positive airway pressure (CPAP) patients have benefited from SONU, but plan to address insomnia in the near future. There will be more to come as we roll out our science-based approach to treating America’s most important chronic conditions. Separately, we are harnessing the power of AI to help patients get ahead of their allergies based on our patented personalized anatomy-based allergy prediction app that will be unveiled in quarter four of this year. Stay tuned as we help 30 million people with chronic rhinitis through their journey with SONU and our AI.

References:

• Evaluation of automatic class III designation (de novo) summaries. https://www.fda.gov/about-fda/cdrh-transparency/evaluation-automatic-class-iii-designation-de-novo-summaries. Updated May 29, 2024. Accessed Aug. 20, 2024.
• Luong AU, et al. Int Forum Allergy Rhinol. 2023;doi:10.1002/alr.23284.
• SoundHealth receives $7 million seed round funding and launches SONU, the world’s first FDA-authorized, AI-enabled, wearable device for treating nasal congestion due to allergic and non-allergic rhinitis. https://soundhealth.life/releases/soundhealth-funding-fda-and-product-launch/. Published July 24, 2024. Accessed Aug. 16, 2024.