FDA approves pediatric indication for SONU wearable device to treat nasal congestion | Image credit: Contemporary Pediatrics

The FDA has approved an expanded pediatric indication for the SONU Band (SoundHealth) for at-home treatment of moderate-to-severe nasal congestion because of allergic and non-allergic rhinitis in individuals aged 12 years and older.¹

According to an announcement from SoundHealth, the expanded approval makes the FDA De Novo authorized, AI-enabled device the first FDA-approved, drug-free solution for nasal congestion and allergies.

According to the FDA, a De Novo classification request provides a "marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device."²

"SONU offers a promising new option for children struggling with chronic nasal congestion," said Alan Greene, MD, adjunct professor of Pediatrics, Stanford University, and principal investigator for SONU. "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."

Clinical data for SONU Band

According to a study published in Sleep, results demonstrated that the use of the SONU headband was associated with increased hours of CPAP use and improved CPAP adherence, as well as reduced nasal symptoms.³

In a prospective, non-randomized study approved by an institutional review board, researchers evaluated whether a vibrational headband could improve CPAP adherence in adults with obstructive sleep apnea (OSA) who reported nasal congestion as a barrier to consistent use. Twenty-five adults participants with OSA (mean AHI 31.6) and new to CPAP within the prior 90 days participated. Each used the Sonu vibrational headband system (SoundHealth Systems) for 15 minutes nightly before applying their CPAP mask over a 28-day period. The system, worn above the eyebrows, uses facial scans via a smartphone app to estimate sinonasal volume and generate personalized acoustic frequencies. Participants tracked nasal symptoms and CPAP use throughout the study.

Compared to baseline, mean CPAP use increased from 2.7 to 4.0 hours per night during the intervention (48% increase; P =0.004). Among a subgroup of 12 participants with full 28-day data, total CPAP use rose 45% (P = 0.0107). Medicare-defined CPAP adherence improved from 30.0% to 45.8% (P = 0.0175), and total nasal symptom scores dropped by 56% (P = 0.0016).

These findings suggested the SONU system may enhance nightly CPAP use and relieve nasal congestion, potentially addressing a key cause of early CPAP discontinuation.

Function of SONU Band

According to SoundHealth, SONU uses the company's proprietary AI technology with an associated app that scans the patient's face using a smartphone and creates a digital map of sinuses and calculates optimal resonant frequencies. After an initial scan, the patient places the SONU Band around their head, which delivers frequencies that are tailored to the patient based on the app's calculations.

The device uses acoustic vibrational energy to provide personalized relief for nasal congestion. The band produces sound waves that "gently vibrate the nasal cavity. These micro vibrations help reduce swelling, open nasal passages and drain healthy mucus," stated the company. Vibration associated with humming has been previously shown to decrease symptoms of nasal congestion, stated SoundHealth, which could in turn exert a decongestant and anti-inflammatory effect on the nasal passages. Using the personalized sound waves, the device provides relief in 15 minutes or less.

"Nasal congestion and allergies don’t have to be life-altering," said Paramesh Gopi, founder and CEO of SoundHealth. "We are thrilled to now be able to offer relief from congestion to children and will continue to work toward helping people breathe better.”

References:

1. SONU Band by SoundHealth receives pediatric FDA approval. SoundHealth. Press release. June 3, 2025. Accessed June 4, 2024.

2. De Novo classification request. FDA. Press release. October 4, 2022. Accessed June 4, 2025. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request

3. Munafo D, Gopi P, Mohan V, et al. 0486 The Effect of Acoustic Resonance Therapy on CPAP Adherence. Sleep. Volume 46. May 2, 2023. https://doi.org/10.1093/sleep/zsad077.0486