Treatment with acoustic vibrations using a headband significantly improved nasal congestion in pediatric rhinitis patients, based on data from a feasibility study of 31 individuals aged 12 to 21 years.

Chronic rhinitis with congestion is extremely common in children, and many parents would like to identify ways to manage it without pharmacotherapy, said lead author Ashoke Khanwalkar, MD, assistant professor of endoscopic sinus and skull base surgery at the University of Colorado Anschutz School of Medicine in Aurora, Colorado.

“Parents express concerns about challenges with adherence, concerns surrounding medication side effects, and an overall desire to minimize medication exposure,” said Khanwalkar. The new study illustrates the potential benefit of the first FDA-cleared acoustic resonance therapy device for children suffering from chronic rhinitis, he said.

Acoustic resonance therapy (ART) involves the delivery of individually calibrated acoustic vibratory energy to the sinonasal cavities to reduce nasal congestion. ART has been shown to be safe and effective in adults, and a headband device known as SONU was approved by the FDA in 2025 for use in children older than 12 years.

In a study published in OTO Open, Khanwalkar and colleagues evaluated the ability of the SONU headband to improve nasal congestion in children and teens aged 12 to 21 years. The study population included 15 patients aged 12-15 years and 16 patients aged 16-21 years; all had baseline nasal congestion, defined as a subscore of at least two out of three on the Total Nasal Symptom Score (TNSS). The primary outcome was changes in the nasal congestion subscore on the TNSS over a 2-week treatment period compared with baseline. The treatment consisted of wearing the SONU headband for 15 minutes twice daily. Participants were instructed to continue any regular medications and discontinue any as-needed medications during the treatment period.

Overall, use of the headband reduced the nasal congestion subscore by an average of 35.2%, a change of -0.76 points (95% CI, -0.97 to -0.54; P < .0001). The secondary outcome of aggregate TNSS changed significantly from baseline by -2.74 (95% CI, -3.41 to -2.06; P < .0001), which translated to a 40.5% reduction in congestion. Both age groups showed significant improvements from baseline according to TNSS scores (P < .0001 for both groups).

Post hoc analyses of TNSS subcomponents of sneezing, nasal itching, and rhinorrhea also showed significant improvements after sound wave treatment compared with baseline.

Adherence to the intervention was high, at 85.9%, and 373 of a possible 434 treatments were completed. No adverse events associated with the treatment were reported.

“We were excited to observe possible benefits in the pediatric population that were comparable to that seen in more robust studies of the adult population,” Khanwalkar said. “When considering the effect size, acoustic resonance therapy appears to offer congestion relief that is similar to that seen with nasal corticosteroids without the need for medication exposure in this young population, although we did not perform a head-to-head comparison of the two treatments in our study,” he said.

Takeaways and Research Gaps

Novel and innovative treatments are desirable to manage pediatric rhinitis, said Khanwalkar. ART is expanding as a first-line treatment for adults suffering from chronic rhinitis, and its individualized treatment paradigm and favorable side effect profile are making it popular with both primary care physicians and specialists, he said. “For children specifically, acoustic resonance therapy may be a preferable alternative to medication management,” he said. 

The study’s main limitation was the lack of a placebo or sham arm, and a double-blind, randomized, sham-controlled trial in the pediatric population would reliably confirm clinical benefit, Khanwalkar said. Larger sham-controlled studies in adults showed significant improvement using the device compared with the sham, which was reassuring and led to FDA clearance, he said. The current study evaluated children older than 12 years, but Khanwalkar and colleagues intend to study effects in children younger than 12 years as well.

Promising Nonpharmacologic Option

Any investigation of nonpharmacologic and zero-risk intervention in children is exciting, particularly for such a commonly reported symptom as nasal congestion, said Emily F. Boss, MD, MPH, professor of otolaryngology, pediatrics, and health policy & management at Johns Hopkins University, Baltimore.

Although the results are encouraging, the authors acknowledged the limitations, notably the lack of a control group, said Boss.

Therefore, “it is not clear whether the improvement was truly due to the treatment itself or if the results reflect the natural course of symptoms or disease, placebo effect, or reporting bias,” she said. The reliance on self-reports was an additional limitation, and symptoms are subjective, although the TNSS is a validated measure, she noted. The small number of patients also makes for less reliable subgroup comparisons, such as for previous medication use, Boss added.

“All of this said, patients in this study reported feeling better, and the promise of any no-risk and potential-reward intervention that does not involve medication, surgery, or use of health resources is very appealing,” Boss said.

The study was funded by SoundHealth, the manufacturer of the SONU device, and Khanwalkar reported serving on the scientific advisory board for the company. Boss reported having no financial conflicts to disclose.