Results Demonstrate Device Safety and Effectiveness
SinuSonic announced today publication of safety and effectiveness data of the company’s device. Study outcomes were published online in the prestigious International Forum of Allergy and Rhinology (IFAR) — the official journal of the American Rhinologic Society (ARS) and the American Academy of Otolaryngic Allergy (AAOA) - in a paper titled, ‘Safety and Efficacy of a Novel Device Combining Acoustic Vibration with Oscillating Expiratory Pressure for the Treatment of Nasal Congestion’.
A majority of current treatments for nasal congestion and rhinitis are decongestants, antihistamines, and topical steroid nasal sprays, which provide only partial or temporary relief and occasionally with significant side effects. A revolutionary solution for congestion relief, the SinuSonic device enables patients to treat moderate to severe nasal congestion by simply breathing into the device, triggering the application of gentle acoustic vibrations and light resistant pressure to naturally provide relief.
The prospective study, conducted at the Medical University of South Carolina in late 2019, reports clinically and statistically significant improvements in 40 patients with chronic nasal congestion. Patients used the SinuSonic device twice daily for five weeks. Rhinoscopy and patient questionnaires were used to assess safety. Peak nasal inspiratory flow (PNIF), which provides objective measurements, along with clinically recognized qualitative measures were used to assess efficacy. In summary, preliminary data on the use of acoustic vibration and oscillating expiratory pressure for patients with nasal congestion is compelling and promising.
“We were excited to see measurable positive changes in both objective nasal airflow as well as patient reported symptom scores and quality of life,” said Dr. Rodney Schlosser, an internationally known sinus specialist and one of the lead researchers on the study. “Chronic nasal congestion afflicts approximately 20 percent of the population, and often with significant quality of life impacts. Our initial results demonstrate that SinuSonic is a safe and effective treatment alternative to conventional pharmacologic and surgical treatment for these patients.”
- Patients exhibited significant increases (15%) in PNIF within five minutes of using the device (p<0.001).
- Following a two week, twice-daily regimen, PNIF scores increased over 30% versus initial baseline - a mean improvement of 25.0 L/min, and statistically and clinically significant (p<0.001).
- The Total Nasal Symptom Scores improved by 3.7 points, with 80% of patients achieving a clinically relevant improvement (p<0.001).
- Improvements were seen for all patient-reported outcome metrics at each interval, including reduced symptoms of nasal congestion, nasal drainage and sinonasal pressure.
- No major adverse events detected, with 97.5% of subjects reporting zero pain or discomfort at study conclusion.
- At study completion, 87.5% of subjects indicated they would recommend SinuSonic to a friend or family member.
This study data will be presented to the American Rhinologic Society during the Combined Otolaryngology Spring Meetings in Atlanta, Georgia on April 22-26, 2020. For more information on SinuSonic, to request a sample, or to schedule a demonstration, please call or email our editorial contacts.
ABOUT NASAL CONGESTION
Chronic nasal congestion impacts roughly 20% of the population and is associated with reduced quality of life, difficulty sleeping, reduced daytime performance, and increased healthcare utilization. It has been estimated that the financial impact of chronic nasal congestion is more than $5 – 10 billion annually. A survey conducted by Allergies in Americas found that despite the availability of pharmacologic options, many patients are not satisfied with available options.
Founded in Columbia, South Carolina, and born through the research and partnerships of Richard K. Bogan, MD and David J. Lewis, SinuSonic is the first-ever patent(s) pending nasal congestion relief device to use acoustic vibrations to help provide nasal congestion relief. SinuSonic is designed in the U.S. with parts molded in the U.S. and assembled in an FDA-registered facility in Columbia, South Carolina. Since launching in July 2019, SinuSonic is being used in all 50 states. For more information and to view instructional videos, visit www.sinusonic.com.
Though Dr. Schlosser and Dr. Soler are currently employed by the Medical University of South Carolina (MUSC), neither the Medical University of South Carolina, nor any affiliated organizations shall be responsible for information provided herein under any theory of liability or indemnity.