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SinuSonic Clinical Trial Data Show Safety and Efficacy for a Novel, Nonpharmacologic Device for Nasal Congestion Relief

FOR IMMEDIATE RELEASE

Columbia, S.C., Nov. 26, 2019 – Healthy Humming, LLC is pleased to announce positive topline data from a prospective outcomes study, which assessed the safety and efficacy of the SinuSonic, a nasal congestion treatment device which combines nasal acoustic vibration with oscillating expiratory pressure.

While chronic nasal congestion impacts millions of Americans each year1, currently available treatments, including pharmacologic and surgical options, demonstrate variable efficacy and side effects. The SinuSonic is the only patents-pending treatment option available today that combines the delivery of acoustic vibrations with the application of oscillating expiratory pressure to relieve nasal congestion. The latest independent study, performed at the Medical University of South Carolina, investigated both the safety and efficacy of SinuSonic for the treatment of nasal congestion.

“We were quite surprised at the effectiveness of the SinuSonic device for patients with nasal congestion. Our data, which will be presented formally early next year, showed significant improvement across all primary and secondary study endpoints after use of SinuSonic, including both objective and patient-reported outcomes,” said principal author, Zachary M. Soler, M.D., M.Sc. of the Medical University of South Carolina.

Topline outcomes from the study included:

  • Patients exhibited significant increases (15%) in Peak Nasal Inspiratory Flow2 (PNIF) within five minutes of using the device (p<0.001).
  • After two weeks of twice-daily use, PNIF scores increased over 30% versus initial baseline, a mean improvement of 25.0 L/min which was both statistically and clinically significant (p<0.001).
  • The Nasal Obstruction and Septoplasty Effectiveness (NOSE) score improved from a mean 50.4 to 23.3, a difference which was both statistically and clinically significant (p<0.001).
  • Significant improvements were seen for all patient-reported outcome metrics at each time point, including symptoms of nasal congestion, nasal drainage, and sinonasal pressure.
  • No major adverse events were detected, with 97.5% of subjects reporting no pain or discomfort at the study conclusion.
  • At study completion, 87.5% of subjects noted they would recommend SinuSonic to a friend or family member.

“We’re encouraged by the preliminary topline results from this phase I/II clinical trial,” said David Lewis, co-founder of Healthy Humming. “These results should give confidence to patients and physicians that SinuSonic is supported by scientific evidence demonstrating that patients not only feel better but have real changes in nasal airflow after using our device. We’re excited for the full study results to be presented and published next year. In the meantime, we look forward to spreading the word that SinuSonic is a great option for millions of Americans suffering from nasal congestion.”

 This latest study aimed to test the safety and effectiveness of the SinuSonic device on adults with moderate to severe nasal congestion. The study was performed at the Sinus Center of the Medical University of South Carolina. While final results will be formally presented in early 2020, more information about the study can be found posted on the U.S. National Library of Medicine's clinical study resource center by visiting ClinicalTrials.gov

 

Disclaimers

Though Dr. Soler is 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.

1Stewart M, Ferguson B, Fromer L. Epidemiology and burden of nasal congestion. Int J Gen Med 2010;3:37-45

2 Peak Nasal Inspiratory Flow is an objective measure that measures nasal airflow during inspiration and supplements standard patient reported outcome measures.