SinuSonic for ETD and Facial Pain: Acoustic Vibration + Oscillating Expiratory Pressure

Treatment of Eustachian Tube Dysfunction (ETD) and Facial Pain With Combined Acoustic Vibration and Oscillating Expiratory Pressure

This study was originally designed with three aims: (1) healthy controls to assess nasal nitric oxide, (2) adults with Eustachian Tube Dysfunction (ETD), and (3) adults with facial pain/pressure. However, only the ETD cohort (Aim 2) was initiated and enrolled. During study conduct, additional symptom and pain assessments (including MPQ-SF and mBPI-sf) were collected in the ETD cohort for exploratory purposes. All results in this record reflect ETD cohort participants who used the SinuSonic device twice daily for 6 weeks.

Study Overview

• Status: Completed
• Conditions: Facial Pain; Eustachian Tube Dysfunction
• Intervention / Treatment: Device: SinuSonic Device

Detailed Description

The original protocol included three planned cohorts:

• Aim 1 - healthy controls for exhaled nasal nitric oxide (NO) testing;
• Aim 2 - adults with Eustachian Tube Dysfunction (ETD) to evaluate safety and efficacy;
• Aim 3 - adults with facial pain/pressure.

Only Aim 2 (ETD cohort) was opened to enrollment. Aims 1 and 3 were not initiated, and no participants were enrolled in those cohorts.

During study conduct, several patient-reported outcome measures originally associated with Aim 3 (MPQ-SF and mBPI-sf) were also administered to the ETD cohort for exploratory symptom profiling. Therefore, the Results section includes ETD-specific measures (ETDQ-7, ETD Symptom VAS, tympanogram) as well as pain-related measures for participants enrolled in the ETD cohort. All analyses derive exclusively from the ETD cohort participants (N=29 with baseline data).

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Sinus Center - Medical Univesity of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

AIM 1

Inclusion Criteria:

• Adults 18 years or older with no symptoms of URI, ETD or other ENT conditions

Exclusion Criteria:

• Sinonasal or ear surgery within last 3 months (including balloon ET dilation)
• Any ENT condition that may impact upper airway to include sinusitis, otitis, or allergies
• Upper respiratory illness within last 2 weeks
• Topical decongestant use in last week
• Current nasal crusting or ulceration on rhinoscopy
• History of severe nose bleeding within last 3 months
• Known pregnancy
• Allergic sensitivity to silicone or any other component of device
• Inability to read and understand English
• Inability to perform treatment due to underlying medical condition

AIM 2

Inclusion:

• Adults 18 years or older with diagnosis of ETD by an otolaryngologist
• ≥6 months of symptoms duration
• ≥3 ETD symptoms (ear pressure, feeling that ears are clogged, cracking/popping of ears, muffled hearing, tinnitus)
• ETDQ-7 score ≥ 3
• Audiogram within the last year

Exclusion:

• Sinonasal or ear surgery within last 3 months (including balloon ET dilation)
• Indwelling ear tubes
• Tympanic membrane perforation
• Hx of cholesteatoma, mastoidectomy, tympanoplasty, or ossicular chain reconstruction
• Patulous ET
• Hx of Meniere's disease
• Moderate or severe nasal valve collapse
• Grade 3-4 polyps
• Upper respiratory illness within last 2 weeks
• Topical decongestant use in last week
• Current nasal crusting or ulceration on rhinoscopy
• History of severe nose bleeding within last 3 months
• Known pregnancy
• Allergic sensitivity to silicone or any other component of device
• Inability to read and understand English
• Inability to perform treatment due to underlying medical condition

AIM 3

Inclusion:

• Adults 18 years or older who complain of facial pain or pressure
• ≥3 months of symptoms duration (can be intermittent)
• Pain/pressure VAS score ≥ 5

Exclusion:

• Sinonasal surgery within the last 3 months
• Grade 3-4 polyps
• Upper respiratory illness within last 2 weeks
• Topical decongestant use in last week
• Current nasal crusting or ulceration on rhinoscopy
• History of severe nose bleeding within last 3 months
• Known pregnancy
• Allergic sensitivity to silicone or any other component of device
• Inability to read and understand English
• Inability to perform treatment due to underlying medical condition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SinuSonic Device; Participants used the SinuSonic device twice daily for 3 minutes in the home setting for 6 weeks. Baseline and 6-week assessments included ETDQ-7, ETD Symptom VAS, and tympanogram. Additional symptom and pain measures (MPQ-SF, mBPI-sf) were collected for exploratory purposes in this cohort.	Device: SinuSonic Device; A medical device that combines acoustic vibration with oscillating expiratory pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eustachian Tube Dysfunction (ETD) Symptom Visual Analog Scale (VAS) - Total Score	Five ETD symptoms (ear pressure, ear clogging, cracking/popping, muffled hearing, tinnitus) are each rated on a 10-cm line from 0 = "Not troublesome" to 10 = "Worst thinkable/troublesome." The total score is the sum of all five items (range 0-60). Higher scores indicate worse symptoms.	6 weeks (baseline to 6-week follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
McGill Pain Questionnaire - Short Form (MPQ-SF) Total Score	The MPQ-SF includes 15 descriptors scored from 0 (none) to 3 (severe). Total score ranges from 0-45. Higher scores indicate worse pain.	4 weeks
Modified Brief Pain Inventory - Short Form (mBPI-sf): Worst Pain	Participants rate worst pain on an 11-point scale from 0 = "No pain" to 10 = "Worst pain imaginable." Higher scores indicate worse pain.	4 weeks

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2020
• Primary Completion (Actual): April 25, 2023
• Study Completion (Actual): April 25, 2023

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Facial Pain
• Other Study ID Numbers: PRO#00097842

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not Applicable. The investigators plan to publish this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No