N/A N=30 Treatment

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

Eustachian Tube Dysfunction · Facial Pain

Bottom Line

View on ClinicalTrials.gov: NCT04404036 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2026

Primary outcome: Primary: Eustachian Tube Dysfunction (ETD) Symptom Visual Analog Scale (VAS) - Total Score — 59.6 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SinuSonic Device (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medical University of South Carolina
Primary completion: Apr 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Eustachian Tube Dysfunction (ETD) Symptom Visual Analog Scale (VAS) - Total Score	59.6	—
SECONDARY McGill Pain Questionnaire - Short Form (MPQ-SF) Total Score	12.2	—
SECONDARY Modified Brief Pain Inventory - Short Form (mBPI-sf): Worst Pain	4.4	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04404036). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.