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.

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).

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

Not Applicable. The investigators plan to publish this study.

One participant withdrew before baseline. Therefore, 29 participants completed baseline assessments and were included in all analyses.

Participants were monitored for adverse events from baseline through 6 weeks, consistent with the ETD protocol.

Non-serious adverse events were monitored throughout the study. No events were observed; therefore, 29 participants were at risk Only the ETD cohort was enrolled; all AE data derive from these participants.

Only the ETD cohort enrolled; other planned cohorts were not initiated. Pain measures were collected for exploratory use in ETD participants. This single-arm pilot with a small sample lacks a control group, limiting generalizability and causal interpretation.