An interventional study of EarFlo Device in Otitis Media With Effusion (OME), Eustachian Tube Dysfunction and Otitis Media With Effusion, sponsored by Philip Perez. Not yet recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Philip Perez · Not applicable, Interventional, and Treatment
This study evaluates the use of the EarFlo device in adults with clinically confirmed Eustachian tube dysfunction and/or otitis media with effusion. The purpose of the study is to assess the safety, tolerability, and short-term effects of device use on ear pressure symptoms and middle ear function.
Participants will complete a brief symptom questionnaire, undergo routine ear examinations and testing, and use the EarFlo device once during a clinic visit. Ear examination and testing will be repeated after device use to evaluate any short-term changes. This study involves a single study visit and does not include any surgical or invasive procedures.
Otitis media with effusion (OME) is a condition characterized by the presence of fluid in the middle ear and may occur in both children and adults. Eustachian tube dysfunction (ETD) is commonly associated with OME and may contribute to symptoms such as ear fullness, pressure, muffled hearing, and discomfort due to impaired ventilation of the middle ear.
The EarFlo device is designed to promote Eustachian tube opening during swallowing. The EarFlo device has been previously evaluated in pediatric populations with otitis media with effusion and is FDA-cleared for its intended use.This study aims to evaluate the safety, tolerability, and short-term effects of the EarFlo device in an adult population diagnosed with OME and/or ETD.
This is a prospective, single-visit, non-randomized interventional study evaluating the safety, tolerability, and short-term effects of the EarFlo device in adults with otitis media with effusion (OME) and/or Eustachian tube dysfunction (ETD). The study focuses on short-term changes in subjective symptoms and objective middle ear findings following a single supervised use of the device in a clinical setting.
Eligible participants will attend one study visit. At baseline, participants will complete a validated symptom questionnaire and undergo routine otologic evaluation, including otoscopic examination and tympanometry, as clinically appropriate. Otoscopic images of the tympanic membrane and middle ear will be captured prior to device use.
Participants will then receive instruction on proper use of the EarFlo device from trained study personnel. The device will be used once during the visit while the participant drinks a liquid of their choice. Device use is noninvasive and does not involve surgical procedures or sedation.
Following device use, participants will repeat middle ear assessments, including tympanometry and otoscopic examination. Post-use otoscopic images will be captured and compared with baseline images. Otoscopic images will be reviewed and categorized as improved or not improved by a physician who is blinded to the timing of image acquisition (pre- or post-device use).
The primary objectives of this study are to evaluate the safety, tolerability, and short-term effects of the EarFlo device in adults and to obtain preliminary estimates of its short-term effects on ear pressure symptoms and middle ear findings following a single supervised use. As a single-arm pilot study, the findings are intended to inform the design of future controlled studies. No long-term follow-up is required.
88 studies on the registry are indexed under Otitis Media with Effusion; 17 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 61 interventional studies indexed under Otitis Media with Effusion.
Browse Otitis Media with Effusion studies →This is the only study on the registry with Philip Perez as lead sponsor.
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Exclusion Criteria:
Participants in this single arm will undergo baseline assessments, use the EarFlo device once during a clinic visit, and complete post-use assessments to evaluate short-term changes in ear symptoms and middle ear function.
Device: EarFlo Device
The EarFlo device is a non-invasive, cup-based device used during swallowing to help equalize middle ear pressure. By delivering a controlled puff of air through the nose during swallowing, it assists Eustachian tube opening to relieve negative middle ear pressure. Participants will use the device once during a single clinic visit while drinking water or a beverage of their choice. No surgery or invasive procedures are involved.
Also known as: Earflo (Model EF001)
Change in middle ear pressure and compliance measured by tympanometry following single use of the EarFlo device
Change in middle ear pressure measured using tympanometric peak pressure (daPa) immediately before and immediately after a single supervised in-clinic use of the EarFlo device. Tympanometric peak pressure values will be compared to evaluate short-term changes in middle ear function. More positive values indicate improved middle ear pressure equalization.
Time frame: Immediately before EarFlo device use (baseline) and immediately after EarFlo device use (post-intervention) during the single study visit
Blinded otoscopic image assessment of middle ear effusion before and after EarFlo device use
Otoscopic images obtained immediately before and immediately after EarFlo device use will be independently reviewed by a blinded physician. Images will be classified as improved or not improved based on predefined evidence of middle ear effusion and tympanic membrane appearance.
Time frame: Immediately before EarFlo device use (baseline) and immediately after EarFlo device use (post-intervention) during the single study visit
Incidence, severity, and relatedness of adverse events
Safety and tolerability of the EarFlo device in Adults will be assessed based on the number and percentage of participants experiencing adverse events. Adverse events will be summarized according to incidence, severity, and relationship to the EarFlo device or study procedure.
Time frame: From initiation of EarFlo device use through the end of the single study visit, up to 30 minutes.
Plan to share: No — There is no current plan to share individual participant data (IPD). Any future data sharing would require separate review and approval and would be conducted in accordance with institutional policies and applicable regulations.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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