EarFlo: A Non-Invasive Treatment for Otitis Media With Effusion & Eustachian Tube Dysfunction in Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPhilip Perez
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years and older.
Adults with confirmed Otitis Media with Effusion (OME) diagnosis with clinical assessment.
Adults with confirmed dilatory ETD (Eustachian Tube Dysfunction) on clinical assessment.
Willingness to refrain from initiating new treatments for OME/ETD (e.g., new surgical or device treatments, tympanostomy tubes) during the study period. Standard care will not be refrained if needed.
Disqualifiers
Presence of acute otitis media, ear infection, or otorrhea within the past 4 weeks.
Any medical, psychiatric, or cognitive condition that, in the opinion of the investigators, would interfere with study participation or compliance.
Inability to use the EarFlo device as instructed (e.g., due to severe nasal obstruction, craniofacial anomalies, or neuromuscular disorders).
Recent eye, ear or nose surgeries or ear trauma. (<4 weeks)
Trial design
Design model
Single group
Treatments tested in this trial
EarFlo Device
DeviceThe 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: EarFlo Intervention ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 visit2
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 visitSecondary outcomes
1
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.Sponsors and contacts
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Source ClinicalTrials.gov
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