EarFlo: A Non-Invasive Treatment for Otitis Media With Effusion & Eustachian Tube Dysfunction in Adults

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Philip Perez
Study ID
NCT07777302
Status
Not Yet Recruiting

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Conditions

  • Eustachian Tube Dysfunction
  • Otitis Media With Effusion
  • Otitis Media With Effusion (OME)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EarFlo Device — 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.

Study Details

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.

Key Dates

First listed
Aug 20, 2026
Start date
Aug 27, 2026
Status verified
Aug 2026
Primary completion
Nov 30, 2027
Completion
May 15, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: EarFlo Intervention Arm
    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.

Primary Outcome Measure

Change in middle ear pressure and compliance measured by tympanometry following single use of the EarFlo device [ Time Frame: Immediately before EarFlo device use (baseline) and immediately after EarFlo device use (post-intervention) during the single study visit ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Eye and Ear Institute / UPMC PresbyterianPittsburghPennsylvania15213-
UPMC MercyPittsburghPennsylvania15219-
UPMC MontefiorePittsburghPennsylvania15213-
UPMC ShadysidePittsburghPennsylvania15232-

Find similar trials in Pittsburgh, PA

By research site
Eye and Ear Institute / UPMC Presbyterian· Pittsburgh, PAUPMC Mercy· Pittsburgh, PAUPMC Montefiore· Pittsburgh, PAUPMC Shadyside· Pittsburgh, PA

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