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

NCT07777302 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-08-20

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Earflo Inc.

    collaborator UNKNOWN

  • Philip Perez

    lead OTHER

Principal Investigators

  • Philip L Perez, MD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-27
Primary Completion
2027-11-30
Completion
2028-05-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07777302 on ClinicalTrials.gov