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NOT YET RECRUITING
NCT07777302
NA

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

Sponsor: Philip Perez

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-08-27

Completion Date

2028-05-15

Last Updated

2026-08-20

Healthy Volunteers

No

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.

Locations (4)

Eye and Ear Institute / UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

UPMC Montefiore

Pittsburgh, Pennsylvania, United States

UPMC Mercy

Pittsburgh, Pennsylvania, United States

UPMC Shadyside

Pittsburgh, Pennsylvania, United States