EarFlo: A Non-Invasive Treatment for Otitis Media With Effusion & Eustachian Tube Dysfunction in Adults
Philip Perez
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.
Description
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 aim…