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

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.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. (\