What this study is
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.
What's being tested
- EarFlo Device
Intervention · 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
- Sponsor
- Philip Perez
- Conditions
- Otitis Media With Effusion (OME) · Eustachian Tube Dysfunction · Otitis Media With Effusion
- Enrolling
- 100 people
- Starts
- 2026-08-27
- Est. completion
- 2028-05-15
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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. (<4 weeks)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (4)
4 openEye 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
Study team
Sponsor
Philip Perez
Study ID STUDY25050186
Principal investigator
Philip L Perez, MD
University of Pittsburgh
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.