Otitis Media With Effusion (OME)NCT07777302
EarFlo: A Non-Invasive Treatment for Otitis Media With Effusion & Eustachian Tube Dysfunction in Adults
A study testing EarFlo Device in people with Otitis Media With Effusion (OME) and Eustachian Tube Dysfunction, run by Philip Perez at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Otitis Media With Effusion (OME), Eustachian Tube Dysfunction, Otitis Media With Effusion
- What is being tested?
- EarFlo Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 Aug 2026to 15 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Zarna P Lalwani, BDS, MPH contact
United States4 sites
Eye and Ear Institute / UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
UPMC Montefiore
Pittsburgh, Pennsylvania, 15213
UPMC Mercy
Pittsburgh, Pennsylvania, 15219
UPMC Shadyside
Pittsburgh, Pennsylvania, 15232
About this study
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.
Read the detailed 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 aims to evaluate the safety, tolerability, and short-term effects of the EarFlo device in an adult population diagnosed with OME and/or ETD.
This is a prospective, single-visit, non-randomized interventional study evaluating the safety, tolerability, and short-term effects of the EarFlo device in adults with otitis media with effusion (OME) and/or Eustachian tube dysfunction (ETD). The study focuses on short-term changes in subjective symptoms and objective middle ear findings following a single supervised use of the device in a clinical setting.
Eligible participants will attend one study visit. At baseline, participants will complete a validated symptom questionnaire and undergo routine otologic evaluation, including otoscopic examination and tympanometry, as clinically appropriate. Otoscopic images of the tympanic membrane and middle ear will be captured prior to device use.
Participants will then receive instruction on proper use of the EarFlo device from trained study personnel. The device will be used once during the visit while the participant drinks a liquid of their choice. Device use is noninvasive and does not involve surgical procedures or sedation.
Following device use, participants will repeat middle ear assessments, including tympanometry and otoscopic examination. Post-use otoscopic images will be captured and compared with baseline images. Otoscopic images will be reviewed and categorized as improved or not improved by a physician who is blinded to the timing of image acquisition (pre- or post-device use).
The primary objectives of this study are to evaluate the safety, tolerability, and short-term effects of the EarFlo device in adults and to obtain preliminary estimates of its short-term effects on ear pressure symptoms and middle ear findings following a single supervised use. As a single-arm pilot study, the findings are intended to inform the design of future controlled studies. No long-term follow-up is required.
- Being tested
- EarFlo Device
- Keywords
- OME, ETD, Otitis Media with Effusion, Eustachian Tube Dysfunction, EarFlo, Noninvasive Device, Middle Ear Function, Ear Pressure symptoms, autoinflation
- Medical subject headings
- Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EarFlo DeviceDevice
Also called Earflo (Model EF001)
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 group | Role | What they receive |
|---|---|---|
| EarFlo Intervention Arm | Experimental | Participants in this single arm will undergo baseline assessments, use the EarFlo device once during a clinic visit, and complete post-use assessments to evaluate short-term changes in ear symptoms and middle ear function. Receives: Device: EarFlo Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in middle ear pressure and compliance measured by tympanometry following single use of the EarFlo device
Change in middle ear pressure measured using tympanometric peak pressure (daPa) immediately before and immediately after a single supervised in-clinic use of the EarFlo device. Tympanometric peak pressure values will be compared to evaluate short-term changes in middle ear function. More positive values indicate improved middle ear pressure equalization.
Measured: Immediately before EarFlo device use (baseline) and immediately after EarFlo device use (post-intervention) during the single study visit
Blinded otoscopic image assessment of middle ear effusion before and after EarFlo device use
Otoscopic images obtained immediately before and immediately after EarFlo device use will be independently reviewed by a blinded physician. Images will be classified as improved or not improved based on predefined evidence of middle ear effusion and tympanic membrane appearance.
Measured: Immediately before EarFlo device use (baseline) and immediately after EarFlo device use (post-intervention) during the single study visit
Secondary outcomes (1)
Incidence, severity, and relatedness of adverse events
Safety and tolerability of the EarFlo device in Adults will be assessed based on the number and percentage of participants experiencing adverse events. Adverse events will be summarized according to incidence, severity, and relationship to the EarFlo device or study procedure.
Measured: From initiation of EarFlo device use through the end of the single study visit, up to 30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start27 Aug 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion15 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Otitis Media With Effusion (OME)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, single-group design. All participants receive the same intervention, that is a single supervised in-clinic use of the EarFlo device. Each participant serves as their own control, with outcomes assessed within-subject by comparing baseline (pre-use) measurements to those obtained immediately after device use. There is no separate control or comparison group.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philip Perez
- Sponsor type
- University, hospital or other
- Collaborators
- Earflo Inc.
- Responsible party
- Sponsor-investigator, Philip Perez, University of Pittsburgh
- Investigators
- Philip L Perez, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777302
- Sponsor's protocol ID
- STUDY25050186
- Status last verified
- Aug 2026
- First submitted
- 21 Jul 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no current plan to share individual participant data (IPD). Any future data sharing would require separate review and approval and would be conducted in accordance with institutional policies and applicable regulations.
Publications
Hura N, Soto MJ, Lalwani Z, Oldakowska I, Oldakowski M, Bumbak P, Santa Maria PL. A novel autoinflation device for persistent pediatric otitis media with effusion: A prospective single-arm cohort study. Am J Otolaryngol. 2026 Jul-Aug;47(4):104862. doi: 10.1016/j.amjoto.2026.104862. Epub 2026 Jun 12.
PubMed 42296786
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EarFlo: A Non-Invasive Treatment for Otitis Media With Effusion & Eustachian Tube Dysfunction in Adults
- ClinicalTrials.gov ID
- NCT07777302
- Acronym / sponsor ID
- STUDY25050186
- Keywords
- OME, ETD, Otitis Media with Effusion, Eustachian Tube Dysfunction, EarFlo, Noninvasive Device, Middle Ear Function, Ear Pressure symptoms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Philip PerezUniversity, hospital or other
- Collaborators
- Earflo Inc.
- Study start
- 27 Aug 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 aims to evaluate the safety, tolerability, and short-term effects of the EarFlo device in an adult population diagnosed with OME and/or ETD.
This is a prospective, single-visit, non-randomized interventional study evaluating the safety, tolerability, and short-term effects of the EarFlo device in adults with otitis media with effusion (OME) and/or Eustachian tube dysfunction (ETD). The study focuses on short-term changes in subjective symptoms and objective middle ear findings following a single supervised use of the device in a clinical setting.
Eligible participants will attend one study visit. At baseline, participants will complete a validated symptom questionnaire and undergo routine otologic evaluation, including otoscopic examination and tympanometry, as clinically appropriate. Otoscopic images of the tympanic membrane and middle ear will be captured prior to device use.
Participants will then receive instruction on proper use of the EarFlo device from trained study personnel. The device will be used once during the visit while the participant drinks a liquid of their choice. Device use is noninvasive and does not involve surgical procedures or sedation.
Following device use, participants will repeat middle ear assessments, including tympanometry and otoscopic examination. Post-use otoscopic images will be captured and compared with baseline images. Otoscopic images will be reviewed and categorized as improved or not improved by a physician who is blinded to the timing of image acquisition (pre- or post-device use).
The primary objectives of this study are to evaluate the safety, tolerability, and short-term effects of the EarFlo device in adults and to obtain preliminary estimates of its short-term effects on ear pressure symptoms and middle ear findings following a single supervised use. As a single-arm pilot study, the findings are intended to inform the design of future controlled studies. No long-term follow-up is required.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, single-group design. All participants receive the same intervention, that is a single supervised in-clinic use of the EarFlo device. Each participant serves as their own control, with outcomes assessed within-subject by comparing baseline (pre-use) measurements to those obtained immediately after device use. There is no separate control or comparison group.
| Arm | Type | Receives |
|---|---|---|
| EarFlo Intervention Arm | Experimental | Device: EarFlo DeviceParticipants in this single arm will undergo baseline assessments, use the EarFlo device once during a clinic visit, and complete post-use assessments to evaluate short-term changes in ear symptoms and middle ear function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EarFlo DeviceAlso: Earflo (Model EF001)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. | Device | EarFlo Intervention Arm |
Primary outcome
Change in middle ear pressure and compliance measured by tympanometry following single use of the EarFlo device
Time frame: Immediately before EarFlo device use (baseline) and immediately after EarFlo device use (post-intervention) during the single study visit
Change in middle ear pressure measured using tympanometric peak pressure (daPa) immediately before and immediately after a single supervised in-clinic use of the EarFlo device. Tympanometric peak pressure values will be compared to evaluate short-term changes in middle ear function. More positive values indicate improved middle ear pressure equalization.
Blinded otoscopic image assessment of middle ear effusion before and after EarFlo device use
Time frame: Immediately before EarFlo device use (baseline) and immediately after EarFlo device use (post-intervention) during the single study visit
Otoscopic images obtained immediately before and immediately after EarFlo device use will be independently reviewed by a blinded physician. Images will be classified as improved or not improved based on predefined evidence of middle ear effusion and tympanic membrane appearance.
1 secondary outcome
Incidence, severity, and relatedness of adverse events
Time frame: From initiation of EarFlo device use through the end of the single study visit, up to 30 minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Background: PubMed 42296786Hura N, Soto MJ, Lalwani Z, Oldakowska I, Oldakowski M, Bumbak P, Santa Maria PL. A novel autoinflation device for persistent pediatric otitis media with effusion: A prospective single-arm cohort study. Am J Otolaryngol. 2026 Jul-Aug;47(4):104862. doi: 10.1016/j.amjoto.2026.104862. Epub 2026 Jun 12.
- Individual participant dataSharing planned: No. There is no current plan to share individual participant data (IPD). Any future data sharing would require separate review and approval and would be conducted in accordance with institutional policies and applicable regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zarna P Lalwani, BDS, MPH contact
Philip L Perez, MD principal investigator
University of Pittsburgh
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EarFlo Device in people with Otitis Media With Effusion (OME) and Eustachian Tube Dysfunction, run by Philip Perez at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zarna P Lalwani, BDS, MPH (zpl5@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in middle ear pressure and compliance measured by tympanometry following single use of the EarFlo device (time frame: Immediately before EarFlo device use (baseline) and immediately after EarFlo device use (post-intervention) during the single study visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07777302, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.