The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00393159

Enrollment

Registered

2006-10-26

Start date

2006-10-31

Completion date

Unknown

Last updated

2006-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conductive Hearing Loss, Otitis Media

Keywords

Effusion, Otitis, Media, Ear, Popper, Children

Brief summary

This study is designed to check the effect of the use of the ear popper device on serous otitis media in children and on the conductive hearing loss accompanying the otitis. It is intended that 30 children aged 3-18 years will participate in the study. The inclusion criteria are : clinical serous otitis media for a duration of more then 3 months, a conductive hearing loss of at least 15 decibels air bone gap and tympanometry type B or C. The children will use the ear popper for 7 weeks. They will undergo otologic examination, audiometry and tympanometry at the beginning ao the trial, at 7 weeks and at 3 months from the beginning of the trial. The otologic findings and the audiometry and tympanometry results before and after the trial will be compared. We will try to determine whether the use of the ear popper in the test group will improve the conductive hearing loss and prevent the need for tympanostomy tube insertion.

Interventions

DEVICEEar Popper

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 18 Years

Healthy volunteers

Yes

Inclusion criteria

* Serous Otitis Media for More Then 3 months * Conductive Hearing Loss of More Then 15 decibels. * Tympanometry type B or C.

Exclusion criteria

* No History of Tympanostomy Tube Insertion or Adenoidectomy * No Cranio or Facial Malformations * No Acute Upper Respiratory Tract Infection or Acute Otitis Media

Design outcomes

Primary

Measure	Time frame
Audiometry and tympanometry test results at at 7 weeks and 3 months from beginning of use of the ear popper.	—
Otoscopic findings at at 7 weeks and 3 months from beginning of use of the ear popper.	—

Secondary

Measure	Time frame
Hearing improvement at 7 weeks and 3 months from the beginning of the trial.	—
Rate of referrals for tympanostomy tube insertion at 3 months	—

Countries

Israel

Contacts

Primary ContactYael Oestreicher, MD

dkyo@barak-online.net.il972-3-6974517

Backup ContactAri DeRowe, MD

972-3-6974517

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026