The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children
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ClinicalTrials.gov Identifier: NCT00393159
Recruitment Status : Unknown
Verified October 2006 by Tel-Aviv Sourasky Medical Center. Recruitment status was: Recruiting
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.
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Ages Eligible for Study:
3 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Serous Otitis Media for More Then 3 months
Conductive Hearing Loss of More Then 15 decibels.
Tympanometry type B or C.
No History of Tympanostomy Tube Insertion or Adenoidectomy
No Cranio or Facial Malformations
No Acute Upper Respiratory Tract Infection or Acute Otitis Media