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

Tel Aviv Sourasky Medical Center

Status and phase: Unknown; Phase 4

Conditions: Otitis Media; Conductive Hearing Loss

Treatments: Device: Ear Popper

Study type: Interventional

Funder types: Other

Identifiers

NCT00393159

TASMC06YO3567CTIL

Details and patient eligibility

About

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.

Sex: All

Ages: 3 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)