Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Comparison of Surgical and a New Non-Surgical Treatment Methods for Secretory Otitis Media in Children- Hearing and Socioeconomic Aspects
Brief Summary:
Secretory otitis media (SOM) or middle ear effusion is a common finding affecting children in the age of 4-5 years. It is usually associated with 5-15 deci Bells hearing loss. Although spontaneous resolution with normalisation of hearing is the usual outcome, this can take several months. Secretory otitis media is the most common cause of hearing impairment in the paediatric age group. When the hearing loss caused by SOM is bilateral and persists for 3-6 months or more, surgery with tympanostomy tube insertion under general anaesthesia is indicated. In Sweden, 10000 children undergo this operation annually. Although many children with unilateral or bilateral SOM improve in the summer, the problem usually recurs in the autumn or winter. The cost of SOM for the Swedish society was 600 million Swedish crowns 2005.
In two previous studies, the investigators concluded that the nonsurgical treatment method, that was developed to assist children with SOM equalising their middle ear pressure, could normalise the hearing level in 80 % of children with SOM of minimum duration of 3 months. These children avoided therefore grommet insertion.
The investigators would like to assess the effect of this new treatment method on mainly the hearing threshold of children with SOM. The investigators expect that using the new method could help children with SOM avoid operation with grommet insertion.