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Long-term outcomes of children with and without cleft palate receiving early treatment for otitis media with effusion (OME) are unclear. To compare long-term otological and audiological outcomes between children with and without cleft palate treated with tympanostomy for OME before the age of 2 years. Ninety-five children (180 ears) with cleft palate (study group) and 97 children (185 ears) without (control group) were followed-up to a maximum age of 7 years. We retrospectively analyzed the audiological outcomes at the age of 7 years, and