We conducted a randomized, controlled clinical trial to investigate the efficacy of treatment of persistent middle ear effusion (MEE) and associated hearing loss with a modified Politzer device used in the home setting over a 7-week perio d. Effi cacy was determined by comparing preand posttherapy air-conduction thresholds, tympanometric peak pressures, and otoscop ic find ings. The study group was made up of94 children (1 74 ears), aged 4 to 11 years, who had at least a 2-month history of MEE and assoc iated hearing loss.At study send,patients in the treatment group expe rienced statistically sign ificant improvements in all measured outcomes; no significant improvements were seen in the control group in all measured outcomes. At study 's end, the hearing sensitivity of73 .9% ofthe treated ears was within normal limits, compared with only 26. 7% ofthe control ears. Thesefindings demonstrate that home treatm ent ofchildren with persistent MEE and associated hearing loss with the modified Politzer device is highly efficacious.