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 period. Efficacy was determined by comparing pre- and posttherapy air-conduction thresholds, tympanometric peak pressures, and otoscopic findings. The study group was made up of 94 children (174 ears), aged 4 to 11 years, who had at least a 2-month history of MEE and associated hearing loss. At study's end, patients in the treatment group experienced statistically significant 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 of 73.9% of the treated ears was within normal limits, compared with only 26.7% of the control ears. These findings demonstrate that home treatment of children with persistent MEE and associated hearing loss with the modified Politzer device is highly efficacious.