To evaluate changes in health-related quality of life for children with otitis media. Cohort study using a 6-item quality-of-life survey (OM-6) representing the domains of physical suffering, hearing loss, speech impairment, emotional distress, activity limitations, and caregiver concerns. Hospital-based pediatric otolaryngology practice in a metropolitan area. One hundred eighty-six children aged 6 months to 12 years (median age, 3.4 years) with chronic otitis media with effusion or recurrent acute otitis media. The OM-6 was completed at entry by the child's caregiver and again at least 4 weeks after routine clinical care. Otoscopic findings, static admittance, tympanometric width, audiometric thresholds, and ear-related global quality of life (10-point visual scale) were recorded concurrently. Test-retest reliability, construct validity, and responsiveness to longitudinal change of the OM-6 survey score (mean value of the 6 items). Excellent test-retest reliability was obtained for the survey score (R=0.87) and individual survey items (R> or =0.71). The median survey score was 2.8 (95% confidence interval, 2.7-3.0) of a maximum 7.0, with higher values indicating poorer quality of life. Construct validity was shown by significant correlations between the survey score and global ear-related quality of life (R=-0.64), between physical suffering and physician visits in the past month (R=0.47), and between caregiver concerns and antibiotics consumed in the past month (R=0.26). The mean change in survey scores after tympanostomy tubes was 1.7, with a standardized response mean of 1.7 (95% confidence interval, 1.4-2.0), indicating large responsiveness to change. The change score was reliable (R=0.82) and correlated well with the degree of reported clinical change (R=0.66). The OM-6 is a valid, reliable, and responsive measure of quality of life for children with otitis media. The brevity and ease of administration make the OM-6 ideal for use in outcomes studies, clinical trials, and routine clinical care.