Learning Objectives: A questionnaire to assess HRQoL concerning the ear was developed and compared to the score of a new classification system for cholesteatoma.

Introduction: In otology, surgical outcome is most often assessed by reporting postoperative hearing thresholds. Subjective complaints are not always and systematically reported, although several patient-reported outcome measure exist for chronic otitis media. However they lack certain relevant symptoms concerning the ear a health-related quality of life (HRQoL).

Methods: A new questionnaire for comprehensively measuring HRQoL was developed and an electronic application was chosen to facilitate and accelerate data analysis. In a first step, it was tested in a cohort (n = 85) and the number of questions was reduced from 33 to 21 using sequential statistical analysis. Then the adjusted questionnaire was validated in a second cohort (n = 76). Finally, the validated questionnaire was tested in a cohort of patients with Otitis media cholesteatomatosa preoperatively and up to 3 months postoperatively to compare HRQoL to characteristics of the colesteatoma defined by a newly developed classification of cholesteatoma (ChOLE).

Results: Statistical analysis allowed a reduction of questions from 33 to 21. Validation revealed a Cronbach's α of 0.91, indicating excellent internal consistency. Moreover, the questionnaire was able to discriminate between patients with chronic otitis media and healthy participants (p < 0.0001), thus possessing good discrimination validity. Finally, first experience comparing HRQoL assessed by the questionnaire with stage of disease defined by the ChOLE classification showed good correlation.

Conclusions: Sufficient information on reliability and validity of the questionnaire was obtained. It can be applied to quantify HRQoL in patients with cholesteatoma and shows good correlations to the ChOLE classification.