OBJECTIVES: Acute otitis media (AOM) is one of the commonest paediatric bacterial infections and is often recurrent. AOM may impact upon parents’ quality of life (QoL), but there are currently no validated tools devoted specifically to measuring this impact.  METHODS: An AOM-specific questionnaire was developed, based on a published questionnaire measuring the effect of children’s recurrent ear, nose and throat infections on parents’ QoL. Fourteen AOM-related questions were grouped into three scores: emotional score (ES; eight items), daily disturbance score (DDS; six items) and total score (TS; 14 items). A fifteenth generic question assessed overall quality of life (global score; GS). Responses were measured using a five-point Likert scale; higher scores indicate greater impact on QoL. Validation of the questionnaire followed a standard procedure for QoL tools, with multitrait analyses and internal consistency reliability using Cronbach’s alpha. The tool was applied in a large, prospective, observational cohort study including 5882 healthy children aged <6 years enrolled from 73 medical practices in Germany, Italy, Spain, Sweden and the UK, 1113 of whom experienced a total of 1419 AOM episodes during follow-up.   RESULTS: The questionnaire was completed for 1063 episodes (75%). The item convergent and discriminant validity criteria were met successfully. The homogeneity and satisfactory consistency of the GS showed correlations between 0.4 and 0.6 for 12 items. The internal consistency reliability of the questionnaire was assessed as “good” or “excellent”. All scores had a mean around 30/100 (ES: 30.49 [SD: 20.30]; DDS: 29.35 [SD: 21.99]; TS: 30.00 [SD: 19.37]; GS: 30.02 [SD: 26.24]) and increased significantly with AOM severity, assessed by parents using a faces scale tool (AOM-FS). CONCLUSIONS: An AOM-specific parental QoL questionnaire was successfully developed and validated, demonstrating good performance across five European countries. Correlation was observed between AOM severity and QoL scores.