Summary Background Tinnitus prevalence studies report large variability across countries that might be due to inconsistent research methods. Our study aimed to report a single Pan-European estimate for tinnitus prevalence and investigate the effect of individual and country-level characteristics on prevalence. We explored the relationships of healthcare resource use and hearing difficulty with tinnitus symptoms. Methods Between 2017-2018, a cross-sectional European Tinnitus Survey (ETS) was conducted in 12 European Union nations (Bulgaria, England, France, Germany, Greece, Ireland, Italy, Latvia, Poland, Portugal, Romania, and Spain), using a standardised set of tinnitus-related questions and response options in country-specific languages. We recruited 11,427 adults aged ≥18 years. Findings Prevalence of any tinnitus was 14·7% (14·0% in men and 15·2% in women), ranging from 8·7% in Ireland to 28·3% in Bulgaria. Severe tinnitus was found in 1·2% participants (1·0% in men and 1·4% in women), ranging from 0·6% in Ireland to 4·2% in Romania. Tinnitus prevalence significantly increased with increasing age and worsening of hearing status. Healthcare resource use for tinnitus increased with increasing tinnitus symptom severity. Interpretation This is the first multinational report of Pan-European tinnitus prevalence using standardised questions. The overall prevalence estimates refine previous findings, although widespread inter-country heterogeneity was noted. The results indicate that more than 1 in 7 adults in the EU have tinnitus. Extrapolating to the overall population, approximately 65 million adults in EU28 have tinnitus, 26 million have bothersome tinnitus and 4 million have severe tinnitus. Funding National Institute for Health Research, European Union's Horizon 2020, Medical Research Council, and GENDER-Net Co-Plus Fund.

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