Clinical and economic burden of otitis media in children under 5 years of age in the United States: A retrospective study.

Reductions in all-cause otitis media (OM) following widespread pneumococcal conjugate vaccine use have plateaued. Granular burden of disease data are needed to guide evaluation and implementation of new measures targeting OM prevention. We conducted a retrospective study to assess the incidence and treatment costs of OM, tympanostomy tube placement (TTP), and hearing loss in children aged <5 years in the United States (US). OM episodes and TTP between 2016 and 2017 were identified in IBM MarketScan Commercial Claims and Encounters, Medicare Supplemental and Coordination of Benefits, and Multi-Medicaid databases using diagnosis codes (ICD-10). The incidence rate per 100,000 person-years (IR) of OM in <5-year-olds was 62,726 in Commercial/Medicare databases and 55,874 in Medicaid. IRs peaked at 9-<12 months (115,552 and 110,960, respectively). Approximately 5% and 4% of OM episodes in the respective databases had TTP (IR 3233 and 2404). Around 2% of children with OM had hearing loss (IR 1468 and 1109, respectively), of whom 41% had TTP. We estimated that there were 11.1 million OM episodes in 2020 costing USD 4.8 billion. 243,618 children were estimated to have OM with hearing loss at a direct total cost of USD 637 million, or 13% of the overall cost. The clinical and economic burden attributable to OM in the US was high in children aged <5 years during the study period. Novel approaches are needed to improve and broaden vaccine-induced protection against OM and its complications. The study results could guide policymakers considering age-specific interventions to reduce the OM burden.