Diagnostic performance and clinical follow-up of a universal newborn hearing screening program using OAE and ABR in a middle-income country.

Background: Congenital hearing loss (CHL) affects language development and quality of life of children. Although high-income countries have implemented neonatal hearing screening (NHS) programs, data regarding the implementation of such programs in middle-income countries are limited. This study evaluated NHS coverage and the incidence of hearing loss, the diagnostic performance of two screening tests, and the associated risk factors (RFs), characterizations, and two-year follow-up data of affected infants in a middle-income country.

Methods: An ambispective cohort study was conducted in a high-complexity hospital in Bogotá, Colombia (2020-2023). Screening was performed in two stages using otoacoustic emissions (OAE) and automated brainstem response (ABR) evaluations. Infants who failed both stages were referred to otolaryngological assessments. Poisson regression was used to identify the associated RFs, and the diagnostic performance metrics for OAE assessment were estimated using the ABR data as the reference.

Results: The NHS coverage was 69.8 %. CHL was diagnosed in four children (3/1.000). The follow-up rate was 75 %. Neonatal unit admission was associated with a higher risk of CHL (relative risk: 10.77, 95 % confidence interval: 2.10-5.18). In the first stage, OAE assessment showed 72.2 % sensitivity and 99.4 % specificity, while in the second stage, their sensitivity and specificity were 71.4 % and 100 %, respectively. The agreement between OAE and ABR assessments was substantial in the first stage (κ = 0.791) and moderate in the second stage (κ = 0.397).

Conclusions: These findings emphasize the importance of implementing strategies to improve NHS coverage and ensure comprehensive follow-up in middle-income countries, thereby improving the quality of life of patients in these countries. Despite the high specificity and sensitivity, the variability in test agreement highlights the need for structured two-stage screening protocols combining OAE and ABR assessments.