Practice and challenges of newborn hearing screening: Analysis of a five-year database in Italy

Abstract Early identification and treatment of hearing impairments are essential for children’s development. International guidelines recommend a stepwise approach for conductive hearing screening in newborns. However, while the majority of countries around the world implemented universal newborn hearing screening, inconsistencies remain in terms of procedures and data management. In particular, Level 3 of the screening pathway—comprising diagnostic confirmation and therapeutic management—has received limited attention in the literature, despite its central role in determining program effectiveness and patient outcomes. This study investigates the clinical and organizational aspects of Level 3 within the neonatal hearing screening program of the Friuli-Venezia Giulia Region in Italy, analyzing data from 106 children enrolled between 2019 and 2023. The analysis considers the regional protocol, the roles of birthing centers, pediatricians, hospitals, and the Regional Center for Pediatric Hearing Loss Care, and subdivides Level 3 into four Phases (A–D) reflecting both organizational and diagnostic functions. By examining patient flow, false positives, loss to follow-up/documentation, and management practices, the study highlights how organizational factors—particularly the coordination between local and specialized facilities— produce “cascade” outcomes directly affecting diagnostic timelines and treatment initiation. Findings provide critical insights into weaknesses of the current system and propose directions for improving program efficiency, accuracy, and overall quality of care. Competing Interest Statement The authors have declared no competing interest. Funding Statement This work was supported by the Italian Ministry of Health, throught the contribution given to the Institute for Maternal and Child Health IRCCS Burlo Garofolo, Trieste - Italy. The work is part of the project 5x1000 (year 2022) Gli screening neonatali in Regione FVG: sviluppo e integrazione attraverso lo sviluppo di una nuova piattaforma (CUP:C93C24000300005 - subcentro: 5MILL22R). Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of the Institute for Maternal and Child Health-IRCCS Burlo Garofolo, Trieste, Italy (protocol code IRB BURLO 08/2020, approved on 1 December 2022). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data Availability Codes and data are available online at https://osf.io/5jeby/overview?view_only=d4d53b57f8384489befd32c0c4b525df. https://osf.io/5jeby/overview?view_only=d4d53b57f8384489befd32c0c4b525df