J Craniofac Surg. 2026 Jun 1. doi: 10.1097/SCS.0000000000012978. Online ahead of print.
ABSTRACT
BACKGROUND: Ear anomalies, common in newborns, affect psychosocial development. While otoplasty carries surgical risks, nonsurgical molding within the first weeks of life effectively corrects many deformities using splints like the EarWell system. However, success is time-sensitive, and technique standardization is lacking. This meta-analysis compares commercial systems and custom procedures, evaluating success rates and complications for different auricular anomalies.
METHODS: The authors searched for relevant articles up to October 2025 from PubMed, Scopus, and Web of Science. Two independent reviewers extracted data from the selected studies, including baseline information, outcomes, success rates, complications, and parental satisfaction metrics. All data analyses were performed using R version 4.3.3.
RESULTS: The authors collected 1208 records after excluding 795 duplicates. Thorough screening resulted in the retrieval of 49 entries eligible for inclusion in our review. Our analysis found high success rates across all methods. The EarWell system achieved 93% success, custom methods 91%, and other commercial systems 88%, with no statistically significant differences (P=0.155). Good-to-excellent outcomes occurred in 95% of cases. EarWell was more effective for deformations (96%) than malformations (82%), while custom methods reached 97% for deformations. Parental satisfaction was high overall (89%) but differed significantly by method (P=0.017), with custom methods at the forefront at 96%, followed by EarWell (88%) and other commercial systems (81%). However, meta-regression showed EarWell was associated with 1.6 times higher parental satisfaction odds (OR: 1.593, P=0.024). Complication rates were 13% for EarWell and other commercial systems, and 8% for custom methods (P=0.567). Longer treatment duration slightly reduced overall success odds (OR: 0.996, P=0.023). Device type and age at intervention did not significantly affect outcomes.
CONCLUSION: Nonsurgical ear molding is safe and effective. Since custom splints match commercial devices in efficacy, low-cost methods are viable alternatives.
PMID:42223983 | DOI:10.1097/SCS.0000000000012978
