Outcomes of a Molding Device for Congenital Auricular Deformities.

Objectives: The EarWell Infant Ear Molding Device provides non-surgical correction for congenital ear deformities, but parental satisfaction data remain limited. This study evaluates our experience treating 120 infants with the EarWell system and assesses parental satisfaction with outcomes.

Method: We conducted a prospective case series of 120 infants treated with the EarWell device between January 2017 and January 2024. We collected demographic and clinical data, documented pre- and post-treatment ear conditions with photographs, and evaluated parental satisfaction via telephone interviews and questionnaires.

Results: The study included 120 infants (181 ears) with an overall success rate of 87.3% post-treatment and 81.8% at long-term follow-up. Treatment was most effective when initiated within the first week of life (93.8% success) compared to 8-14 days (90.6%) and 15-28 days (79.7%). Ear deformations achieved higher correction rates (95.2%) than malformations (76.3%). Minor complications occurred in 18.8% of cases, primarily pressure ulcers (14.4%) and dermatitis (4.4%). Parental satisfaction was high, with 78.3% of parents reporting being satisfied or very satisfied with outcomes, correlating with objective clinical results.

Conclusion: The EarWell Infant Ear Molding Device is an effective, safe, and parent-approved non-surgical intervention for congenital auricular deformities. Treatment is most successful when initiated within the first week of life and for ear deformations rather than malformations. Early intervention results in better outcomes and fewer complications. High parental satisfaction correlates with objective clinical improvements, supporting ear molding as a first-line treatment for congenital auricular deformities when applied during the optimal window of neonatal cartilage malleability.

Level of evidence: 4: