Objective: To investigate the clinical effect and related influencing factors of EarWell auricular orthosis in correction of congenital auricular malformation in children. Methods: A total of 353 children (490 ears) with congenital auricle deformity treated in Huangshi Maternal and Child Health Hospital from June 2020 to August 2023 were included, and all of them were corrected with EarWell auricle orthosis. They were divided into three groups according to age (birth date). Group A: 0 ~ 7 days, 128 cases (202 ears); Group B: 8 ~ 42 days, 123 cases (162 ears), group C: 43 d ~ 3 months, 102 ears (126 ears). The ear morphological data of children before and after correction were compared. Pearson correlation analysis and multivariate logistic regression analysis were used to evaluate the correlation between age, auricle deformity type, ear morphological data difference before and after correction and therapeutic effect. Results: After correction, the facial ear length, morphological ear length, facial ear width and morphological ear width were all longer than before correction, while the vertical distance between cranial ear was shorter than before correction, the difference was statistically significant (P<0.05). There was no significant difference in cranial ear Angle between children before and after correction (P>0.05). There were statistically significant differences in treatment time, VAS score, correction effect and incidence of adverse reactions among the three age groups (P<0.05). There were significant differences in treatment time, VAS score, correction effect and incidence of adverse reactions among different types of auricle deformity (P<0.05). There was a correlation between the efficacy index and the difference of facial ear length (r=-0.164). The results of multivariate logistic regression analysis showed that There was an independent correlation between age, facial ear length difference, and auricle deformity type and curative effect (P=0.002, P=0.011, P=0.047, P=0.038, P=0.028, P=0.044, P=0.009, P=0.003, P=0.006, P=0.020, P=0.013). Conclusion: EarWell orthosis has significant correction effect on children with congenital auricular malformations, but the noninvasive correction effect of flaring ear is worse than that of other types of auricular malformations. Age, facial ear length difference and type of auricle deformity were predictive factors of EarWell ear orthosis.