Customized Orthosis for Nonsurgical Correction of Congenital Auricle Deformities in Newborns

A misshaped pinna, caused by extrinsic pressures such as birth canal extrusion or incorrect position, is a common congenital auricular deformity in newborns. Surgery is a routine option to address this deformity, but it is traumatic and may lead to unacceptable aesthetic outcomes. Commercial ear mold orthoses with uniform size have been used for nonsurgical orthotic treatment, but are not applicable in all cases, depending on the auricle morphology. The authors used computer-aided design and three-dimensional (3D) printing technology to develop a novel customized orthosis for congenital auricular deformities. 3D ear models were constructed using computer-aided design software and a novel customized orthosis model was established after a process of correction, adjustment, and construction, with precise matching to allow tight attachment to the outer ear free from uneven skin pressing. After 3D-printing a customized orthosis injection mold, medical silicone injection molding was used to produce customized orthoses. Clinical application was conducted in 3 newborns and achieved satisfactory results. This novel customized auricle orthosis is an effective option for nonsurgical correction of a misshaped pinna.