"Customized orthosis for non-surgical correction of congenital auricle deformities in newborns.".

A misshaped pinna, caused by extrinsic pressures such as birth canal extrusion or incorrect position, is typically one of congenital auricular deformities in newborns. As an approach to this deformity, surgery is a routine option, but it may lead to uncomfortable outcomes traumatically and aesthetically. Commercial ear mold orthosis with uniform size has achieved an effect of non-surgical orthotic treatment, but it is not applicable among all newborns in terms of the auricle morphologies. This research was to employ the CAD and 3D printing technology to develop a novel customized orthosis for congenital auricular deformities. The 3D models of the ears were reconstructed using CAD soft and a novel customized orthosis model was established after a process of correction, adjustment, and construction with simple wearing and precise matching to allow its tight attachment to the outer ear free from uneven skin pressing. After 3D printing customized orthosis injection mold, medical silicon injection molding was used to produce customized orthosis. Clinical application was conducted in three newborns and achieved satisfactory results. This novel customized auricle orthosis is expected to spread clinically for the purposes of improving the cure rate of non-surgical correction and reducing the occurrence of complications from surgery and anesthesia.