It is estimated that more than 5 million infants with CAD need to be corrected in China every year.[5] These deformities cause no functional or hearing issue, but result in psychological stress, self-abasement or social avoidance usually related to bullying.[6] Since the late 1980s, many authors demonstrated that permanent correction occurred by forcing the ear into the proper position for several weeks. Due to this treatment being initiated at an early age, children are no longer exposed to the psychosocial consequences of having an abnormal ear.
Up to date, the EarWell system and some Chinese domestic ear molding systems have shown excellent outcomes in correction of CAD. However, many infants in rural China fail to take advantage of this nonsurgical intervention, due to high price and not be covered by any medical insurance, especially those with bilateral CAD.
During ear correction, it is found that the shape of the antihelix and scapha is very important to maintain the normal morphology of the auricle. Different from EarWell or other ear molding system, the Antihelix Former of the GTK Ear Correction Kit is separated from the Shell and can be adjusted to apply to different ear. As a result, different side of auricle can wear the adjustable components. Theoretically, the adjustable Retractor and Antihelix Former can counteract of the resistive forces of the abnormally inserted superior auricular muscle, such as shortened auricular transverse muscle and auricular oblique muscle[7]. Therefore, the skin is kept stretched and expanded. This is the main indicator of excellent results for ear molding in most studies. In our study, the Antihelix Former is used to revise the superior crus of the antihelix. The Retractor fixed in the scapha applies pressure to the helix, correcting a deformed rim helix and incurved scaphoid fossa. Therefore, this is useful for anomalies of the helical rim, lop ear, Stahl’s ear, prominent ear, cup ear and even cryptotia, to deepen the scapha, create a well-defined superior crus.
It is widely agreed that time of treatment initiation is the most important factor in success. [8, 9]Currently, delayed molding is not a common practice, with Daniali and colleagues citing a 50% failure rate for molding initiated after 3 weeks of age. [10]As a result of high level of circulating maternal estrogen, which reaches its peek within 72 hours after birth and decrease rapidly over the coming 6 weeks, the malleability of the auricular cartilage is hypothesized to be influenced during the neonatal period. [11–13]Early detection and diagnosis of CAD is crucial since ear molding takes advantage of the plasticity of auricular cartilage during the early time after birth.
Clinically, when we detect a newborn with CAD that could respond to nonsurgical molding, 48-72h observation will be carried out by both family members and doctors. [14]If there is no significant improvement in auricle morphology, ear molding will be advised. In this study, all the enrolled infants were younger at the initiation of correction. It can be noticed from the results that the treatment duration was short and the effective rate was as high as 100% when the initiation is within the first 2 weeks after birth. Moreover, it is recommended that collaboration with midwifes, obstetricians, and pediatricians is key for early identification. [15]
Previous studies have described rare complications in patients treated with ear molding system, including skin ulcers, dermatitis, infection, and bleeding, but no cartilage damage. The skin of the cranioauricular junction area or the helical rim would be worn by cradle or rigid retractors reported in other studies. [16] If no proper intervention, infection would follow behind. Usually, the cradle or shell can loosen with moisture. During our correction, thin cotton sheet is applied along the cranioauricular junction area to prevent moisture build up over time. Meanwhile, some double-sided adhesive tapes were applied to fix the appliance and protect skin. In our study, the most common complications were skin redness and rashes, which can recover spontaneously without any specific treatment. The lower incidence of complications might be related to early initiation and those medical skills to protect skin.
The notable shortcoming of using only appliances is that all molding takes place on the lateral surface of the ear. For Concha Crus ear, in addition to the Retractor and Antihelix Former, the Conchal Former should also be used for shaping. The Conchal Former reverses a protruding conchal strut, and the cap stabilizes the device, exerting consistent pressure on the retractor. In the future, related studies will be further designed to provide clinical data.
The major limitation of this study is the limited number of cases. While ear molding has exhibited a high efficacy, it has yet to achieve widespread use due to a lack of recognition, delays in proper diagnosis, or an incorrect assumption that most ear deformities will self-correct. Besides cost, unfamiliarity with the technique, what kind of ear anomalies can be treated, and the age at which molding should be initiated have long been the reasons for a delay in the implementation of this technique. In the near future, cooperation of doctors in different department, general public and newborns’ parents are important in the process of the therapy.
To our knowledge, this is the first study to explore the advantages of Chinese domestic ear molding system in correcting bilateral CAD. Our findings indicated that Retractor and Antihelix Former showed substantial efficacy in molding CAD in newborn. Our results reveal that only one set of domestic ear molding system can be used flexibly to correct bilateral CAD, reducing the cost for correction in bilateral cases. After clinical promotion, it is expected to benefit more infants. More and more infants with CAD will be include in such a research to establish the advantage of domestic ear molding system in bilateral ear correction in our future work.