Of note, of the 303 ear deformities treated from 111 patients (212 ears), 91 ears (43 percent) had mixed deformities, defined as having more than one identifiable deformational anomaly. The clinical photographic grading results were stratified by ears treated with only one deformation versus multiple identified deformations, regardless of the type of deformation. Ears with only one deformation had an excellent to good outcome in 97 percent and a fair outcome in 3 percent. Ears with mixed deformities had excellent to good outcomes in 88 percent and fair outcomes in 12 percent.
Treated malformations included cryptotia [3 ears (1.7 percent)] and constriction [172 ears (98.3 percent)]. All the cryptotia ears were corrected completely and graded as having excellent posttreatment photographic outcomes. Using the constriction classification system, the reviews assigned pretreatment severity classes to the constricted ears: 77 class I ears, 81 class II ears, and 14 class III ears. [See Figure, Supplemental Digital Content 4, which shows the distribution of constricted ear malformations by pretreatment constriction severity class (172 ears), http://links.lww.com/PRS/C70.] Grading of posttreatment photographs demonstrated significant decreases in constriction class severity (Table 3). Constriction was significantly improved as evidenced by a reduction in constriction severity class by, on average, 1.24 points (p < 0.01). Overall posttreatment outcomes were graded as excellent to good in 88.2 percent, fair in 11 percent, and poor in 0.8 percent of constricted ears, with 96.7 percent interrater reliability. Premolding and postmolding photographs of each constriction severity class have been selected to demonstrate typical treatment outcomes (Figs. 3 and 4). [See Figure, Supplemental Digital Content 5, which shows the cases of class I constricted ears before (left) and after (right) molding treatment, http://links.lww.com/PRS/C71.]
Complications consisted primarily of minor superficial excoriations in 36 ears (22 deformational ear anomalies and 14 constricted ears), with an overall 7.6 percent rate of incidence for the entire series of treated newborns (7.2 percent incidence for deformational versus 8.1 percent for constricted ears). Of these excoriations, 97.8 percent healed after temporarily suspending helical rim retractor expansion for 5 to 7 days. (See Figure, Supplemental Digital Content 6, which shows that superficial excoriations from the helical rim retractor were the most common complication. Approximately 98 resolved with temporary suspension of helical rim expansion for 5 to 7 days, http://links.lww.com/PRS/C72.) It is important to note that infants treated for malformations were seen weekly (twice as frequently) to both advance the treatment but also to monitor for abrasion or irritation from the increased pressure and tension being applied. We believe this protective measure has been effective as demonstrated by the nearly equal incidence of complications between the two groups. Eight ears developed an allergic reaction to the device adhesive requiring early termination of ear molding, and one ear developed an infection.
This study presents the largest series of newborns with auricular deformations and malformations undergoing ear molding with the EarWell Infant Ear Correction System, using a standardized treatment protocol, and with photographic documentation for outcomes assessment. Although our experience with molding newborn ears dates back to the late 1980s, the EarWell Infant Ear Correction System has been our preferred method of treatment for the past 6 years. Our experience has taught us that the early initiation of treatment is advantageous with all molding techniques. The opportunity for early treatment can be hampered by a failure to convince pediatricians that the majority of misshapen newborn ears do not self-correct, and that watchful waiting effectively eliminates the opportunity for nonsurgical correction. Furthermore, no self-correction was seen among newborn infants with malformed ears, defined as ears with missing skin and cartilage.
The results of the deformational anomalies treated in this series are consistent with the current body of literature. Ear molding with the EarWell System provides consistently efficacious results in correcting lidding, conchal crus, helical rim, prominence, and Stahl deformities, with high rates of good to excellent qualitative outcomes. Ear molding treatment had nearly complete correction of all effaced antihelical folds. Of all the deformities treated, the prominent ear had the greatest number of ears with retained residual deformity (19.6 percent). Nevertheless, 88 percent of the treated prominent ears had an excellent to good outcome. The newborns with residual deformity typically are associated with a history of autosomal dominant genetics for ear prominence running through each generation of their family. That being said, we were unable to differentiate those who would have a stable complete correction versus those who would have relapse with residual deformity. In addition, it is important to point out a significant decrease in the number of prominent ear deformities treated in this consecutive series of newborns than reported in previously published nursery study data by the same senior author (H.S.B), 9 percent versus 45 percent. This change is directly attributable to two factors: (1) a failure to distinguish between some cup ear malformations and prominent deformities in the nursery study and (2) a propensity among referring pediatricians to completely overlook the prominent ear deformity. This bias in diagnosis is completely understandable because the infant cup ear stands out as abnormal to both parent and physician, whereas the prominent ear deformity “flies under the radar,” generally requiring direct measurement for diagnosis. The normal projection of the newborn ear is 5 to 7 mm. Borderline projection ranges from 7 to 10 mm, whereas ears projecting over 10 mm are clearly abnormal. With growth to adulthood, there is roughly a three-fold increase in the projection of a newborn infant ear. It cannot be stressed enough that the diagnosis of prominent ear is often subtle and requires direct measurement of ear projection from the cranial skin to the midpoint of the helical rim with a ruler or projectometer (Fig. 5).
The data comparing the clinical outcomes of ears with a single deformity to ears with multiple identifiable deformities warrant attention. Ears with mixed deformities had a higher rate of fair photographic outcomes (3 percent versus 12 percent, respectively). Although the overall results demonstrate that ears with multiple identifiable deformational anomalies can be effectively treated with ear molding techniques, it is important to counsel families that the posttreatment outcome may be negatively impacted by compounding deformations.
Historically, the constricted ear has had a multitude of imprecise descriptors, such as lop, cup, lidding, and many others. Often, there is an intermixing of deformational and malformational adjectives that further obfuscates. To accurately measure outcomes in a study about the treatment of constricted ears, it was essential that our definition of the constricted ear be precise and unambiguous. A malformation must have missing tissue, and even the mildest constriction, by definition, must demonstrate a tissue deficit to be classified as constricted ear. For this reason, we chose to use a new classification system as an alternative to the Tanzer classification system because the Tanzer I constricted ear describes a lidding deformation, not a constriction malformation.11 In contrast, the class I constriction as defined in this study clearly must have a demonstrable deficit of skin and cartilage. We perform a simple diagnostic test during the clinical examination to differentiate between a lidding deformation and a class I constriction. (See Video, Supplemental Digital Content 7, which describes how to distinguish between lidding and constriction, available in the “Related Videos” section of the full-text article on PRSJournal.com or, for Ovid users, at http://links.lww.com/PRS/C73.) With a cotton-tip applicator placed under the area of helical hooding, there should be no resistance in elevating the helical rim and shaping the superior crus to produce a normal appearing ear. If the hooding cannot be lifted with the cotton-tip applicator, the auricle is at a minimum a class I constriction. The result of this clinical test is documented in each patient’s initial examination, and it provided the basis of how infants were accurately diagnosed with the correct anomaly.
Successful correction of the constricted ear depends on expanding an auricle that is deficient of tissue. (See Figure, Supplemental Digital Content 8, which shows an example of auricular expansion during ear molding treatment demonstrated by consecutive photographs of a newborn with bilateral class I constricted ears, http://links.lww.com/PRS/C74.) Helical rim retractors exert gentle, sustained force on the auricular tissue, resulting in helical rim tissue expansion and longitudinal auricular lengthening. Biological creep is a core plastic surgery principle; when tissue is chronically stretched, stretch-induced signal transduction pathways lead to an increased production of collagen, epidermal proliferation, fibroblast mitosis, and angiogenesis. Expansion of auricular cartilage, a tissue with much higher resistance than skin, requires directed and sustained force to stimulate the tissue expansion necessary to achieve good to excellent results in the majority of class I and II constrictions. To correct a constricted ear malformation, helical tissue expansion and a decrease in conchal projection is necessary. The EarWell device uses the posterior shell or base plate as the foundation for the anterior and laterally directed forces generated by the retractors and conchal conformer, respectively. The base plate also serves as a foundation for the placement of silicone molding material to customize the final shaping. Alternative molding systems that only bend the ear cartilage back along the antihelix fail to produce the vectors and forces needed to truly expand the tissue deficiency of a constricted ear.
With increasing severity into class II and III constriction, many constricted ears present with a second inner ring of constriction along the antihelix. This “purse-string” of the cartilage is antihelical cartilage tissue deficiency (Fig. 6). This inner ring of constriction causes the inferior limb of the triangular fossa, the antihelix, the antitragus, and the lobule to bow forward, increasing the auricle’s prominence and further narrowing and constricting the concha. The plastic surgery literature often refers to this phenotypic presentation of antihelical cartilage deficiency as “cup ear deformity.” In our opinion, it is a malformation secondary to its inherent tissue deficiency. In essence, this second ring of inner deficiency and conchal bowl constriction can block the posterior expansion of the concha, making correction of the constricted prominent ear (the cup ear) particularly problematic.
For the class III constricted ear, ear molding was unable to resolve all the elements of the constriction, but there were clear improvements in the auricular structure, such as increased definition of the scapha, decreased conchal bowl constriction, and increased longitudinal axis length, that transformed many grossly malformed ears to acceptable frameworks (Fig. 4). Despite the remaining elements of constriction, the natural contours of these molded ears remain superior to the contours of a surgically modified constricted ear. Finally, through molding, the class III constricted ears have had important modifications to the auricular framework that effectively “downgraded” the constriction severity, allowing for optimization of eventual surgical outcome.
Lastly, the effect of age at treatment initiation has been a persistent question from many providers. The importance of early recognition of ear anomalies cannot be overstated. We have made considerable efforts to educate referring pediatricians how to recognize and rapidly refer affected infants; thus, within the constricted ear treatment group, only five ears had treatment initiated beyond 3 weeks after birth. Although these five ears all achieved excellent to good photographic outcomes, we cannot endorse the efficacy of ear molding with late initiation of treatment with such a small subset of patients for outcome analysis, and we strongly advise, based on our experience, that reliably retained and consistent results are achieved with early initiation of treatment. The only cases when we agreed to initiate treatment late were cases when families insisted on attempting molding with the understanding we could not guarantee complete correction or that relapse would not occur. These concerns are based on the recognized loss of pliability and increased stiffness in infant cartilage after 6 to 8 weeks of age and on reduced outcomes from a previous study when treatment was initiated after 3 weeks.4
Although the major limitation of this study is its retrospective study design, every attempt was taken to minimize review bias by blinding reviewers to each other and all clinical details. Furthermore, individuals with financial interest in the EarWell System were excluded from involvement in data collection, photographic grading, and data analysis. Finally, although all surgeons within this practice were trained in the technique of ear molding by the senior author (H.S.B), multiple practitioners invariably introduce some technical variability.
As the cohort of infants with constricted ears grows, future studies will evaluate long-term patient and family satisfaction, psychological well-being, and the need for future surgical intervention.
Just as the medical community has accepted nasoalveolar molding as a valuable intervention with the power to decrease the severity of malformation and optimize cleft surgery outcomes, newborn ear molding deserves similar recognition and acceptance. This study adds to the body of literature supporting the efficacy of newborn ear molding to correct this extremely common congenital anomaly. Ear molding with the EarWell System effectively corrects both deformational and malformational auricular anomalies. Mildly to moderately constricted ears are reliably corrected to a good to excellent result. In the case of severely constricted ears, this nonsurgical therapy is capable of “downgrading” the constriction severity to allow for easier surgical correction at a later date.
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