Ear Molding in Children-Timing, Technique, and Follow-up: A Systematic Review.

Background: Nonsurgical management of congenital ear anomalies using molding devices shows efficacy but lacks standardization of treatment protocols and outcome measures. Learning Objective: To compare ear molding techniques and identify factors related to treatment outcomes. Design Type: Systematic review of the literature (1990-2021). Methods: Studies reporting molding for congenital ear anomalies were assessed. PRISMA guidelines were used. Data extracted included: age at treatment initiation, treatment duration, correction rates, and complications. Data analysis included descriptive statistics and outcomes were compared using the Student t-test. Results: In total, 37 studies with 3,341 patients (mean patients per study, 95; range, 5-488) were included. Infants in whom treatment was initiated at 4.8 weeks (median, 3.7; range, 0.9-8.8 weeks) were treated for 5.1 weeks (median 4.7, range 2.6-7.6 weeks) with 11.0 months follow-up (median 11.4, range 1.4-21.0 months). Individualized devices (physician-customized) were used more (62.2% of studies) than commercial devices. No difference in correction (p = 0.44) or complication rates (p = 0.19) was identified between devices. Totally, 70.3% of studies reported complications and 40.5% of studies included long-term follow-up data. Conclusions: The available evidence supports initiating ear molding in the first weeks of life to be most effective, yet outcome data should be standardized in future studies to improve evidence quality.

The non-operative correction of ear anomalies in infants using the EarWell infant corrective system in the Netherlands.

BACKGROUND: Congenital ear anomalies are regular but often overlooked occurrences. The golden standard of treatment has been to surgically correct these anomalies at a minimum age of 5 to 7 years. As of the last century, ear molding has developed to be a safe, reliable, and effective treatment method. Different treatment methods are still under investigation. This study aims to investigate the use of the EarWell Infant Corrective System in the Dutch population. METHODS: Children aged 0-12 weeks were included in the Zuyderland Medical Center to be treated with the EarWell Infant Corrective System in case of ear deformations. Every 2 weeks, the system was replaced and correction was evaluated by both physician and parents. RESULTS: Seventy-three participants were included, of whom 123 ears in total were treated. Age at initiation was 35.5 days on average; treatment lasted an average of 59 days. Parents and physicians both reported an amelioration of all ear anomalies after treatment, scoring the correction grade an 8.8. Overall satisfaction with the treatment method was 9 or higher for both groups. CONCLUSIONS: The EarWell Infant Corrective System is a safe, reliable, and effective treatment method for the correction of ear anomalies in infants.

Ear Molding Therapy of Congenital Ear Anomalies: Long-Term Aesthetic Outcomes and Caretaker Satisfaction.

INTRODUCTION: Ear molding is a safe, non-surgical approach to treat newborns with congenital ear anomalies. In this study, we aimed to investigate long-term aesthetic outcomes and caretaker satisfaction from ear molding therapy. METHODS: A retrospective chart review from 2018 to 2020 was conducted for infants who underwent ear molding treatment at our institution. Patient demographics and treatment related variables were collected. Caretakers were surveyed regarding their experience, expectations, and aesthetic outcome at 1 year (short-term) and 3 years (long-term) from treatment. Independent physicians evaluated treatment efficacy. Responses were converted to a Likert scale (1-5), with 5 representing most desirable. RESULTS: Overall, 38 of 42 patients participated in our long-term study (90%) for a total of 62 ears. Average follow-up was 3.31 ± 0.50 years after completion of treatment. Mean age at treatment was 23.2 ± 19.7 days with a mean treatment duration of 21.7 ± 7.7 days. Caretakers' satisfaction regarding auricular appearance remained high (short-term: 4.18 vs. long-term: 4.17, p = 0.54) and anticipated social distress decreased over time. Physician aesthetic evaluations were favorable between "somewhat effective" and "very effective" and remained consistent over time (short term: 3.46 vs. long-term: 3.31, p = 0.31). Furthermore, physician evaluations were higher for deformations than malformations (p = 0.04) and in children who began treatment by 30 days old (p = 0.04). CONCLUSION: Caretaker satisfaction from ear molding therapy remained high after long-term follow up, and social distress from the perception of their child's ears decreased with time. Physician aesthetic ratings confirmed efficacy, with better outcomes seen in deformations than in malformations. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Ear Molding for Congenital Auricular Deformities: Efficacy and Factors Affecting Outcomes.

Objective: This study's aim was to assess the effectiveness of ear molding for congenital auricular deformities, analyze the factors affecting prognosis, and provide more clinical data supporting nonsurgical correction for this condition. Methods: A prospective study of a consecutive series of infants treated with ear molding from January 2021 to December 2022 in the department of otolaryngology, Second Affiliated Hospital of Harbin Medical University, was conducted. Demographic and clinical information were collected, and photographs of the ear were taken before and after treatment. Treatment efficacy and the relevant influencing factors were evaluated. Results: Thirty-five patients, including 59 with congenital ear anomalies, underwent noninvasive ear molding. The deformity type, treatment initiation age, and number of treatment cycles affected treatment efficacy. Earlier treatment initiation was associated with a shorter treatment period. Treatments were started earlier if decision-makers were more anxious. Conclusion: The earlier the neonatal auricle deformity is treated, the shorter the treatment time and the more ideal the clinical effect will be. Early noninvasive treatment for microtia is valuable. Early detection and parental awareness and education can help children receive treatment earlier and improve the success rate.

Extraction of a Foreign Body From the Middle Ear Following a Complicated Hearing Aid Fitting: A Case Report.

Ear molding is a safe way to evaluate the ear for hearing aid fitting. A very rare complication of ear molding is the entry of a foreign body into the middle ear. We report the case of a three-year-old boy who had a perforated left tympanic membrane and bilateral sensorineural hearing loss that required the use of hearing aids. During the ear molding procedure, the molding material was unintentionally introduced into his middle ear cavity, necessitating immediate surgery to remove it. Such patients with tympanic membrane perforation must be handled cautiously while an aural impression is taken via ear molding to prevent introducing a foreign body into the middle ear.

Changes of Age-related Auricular Cartilage Plasticity and Biomechanical Property in a Rabbit Model.

OBJECTIVES: Ear molding is an emerging technique that can correct auricular deformities. Treatment initiation time is the most important prognostic determinant of ear molding. Here, we aimed to examine why auricular cartilage plasticity appeared to diminish with age. Thus, we characterized age-related changes in the biomechanical, biochemical, and morphological properties of auricular cartilage. METHODS: New Zealand rabbits were used as the experimental animal. We examined immature [postnatal 0 day (P0), 5 days (P5), 15 days (P15)], young [2 months (2M)], and mature [6 months (6M)] rabbits. Rabbits' ears were splinted and folded using adhesive fixation strips. Folding duration ranged from 1 day to 5 days to 10 days. Photographs were taken to calculate the retained fold angle. Cartilage morphology and extracellular matrix (ECM) content were examined histologically (using hematoxylin-eosin, Safranin O, elastic Van Gieson, and Masson's trichrome). Water content, DNA content, and cell density were also analyzed. Biomechanical properties were measured using a Nano indenter. RESULTS: Immature ears had smaller angles after strip removal, and the angled deformation lasted a longer time. Cartilage matrix compositions, including glycosaminoglycan (GAG), elastin fiber, and collagen, increased over development. The water content, DNA content, and cell density decreased with age. Young's modulus was significantly higher in mature cartilage. CONCLUSIONS: Here, we successfully established an animal model of ear molding and demonstrated that immature cartilage was associated with better plasticity. We also found that the cartilage's biomechanical property increased with the accumulation of ECM. The biomechanical change could underlie age-related shape plasticity. LEVEL OF EVIDENCE: NA Laryngoscope, 133:88-94, 2023.

The Treatment Effect of Non-Surgical Ear Molding Correction in Children with Mild Cryptotia Deformity.

OBJECTIVE: To investigate the treatment effect of non-surgical ear molding correction in children with mild cryptotia deformity. METHODS: 51 cases were collected from 2016 to 2021. They were divided into four groups (6 months-1 year group, 1-3 years group, 3-6 years group, and ≥6 years group). The effective rate, recurrence rate, complication rate, and treatment duration of non-surgical ear molding correction were analyzed among the four groups. RESULTS: 3 months after the end of corrective treatment, the overall effective rate was 92.2% (47/51), the overall recurrence rate was 7.8% (4/51), and there was statistical significance among the four groups (p = 0.001). The overall complication rate was 2.0% (1/51), and there was no statistical significance among the four groups (p = 1.000). There was statistical significance in the treatment duration among the four groups (p < 0.001), and the mean duration of treatment was positively correlated with the age at treatment (p < 0.001, R = 0.614). CONCLUSIONS: We first propose and recommend that the treatment time window for non-surgical ear molding correction be maximally extended to 6 years old in children with mild cryptotia deformity. There is a high success rate of non-surgical ear molding correction in children with mild cryptotia deformity. The complication rate is low. There is a positive correlation between the mean treatment duration and the age at treatment, and the treatment duration increases with the growth of months. LEVEL OF EVIDENCE: 4 Laryngoscope, 133:2122-2128, 2023.

Using ear molding to correct auricular helix adhesion deformity.

Objectives: This study examined the effectiveness of Byrd's EarWell system for the treatment of auricular helix adhesion. Methods: The newborns with helix adhesion were treated with ear molding. The photos of pinna were taken before, during, and after the treatment. The immediate and long-term outcomes, as well as the complications, were assessed by two independent plastic surgeons. Study design: A retrospective study. Data on family history, neonatal weight, gestational age, delivery method, laterality, gender, age of initiating treatment, medical comorbidities, duration of treatment, and follow-up time were collected. Study site and period: From 2019 to 2021, infants treated with the EarWell System in the Eye and ENT Hospital of Fudan University were enrolled in this study. Results: A total of 46 newborns (66 ears) with helix adhesion were included. The average onset time of treatment was 4.57 ± 3.63 weeks. The average duration of treatment was 7.40 ± 2.05 weeks. 97.0% ears' (64/66) immediate results were excellent or good. During long-term follow-up, 95.5% ears achieved excellent or good outcomes. Age of initiation treatment significantly affected immediate (p = 0.001) and long-term (p = 0.004) outcomes. Conclusions: EarWell System was an effective method to correct auricular helix adhesion. Using this approach, patients with helix adhesion could avoid surgeries. Age of initiation treatment was the predictor of successful correction.

Efficacy of Classic Ear Molding for Neonatal Ear Deformity: Case Series and Literature Review.

BACKGROUND: We analyzed an original case series of the classic ear-molding method and evaluated the efficacy and complication rate of the method compared to commercial ear-molding products by meta-analysis to draw conclusions on the efficacy of the classic method. METHODS: From January 2019 to March 2022, we selected patients who underwent classic ear molding for newborn ear deformities at our institution and reviewed the patient age, treatment time, efficiency and complications. Additionally, the PubMed, EMBASE, and Scopus databases were searched, and meta-analysis (following the PRISMA guidelines) was performed. RESULTS: In the case study, the success rate (excellent and good outcomes) of the classic ear-molding method was 92.6%. The mean age at application and mean duration of application were 5.81 ± 6.09 days and 32.13 ± 7.90 days, respectively. In the systematic review, the classic method group showed a statistically smaller success rate (proportion of 0.79) and statistically smaller complication rate (proportion of 0.05) than the commercial product group (proportion of 0.83). CONCLUSIONS: Compared with commercial products, classic ear molding has remarkable and comparable therapeutic effects on neonatal auricular deformities. Additionally, the classic ear-molding method is more suitable for infants with auricular deformities from socioeconomically vulnerable areas. Thus, the classic ear-molding method could be a better option for congenital ear anomalies than commercial ear-molding products.

Noninvasive ear molding in the correction of ear anomalies: A systematic review and meta-analysis.

OBJECTIVE: Ear molding has been used for the treatment of congenital external ear anomalies. The purpose of this study is to systematically review ear molding therapy and perform a meta-analysis to determine its efficacy. METHODS: A systematic review and meta-analysis of the literature was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The PubMed and Embase databases from January 2009 to April 2021 were searched. Individual studies were eligible for inclusion if they evaluated noninvasive ear molding for congenital ear anomalies, featured at least 50 ears, and were published in English. RESULTS: 15 studies (one RCT and 14 clinical series) with a total of 1729 children undergoing molding of 2508 ears were identified and included in the meta-analysis. Meta-analysis of the eight studies with reported success rates as determined by clinician assessment showed an overall success rate in 87.4% of ears. Meta-analysis of the three studies with reported efficacy as assessed by laypersons showed an overall success rate of 92%. All studies reported a variety of minor skin-related complications in the ear, such as eczema, excoriation, infection, irritation, rash (allergic or nonallergic), and ulceration. Generally, complications were not reported to be serious and were noted to resolve with minimal to no intervention. CONCLUSION: To the authors' knowledge, this study represents the largest modern systematic review and meta-analysis analyzing the efficacy of ear molding. A review of the 15 studies included suggests that ear molding is an effective and safe treatment for congenital ear anomalies with a high success rate. However, the strength of this body of evidence is reduced by a lack of comparative studies, heterogeneous patient populations, treatment protocols, and ear assessment scales.

Non-Surgical Correction of Congenital Ear Anomalies: A Critical Assessment of Caretaker Burdens and Aesthetic Outcomes.

INTRODUCTION: Congenital ear anomalies result from cartilage and skin compression in utero. They can be corrected in infancy before the cartilage hardens and loses its malleability. Caretaker burden of ear molding and its impact on esthetic outcomes has not been studied. METHODS: Demographic and procedural variables were retrospectively collected for infants who underwent ear molding. Parents were surveyed regarding their experience, caretaker burden, and esthetic outcome. Outside physicians were provided with pre- and post-treatment photographs and asked to rate outcomes. A Likert scale was developed for responses and converted to a numeric score from 1 to 5 with 5 as the most desirable. RESULTS: Seventy-four patients comprising 121 ears were included. Mean age at treatment was 20.1 ± 21.4 days with treatment duration of 21.1 ± 7.7 days. Parental participation in the survey was 70.1%. Questions that queried parents' experiences revealed a "very positive" experience with minor burden related to bathing and cleaning (Mean Likert Score 4.1, Range 1-5). Favorable parent-reported outcomes were obtained regarding anticipated social distress (4.28, 1-5), satisfaction with results (4.27, 1-5), and perception of final appearance (4.18, 1-5). Physician assessments of esthetic outcomes were slightly lower, but favorable between "somewhat effective" and "very effective" (3.46, 1-5). Earlier treatment trended favorably, but did not reach significance. Ear malformations had higher parent-reported satisfaction than ear deformations (4.75 ± 0.46 vs 4.21 ± 1.25, p = 0.025). CONCLUSION: Despite the additional obligation for new parents, infant ear molding is rated low in terms of caretaker burden. Esthetic outcomes are excellent as assessed by parents and physicians. However, caretakers reported higher esthetic outcomes than physician evaluations. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Comparison of 2 Ear Molding Systems for Nonsurgical Management of Newborn Auricular Deformities.

BACKGROUND: Congenital auricular deformities are common diseases in newborn infants. We compared the efficacy of 2 ear molding systems in the nonsurgical management of newborn auricular deformities in Chinese infants. METHODS: A total of 462 newborns with auricular deformities were treated with either the EarWell or the LiangEar ear molding systems. The posttreatment outcome was graded as excellent, fair, and poor. The differences in effectiveness between the 2 ear molding systems and factors that may affect the posttreatment outcome were analyzed. RESULTS: Both ear molding systems showed substantial efficacy in the treatment of newborn auricular deformities. The effective rate was comparable between the EarWell and the LiangEar systems for 4 types of auricular deformities (cryptotia, prominent ear, helical rim abnormality, and cup ear), while the costs for the LiangEar systems were half as much as that for the EarWell systems. Multivariate regression analysis showed that earlier time points at treatment initiation, less severe auricular deformities, treatment duration, and breastfeeding were the most significant predictive factors for a better outcome. CONCLUSION: Our findings demonstrate that using the EarWell and the LiangEar systems are both optimal nonsurgical approaches for treatment of most newborn auricular deformities.

Using Ear Molding to Treat Congenital Auricular Deformities.

Objective: To explore the utility of ear molding in the treatment of congenital auricular deformations. Study Design: A retrospective chart/photograph review of a consecutive series of infants treated with the EarWell System from 2017 to 2020 was performed. Data on type of auricular deformity, treatment side, and auricular length and width were collected weekly for all study participants. Result: A total of 173 patients (274 ears) with congenital auricular anomalies were included. The treatment duration for lop ears and Stahl's ears was shorter than for other deformations. The mean treatment EarWell duration of participants who started ear molding within 14 days of birth was shorter than that of those who started treatment more than 14 days after birth with the same ear deformation. For participants with unilateral ear deformities, the length and width of both the affected and healthy ears increased over the course of treatment, equalizing after 3 weeks. For participants with bilateral ear deformities, the length and width of both ears increased rapidly over the first 3 weeks of treatment, and the length and width of both ears gradually equalized after treatment. Conclusion: Ear molding is an important intervention for treating congenital auricular deformations, and can increase auricular length and width. Early identification and initiation of treatment is crucial in the management of congenital auricular deformation.

Implementation of auricular malformation screenings in the newborn population.

BACKGROUND AND OBJECTIVE: Research has shown that it is important to initiate ear molding early for children with auricular malformations in order to achieve the best results. Currently our institute relies on the traditional primary care physician (PCP) referral system, which does not recognize the time sensitivity of the visit in patients with auricular malformations. The purpose of the current research is to implement a new screening protocol for identifying auricular malformations in the newborn population and thus expedite the clinic visit and necessary intervention. METHODS: The hearing screen technicians (HSTs) were trained to identify some of the most common auricular malformations. A picture guide of 11 types of auricular malformations were given to the HSTs to use as a reference. At the time of the newborn hearing screen, the HSTs examined the pinnas of each baby. When an auricular malformation was identified, the auricular malformation team was immediately alerted and a bedside consultation with ENT occurred. RESULTS: Comparison was made of the referral rate between pre- and post-implementation of the protocol which showed an increased rate of identification (five referrals in the 12-month period pre-implementation versus eighteen referrals in the 15-month period post-implementation). CONCLUSION: We successfully implemented an auricular malformation screening protocol that was linked to newborn hearing screenings. The frequency of identification has increased with the implementation of the new screening protocol and has resulted in earlier initial ENT consultations for ear molding with the goal of improving patient satisfaction and results.

Efficacy and Timing of Neonatal Ear Correction Molding.

BACKGROUND AND AIM: Given the incidence of congenital auricular anomalies varies racially, this study aimed to investigate the efficacy and timing of ear correction molding in infants with auricular anomalies. MATERIALS AND METHODS: A total of 141 auricular anomalies of 100 infants less than 4 months of age were treated using the Earlimn molding system. Treatment outcomes were graded (three categories) in terms of auricular morphology. The efficacies and outcomes of modeling were evaluated in infants according to age and anomaly type. RESULTS: The mean age at which correction was initiated was 35.13 days of life, and the average treatment duration was 17.81 days. Of all anomalies, 86% were corrected. Both deformations and certain malformations were satisfactorily corrected. The outcomes of children with conchal crura and mixed anomalies were relatively poor. Although no differences in treatment efficiency were evident among the three age groups, infants < 3 weeks old required shorter treatment courses than those > 6 weeks old. The only complications were mild skin ulcers. CONCLUSIONS: Ear correction molding is remarkably effective for infants with auricular deformations/malformations. Molding efficacy depends on the type of anomaly. Initiation of molding at less than 6 weeks of age is essential to minimize treatment duration. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Deformations of the Ear and Their Nonsurgical Correction.

The incidence of congenital ear deformities has been documented to be as high as 58% of all newborns. Unfortunately, the majority of these deformations do not spontaneously self-correct, leaving the child with a permanent deformity that can only be corrected through surgery. With the evolving simplicity of ear molding that can be done in the office, this can obviate the need for unnecessary surgery that comes with its own set of complications and a higher cost. Early detection and early treatment is key for successful ear molding. The purpose of this article is to review the types of deformational ear deformities and the most up-to-date literature on ear molding, increase awareness to this topic, and ultimately increase patient and parental satisfaction with their overall care.

Nonsurgical Management of Congenital Auricular Anomalies.

Congenital auricular deformities often can be corrected by neonatal ear molding techniques, which have evolved significantly over a 25-year period with commercially available molding systems now available. Indications for molding and methodology for best optimizing results have been well described in the literature, although recent studies have explored methodology for reduction in the cost of technique and also called for increased awareness among pediatric practitioners of the importance of early institution of therapy.

A Simplified Nonsurgical Method for the Correction of Neonatal Deformational Auricular Anomalies.

Despite reported success of early nonsurgical splinting of congenital ear deformities, the technique has not been widely utilized due to difficulty with application and positional maintenance of these devices. Delay in treatment can result in unnecessary surgery for the child later in life. In response to this need, we developed a simplified system consisting of Velcro, conformers, and polysiloxane gel that can be applied in 3 steps. Before and after photos after application of the device were graded by a plastic surgeon independent of the study. A total of 33 ear deformities were treated. In all, 92.3% of ears achieved significant improvement and normalization of their ears after therapy. This device allows for a more straightforward and individualized application than current products available. Our hope is that practitioners involved early in the infant's care will utilize this technology resulting in improved outcomes and avoiding unnecessary surgery.

Effectiveness of ear molding in the treatment of congenital auricular deformation / 中国耳鼻咽喉头颈外科

OBJECTIVE To evaluate the short-term efficacy of ear molding in the treatment of congenital auricular deformation. METHODS Twenty-four infants(twenty-eight ears) were treated with ear molding devices(EarWell Infant Ear Correction System). Doctors and parents were surveyed 1 months after treatment. RESULTS All cases were treated successfully without severe complications. 25 ears(89％) and 26(92％) were rated as very satisfied or satisfied by doctors and parents, respectively. CONCLUSION Ear molding is a noninvasive treatment, and effectively corrects congenital auricular deformation.