International Journal of Pediatric Otorhinolaryngology 159 (2022) 111189

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International Journal of Pediatric Otorhinolaryngology

journal homepage: www.elsevier.com/locate/ijporl

Noninvasive ear molding in the correction of ear anomalies: A systematic

review and meta-analysis
Elias S. Saba a, Stanley Mui b, Luke J. Schloegel a, *
a
Department of Head and Neck Surgery, Kaiser Permanente Oakland, USA
b
Department of Head and Neck Surgery, Kaiser Permanente San Francisco, USA

A R T I C L E I N F O A B S T R A C T

Keywords: Objective: Ear molding has been used for the treatment of congenital external ear anomalies. The purpose of this
Ear molding study is to systematically review ear molding therapy and perform a meta-analysis to determine its efficacy.
Ear malformations Methods: A systematic review and meta-analysis of the literature was conducted using the Preferred Reporting
Ear deformations
Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The PubMed and Embase databases from
Systematic review
Nonsurgical
January 2009 to April 2021 were searched. Individual studies were eligible for inclusion if they evaluated
Correction 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.

1. Introduction intervention, noninvasive ear molding, or surgical correction.

Congenital external ear anomalies are inborn structural abnormal­
ities of the auricle with a reported incidence that ranges widely from 6%
to 58% of newborns [1–5]. These anomalies may occur as an isolated
condition or as part of a congenital syndrome characterized by multiple
anomalies.
Ear abnormalities may pose cosmetic concerns resulting in childhood
psychological distress [6]. Certain abnormalities may be amenable to
early correction in the newborn phase of life, and may thus avoid these
adverse future sequelae. Ear abnormalities that are not amenable to
early correction, or that do not receive intervention within the first few
weeks of life often require surgical intervention after the child is five
years of age when the auricle is close to 90% of its adult size. Depending
on the severity and type of anomaly, management options include no
Ear molding is a noninvasive intervention that aims to normalize the
shape of an anomalous ear by applying direct pressure, using various
materials including tape, common household items and prefabricated
devices. Proponents recommend initiation of ear molding for children
before three weeks of age with treatment for at least two to six weeks.
Although ear molding has been in use since the early 1980s, its wide­
spread acceptance has been hampered by delays in proper diagnosis of
ear anomalies, the accessibility of suitable molding materials, the
incorrect assumption that ear anomalies will self-correct, and a lack of
information for patients about ear molding. The objective of this study is
to systematically review outcomes of ear molding therapy.

* Corresponding author. Department of Head and Neck Surgery, 3600 Broadway, 4th floor, Oakland, CA, 94611, USA
E-mail address: Luke.j.schloegel@kp.org (L.J. Schloegel).

https://doi.org/10.1016/j.ijporl.2022.111189
Received 30 December 2021; Received in revised form 10 April 2022; Accepted 22 May 2022
Available online 25 May 2022
0165-5876/© 2022 Elsevier B.V. All rights reserved.
E.S. Saba et al. International Journal of Pediatric Otorhinolaryngology 159 (2022) 111189

2. Material and methods described only in conference abstracts or letters, enrolled fewer than 50
treated ears, presented case reports, performed anthropometric mea­
2.1. Search strategies and study selection surements of deformed ears, and/or described a protocol of a future RCT
comparing ear molding and waitlisting.
Molding methods have been in use as early as the 1980s and have The remaining 15 records, for 15 studies, met the chosen PICOTS
used varying splinting approaches which have been continually criteria chosen to answer the question of “What is the efficacy and safety
improved over the years with the creation of more standardized prac­ of ear molding to correct congenital ear deformities” (Table 1). The
tices and the introduction of prefabricated molding devices. Papers articles’ full texts were reviewed.
included in our review involved studies published in 2009 or later to
allow for a modern review of molding outcomes.
Fig. 1 displays a Preferred Reporting Items for Systematic Reviews
and Meta-Analyses (PRISMA) diagram that details how the included
studies were selected for analysis. Eligible studies were identified Table 1
through a search using the Embase and PubMed databases. Abstracts Eligibility for Inclusion for Review and Meta-Analysis. The below table discusses
were identified by combining the following search terms: 1. Ear, auricle, the PICOTS criteria underlying the study formulation.
and auricular and 2. Abnormality, abnormalities, anomaly, anomalies, PICOTS Criteria
deformation, deformations, deformity, deformities, malformation and mal­
Population Children with at least 50 ears treated for congenital ear anomalies
formations and 3. Mold, molds, molding, noninvasive correction, non- Intervention Any noninvasive ear molding method
invasive correction, nonsurgical correction, non-surgical correction, nonin­ Comparator Ear molding with other prefabricated devices or non-prefabricated
vasive treatment, non-invasive treatment, nonsurgical treatment, non- methods, surgery
surgical treatment, splint, splints, and splinting. Outcomes Any, including cosmetic satisfaction and adverse events
Timing Any duration of treatment and follow-up
This search yielded 294 unique records (193 in Embase and 203 in Setting Outpatient for ear molding, inpatient for surgical treatment
PubMed, minus 102 duplicates), of which 232 were excluded for being Study design Any non-case report study described in an English full-text article
unrelated to ear molding, and 47 ear molding-related articles were published since January 2009
excluded because they were review articles, not published in English,

Fig. 1. Prisma Diagram. The figure below shows the methodology for papers included in this study. A breakdown of reasons for excluded is discussed in the methods section.

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E.S. Saba et al. International Journal of Pediatric Otorhinolaryngology 159 (2022) 111189

3. Results
3.1. Results of literature search
The literature search on ear molding for congenital ear anomalies
yielded 15 studies that met the search criteria. There was one RCT and
14 clinical series (five prospective, six retrospective, and three unknown
if prospective or retrospective) involving a total of 1729 patients with
2508 ears undergoing molding. The characteristics of the 15 studies are
summarized in Table 2. Most studies primarily involved ear deformities
rather than malformations. The most common ear molding device was
EarWell, which was used as the sole device in five studies and one of two
devices in three other studies. The patients were primarily younger than
three weeks in five studies, and treatment duration was at least four
weeks in nine studies. The reported post-treatment follow-up ranged
from none to approximately 16 months.
All 15 studies reported efficacy rates for ear molding based on
assessment by clinicians and/or laypersons (i.e., parents or crowd­
sourced raters) according to the number of patients, ears, or ear
anomalies (Table 3). Because of heterogeneity in rating scales—with
some studies categorizing results as excellent, good, fair, or poor and
other studies using different categories—this report bases success rates
on the sum of outcomes closest to excellent and good descriptions. The
results were subjected to meta-analyses with random effects models
created with the software tool Comprehensive Meta-Analysis, version
3.3.070.
3.2. Study outcomes and meta-analyses
A comparison of study outcomes and conducted meta-analyses can
be reviewed in Tables 3 and 4 respectively. Twelve studies reported
success rates as determined by clinicians (rather than laypersons)
assessment, ranging from 28% to 100%. Of these twelve studies, eight
reported rates based on the number of ears evaluated (rather than
number of patients evaluated). A meta-analysis of these eight studies
reflected an overall success rate of 87.4%. Five studies reported efficacy
as assessed by laypersons (rather than clinicians), with success rates
ranging from 78% to 96%. Of these five studies, three reported rates
based on the number of ears evaluated. A meta-analysis of these three
studies showed an overall success rate of 92%. Meta-analysis of the four
studies with clinician-rated ear-based success rates for populations with
children primarily younger than three weeks of age demonstrated an
overall success rate of 90%.
3.3. Complication rates
All studies reported a variety of skin-related complications in the ear,
such as eczema, excoriation, infection, irritation, rash (allergic or
nonallergic), and ulceration. Rates of these events ranged from 0.3% to
49%. Generally, complications were reported to be minor and often
resolved with minimal to no intervention. However, adverse events were
the main reason for patient dropout in two studies [7,8].
4. Discussion
The reported incidence of congenital ear anomalies widely ranges. As
earlier studies report an incidence around 20% and later studies have
reported incidences as high as 58%, it has been hypothesized that either
the incidence of ear anomalies is increasing, or that there has been
increased detection of these anomalies resulting in clinical presentation
[4,9,10]. In some areas of the world, such as the Pearl River Delta area in
China, as many as 57% of infants have a deformity of one or both ears at
1 week of age [11]. Given this incidence, guidance is required regarding
the appropriate use of ear molding for the correction of congenital ear
anomalies.
The 15 studies included in this review suggest that ear molding is an
effective and safe treatment for congenital ear anomalies, but this body
of evidence is limited by a lack of comparative studies, heterogeneity in
populations and protocols, patient dropout, and small evaluable group
sizes (Table 5). We next discuss a variety of factors affecting molding

Table 2
Characteristics of the 15 Studies Reviewed. The below table discusses the treatment characteristics involved in each study.
Study Characteristics

Design Study Enrolled Ear Anomaly Type (# Ears, Ear Molding Timeframe of Ear Molding
Population unless noted) Device
Age at Start of Treatment Length of post-
# # Deformity Malformation Treatment (weeks) Duration treatment follow-up
Patients Ears (weeks) (months)

RCT Xiong 2020 250 282 207 75 EarWell 1.7 to 16 ≤8 6

212 250 170 80 LiangEar
Clinical series, Zhuang 100 129 90 51 anomalies Earlimn 5.0 (mean) 2.5 (mean) 0
prosp 2020 anomalies
Chan 2019 67 105 70 35 EarWell 2.2 (mean) 4.1 (mean) 6
Doft 2015 96 158 100 58 EarWell ≤6 2 (mean) 12
Fraser 2013 54 90 49 patients NR Ear Buddies 3.7 (mean) 4 (mean) 0
van Wijk 132 209 209 0 Ear Buddies 8.8 (mean) ≤4 12
2012
Clinical series, Nigam 2020 175 272 272 0 EarWell or 2.9 (mean) 4.4 (mean) 0.5 (mean)
retro InfantEar
Patel 2020 55 85 85 0 InfantEar 4.9 (mean) 4.5 (mean) 0
Wang 2020 40 55 0 55 Prefabricated 15 (median) 0.1 to 26 ≤16b
(brand NR)
Zhang 2019 105 141 102a 24a EarWell 9.6 (mean) 4.8 (mean) 0
Daniali 2017 201 387 212 175 EarWell 1.8 (mean) 5.3 (mean) 0
Woo 2017 54 80 93 4 anomalies Babyears 7.6 (mean) 6.3 (mean) 2.2 (mean)b
anomalies
Clinical series, Zhou 2019 108 135 0 135 EarWell or Yier 14.4 (mean) 5.2 (mean) ≥3b
NR if prosp or Auricle
retro Byrd 2010 34 58 58 EarWell <1 6 0
Schonauer 46 72 72 0 Non- <2 3 to 6 2 to 12b
2009 prefabricated
a
Zhang 2019 and Fraser 2013 included 15 ears and 5 children with mixed anomalies, respectively, which are not counted in the Ear Anomaly Type columns because
the full text did not provide details about whether those mixed anomalies comprised deformities, malformations, or both.
b
Unclear if the follow-up period reported in the full text included the treatment duration or was entirely after treatment.

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E.S. Saba et al. International Journal of Pediatric Otorhinolaryngology 159 (2022) 111189

Table 3
Study Results: The below table reports treatment outcomes for each of the included studies.
Design Study Population Evaluateda Ear Assessor Success Rate (%) Rate Of Dermatologic Adverse Event (%)**

Clinician Layperson

RCT Xiong 2020 282 ears (EarWell) X 74 4.3

250 ears (LiangEar) X 73 4.4
Clinical series, prosp Zhuang 2020 141 ears X 86 1.6
Chan 2019 71 ears X 86 46
41 patients X 85
Doft 2015 158 ears X 96 3.1
Fraser 2013 42 patients X 86 9.5
49 patients X 78
van Wijk 2012 81 patients X 28 9.3
Clinical series, retro Nigam 2020 100 ears X 85 0.7 to 6.6
Patel 2020 59 ears X 92 20.0
Wang 2020 49 ears X 59 38.8 or 40.8
Zhang 2019 141 ears X 96 4.8 or 5.7
Daniali 2017 387 ears X 91 0.3 to 9.3
Woo 2017 41 patients X 93 53.7
Clinical series, Zhou 2019 135 ears X 100 0.7 to 20
NR if prosp or retro Byrd 2010 58 ears X 90 2.9 or 8.8
Schonauer 2009 56 ears X 98 4.3
a
Studies differed on whether they reported # of patients evaluated after molding or # of ears evaluated after molding. We have delineated these differences here.

4.2. Early vs delayed molding

Table 4
Meta-analysis Results. The below table shows treatment results for various papers
The newborn at birth initially has elevated levels of maternal es­
with similar focus.
trogen allowing for increased malleability of the ear cartilage. Ear
Meta-Analysis Focus Number of Studies Included Success molding takes advantage of neonatal cartilage’s estrogen-induced high
Studies Rate
plasticity and the principle that a stretching force chronically placed on
Included
tissue causes stretch-induced signal transduction pathways to trigger
Outcomes Based on 8 Xiong, Chan, Wang, 87.4%
angiogenesis, epidermal proliferation, fibroblast mitosis, and increased
Clinician Zhang, Daniali, Zhou,
Assessment Byrd, Schonauer production of collagen. As neonatal estrogen levels gradually decrease
Outcomes Based on 3 Doft, Nigam, Patel 92% from roughly the third day of life to the sixth week of life, it has been
Layperson suggested that molding outcomes are improved in patients who initiate
Assessment molding prior to three weeks of age.
Outcomes with 5 Xiong, Chan, Zhang, 89%
EarWell Only Daniali, Byrd
In 4 of the included 15 studies, most patients were younger than
Outcomes with 4 Chan, Daniali, Byrd, 90% three weeks of age. A meta-analysis of these studies showed an overall
Children <3 Weeks Schonauer success rate of 90% in patients younger than three weeks of age. Upon
of Age initial inspection, this appears to be a comparable success rate to the
87.4% success rate calculated from our meta-analysis considering the 8
studies featuring outcomes based on clinician assessment. However, it is
efficacy.
important to note that the meta-analysis considering these 8 studies
included the 4 studies featuring patients younger than three weeks of
4.1. Deformities vs malformations
age, and thus analyzed similar patient cohorts. Comparing individual
study data better elucidates that intervention is more effective during
Congenital ear deformities are typically classified as deformities,
the first three weeks of life. In one included study, only ½ of infants had a
involving an ear with misshapen but fully retained chondrocutaneous
good response when molding was initiated after 3 weeks from birth
components, or malformations, in which there is a deficiency of carti­
[10]. Another study featuring 175 patients/272 ears showed satisfaction
lage, skin, and/or soft tissue as a result of abnormal embryologic
was significantly higher in patients when initiation was conducted prior
development. Classical teaching has suggested that ear molding is more
to 3 weeks (97%) in comparison to delayed molding (79%), and also
appropriately used for the treatment of deformities rather than malfor­
reported increased rates of device fall-outs and replacements in the
mations. However in clinical practice, patients may present with a
delayed molding group [12]. Other studies comparing initiation of
combination of abnormalities resulting in a wide spectrum of ear
molding in children prior to <6 weeks in comparison to initiation of
anomalies, and in some cases, differentiating deformity from malfor­
molding after 6 weeks reproduce statistically significantly better results
mation may be difficult [12]. A comparison of success rates in patients
in the early molding group [7,14].
undergoing ear molding intervention for malformations versus de­
Though limited data exist, it has also been suggested that certain
formities was desired; however due to the variable use of these defini­
deformities may be more influenced by the time of initiation of molding.
tions across studies, a meaningful comparison could not be assessed.
One author has suggested that deformities of the upper third of the ear
Within the classification of congenital ear deformities, approxi­
(Lop ear and Stahls) respond to therapy only during the neonatal period
mately 30% will correct spontaneously, but there is no way to determine
[15]. Despite findings that earlier initiation of molding may result in
which ones will improve [4,10,13]. Given the inability to predict which
improved outcomes, delayed molding may still yield beneficial out­
deformities will self-correct, advocates generally recommend ear
comes for some patients with cryptotia. One study involving 108 pa­
molding to treat all ear deformities. However, in practice, many mild
tients/135 ears with cryptotia showed 100% efficacy (defined as good or
deformities may correct on their own and can be observed. Most
excellent) in correcting cryptotia in children both <6 and >6 months,
non-mild malformations will not improve with molding and appropriate
though infants <6 months had shorter treatment time and lower com­
clear guidance should be given to families.
plications [16].

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 E.S. Saba et al.
Table 5
Limitations of Studies. The below table details the limitations of each of the included studies.
Table 5
Study Limitations According to GRADE Criteria

GRADE Domain Identified Limitation Study (listed in same order as Table 3)

Xiong Zhuang Chan Doft Fraser van Nigam Patel Wang Zhang Daniali Woo Zhou Byrd Schonauer
2020 2020 2019 2015 2013 Wijk 2020 2020 2020 2019 2017 2017 2019 2010 2009
2012

Within Design/ Not a comparative study X X X X X X X X X X X X X X

study Implementation Retrospective design, or X X X X X X X X X
unknown if prospective or
retrospective
Short or no follow-up beyond X X X X X X X
end of treatment to determine
durability of effect
Directness Patient age likely older than X X X X X X X X X X
three weeks
5

Main assessment involving X X X X X X X X X

review of ear photos
Assessment of ears by X X X
laypersons only
Efficacy data only per patient X X X X
or ear anomaly, not per ear
Among Consistency Heterogenous patient X X X X X X X X X X X X X X X

International Journal of Pediatric Otorhinolaryngology 159 (2022) 111189

studies populations, treatment
protocols, ear assessment
scales, and follow-up
durations
Precision Relatively small evaluable X X X X X X X X
group sizes (fewer than 100
ears or patients)
Attrition (by 11%–63% before X X X X X X X X
end of study)
Publication bias Vendor involvement X X X X
E.S. Saba et al.
4.3. Type of molding device
Our subgroup meta-analyses featuring five of the fifteen papers
included in this study demonstrated overall clinician-assessed ear-based
success rates of 89% for EarWell. However, insufficient data exists
comparing the efficacy rates across molding techniques. One study
featuring 462 babies/532 ears treated in China showed similar rates of
efficacy between the EarWell and LiangEar systems, though noted that
within their healthcare system, the LiangEar system cost half as much in
comparison to the Earwell system [1]. Anecdotal reports exist featuring
modification of molding technique for certain deformity types. For
example, in children with cryptotia, one group of practitioners recom­
mend using double sided tape between the scalp and ear to pull out the
pinna for 7–10 days prior to placing a fabricated device [17]. The de­
cision to pursue one type of molding device over another may depend on
provider preference and cost to the patient and/or healthcare system.
4.4. Genetic predisposition
It has been suggested that patients with a genetic predisposition to
ear anomalies, suggested by a family history of ear anomalies, may have
worsened corrective outcomes in comparison to patients with idiopathic
ear deformities. Though insufficient evidence exists to support this
theory conclusively, anecdotal evidence was discussed in a few studies.
Byrd et al. noted that several patients with prominent ears who had
recurrence of overprojection after correction had a family history of
prominent ear deformity, suggesting that this genetic influence
“destined them to late recurrence” [10]. Another study discussed similar
failure of correction at the 3–4 month mark in 2 patients with 1st degree
relatives with ear deformity. The authors projected that correction failed
at the 3–4 month mark due to overgrowth of the concha at an obtuse
angle from the scalp [4].
4.5. Improving outcomes via earlier detection and treatment of ear
anomalies
Because earlier initiation of molding is associated with improved
cosmetic outcomes, several methods have been proposed to promote the
early detection of ear anomalies. In one quality improvement project
involving the detection of ear deformities in 96 patients/158 ears within
the newborn nursery, 82% of patients had molding initiated within the
newborn nursery with excellent results recorded in 96% of deformities.
In two other studies, patients noted to have an ear deformity at birth
were observed for a short period of time (48–72 h in one study, 5–7 days
in the second study) to allow time for self-correction. If no improvement
was noted on follow-up, ear molding was initiated [10,18].
One study involved the creation of an innovative leaflet distributed
by hearing screeners that allowed parents to self-report for referral if
they had any concerns about the appearance of their child’s ear. The
overall rate of referral was 0.7%, consisting of 88 babies presenting after
the distribution of 13,403 leaflets. Despite our concerns that this might
result in over-referral, parents were typically satisfactory at determining
whether their children might need molding, consistent with other results
showing similar assessment of ear outcomes by surgeons and parents [5,
8]. Another innovative Mayo Clinic study involved teaching hearing
screeners to identify neonates with ear deformities and refer to the
child’s general pediatrician, who would then refer to the otolaryngolo­
gist as needed [19]. Regardless of referral pathway, the results described
in this meta-analysis confirm that healthcare providers should optimize
early molding intervention to improve patient outcomes.
4.6. Study limitations
There are several limitations in a review study of this nature (see
Table 5). There was likely a high degree of observer bias as many of the
assessors had an expectation of improved appearance. The nature of this
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International Journal of Pediatric Otorhinolaryngology 159 (2022) 111189
problem makes a control group difficult to create and therefore most of
the studies were not comparative. Also, many of these mild deformities
will correct on their own. Therefore, many of the patients who were
fitted with the molding device early in the newborn period would have
improved with or without the device. This may be one of the most
challenging aspects of implementing this device as it favors over­
treatment in patients with mild deformities. This has implications of
increased overall cost to our healthcare system. It also must be noted
that 4 studies involved vendor sponsorship which may lead to publica­
tion bias.
5. Conclusions
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 limited by
a lack of comparative studies, heterogeneous patient populations,
treatment protocols, and ear assessment scales.
Submission declaration
This work has not been published previously.
Declaration of competing interest
None.
Acknowledgment
Thank you to Anthony Lee for the analysis.
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