756678

research-article2018
AORXXX10.1177/0003489418756678Annals of Otology, Rhinology & LaryngologyDy and Lapeña

Original Article
Annals of Otology, Rhinology & Laryngology

External Auditory Canal Dimensions, Age,

1­–5
© The Author(s) 2018
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DOI: 10.1177/0003489418756678
https://doi.org/10.1177/0003489418756678

Persons With Down Syndrome journals.sagepub.com/home/aor

Alexander Edward S. Dy, BS, MD1,

and José Florencio F. Lapeña, Jr., MA, MD2 

Abstract
Objective: To investigate associations between age, external auditory canal (EAC) dimensions, and cerumen retention/
impaction among persons with Down syndrome (DS).
Methods: This cross-sectional study evaluated EAC dimensions, cerumen retention/impaction, and middle ear status with
pneumatoscopy after extraction in 130 persons with DS. Descriptive and inferential statistics correlated age, presence of
impacted/retained cerumen, and EAC diameter.
Results: Of 260 ears in 67 males and 63 females with average age of 9.48 years, 72.3% (188) had EAC of ≤4 mm. Those ≤1
year were 4.97 times more likely to have cerumen problems than those >1 year (95% CI, 1.45-17.02, P = .011). The odds
of having cerumen problems with an EAC diameter of ≤4 mm were 3.31 times higher than with a diameter of 5 mm (95%
CI, 1.46-7.50, P = .004), and odds of having cerumen impaction were as much as 6.19 times higher (95% CI, 2.38-16.08,
P < .001). Male gender and low-lying external ear were also associated with increased odds of cerumen problems.
Conclusion: There is a high prevalence of cerumen retention/impaction in persons with DS compared to the general
Philippine population and a higher prevalence rate for EAC stenosis than elsewhere. A canal diameter of 4 mm and below
and age 1 year or less are associated with a significantly higher likelihood of cerumen retention/impaction.

Keywords
Trisomy 21, ear canal, external auditory canal, ear wax, stenosis, Down syndrome, pediatric ear disorders, pediatric
otolaryngology, common childhood external ear problems

Introduction 21, otolaryngology, cerumen retention, and/or cerumen

Down syndrome (DS) is the most common chromosome
abnormality in children, with an incidence of 1 in 700 live-
births,1 and has been associated with external auditory canal
(EAC) stenosis, predisposing to cerumen retention and
impaction, which may in turn lead to conductive hearing
loss.2 To the best of our knowledge, there are no published
studies in the English literature on the natural history of ear
canal stenosis, but up to 50% of newborns with DS are said
to have EAC stenosis, and a significant number require
cerumen cleaning.2
Although the current recommendation is for persons
with DS to undergo otologic assessment every 3 months
until the age of 3 to allow sufficient widening of the EAC
and lessen impaction episodes,2 the association of EAC
diameter, age, and cerumen retention and impaction in
persons with DS has not been adequately elucidated.
A comprehensive English literature search of MEDLINE
(PubMed), EMBASE, and HERDIN using the keywords
external auditory canal stenosis, Down syndrome, Trisomy
impaction yielded no previous studies showing that such an
association exists. Moreover, it has not been established
whether cerumen impaction or retention increases or
decreases at a particular age or EAC diameter.
In this study, we explore the possible association between
ear canal dimensions and ages of persons with DS and the
presence of cerumen. We hypothesize that at a certain diam-
eter and age, cerumen problems decrease significantly.
Our study aims to investigate the association between age
and average EAC diameter, age and cerumen retention or
1
Department of Otorhinolaryngology, Philippine General Hospital,
University of the Philippines Manila, Manila, Metro Manila, Philippines
2
Department of Otorhinolaryngology, College of Medicine-Philippine
General Hospital, University of the Philippines Manila, Manila, Philippines
Corresponding Author:
José Florencio F. Lapeña, Jr., MA, MD, Department of
Otorhinolaryngology, Ward 10, Philippine General Hospital, University
of the Philippines Manila, Taft Avenue, Ermita, Manila 1000, Philippines.
Emails: lapenajf@upm.edu.ph, jflapena@up.edu.ph
2 Annals of Otology, Rhinology & Laryngology 00(0)
impaction, and EAC diameter and cerumen retention or
impaction among persons with DS.
Materials and Methods
Study Design
With Institutional Review Board approval from the
University of the Philippines Manila Research Ethics
Board (UPMREB – [ORL]-2016-276-01), this cross-sec-
tional survey considered as source population all persons
with DS seen during the second annual United for Down
free clinic of the Down Syndrome Association of the
Philippines (DSAP) on March 20, 2016, at the Unilab
Bayanihan Center, Mandaluyong City, Philippines. The
nationwide multispecialty free clinic has been conducted
annually by DSAP since 2001 and in partnership with
United Laboratories since 2015.
Study Participants
Of those who attended the multispecialty free clinic, partici-
pants who consulted at the otorhinolaryngology clinic with
written informed consent of a parent or guardian were con-
sidered for inclusion in this study. The number of partici-
pants was sufficient for the computed sample size of 100,
determined by statistical analysis for a statistical power of
95% with a .05 significance level.3 Those with incomplete
records and records of persons with DS who did not assent
to ear evaluation and/or cleaning were excluded prior to sta-
tistical analysis.
Study Variables/Outcomes
General information, including age, gender, and vital signs,
were obtained and recorded by DSAP volunteers. Senior
otorhinolaryngology (ORL) residents of the Philippine
General Hospital, University of the Philippines Manila per-
formed otologic evaluations, recording the EAC diameter at
the largest dimension at which a pneumatic seal was
obtained with an Insufflation Bulb System (LumiView Part
21502, Welch Allyn Inc, New York, New York, USA) using
standard 2.0 mm, 3.0 mm, 4.0 mm, and 5.0 mm ear speculae
(LumiView Part 22100, Welch Allyn).
The same residents recorded the presence of impacted or
retained cerumen or absence thereof (in which case pneu-
matoscopic findings were recorded). Pneumatoscopy and
EAC diameter recording were deferred postextraction in the
presence of cerumen. Cerumen impaction was defined as an
accumulation of cerumen that completely occludes the
entire EAC, causes symptoms and prevents a needed assess-
ment of the ear canal/tympanic membrane or audiovestibu-
lar system, or both. Cerumen retention was defined as an
accumulation of cerumen that partially occludes the EAC,
may or may not cause symptoms, and interferes with full
assessment of the ear canal/tympanic membrane or audio-
vestibular system, or both. Neither symptoms, nor the
audiovestibular system were evaluated in this study.
For all ears with impacted or retained cerumen, other
residents blinded to the EAC dimensions and type of
cerumen (impacted or retained) recorded, extracted the
cerumen in a second room and recorded otoscopic out-
comes for the tympanic membrane (intact: clear, dull,
retracted; perforated: %; mobility: mobile, sluggish,
nonmobile). Unsuccessful or incomplete cerumen extrac-
tion was likewise recorded as impacted or retained.
Senior residents blinded to the extraction procedure and
findings reevaluated and separately recorded postextrac-
tion pneumatoscopic findings and EAC dimensions in
the first room. An attending pediatric otolaryngologist
assisted with difficult extractions and confirmed equivo-
cal findings.
Parents or guardians were informed of the final otologic
evaluation findings and advised on ear and hearing health
promotion and disease prevention. Parents or guardians of
persons with DS needing further evaluation or treatment
were advised to consult the specialist providers of their
choice or the public ORL specialty clinics of the Philippine
General Hospital, U.P. Manila.
Statistical Analysis
Descriptive and inferential statistics were calculated,
including correlation between presence of impacted or
retained cerumen, age, and EAC diameter. Descriptive sum-
mary measures for continuous variables were presented in
terms of mean ± standard deviation, and for categorical
variables, summaries were presented in frequency counts
and proportions. Pairwise comparisons between the EAC
sizes of males and females utilized the independent t test,
while comparison of EAC sizes between left and right ears
utilized the dependent t test. Correlation between EAC size
and age was analyzed using Spearman rank correlation and
linear regression. Association between EAC size and ceru-
men impaction and retention was analyzed using Fisher
exact test. Logistic regression analysis was also used to test
association between age and EAC size with cerumen reten-
tion and impaction. Crude associations were interpreted in
terms of odds ratio. Confounders were introduced to obtain
the adjusted associations using multivariate logistic regres-
sions. Probable confounders were determined at a P value
.25 cutoff, and significant confounders were selected based
on the 5% change in estimate criterion. All data were
encoded in MS Excel version 16 (Microsoft Corporation,
Redmond, Washington, USA) and statistical analyses per-
formed using Stata MP64 version 13 (StataCorp LP, College
Drive, Texas, USA). All hypotheses tests used a .05 α level
of significance.
Dy and Lapeña 3
Results
A total of 194 persons with DS were seen during the second
annual United for Down free clinic of the DSAP. Of these,
130 participants who met selection criteria were included in
the study. The average age was 9.48 years (range, 3
months-35 years). There were 67 males and 63 females,
with a male to female ratio of 1.06.
Mean EAC values for the right ear measured 3.93 ± 0.84
mm for males and 3.82 ± 0.86 mm for females. Mean EAC
values for the left ear were 3.93 ± 0.84 mm for males and
3.83 ± 0.85 mm for females. There was no significant dif-
ference in EAC sizes between males and females and
between right and left ears (P = .304 and P = .942, respec-
tively). Thus, each ear was treated as a single sample in a
homogeneous population, for a total of 260 ears.
Six (2.3%) ears had an EAC size of 2 mm, with the
majority closely distributed into 3 mm (93, 35.8%), 4 mm
(89, 34.2%), or 5 mm (72, 27.7%) EAC diameter. A total of
188 (72.3%) had EAC stenosis of ≤4 mm.
External ear gross examination showed that 206 (79.2%)
were low-set, while the rest were normally located.
Otoscopy revealed 57 (21.9%) had retained cerumen, 108
(41.5%) had impacted cerumen, while the rest (95, 36.5%)
had no cerumen. Only 4 ears (1.5%) had discharge, in all
cases characterized as foul smelling. Of these, only 1 ear
had a perforated tympanic membrane (TM), estimated at
40%, centrally located. Twenty-one ears (8.1%) had a dull-
appearing TM with effusion. Five ears (1.9%) had a
retracted TM, and 26 ears (10.0%) had a nonmobile TM,
but these likely included some of those that were identified
as dull (e.g., those with mucoid effusion or glue ear). None
of the ears had undergone tympanostomy tube insertion.
Apart from these ears where an abnormality was identified,
all the other ears were normal on otoscopy.
Correlating EAC diameters with age, linear regression
revealed that each year added in age increased the EAC
diameter size by 0.063 times (95% CI, 0.053-0.074, P <
.001). EAC size was found to have a direct, moderate cor-
relation with age (rho = 0.64, P < .001)
Overall, 165 ears (63.5%) of all evaluated persons with
DS had cerumen retention/impaction. When analyzed for
age, those 1 year and younger were 4.97 times more likely
to have cerumen problems compared to those older than 1
year (95% CI, 1.45-17.02, P = .011).
Student t test correlating average EAC sizes of ears with
cerumen problems (either retention or impaction) and those
without showed that the difference (4.03 mm in normal ears
vs 3.78 mm in those with retained or impacted cerumen)
was statistically significant (P = .021).
There was an increasing tendency for cerumen impac-
tion with decreasing EAC diameter—26.4% at 5 mm,
46.1% at 4 mm, 49.5% at 3 mm, and 33.3% at 2 mm—and
a notable increase in all cerumen problems (both retention
and impaction) with decreasing EAC diameter: 54.2% at 5
mm, 64.0% at 4 mm, 68.5% at 3 mm, and 100% at 2 mm;
Fisher exact test proved this association to be statistically
significant (P = .006).
Multivariate logistic regression analysis to determine
association between EAC diameter and the presence of
cerumen problems, controlling for confounders (age, gen-
der, external ear location, TM mobility, TM appearance),
showed that the odds of having a cerumen problem with an
EAC diameter of 4 mm and below (EAC stenosis) were
3.31 times higher than with an EAC diameter of 5 mm (95%
CI, 1.46-7.50, P = .004). The odds of having cerumen
impaction in particular were as much as 6.19 times higher
(95% CI, 2.38-16.08, P < .001) in this group.
Male gender (odds ratio [OR] = 3.28, 95% CI, 1.68-6.38,
P < .001) and having a low-lying external ear (OR = 2.72,
95% CI, 1.05-7.05, P = .040) were also associated with
increased odds of having cerumen problems.
Discussion
Our results showed statistically significant correlations
between age and average EAC diameter, age and presence
of cerumen retention or impaction, and EAC diameter and
presence of cerumen retention or impaction among persons
with DS.
The importance of cerumen impaction lies in its deleteri-
ous effect on linguistic, social, and intellectual development
brought about by conductive hearing loss or impairment.4 It
is a common ORL condition that affects millions of people
worldwide. Annually, around 8 million patients in America5
and 2.3 million patients in the United Kingdom4 undergo
procedures to address cerumen problems. In persons with
DS, however, it is underrecognized and undertreated by
physicians and parents alike.1
In the Philippines, the prevalence of cerumen impaction
in the general population ranges from 11% to 27%.6,7 Our
study shows that the prevalence rate of cerumen impaction
and retention in this sample of Filipinos with DS is remark-
ably higher at 63.5%.
Otologic problems of persons with DS are multiple,
with EAC stenosis among the more obvious. Based on ear
canal impressions, the average bony EAC diameter in the
general Filipino population is approximately 7.5 mm × 6.5
mm (slightly larger in males than females).8 Using stan-
dard round ear specula, our study found no statistically sig-
nificant sexual differences in actual soft tissue EAC
dimensions, in contrast to the “longer, wider, deeper . . .
average height and width of ear canal openings and aver-
age depth of the first bend” in 20 males versus 18 females
reported by Yu et al9 based on a computed tomography
(CT)–generated ear canal model in neighboring Taiwan,
where the average EAC diameter was approximately 9 mm
× 6 mm. In Japan, bony EAC dimensions ranged from 3.2
4 Annals of Otology, Rhinology & Laryngology 00(0)
to 7.1 mm antero-posterior and 3.4 to 10.3 mm supero-
inferior,10 but these were also CT-based (not clinical) mea-
surements that did not account for EAC soft tissue.
Although the bony EAC is ovoid, round ear specula can
achieve a pneumatic soft-tissue seal at a clinical limit
where the largest available speculum can be inserted and
ear examination and manipulation performed.
Although no universally accepted definition of stenosis
has been established, a study of patients with congenital
aural stenosis defined stenosis as a canal diameter of 4 mm
or less.11 This diameter was selected due to the noted
absence of cholesteatoma formation in patients with EAC
diameters exceeding this value.11 Using this definition, we
determined the prevalence rate of EAC stenosis in our study
population to be 72.3%. This is notably higher than the pub-
lished prevalence rates of 38% and 50% in persons with DS
elsewhere.12,13 Furthermore, in our study population, those
with EAC stenosis (EAC diameters ≤4 mm) had a signifi-
cantly higher likelihood of having cerumen impaction or
retention.
Persons with DS are known to have a higher prevalence
of low-set ears. Seventy-nine percent of our study popula-
tion had low-set ears, and this finding was statistically
proven to be associated with increased odds of having ceru-
men problems. Whether this may be related to the relation-
ship of embryologic pinna and EAC development remains
to be seen. Meanwhile, although we considered ears low-set
when the helix was situated below a horizontal plane
through both medial canthi without measuring the actual
downward displacement, our results suggest that a low-
lying pinna among persons with DS may be associated with
an underlying EAC or even middle ear problem.
Although other otologic examination findings had low
prevalences in our study population with no apparent trends
with regards to the presence of cerumen problems, they
may provide interesting reflection points.
Dull-appearing tympanic membranes with middle ear
effusion were seen in 21 ears (8.1%). This finding is impor-
tant to note as middle ear effusion causes hearing loss and,
as a potential consequence, delay in speech development.14
However, this rate is remarkably lower than those in previ-
ous studies with prevalences as high as 60%.12,14 Whether
this reflects the experientially lower prevalence of otitis
media with effusion (as well as rhinosinusitis and adenoton-
sillitis) among the pediatric population in tropical settings
like the Philippines (compared to cold-season variations in
temperate climates) may be a subject for further inquiry.
Not dissimilar to the low prevalence rate of 8% in pub-
lished literature,12 only 5 ears (1.9%) had retracted TMs,
and 26 ears (10.0%) had nonmobile TMs. Exact etiologies
were not established during examination, but possible
causes (other than failure to obtain a seal between specu-
lum and EAC) include the increased prevalence of upper
respiratory tract infections in this population due to their
immunocompromised status subsequently causing middle
ear effusion,15 anatomic variations such as anomalous
insertion of the Eustachian tube (ET) into the nasopharynx
and the resultant ET dysfunction,2 and generalized hypoto-
nia and decreased function of the tensor veli palatini
muscle.14
Of the 4 ears (1.5%) with foul-smelling discharge, only
1 had a 40% centrally perforated TM. The 3 had otitis
externa; only the latter had otitis media. As these persons
routinely follow up at the annual DSAP free clinic (which
has been conducted annually for 15 years), this low inci-
dence is not surprising, although it may not be reflective of
other populations with DS. Perforations in the TM are usu-
ally late sequelae when otitis media with effusion remains
undiagnosed.16
Our study limitations include design bias. Of the 194 per-
sons with DS who attended the multidisciplinary free clinic,
the 130 who consulted the otorhinolaryngology clinic were
more likely to have problems with their ears than those who
did not consult the ORL clinic at all. However, all those who
consulted at the otorhinolaryngology clinic underwent ear
evaluation, regardless of whether or not they had ear-related
complaints. Not having a control group of age-matched non-
DS Filipino children is another limitation of our study, but
the study setting and our resources constrained us from
recruiting such an age- and gender-matched control group.
We are also limited by ascertainment bias. Our sample may
not fairly represent the larger population of persons with DS
to whom the results may be applied, but the consecutive
sampling employed, including persons with DS who did not
have otologic complaints, may lessen this bias. Our choice
of commercially available, standard ear speculae (rather
than radiologic or volumetric means) to measure EAC size
pose another limitation to our study as recorded dimensions
only correspond to the largest dimensions at the speculum
tip at which a pneumatic seal could be obtained, and this
point may vary with EAC configuration. In our experience,
this point often corresponds to a narrower portion of the
EAC than the external auditory meatus but is clinically sig-
nificant in that the standard speculum cannot be inserted fur-
ther—limiting the clinician insofar as visualization of more
medial structures and instrumentation to extract cerumen are
concerned. Despite these limitations, our study generated
scientifically sound, useful data.
To the best of our knowledge, this is the first study to
explore the association of age, external auditory canal
diameter, and cerumen retention or impaction among Asians
in general and Filipino children in particular with DS. Aside
from providing baseline normative values, identification of
such an association can influence the formulation of guide-
lines for otologic and audiologic assessment in this popula-
tion. In particular, stringent recommendations for persons
with DS to undergo otologic assessment every 3 months
until the age of three2 may be reconsidered in low- and
Dy and Lapeña 5
middle-income country settings where quarterly otologic
assessment for 3 years will be difficult to obtain, by recom-
mending clinical vigilance especially (perhaps only?) in
those with an EAC diameter of ≤4 mm and age ≤1 year
rather than in all children with DS.
Further validation of our findings by prospective studies
involving larger populations may pave the way to recom-
mend more appropriate screening and follow-up of persons
with DS in the Philippines and elsewhere as well as among
other populations expected to have relatively small EAC
diameters. Such studies may include pre- and postextrac-
tion audiograms to elucidate the significance of the pres-
ence and removal of cerumen. Future studies may scout for
similar trends and seek to establish critical EAC diameters
in the general pediatric population and children with other
congenital conditions involving the ears.
Conclusion
In conclusion, our study showed a high prevalence of ceru-
men retention or impaction in Filipinos with DS compared
to the general Philippine population and a remarkably
higher prevalence rate for EAC stenosis than elsewhere.
Our findings support the hypothesis that at a certain diam-
eter and age, cerumen problems decrease significantly; in
particular, an EAC diameter of ≤4 mm and age ≤1 year are
associated with a significantly higher likelihood of cerumen
retention or impaction.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect
to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research,
authorship, and/or publication of this article.
ORCID iD
José Florencio F. Lapeña https://orcid.org/0000-0002-5794-
1878
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