International Journal of Pediatric Otorhinolaryngology 81 (2016) 2125

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International Journal of Pediatric Otorhinolaryngology

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

ABR thresholds in infants born with CLP and OME and

infants with OME
H. Sundman a, T. Flynn b,*, B. Tengroth a, A. Lohmander b
a
b

Hearing and Balance Clinic, Karolinska University Hospital, Stockholm, Sweden

Division of Speech and Language Pathology, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden

A R T I C L E I N F O

A B S T R A C T

Article history:
Received 30 August 2015
Received in revised form 2 November 2015
Accepted 30 November 2015
Available online 12 December 2015

Objectives: The aim of this study was to investigate and compare auditory brainstem response (ABR)
thresholds related to otitis media with effusion (OME) in infants with and without cleft palate and/or lip
(CP  L).
Methods: Forty-seven infants with CP  L and 67 infants with OME participated in the study. Hearing
thresholds of ears of infants with OME were compared between groups and within the group with CP  L.
Results: Infants with CP  L and OME presented with similar hearing thresholds as infants with OME and
not CP  L. Within the cleft group, infants with isolated cleft palate and OME demonstrated signicantly
higher hearing thresholds than infants with unilateral cleft lip and palate and OME.
Conclusion: A high prevalence of infants with CP  L present with OME early in life. Hearing thresholds of
these infants are similar to infants without CP  L, but with OME. The ear status and hearing thresholds of
infants with CP  L needs to be monitored to be able to provide the best access to hearing in order to fully
allow speech and language development.
2015 Elsevier Ireland Ltd. All rights reserved.

Keywords:
Auditory brain stem response
Cleft palate
Hearing loss
Otitis media with effusion

1. Introduction
Children born with cleft palate and/or lip (CP  L) present with a
higher prevalence of otitis media with effusion (OME) than children
born without CP  L. Prevalence of OME has been reported to range
from 76 and 97 percent in children with CP  L between the ages of
two and 24 months [111]. This high prevalence of OME is most likely
due to Eustachian tube dysfunction. The tensor veli palatini and the
levator veli palatini muscles are not able to contract properly and
open the Eustachian tube [1,12,13]. Therefore, the Eustachian tube is
unable to equalize pressure and leads to negative pressure in the
middle ear. This negative pressure results in a retracted tympanic
membrane and secretion of mucous from the tissues through osmosis
into the middle ear cavity [2,7].
OME is associated with a mild to moderate, uctuating
conductive hearing impairment across the speech frequencies
[14]. A few studies have investigated this association in young
children [1517]. Gravel and Wallace [15] demonstrated infants at
one year of age with an average of four episodes of bilateral OME
presented with elevated thresholds (37.8 dB nHL) as compared to a

* Corresponding author.
E-mail address: traci.ynn@ki.se (T. Flynn).
http://dx.doi.org/10.1016/j.ijporl.2015.11.036
0165-5876/ 2015 Elsevier Ireland Ltd. All rights reserved.

group of infants (20.3 dB nHL) with an average of less than one

episode. Other studies have investigated OME and the associated
hearing loss in relation to universal newborn hearing screening
(UNHS). Aithal and colleagues [17] demonstrated 68 percent of
newborns (average of 47.5 days), which had OME also had a
hearing loss. For those infants who presented with OME and a
hearing loss, an average threshold of 50 dBnHL was recorded when
the infant was 49 days old [16]. Second, Boudewyns and colleagues
[16] demonstrated 55 percent of the newborns (average 49 days)
who failed screening had a hearing loss associated with OME
ranging between 40 and 60 dBnHL in both ears. These infants were
followed longitudinally and presented with normal hearing by
4.8 months of age. Five of the 64 infants presented with a CP  L.
Furthermore, there have been several studies focusing on OME
and an associated hearing loss in children with CP  L. Four studies
have reported young children with CP  L exhibit a higher prevalence
of hearing impairment than children without CP  L. Broen et al. [2]
demonstrated young children with CP  L were more likely to fail a
hearing screening between 9 and 30 months of age. The other three
studies reported a range between 55 and 93 percent of ears of infants
and young children with CP  L and OME to demonstrate a mild to
moderate hearing loss [9,10,18]. On the contrary, Jocelyn et al. [6]
reported fewer children with CP  L (25 percent) which exhibited
mild to moderate hearing impairment at 12 and 24 months of age as

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H. Sundman et al. / International Journal of Pediatric Otorhinolaryngology 81 (2016) 2125

compared to zero and six percent in the children without CP  L. This

lower percentage of children with hearing impairment may be due to
the signicantly higher number of children with ventilation tubes in
the group of children with CP  L [6].
This contradicting evidence is also seen in the hearing screening
of newborns with CP  L. Three studies reported a range of 12 and
28 percent of newborns with CP  L which failed their newborn
hearing screen [1921]. On the contrary, four other studies described
a higher percentage of hearing impairment, between 70 and
84 percent, in newborns with CP  L with a mild to moderate
conductive hearing loss [10,2224]. This discrepancy may be to
audiometry methodology. Newborn hearing screening was conducted either with otoacoustic emission (OAEs) or automated
auditory brainstem response (AABR) [1921]. These methods, which
utilized a pass/fail criteria, were used in the studies reporting a lower
incidence of abnormal hearing. The other studies obtained a threshold
of hearing via an auditory brainstem response (ABR) [10,22,23]. Determining a threshold is a more detailed denition of hearing
sensitivity and includes newborns with mild hearing loss, which may
have been missed via screening or pass/fail methods. Another factor
which may have contributed to the discrepancy is age of the newborn.
In the studies with a lower rate of abnormal hearing, the infants were
screened at birth; while the studies with a higher rate of abnormal
hearing, the infants were tested when they were older, ranging
between an average of 43 days up to 14 months of age.
Furthermore, these studies do not compare the hearing in
newborns with CP  L to newborns without CP  L, but with OME.
Children with CP  L and OME have been shown to present with
higher thresholds than children without CP  L, but with OME
[7]. Flynn et al. [7] demonstrated children with unilateral cleft lip and
palate (UCLP) with OME and a hearing impairment exhibited
signicantly higher hearing thresholds than children without UCLP,
but with OME and a hearing impairment [7]. Therefore, it is critical to
investigate when this signicant difference may occur as this is a
sensitive period for the development of auditory, speech, and
language skills.
There is insufcient data to conclude the timing and possible
long-term benets of the placement of ventilation tubes [25]. The
NICE guidelines specify, ventilation tubes should only be placed at
palatal closure after careful otological and audiological assessment, not prophylactically [26]. However, Klockars and Rautio [11]
demonstrated the majority of infants with ventilation tubes placed
at four months of age during time of soft palate repair resulted in a
lower prevalence of OME at 12 months of age as compared to
infants who received ventilation tubes at four months of age but
with soft palate repair at 12 months of age [11]. It was
hypothesized that the earlier repair of the soft palate aided the
Eustachian tube to function effectively and allow the ventilation
tubes to not become occluded. Ventilation tubes were placed
either following the diagnosis of OME by otomicroscopy or
paracentesis during surgery or prophylactically. Hearing levels
were not reported.
As it is controversial when to place ventilation tubes, it is crucial
to dene the possible prevalence of an associated hearing
impairment in newborns with and without CP  L. This may lead
to changes in protocol for the placement of ventilation tubes.
Therefore, the aim of this study was to investigate and compare
auditory brainstem response (ABR) thresholds related to otitis media
with effusion (OME) in infants with and without CP  L.
2. Materials and methods
2.1. Materials
The study was a retrospective chart review at a single hospital
(Karolinska University Hospital, Sweden). Medical les between

January 2011 and January 2013 were reviewed for two groups of
possible participants. The two groups included infants with CP  L
(cleft group) and infants without cleft, but with OME (non-cleft
group). For the non-cleft group, all infants with a medical record
containing a diagnosis of OME and ABR threshold levels were
included in the study. Infants in the non-cleft groups were excluded if
they had a medical diagnosis or syndrome, a malformation, or a
hearing impairment not caused by OME. Infants in the cleft group
were excluded if they had an additional medical diagnosis or
malformation, a syndrome, or a sensori-neural hearing impairment.
The rst group (non-cleft group) included infants who failed the
newborn hearing screening and were diagnosed with OME. Sixtysix infants (41 males and 25 females) with a mean age of 97 days
(range: 37197 days) were diagnosed with either unilateral or
bilateral OME. The second group (cleft group) consisted of
50 infants (32 males and 14 females) with a mean age of 65 days
(range: 25145 days). Twenty-six infants presented with an
isolated cleft of the palate (ICP), 14 infants with unilateral cleft lip
and palate (UCLP), and ten infants with bilateral cleft lip and palate
(BCLP).
2.2. Methods
Data were collected from the medical records at the time of the
diagnostic ABR during clinical routine visits between January
2011 and January 2013. Hearing thresholds from the ABR and
otomicroscopy examination were collected.
2.2.1. Hearing sensitivity
The click evoked ABR was obtained while infants were sleeping
using the Interacoustics EP25 (Denmark). The click evoked ABR
was utilized as it is clinical protocol at the Karolinska University
Hospital following a failed OAE screen. Rarefaction pulses were
delivered at a rate of 39.1 stimuli/second through ER-3A ABR insert
earphones. The recording window was 15 ms. Initial stimuli were
presented at 50 dBnHL. Stimuli intensity was increased or
decreased in 10 dB increments and 5 dB increments when
necessary. Thresholds were tracked using wave V. A minimum
of 1700 sweeps for each waveform were obtained. Twenty dBnHL
was the lowest stimuli presented and 90 dBnHL was the maximum
level presented. Threshold was determined when two recordings
were repeated.
The click evoked ABR was performed during natural sleep on
both ears of the infant. If the infant woke during the measurement,
any further collection of data was discontinued until the infant
went back to sleep. Fourteen infants in this study underwent two
ABR assessments. The second ABR was performed due to an
incomplete assessment due to lack of sleep or restlessness. The
lowest estimated threshold obtained was used during the analysis.
2.2.2. Ear status
A pediatric otolaryngologist performed otomicroscopy on the
day of ABR testing to determine ear status. Results were classied
as normal or abnormal (uid lled middle ear cavity or retracted
tympanic membrane).
2.3. Statistical description and analysis
Statistical analysis of the results was performed using the t-test
to compare the mean hearing thresholds between the cleft and
non-cleft groups and the ANOVA to compare cleft types within the
cleft group. Effect size was analyzed with Cohens d. The data were
analyzed using SPSS for Windows (Version 22).
Data collection and analyses were carried out according to
ethical principles for medical research involving human subjects
and with permission from the Head of the Clinical Department of

H. Sundman et al. / International Journal of Pediatric Otorhinolaryngology 81 (2016) 2125

23

Table 1
Number of infants and ears with OME included in the data analysis.
Non-cleft group

Cleft group
UCLP

Bilateral OME
Unilateral OME
Total number of infants and ears

ICP

BCLP

Infants

Ears

Infants

Ears

Infants

Ears

Infants

Ears

39 (59%)
27 (41%)
66

78 (74%)
27 (26%)
105

12 (86%)
2 (14%)
14

24 (92%)
2 (8%)
26

22 (96%)
1 (4%)
23

44 (98%)
1 (2%)
45

8 (89%)
1 (11%)
9

16 (94%)
1 (6%)
17

Table 1 Number of infants and ears included in the data analysis by group. Unilateral Cleft Lip and Palate (UCLP), Isolated Cleft Palate (ICP), Bilateral Cleft Lip and Palate (BCLP).

Hearing and Balance at Karolinska University Hospital, Solna,

Stockholm, Sweden (Swedish Ethical Law 2003:460).
3. Results
The data analysis focused on the individual ears of the
participating infants. There are a total of 116 infants providing
232 ears for examination in the cleft and non-cleft groups. Within
the cleft group, there were 100 ears. Of those 100 ears, 88 presented
with OME on the day of testing. Twelve ears were excluded from
the study including four children with no OME bilaterally (one
infant with BCLP and three infants with ICP). Therefore, data from
88 ears with OME was gathered for further analysis (Table 1). In the
non-cleft group, 66 infants providing 132 potential ears were
studied. Of the 132 possible ears, 105 presented with OME on the
day of testing and were designated for further analysis. In total,
193 ears from infants with OME in the cleft (n = 88) and non-cleft
group (n = 105) were included. The data were analyzed and
compared between the cleft group and non-cleft group and within
the cleft group by type of cleft.
The non-cleft group exhibited a mean threshold of 41.4 dBnHL
(SD: 8.8) and the cleft group exhibited a mean threshold of
40.1 dBnHL (SD: 9.5) (see Fig. 1). There was no signicant
difference between the cleft and non-cleft groups on hearing
sensitivity (F(1, 190) = 0.047, p = 0.829).

Within the cleft group, the mean ABR threshold value for infants
with UCLP was 37.5 dBnHL (SD:  7.9; range: 2050), 44.2 dBnHL
(SD: 8.9; range: 3060) for infants with ICP and 40.3 dBnHL (SD: 7.6;
range: 3055) for infants with BCLP (see Fig. 2). There was a
signicant difference within the cleft group when the group was
divided by cleft type (F(1, 84) = 5.44, p = 0.006). A signicant
difference was present between the UCLP and ICP groups, with
infants with ICP presenting with worse hearing thresholds (p = 0.005)
(see Table 2). This signicant difference had a large effect size
(d = 0.796).
4. Discussion
Eight-eight percent of infants with CP  L presented with OME.
These infants did not demonstrate signicantly worse hearing
thresholds as compared to infants with OME. However, the infants
with ICP, exhibited signicantly higher thresholds than the infants
with UCLP. This has not been previously reported in the literature.
The prevalence of OME in the cleft group (88 percent) is in the
higher range of the previously reported prevalence of between
18 and 94 percent. However, when examining the literature, there
are two groups of results: 18 to 28 percent and 65 to 94 percent.
This study has similar results to other studies stating a prevalence
of OME ranging from 65 to 94 [10,11,23,24]. In contrast, the
present results are considerably higher than the 18 to 28 percent

Fig. 1. Box plots showing maximum, median, and minimum hearing thresholds in dB nHL and rst and third quartile for all ears in the cleft and non-cleft groups with otitis
media with effusion (OME).

H. Sundman et al. / International Journal of Pediatric Otorhinolaryngology 81 (2016) 2125

24

Fig. 2. Box plots showing maximum, median, and minimum hearing thresholds in dB nHL and rst and third quartile for all ears in the cleft group with otitis media with
effusion (OME). Cleft types include: Unilateral Cleft Lip and Palate (UCLP), Isolated Cleft Palate (ICP), Bilateral Cleft Lip and Palate (BCLP).

reported when examining hearing screening results in infants with

CP  L [1921]. This discrepancy in prevalence may be due to
methodological differences and aims of the studies. The studies
reporting a lower prevalence were investigating hearing in infants
with CP  L with a focus on the hearing screening results or
thresholds. However, OME is not always associated with a hearing
loss or a fail on a hearing screen. Andrews and colleagues [10]
illustrated the hearing thresholds and tympanometry results in their
study. Fifteen percent of ears (10/67) exhibited at tympanometry
and mean hearing levels, which passed screening (range: 25
35 dBnHL). In the present study, 30 percent of ears with OME
exhibited mean hearing levels, which passed screening (range: 20
35 dBnHL). The noted difference between 15 and 30 percent may be
due to methodological methods of dening OME. Andrews and
colleagues [10] utilized high-frequency tympanometry (at tympanograms) to indicate the presence of OME while the present study
dened the presence of OME by visualization of the tympanic
membrane by an experienced otolaryngologist who performed
otomicroscopy. OME may be present with other types of tympanometry [27]. The inclusion of infants with syndromes does not explain
the discrepancy, as studies reporting lower and higher prevalence of
OME included infants with syndromes [10,19,21].
In the present study, there was no signicant difference in
hearing thresholds between infants with CP  L and infants without
CP  L. One study has reported hearing thresholds of infants with a
conductive hearing loss due to OME [16]. In this study, an average
Table 2
Comparison of hearing sensitivity within the cleft group.
Cleft groups

Mean difference

Standard error

P value

ICP-UCLP
ICP-BCLP
BCLP-UCLP

6.71
3.91
2.79

2.07
2.39
2.61

0.005
0.236
0.535

Results from Post-doc Tukey test comparing hearing sensitivity between cleft
groups: Unilateral Cleft Lip and Palate (UCLP), Isolated Cleft Palate (ICP), Bilateral
Cleft Lip and Palate (BCLP).

hearing threshold of 50 dBnHL was reported in infants without

CP  L, but with OME; while the present study demonstrated average
hearing thresholds of 41.4 dBnHL and the cleft group and 40.1 dBnHL
in the non-cleft group. The differences in thresholds may be due to
inclusion criteria. In the Boudewyns et al. [16] study, 25 percent of the
infants presented with a known risk factor for hearing loss (6 of them
with craniofacial anomalies) while infants with additional malformations or sensorineural hearing loss were excluded in the present
study. Infants with CP  L in the present study presented with similar
hearing thresholds of infants with CP  L in a previously reported
study [22]. In the present study, the infants with CP  L exhibited an
average threshold of 41.4 dBnHL while infants in the Viswanathan
et al. [22] study presented with 40 dBnHL right ear and 39.7 dBnHL
for left ear. On the contrary, Andrews and colleagues [10] presented
higher thresholds for infants with CP  L with thresholds of 53 dBnHL
in the left ear and 49 dBnHL in the right ear. This difference may be
due to the inclusion criteria. The infants in the present study did not
present with additional malformations and/or syndromes and
22 percent of the infants in the Viswanathan et al. [22] study
presented with syndromes; while 30 percent of the infants included
in the Andrews et al. [10] study presented with syndromes.
The elevated thresholds in infants with ICP and OME in the
present study does not follow previous literature on hearing
thresholds in individuals with CP  L. There is no other study that
compares the hearing thresholds of infants with different cleft types.
However, there are two studies which report type of cleft in relation to
the degree of hearing impairment [22] and hearing screening results
[20]. Both studies present similar results with infants with ICP and UCLP
presenting with worse hearing than those with BCLP. Infants with ICP
and UCLP exhibited a higher prevalence of moderate to severe hearing
impairment (12 and 10 percent) or failure on hearing screening
(13 percent) than infants with BCLP (5 percent). A larger difference
between the ICP and UCLP group may have been seen if Viswanathan
and colleagues [22] and Szabo and colleagues [20] had compared
hearing thresholds instead of categories of hearing impairment or
failure of hearing screening. Both studies did not mention ear status.

H. Sundman et al. / International Journal of Pediatric Otorhinolaryngology 81 (2016) 2125

As infants age, this trend continues with children with ICP and
UCLP presenting with similar hearing thresholds. A study
examined 1 to 3-year-olds with different types of cleft [28]. Six
percent of children with UCLP presented with thresholds above
40 dB HL and seven percent of children with ICP presented with
thresholds above 40 dB HL [28]. Similar results were noted in
another study which examined 6-year-olds [29]. At six years of age,
six percent of children with UCLP presented with a conductive
hearing loss greater than 30 dB HL as compared to four percent of
the children with ICP. Later in life, adolescents with ICP and UCLP
did not present with signicantly different hearing thresholds
[30]. The signicant difference in higher hearing thresholds in
infants with ICP as compared to infants with UCLP in the present
study may disappear with age, as the previously reported literature
included children from one year of age and older, while the present
study included children less than three months of age.
One possible explanation for the signicantly better hearing
levels in the ICP group as compared to the UCLP group may have
been a higher prevalence of additional disabilities or syndromes.
Children with ICP have a higher prevalence of additional
disabilities and/or syndromes than children with UCLP [31,32]. Although additional malformation or syndrome was an exclusionary
criterion, several syndromes may not be evident until the child is
older. The presence of additional disabilities and/or syndromes has
been associated with increased hearing loss [3335]. Flynn et al.
[35] investigated children with ICP with no additional disabilities
and/or syndromes and children with ICP and an additional
disability and/or syndrome. The group of adolescents with ICP
and an additional disability and/or syndrome demonstrated
signicantly higher hearing thresholds than those children with
ICP and no additional malformations and/or syndromes.
A limitation of the present project is the use of click evoked
responses. Click responses were utilized as it is the clinical routine
at Karolinska University Hospital following a failed OAE screen.
Although, the click evoked response may have reected the high
frequencies (20004000 Hz) or was inuenced by one frequency
with a better threshold [36], it was also the methods used by
Viswanathan et al. [22] and Andrews et al. [10]. By utilizing the
same methods, the results from the present study were able to be
compared to the previous literature. However, this may also be a
limitation. More frequency specic thresholds could provide
greater knowledge on the thresholds between the groups.
Further prospective research is needed to accurately dene
when OME begins in infants with CP  L. It is not universally
present at birth, but seems to develop during the rst year of life. By
investigating the timing of the onset of OME and monitoring the
hearing thresholds, knowledge will be expanded in regards to the
timing of the placement of ventilation tubes to allow for normal
hearing levels.
Acknowledgement
Supported by grants provided by the Stockholm County Council
(ALF project).
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