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\begin{document}

\title{Do the size, site and activity of tympanic membrane perforations relate
to hearing loss in Aboriginal and Torres Strait Islander children? An
observational study.}



\author[1]{Jack Morris}%
\author[1]{Zoe Lee}%
\author[1]{Andrew  Carney}%
\author[1]{Linnett Sanchez}%
\affil[1]{Flinders University}%


\vspace{-1em}



  
  \date{May 24, 2024}


\begingroup
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\selectlanguage{english}
\begin{abstract}
Objective: To investigate the effect of size, site and activity of
tympanic membrane (TM) perforation on hearing loss (HL) in Aboriginal
and Torres Strait Islander (ATSI) children. Design: Observational study
Methodology: Children aged 5-18 years who identified as ATSI at 7 Anangu
community schools within the APY Lands and Maralinga Lands of South
Australia underwent 4 frequency pure-tone audiometry (0.5, 1, 2 and
4kHz) and video-otoscopy (VO). VO data was reviewed by surgeons for a
middle ear diagnosis and VO files with TM perforations were then
classified by perforation site (AS, AI, PS, PI, A, P, I) and size
(\textless{}25\%, 25--50\%, 50--75\% or 75--100\%). Results: 575 VO
files with matching audiological data were obtained. Active perforations
(35dBHL; 28-44 IQR) demonstrated greater HL than inactive perforations
(31dBHL; 29-39 IQR) p=0.0029. For inactive perforations there was a
significant difference between \textless{}25\% and all larger
perforations (p\textless{}0.0001) whereas for active perforations the
significance changed to between \textless{}25\% (p\textless{}0.0001) and
25-50\% (p\textless{}0.05) when compared to larger perforations. When
perforation site was compared within all size/activity groups, no
statistically different findings were identified. In all analyses
findings did not change when individual frequencies were compared to
4-frequency pure tone average dBHL. Conclusion: In ATSI children from
remote communities HL is greater in ears with larger perforations and
active middle ear disease but there was no relationship between
perforation site and HL.%
\end{abstract}%



\sloppy


\textbf{Do the size, site and activity of tympanic membrane perforations
relate to hearing loss in Aboriginal and Torres Strait Islander
children? An observational study}

\textbf{Author 1}

\textbf{Author 2}

\textbf{Author 3}

\textbf{Author 4}

\emph{Corresponding author:} \textbf{Corresponding author}

\textbf{Corresponding author's details}

\emph{Funding:} \textbf{Funding statement here}

\emph{Authorship statement}\textbf{:}

Authorship statement here

Ethics statement here

\emph{Abstract:}

\textbf{Objective:} To investigate the effect of size, site and activity
of tympanic membrane (TM) perforation on hearing loss (HL) in Aboriginal
and Torres Strait Islander (ATSI) children.

\textbf{Design:} Observational study

\textbf{Methodology:} Children aged 5-18 years who identified as ATSI at
7 A\emph{n} angu community schools within the APY Lands and Maralinga
Lands of South Australia underwent 4 frequency pure-tone audiometry
(0.5, 1, 2 and 4kHz) and video-otoscopy (VO). VO data was reviewed by
surgeons for a middle ear diagnosis and VO files with TM perforations
were then classified by perforation site (AS, AI, PS, PI, A, P, I) and
size (\textless{}25\%, 25--50\%, 50--75\% or 75--100\%).

\textbf{Results} : 575 VO files with matching audiological data were
obtained. Active perforations (35dBHL; 28-44 IQR) demonstrated greater
HL than inactive perforations (31dBHL; 29-39 IQR) p=0.0029. For inactive
perforations there was a significant difference between \textless{}25\%
and all larger perforations (p\textless{}0.0001) whereas for active
perforations the significance changed to between \textless{}25\%
(p\textless{}0.0001) and 25-50\% (p\textless{}0.05) when compared to
larger perforations. When perforation site was compared within all
size/activity groups, no statistically different findings were
identified. In all analyses findings did not change when individual
frequencies were compared to 4-frequency pure tone average dBHL.

\textbf{Conclusion:} In ATSI children from remote communities HL is
greater in ears with larger perforations and active middle ear disease
but there was no relationship between perforation site and HL.

\emph{Key points:}

\begin{itemize}
\tightlist
\item
  This study evaluated 575 ears of Aboriginal and Torres Strait Islander
  (ATSI) children from the A\emph{n} angu Pitjantjatjara Yankunytjatjara
  (APY) lands in South Australia and is the first of its kind in this
  population.
\item
  The effect of size, site, and activity of tympanic~membrane
  perforation on hearing loss (HL) was investigated using pure tone
  audiometry and video otoscopy measurements.
\item
  HL was greater with middle ear disease activity and with increasing
  perforation size.
\item
  The influence of perforation site on HL is conflicting in the
  literature. This study shows no significant difference in HL with
  perforation location in this population.
\item
  The data demonstrates that children in the APY Lands continue to
  experience significant HL associated with TM perforations.
\end{itemize}

\emph{}

\emph{Introduction:}

According to the World Health Organisation,~tympanic
membrane~(TM)~perforation rates are the highest for Australian
Aboriginal and Torres Strait Islander (ATSI)
children\textsuperscript{1}.~TM~perforations~in ATSI children become an
ongoing problem into adulthood\textsuperscript{2} and previous work from
our group in remote ATSI communities in South Australia demonstrated
perforation rates of 31-50\% with up to 30\% of individuals
demonstrating activity at any one time\textsuperscript{3}. TM
perforations can result in hearing losses as high as
50dB\textsuperscript{4}. Within Australia, ATSI children are
particularly affected as data from the Australian Bureau of Statistics
showed ATSI children experienced 3 times the rates of chronic otitis
media (COM) as non-Indigenous Australian children\textsuperscript{3},
creating a devastating public health problem and secondary educational
disadvantage in this particularly vulnerable
population\textsuperscript{5}.

It has been generally accepted that hearing loss (HL) is greater
with~an~increase in size of~the TM perforation\textsuperscript{6}.
However, perforation site and the effect on hearing is more
controversial with contradictory evidence regarding
this\textsuperscript{6-12}.~Whilst early work showed worse hearing
with~posteroinferior based perforations\textsuperscript{13, 14}, others
have found posterosuperior defects to be worse\textsuperscript{11,
15}and more recent work demonstrated no difference between
sites\textsuperscript{4, 6, 7, 12}. Theories such as loss of the round
window baffle effect resulting in phase-cancellation, as well as an
increase in ossicular chain abnormalities~have been proposed to explain
increases in HL with posterior perforations. The association between an
increase in size and severity of HL\textsuperscript{4, 6, 10, 12, 16} is
reinforced by bio-mechanical studies confirming the progressive loss of
catenary lever ratio with enlarging perforations\textsuperscript{17}.

\emph{Objectives}

The aim of this study was to investigate the relationship between
perforation size, site and disease activity on HL in ATSI children in
the A\emph{n} angu Pitjantjatjara Yankunytjatjara (APY) Lands of South
Australia. To date, no known study has investigated the levels of HL
associated with perforation location and size in ATSI children.
Additionally, this study aimed to provide an epidemiological snapshot of
the hearing levels and severity of perforations in this high-risk and
socio-economically deprived population.

\emph{}

\emph{Methods:}

This paper has been prepared with reference to the STROBE checklist for
cross-sectional studies.

\emph{Dataset}

Data was collected as part of a larger study looking at the effect of
swimming pool use on ear health\textsuperscript{18}. Children from 7
A\emph{n} angu community schools were studied. The A\emph{n} angu
communities are located within the APY Lands and Maralinga Lands. These
lands span an area of approximately 200,000 km\textsuperscript{2} in the
far north-west part of South Australia and are home to a population of
approximately 3500 -- 4000 people\textsuperscript{19}. Visits to the
schools were facilitated by staff at the A\emph{n} angu Education
Service (AES) of the Department of Education (Government of South
Australia). At the time of study, there was no ENT input into medical
services on the Lands, essentially making this a surgically na\selectlanguage{ngerman}ïve and
untreated dataset.

\emph{Data collection}

Pure-tone audiometry was performed at 0.5, 1, 2 and 4kHz using
Auraldomes to reduce ambient noise exposure. All audiometry was
performed in a quiet location with ambient noise recorded as being
within the range of 22-36dBA.

\emph{Video-otoscopy}

Video-otoscopy (VO) footage was obtained with a WelchAllyn (Hillrom,
Chicago, IL, USA) video-otoscope recorded onto a laptop.

\emph{Inclusion and exclusion criteria}

Inclusion criteria:

(1) Identifies as ATSI.

(2) Aged between 5 and 18 years.

Exclusion criteria:

Incomplete VO footage preventing classification of middle ear disease.

Incomplete audiological dataset.

\emph{Classification}

VO data was reviewed by ENT Surgeons (with a previously established
\textgreater{}90\% concordance) to obtain a middle ear diagnosis
(Browning classification) for all children\textsuperscript{20}. VO files
with a visible TM perforation were then analysed by two medical
students, one with a paediatric audiology background. They were trained
by a senior ENT specialist on classifying perforation site and size. The
students received a random sample of the same 20 VO files to classify
independently. These classified files were then reviewed together with a
senior ENT specialist and senior audiologist where \textgreater{} 90\%
diagnostic concordance was confirmed.

Perforations were classified as either \textless{}25\%, 25-50\%, 50-75\%
or 75-100\%. The site of perforations was classified depending on the
perforation size (Fig 1). Perforations deemed \textless{}25\% were
classified by quadrants: AS: anterosuperior, AI: anteroinferior, PS:
posterosuperior, PI: posteroinferior. Perforations of size 25-50\% were
divided into anterior, inferior, and posterior locations. For size
50-75\% they were classified into anteroinferior or posteroinferior
locations. Perforations of 75-100\% were classified as subtotal
perforations. Where perforations didn't completely fit the exact
regions, the closest option was chosen. Where there was any ambiguity,
the VO images were reviewed by all four members of the team (the senior
ENT specialist, senior audiologist and two medical students) to obtain a
final classification.

\emph{Statistical analysis}

Data was collected on an Excel spreadsheet (Microsoft, CA, USA) then
transferred to GraphPad Prism (GraphPad Software, CA, USA) for
statistical and graphical analysis. Classification of left and right
ears were compared using Chi-squared analysis. Audiological data per
classification was compared using Kruskal-Wallis test for non-parametric
data with Dunn's multiple comparison test used to adjust p-values where
appropriate. Percentage and dBHL were rounded to the nearest whole
number. Non-parametric data is reported as median with 25-75\%
inter-quartile range (IQR) and p\textless{}0.05 was regarded as
significant. Power analysis revealed a requirement for n=120 to achieve
80\% power at the 0.05 significance level.

\emph{}

\emph{Results:}

\emph{Left vs Right comparison}

Of the 1128 perforated ears with middle ear diagnosis obtained from the
original swimming pool study\textsuperscript{18}, 575 VO files (284
left; 291 right) with matching audiological data were obtained meeting
the inclusion and exclusion criteria.

Chi-squared analysis revealed no difference between left and right ears
in terms of activity (wet vs dry perforations) or size of perforations.

\emph{Activity of perforations and hearing loss}

Active perforations (35dBHL; 28-44 IQR) had a significantly greater HL
than inactive (31dBHL; 29-39 IQR) p=0.0029 (Fig 2).

\emph{Size of inactive perforations and hearing loss}

Inactive perforations demonstrated a significant difference between
\textless{}25\% and all other larger perforations (p\textless{}0.0001),
and between the 25-50\% and 75-100\% group (p\textless{}0.05) but there
was no significant difference between other groups (Fig 3).

\emph{Size of active perforations and hearing loss}

In contrast to the above finding, there was no significant difference
between the \textless{}25\% and 25-50\% groups but significance was
found between both the \textless{}25\% (p\textless{}0.0001) and 25-50\%
(p\textless{}0.05) when compared the 50-75\% group (Fig 4).

\emph{Location of perforations and hearing loss}

When perforation location was compared within all size / activity
groups, there were no statistically different findings identified (Table
1, Fig 5).

\emph{Comparison of pure-tone and 4-frequency pure tone average (4FPTA)
hearing loss}

When 4FPTA dBHL was compared to individual frequencies (0.5, 1, 2 \& 4
kHz), identical results were obtained, both in terms of positive
differences in perforation size and lack of significance for location
within groups.

\emph{}

\emph{Discussion:}

This study, to our knowledge, is the first describing the relationship
between size, site and activity of perforations in ATSI children. In
keeping with other studies\textsuperscript{21}, active mucosal COM
created a greater HL than inactive disease. Multiple factors such as
otorrhoea, mucosal hypertrophy, sclerotic change of the ossicles and
generalised inflammation have been hypothesised to explain this
finding\textsuperscript{21}.

Increasing TM perforation size also corresponded with an increase in HL.
With active perforations, there was less hearing difference with
increasing size compared to the inactive group, possibly due to oedema
and fluid within the middle ear. We believe the absence of a significant
increase in HL in both active and inactive perforations involving the
50-75\% is due to the small number in the 50-75\% group, making this a
likely Type 1 error. An increase in HL with increased TM perforation
size is consistent with the consensus of both theoretical and clinical
studies in the literature\textsuperscript{4, 6, 8, 10-12, 16}. In a
study of 78 patients (107 ears) with inactive mucosal COM, perforations
were classified as a percentage of total surface area using image
processing software\textsuperscript{8}. A strong correlation was found
between HL and size of perforation\textsuperscript{8}. A study of 300
ears divided perforations into small, medium and large using digital
measurements\textsuperscript{11}. The mean air-bone gap (ABG) increased
with size\textsuperscript{11}. This has been attributed to a decreased
surface area for the amplification of sound, and a reduction in the area
ratio between the TM and the stapes footplate\textsuperscript{14}. The
accuracy of perforation size estimated by 6 physicians was compared to
objective software\textsuperscript{7}. Between the doctors, agreement
was high with kappa measures above 0.81 which compared favourably to the
kappa of between 0.62 and 0.93 utilising the
computer\textsuperscript{7}.

Our study found no difference in HL between frequencies across all
perforation sizes and locations. This contradicts others that showed HL
to be greater in the lower frequencies\textsuperscript{4, 6, 8, 11, 21}.
We hypothesise this~may be due to the unique disease processes and lack
of treatment in our patient group rather than the now discredited
hypothesis of different~anatomical factors between ATSI and Caucasian
ears.

The literature regarding perforation location and hearing levels is
conflicting. We found no statistically significant difference in hearing
levels between perforation location and all size/activity groups. This
is consistent with the findings of several studies using a variety of
methods\textsuperscript{6, 7, 12}. One study used audiometric data
from\selectlanguage{english} 56 subjects\selectlanguage{english} (62 perforations) and found no statistically
significant\selectlanguage{english} difference\selectlanguage{english} in the ABG between anterior and posterior
perforations\textsuperscript{6}. Another studied 38 patients (44
perforations), again with no statistically significant difference found
between anterior and posterior perforations, both in terms of mean air
conduction threshold, mean ABG, and frequency
comparisons\textsuperscript{12}. In 156 adult patients (172
perforations) undergoing myringoplasty for TM repair, there was no
significant difference between pre-operative ABG between all quadrants
for each frequency\textsuperscript{7}. In 35 adult Nigerian patients (42
perforations), no significant difference was found between TM
perforation location and HL in patients with pure conductive
HL\textsuperscript{22}. However, in patients with a mixed HL, the loss
was greater for posterosuperior based perforations\textsuperscript{22}.

Several other studies also demonstrate increased HL with posterior
perforations. Studies consistently utilise the manubrium mallei as the
angled division between anterior and posterior\textsuperscript{6-8, 10,
12, 15, 23}. However, the exact classification of location varies
somewhat and is not often illustrated, making comparison difficult.
Statistically significant findings from a number of studies found that
posterosuperior\textsuperscript{11, 15},
posteroinferior\textsuperscript{14} and posterior\textsuperscript{8, 9,
13} perforations were associated with greater HL. In 70 young adult
males (60 perforations) posteroinferior perforations had greater HL than
anteroinferior perforations, with a greater difference apparent at low
frequencies\textsuperscript{14}. For perforations less than 10\%, this
difference was variable and inconsistent\textsuperscript{14}. More
recently, in the largest study thus far, 700 patients (1400
perforations) with inactive mucosal COM were
studied\textsuperscript{15}. Maximum HL was seen with posterosuperior
perforations (48.6dB) and anterosuperior perforations had the least HL
(24.0dB)\textsuperscript{15}. When perforations involved 2 quadrants,
involvement of a posterior quadrant resulted in higher HL compared to
anterior quadrants but there was no significant difference between
anteroinferior and posteroinferior quadrants\textsuperscript{15}. One
recent study found exclusively posterior perforations had a 12\% greater
ABG when compared with exclusively anterior perforations, however this
was only significant at 500Hz\textsuperscript{8}. Another looked at 90
ears and found the mean HL in anterior perforations was 29.9dB compared
to the posterior perforation group with 44.9dB\textsuperscript{13}.

Many of these studies cite the ``phase-cancellation effect'' as a factor
influencing HL for posterior perforations\textsuperscript{8, 9, 13-15}.
This hypothesises that a posterior perforation exposes the round and
oval windows simultaneously to sound causing phase-cancellation and
further increasing the level of HL\textsuperscript{7, 21}. Contrary to
this belief, experimental and theoretical studies by
others\textsuperscript{4, 6, 24, 25} found that perforation site did not
affect pressure differences between the oval and round windows at all.
Pressures were measured at the stapes and round windows in 11 temporal
bones with no otologic disease\textsuperscript{4}. When anteroinferior
and posteroinferior perforations were then created, no pressure
differences between the two sites were found whereas the main
contributing factor to HL in TM perforations was the sound pressure
difference across the TM\textsuperscript{4}. The same group hypothesised
that wavelengths of sound \textless{}4kHz are actually larger than the
middle ear depth and therefore should not cause phase
cancellation\textsuperscript{6}. Additionally, one other compounding
paper found that posteroinferior perforations had lower mean ABG levels
than anteroinferior and posterosuperior locations by 12-14dB, thereby
further contradicting the phase cancellation theory\textsuperscript{11}.

It is clear from the conflicting literature that there are likely to be
other factors contributing to the variation in hearing levels with
perforations at different locations. Involvement of the manubrium mallei
has been discussed in many studies\textsuperscript{12, 14, 21} with some
finding perforations with malleolar involvement showed greater
HL\textsuperscript{15}. Additionally, in patients with disease lasting
longer than 10 years, the average HL was greater at 52 dB compared to
36dB with disease durations of \textless{}1 year\textsuperscript{15}.

The volume of air in the middle ear and mastoid cell complex also
appears to affect sound transmission. Using computed
tomography\textsuperscript{10} and tympanometry\textsuperscript{6, 11,
12}, mean ABGs correlated inversely with middle ear and mastoid
volume\textsuperscript{6, 10-12}.

Perforation shape may also influence hearing levels with one study
suggesting spindle-shaped perforations created greater conduction
disturbance compared to circular perforations\textsuperscript{21}.

In a multivariate logistic regression analysis on 67 patients (86
perforations) aged 10 and over size of perforation proved to be the only
significant predictor of HL severity\textsuperscript{23}.

The logistical challenges of data collection in our study population due
to age, remoteness and resources mean that the variables measured in the
literature cited above could unfortunately not be measured in this
study.

This study has again demonstrated that children in the APY Lands are
burdened with significant HL associated with potentially preventable and
treatable disease. These findings assist with the qualitative estimation
of HL from otoscopy based on size and site of the perforation. In
resource poor areas such as the APY Lands, simple qualitative measures
hold great value. Hearing losses greater than expected based on this
data may indicate damage to other structures other than the TM.

\emph{Conclusion:}

To the best of our knowledge this study is the first of its kind in
school-aged children and in the ATSI population. We have demonstrated
that perforation location does not significantly affect hearing levels
in this population. Hearing loss was greater with activity and larger
perforations. This study builds the foundation for further research into
perforation characteristics and HL in this significantly affected
population of children.

\emph{Funding information:}

No funding was received for this study.

\emph{Conflict of interest}

The authors declare no conflicts of interest.

\emph{Data availability statement}

Data supporting the findings of this study are available from the
corresponding author on request.\selectlanguage{english}
\begin{longtable}[]{@{}lllll@{}}
\toprule
\textbf{dBHL} & \textbf{\textless{}25\%} & \textbf{25-50\%} &
\textbf{50-75\%} & \textbf{75-100\%}\tabularnewline
\midrule
\endhead
\textbf{Total} & 28 (23-35) & 34 (28-41) & 40 (29-48) & 39
(30-46)\tabularnewline
\textbf{AS} & 27 (22-35) & & &\tabularnewline
\textbf{AI} & 27 (23-35) & & &\tabularnewline
\textbf{PS} & 29 (26-36) & & &\tabularnewline
\textbf{PI} & 27 (23-33) & & &\tabularnewline
\textbf{Ant} & & 31 (26-37) & &\tabularnewline
\textbf{Inf} & & 34 (27-44) & &\tabularnewline
\textbf{Post} & & 34 (26-39) & &\tabularnewline
\textbf{AI} & & & 37 (26-46) &\tabularnewline
\textbf{PI} & & & 42 (32-51) &\tabularnewline
\bottomrule
\end{longtable}

Table 1: Hearing loss in inactive perforations by size and location.
Reported as median 4FPTA dBHL (25-75 inter-quartile limits). AS:
anterosuperior, AI: anteroinferior, PS: posterosuperior, PI:
posteroinferior, Ant: anterior, Inf: inferior, Post: posterior.\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image1/image1}

\end{center}
\end{figure}

Figure 1: Classification of TM perforation site according to size and
site. Perforations divided into areas based around the manubrium mallei.\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image2/image2}

\end{center}
\end{figure}

Figure 2: Hearing loss with active and inactive perforations (Median and
quartile ranges).\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image3/image3}

\end{center}
\end{figure}

Figure 3: Hearing loss and size of inactive perforation (Median and
quartile ranges).\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image4/image4}

\end{center}
\end{figure}

Figure 4: Hearing loss and size of active perforation (median and
quartile ranges).\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image5/image5}

\end{center}
\end{figure}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image6/image6}

\end{center}
\end{figure}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image7/image7}

\end{center}
\end{figure}

Figure 5: Comparison of hearing loss by location and size for inactive
perforations (median and quartile ranges). Left to right:
\textless{}25\%, 25-50\%, 50-75\%.

\emph{}

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