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Journal of Otolaryngology-Head & Neck Surgery


Volume 39, Issue 03, June 2010, Pages 259-268

Simple Mass Loading of the Tympanic Membrane to Alleviate Symptoms of Patulous


Clark Bartlett MD, Ronald Pennings MD, PhD, Allan Ho MBBS, MRCS, FRCS, D
Wijhe, Manohar Bance MB, MSc, FRCS.
Clark Bartlett, Ronald Pennings, David Kirkpatrick, and Manohar Bance: Division of O
and Rene van Wijhe:E.A.R. Lab, Dalhousie University, Halifax, Nova Scotia; and Alla
University of Alberta, Edmonton, Alberta.

ABSTRACT

BACKGROUND:
Patulous eustachian tube (PET) has a major impact on a patient's quality of life. The
mechanisms behind the symptoms, develop treatments based on these, and develop
changes in PET symptoms with a novel intervention. Our hypothesis is that PET sym
eardrum more easily than at the level of the eustachian tube.
METHODS:
In a population of 14 PET subjects and 6 fresh temporal bones, several investigations
used to measure frequencies preferentially transmitted to the ear in PET subjects. An
the eardrum was devised in the temporal bones to damp these frequencies. This was
questionnaire was developed and administered to measure the response to this inter
more common symptoms associated with PET, such as echoing sounds, increased e
sensation in the ear. Mass loading of the eardrum was performed with Blu Tack, a cla
RESULTS/CONCLUSION:
Low frequencies are preferentially transmitted in PET, and eardrum vibrations to thes
loading in human subjects significantly reduced major symptoms of PET, although tem
Translated Abstract Sommaire CONTEXTE:
La bance tubaire (BT), ou trompe d'Eustache bante, se rpercute grandement sur
prsente tude avait pour buts de comprendre les mcanismes sous-jacents aux sym

fonds sur ces mcanismes ainsi que d'laborer et d'utiliser un questionnaire visant
attribuables une nouvelle intervention. Selon notre hypothse, il est plus facile de tr
de la caisse du tympan qu' la hauteur de la trompe d'Eustache.
MTHODE:
Plusieurs examens ont t effectus chez 14 sujets atteints de BT et sur 6 os tempor
audiomtrie nasale afin de mesurer les frquences transmises le plus souvent dans l
consistant en la mise en place d'une charge dans la caisse du tympan a t pratiqu
frquences. On a ensuite appliqu le traitement aux sujets. Nous avons labor un q
participants afin de mesurer la raction l'intervention. Le questionnaire portait, entre
frquents, associs la BT comme l'cho, l'amplification des bruits ambiants et une s
en place d'une charge dans la caisse du tympan a t ralise au moyen d'une subs
(Blu Tack).
RSULTATS/CONCLUSION:
Ce sont les basses frquences qui sont surtout transmises dans la BT, et il est possib
du tympan par la mise en place d'une charge. L'intervention a diminu sensiblement
sujets humains, bien que l'effet ft temporaire.
Keywords
autophony, mass loading, patulous eustachian tube, tympanic membrane.

The eustachian tube (ET) is a structure that connects the nasopharynx with the midd
to allow ventilation and equalization of middle ear pressure. This seemingly simple fu
complex interplay of anatomy and precisely sequenced contractions of a number of m
functionally collapsed to protect the middle ear from nasopharyngeal secretions and n
those generated during sniffing. This closed ET also attenuates sound transmission o
(autophony). The ET typically opens when a subject yawns or swallows.13 In patulo
abnormally patent, even at rest, and, as a result, it can cause a variety of symptoms t
often defined by the presence of autophony, one of the most frustrating symptoms of
autophony can lead to major depression or even suicide., 4 Other symptoms of PET
breathing sounds, and a sensation of a plugged ear., 4 It has been theorized that som
sniffing to try to force ET closure to damp these symptoms., 5The senior author (M.B
mechanism does not so much force closure of the ET as retract the tympanic membr
membrane vibrations and response to the subject's own voice. In either case, sniffing
disease owing to a retracted tympanic membrane from negative pressure in the midd
In most cases, the cause of PET is idiopathic.6 A few predisposing factors include pre
fatigue, and temporomandibular joint syndrome., 79 PET can also be caused by adh
surgery on the adenoids., 10Sometimes PET can be associated with medications suc
Neuromuscular disorders that cause atrophy, such as multiple sclerosis, stroke, and m

postulated to cause PET., 1013


Some patients can be treated with reassurance or treatment of the underlying factors
techniques. In patients who do not improve, few treatments are satisfactory. Many me
iodine, have been tried but largely have not achieved widespread acceptance. Surgic
injections of various substances into the ET opening, including paraffin, Teflon, fat, or
are either temporary or can lead to serious complications, including cerebral thrombo
into the carotid artery)., 10 Other treatments have focused on cauterizing the ET ope
unsatisfactory or caused damage to the trigeminal nerve or stricture and stenosis., 10
tube have helped some patients, but others have found that these increased the patie
authors have started to operate directly on the ET. The abundance of treatment optio
simple, effective treatments for PET, although insertion of a ventilation tube is probab
Enhancing the confusion, currently, there is no clinical tool for evaluating the subjectiv
suffer from PET. A clinical questionnaire would be useful to assist in monitoring the co
and responses to treatment. In other studies, autophony alone has been used as an
patulous condition and response to treatment.2 We wanted to create a questionnaire
then use it clinically to define the response to treatment. Nominally, for the purposes o
the BBK (after the initials of the primary authors) for this article and is shown in fig1a
symptoms that have been reported in the literature to create this questionnaire., 2,10

Figure 1
BBK scale: the questionnaire used to measure the severity of subjective s

Figure 1
Continued.

The studies reported here stem from the central hypothesis described above, namely
from abnormal tympanic membrane vibrations owing to abnormal transmission of aco
symptoms can be addressed at the level of the tympanic membrane by reducing its v
frequencies.
Hence, studies reported here consist of two main parts. The first part identifies the fre
contribute most to symptoms in patients with PET. To do this, we have used nasal au
subjects' auditory thresholds to nasally presented sounds to determine which frequen

PET. In the second part, we describe methods developed to reduce the tympanic me
fresh cadaveric human models and live human subjects with PET.
In particular, this article concentrates on the results of a new model to mitigate the sy
mass loading. We present the results of cadaveric studies that determine the change
loading and then clinical results as evaluated with our BBK questionnaire that specific
after mass loading of the tympanic membrane in a prospective cohort study. Other co
in more detail in companion articles.

Materials and Methods Defining the PET Population


The PET was abstracted from the population of patients who were referred to the spe
Elizabeth II Health Science Centre in Halifax, Nova Scotia (staffed by senior authors
January 2008 and March 2009.
Patients were diagnosed with PET if they met accepted diagnostic criteria. Specificall
made better by lying down without any symptomatic evidence of superior canal dehis
In addition, most had endoscopic evidence of an abnormally patent ET opening on fib
and/or movement of the tympanic membrane on forced respiration with one nostril oc
nasopharyngeal pressure changes. Patients were excluded from the study if they had
including cauterization of the ET opening and injection of any substance such as Gel
opening. They were also excluded if they did not have an intact tympanic membrane.
symptoms for 1 year or more. During the history, patients were screened for potential
Nasal Audiometry Study
To determine the range of frequencies that were most likely to be conducted to the ea
performed.4,18 This technique measures the threshold for detection of a tone, analog
presented to the nasal orifice with the contralateral nares occluded. A 50% detection
preferentially conducted via the PET should have lower thresholds for detection in PE
subjects. It should be noted that those frequencies identified with the lowest threshold
preferentially conducted up the ET because this reduced threshold could also result f
nasal cavities. Hence, the differences between PET and non-PET subjects are the m
With nasal audiometry, we compared 10 subjects with symptomatic PET in at least on
normal hearing and no aural symptoms. The technique used was similar to that descr
phones in the nares and with a calibrated audiometer providing the sound source.4
Cadaveric Fresh Temporal Bone Study
We wanted to change the frequency response of the tympanic membrane and specif
identified as being important in the nasal audiometry studies. To do this, we devised a
Fresh temporal bones harvested within 24 hours of death, although difficult to secure
the living human ear.19 Vibration characteristics of the tympanic membrane in six hum
measured using a Scanning Laser Doppler Vibrometer (PSV400, Polytec, Tustin, CA
performing a cortical mastoidectomy and posterior tympanotomy with removal of the

stapes. The external auditory canal was drilled away and a brass rod was glued with
replace it. Calibrated ER-2 earphones and ER-7 microphones (Etymotic Research, E
brass ring at 1 cm and 2 mm from the tympanic membrane, respectively. In addition,
enlarged ET so that it could just be seen in the protympanum. During recordings, the
measured with another ER-7 microphone. The sample was placed in a latex shell to p
cement. Bones were kept well hydrated with saline throughout recordings.
We attempted to investigate mass loading of the tympanic membrane as a possible m
this with a substance that was nontoxic, we measured vibration characteristics before
Ltd., Stafford, UK), which is a complex mixture of hydrocarbons and a pliable, putty-li
substance is mildly adhesive and nontoxic and often used to hang paper posters. The
quadrants of the tympanic membrane (fig2). The Scanning Laser Doppler Vibromete
measurements of the stapes footplate. The vibration amplitude and frequency were e
beam frequency owing to the motion of these objects elicited by a frequency sweep f
through the ER-2 earphones. Data were exported to MATLAB (Mathworks, Natick, M

Figure 2
Clinical photograph of a right eardrum with Blu Tack on the posterior thir

Clinical Mass Loading of Tympanic Membrane Study


Patients diagnosed with PET were asked to complete a pretreatment questionnaire u
of their symptoms of PET. Once complete, the patients' affected ear or ears were trea
piece of Blu Tack similar to fig2 (which is from a live patient) on the posterior quarter
placement of Blu Tack was performed under a microscope looking through a speculu
No anesthetic was used for the procedure as it was generally well tolerated. A small p
placed carefully on the tympanic membrane using a blunt microspatula. If the patient
was repeated on the opposite ear.
Fourteen patients underwent this procedure. Patients were asked to go home and fill
day or two of having the Blu Tack placed. They were given a copy of their premass l
The results were compared. Statistical analysis of the data was performed using SAS
for medical statistics. Paired t-tests were used for data analysis for pre- and posttreat
considered to indicate statistical significance, with Bonferroni correction as needed fo

Results Demographics
Fourteen patients with PET were studied, nine females (64.3%) and five males (35.7%
patients had bilateral involvement and nine patients had unilateral involvement. Eleve
completed, and some subjects missed some of the questions, so there are not 19 da
measure. Not all patients underwent all tests.

Nasal Audiometry
The results of nasal audiometry showed that in comparing 10 normal ears with 10 PE
the lower frequencies up the ET in PET, as evidenced by the reduced thresholds at th
above 2 kHz between the two groups.

Figure 3
Results of nasal audiometry in 10 ears with patulous eustachian tube (PET
line represents the average pure-tone normal audiometric thresholds of the
shown with standard deviation. The PET patients showed a lower threshold
normal subjects at the lower frequencies.

Cadaveric Eardrum Studies


fig4 shows the results of vibration measurements from the stapes footplate in six fres
loading primarily affects the vibration responses in the low frequencies, those that ha
being preferentially conducted in PET

Figure 4
Normalized stapes footplate vibration amplitudes before and after applicati
membrane. EAC=external auditory canal.

Clinical Eardrum Mass Loading Studies


Table 1 shows the raw results of the subsections of the questionnaire before and afte
representing the average score prior to mass loading and b representing the averag
deviation, standard error, and 95% confidence intervals are reported as well. Table 2
mass loading of the eardrum in the six major symptoms, echoing of own voice in the
(breathing), plugged feeling in the ear (plugged sensation), hearing environmental so
symptoms improving when lying down (lying down), sniffing making symptoms better
pressure), as well as global percentage improvement subjectively estimated by patien
in fig1afig1b. Negative values represent improvements in scores. Clearly, there are l
breathing, plugged sensation, and enviromental sounds.

Table 1
Average Scores and Descriptive Statistics for the BBK Scale Before and A
Tack
Table 2
Mean Difference between Eardrum Pre and PostMass Loading Scores
Encountered

Table 3 and fig5 show the results of paired t-tests on these variables before and afte
breathing, plugged sensation, enviromental sounds, and overall are clearly highly sta
with Bonferroni correction. The variable total, the sum of these four variables, is also
no significant change in lying down, sniffing, or applying pressure.

Figure 5
Results of the BBK questionnaire before and after mass loading the tympa
significant reductions in symptoms of voice echoing, hearing breathing in th
environmental sounds after mass loading.

Table 3
Results of Paired t-Tests for Significant Differences between the Pre an

Discussion
Most PET studies involve treatments targeted at the ET orifice. These various treatm
inflammation of the ET orifice. Unfortunately, these results are typically transient.20
Our studies have flowed systematically from our hypothesis that PET symptoms can
is much more accessible than the ET. We have measured the transmitted frequencie
bone laboratory that targets these frequencies, and then applied this treatment to pat
Our results using nasal audiometry showed that the auditory thresholds were typically
PET subjects. Our results confirmed that these previous studies showing that sound
pronounced at low frequencies.4,17
It is relatively easy to understand why the symptoms echo and breathing get better w
tympanic membrane to low-frequency vibrations and is damped by the mass loading.
stimulus, and the mass limits excursion of the eardrum to static pressure changes. It
sensitivity to enviromental sounds improve. The senior author's (M.B.) hypothesis (ba
many of these patients develop thin atrophic ballooning segments of the eardrum tha
sounds as well as the patient's own sounds transmitted via the PET. This may lead to
environmental sounds do not sound crisp and are muffled. In fact, just focusing a sm
atrophic segment of the eardrum alone often dramatically reduced these symptoms o
enviromental sounds.
The duration of the efficacy of mass loading was highly variable. Two patients had res
of patients had results lasting only 2 to 4 weeks. In patients whose eardrums were hig
was easily dislodged and sometimes lasted only days. Patients were usually immedia
Nevertheless, this change in symptoms represented an important confirmation of the
patients. Given that this can be a subtle diagnosis sometimes, with nonspecific symp

symptoms after application of Blu Tack is a useful diagnostic tool. The intervention its
encountered no adverse effects in 2 years of use of this technique. One or two patien
symptoms even when the mass loading came off the eardrum, with marked reduction
are currently experimenting with changing the frequency response of the eardrum wit
three subjects long term for PET with this, subjects who were initially identified by the
mass loading may function to screen patients for other, potentially longer-lasting treat
To our knowledge, there is no standard questionnaire for PET to help guide treatmen
have used improvement in autophony symptoms as their main outcome measure.2 W
this process. Clearly, this is a tool that needs further work to refine and validate. How
changes in severity scores with mass loading of the eardrum. It is important to note th
of symptoms with application of Blu Tack. There was a range of responses that varied
resolution.
We are not advocating the use of Blu Tack in particular-any safe, nontoxic mass that
function, and we have also used other materials (not reported here) in our learning cu
patients had adverse reactions to the Blu Tack. The main reason for choosing this ma
pliable, putty-like material that could be easily moulded to shape and placed on the e
previously done. Blu Tack has been used safely in the past as an earplug.21
Currently, it is too early to advocate for this treatment until further research is perform
effects of mass loading as a treatment for PET. Randomized controlled trials are idea
this technique.

Conclusions
Mass loading the eardrum with Blu Tack decreased the overall symptoms of PET. Thi
frequency responses to sound. This was initially shown in the temporal bone laborato
the tympanic membrane and measuring the change in vibrational characteristics of th
Subsequently, the treatment was applied clinically. This was shown using a novel sym
Specifically, patients found that there was an improvement in autophony, hearing brea
environmental sounds. These results were short term, and future research is needed
do represent a novel treatment option and a change in paradigm from limiting air flow
focused on.
Acknowledgements
Financial disclosure of authors and reviewers: None reported.
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5 Kobayashi T, Yaginuma Y, Takahashi Y, Takasaka T. Incidence of sniff-related chol
1996;116:746.
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8 Suehs O. The abnormally open eustachian tube Laryngoscope 1960;70:141826.
9 Shambaugh GE Jr. Continuously open eustachian tube Arch Otolaryngol 1938;27
10 O'Connor AF, Shea JJ. Autophony and the patulous eustachian tube Laryngoscop
11Cairns W. The patulous eustachian tube syndrome Palliat Med 1998;12:5960.
12 Virtanen H. Patulous eustachian tube Arch Otolaryngol 1978;86:4017.
13 Cox JR. Hormonal influence on auditory function Ear Hear 1980;1:21922.
14 Dyer RK, McElveen JT. The patulous eustachian tube: management options Otola
15 Virtanen H, Palva T. Surgical treatment of patulous eustachian tube Arch Otolaryn
16 Sehhati-Chafai-Leuwer S, Wenzel S, Bschorer R. Pathophysiology of the eustach
and neck surgeon J Craniomaxillofac Surg 2006;34:3514.
17 Luxford WM, Sheehy JL. Myringotomy and ventilation tubes: a report of 1568 ears
18 Hori Y, Kawase T, Haswgawa J, et al. Audiometry with nasally presented masking
eustachian tube Otol Neurotol 27:5969.
19 Chien W, Ravicz ME, Merchant SN, Rosowski JJ. The effect of methodological dif
motion in live and cadaver ears Audiol Neurootol 2006;11:18397.
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Article Categories:
o Article

Figure1.BBKscale:thequestionnaireusedtomeasuretheseverityofsubjectivesymptomsforpatulous
eustachiantube.

Figure1.Continued.

Figure 1. BBK scale: the questionnaire used to measure the


severity of subjective symptoms for patulous eustachian
tube.

Figure 2. Clinical photograph of a right eardrum with Blu


Tack on the posterior third of the eardrum.

Figure3.Resultsofnasalaudiometryin10earswithpatulouseustachian
tube(PET)comparedwith10normalears.
Theupperlinerepresentstheaveragepuretonenormalaudiometric
thresholdsofthegroups.
Thenormalsubjects'resultsareshownwithstandarddeviation.T
hePETpatientsshowedalowerthreshold(ie,increasedconductionof
sound)thannormalsubjectsatthelowerfrequencies.

Figure4.Normalizedstapesfootplatevibrationamplitudesbeforeandafter
applicationofmassloadingtothetympanicmembrane.
EAC=externalauditorycanal.

Figure5.ResultsoftheBBKquestionnairebeforeandaftermassloading
thetympanicmembranewithBluTack.
Therearesignificantreductionsinsymptomsofvoiceechoing,hearing
breathingintheear,pluggedfeeling,
andsensitivitytoenvironmentalsoundsaftermassloading.

Variable

n Mean SD SE

Echoa
Echob
Breathinga
Breathingb
Pluggedsensation
a
Pluggedsensation
b

17
17
17
17

7.74
3.26
7.68
3.59

2.39 0.58
2.44 0.59
2.11 0.51
2.26 0.55

Lower95%CL Upper95%CL
forMean
forMean
6.51
8.96
2.01
4.52
6.59
8.76
2.53
4.75

17 7.12 2.91 0.71

5.62

8.61

17 3.29 2.14 0.52

2.19

4.40

Enviromental
15
soundsa
Enviromental
15
soundsb
Lyingdowna
14
Lyingdownb
14
Sniffinga
16
Sniffingb
16
Applyingpressure
16
a
Applyingpressure
16
b

6.87 2.69 0.69

5.38

8.36

3.97 2.55 0.66

2.55

5.38

4.86
4.54
6.13
5.78

3.94 1.05
3.92 1.05
3.55 0.86
3.62 0.90

2.58
2.27
4.28
3.35

7.13
6.80
7.97
7.71

4.38 3.50 0.88

2.51

6.24

4.94 3.86 0.96

2.88

6.99

CL=confidencelimit.Thistableincludesonlythoseearsthathavea
premeasurement(variablea)andapostmeasurement(variableb).
Table1.AverageScoresandDescriptiveStatisticsfortheBBKScale
BeforeandAfterMassLoadingoftheEardrumwithBluTack

Variable
Echo
Breathing
Pluggedsensation
Enviromentalsounds
Lyingdown
Sniffing
Applyingpressure
Overall

Mean
4.47
4.09
3.82
2.9
0.32
0.34
0.56
73.09

SD
2.71
2.62
2.6
3.01
2.07
2.84
1.79
28.59

Minimum
10
8.5
8
7
6
8
2
12.5

Maximum
0
0
0
2
2
4
4
100

Table2.MeanDifferencebetweenEardrumPreandPostMassLoading
ScoresandMinimumandMaximumDifferencesEncountered

Variable

n Mean

Echo

17 4.47

Breathing

17 4.09

Plugged
sensation
Enviromental
sounds
Lyingdown
Sniffing
Applying
pressure
Total
Overall

17 3.82

Lower
Upper
p>|t|
SE
Improvements 95%CL 95%CL
*
forMean forMean
<.
0.66
Yes
5.87
3.08
0001
<.
0.63
Yes
5.43
2.74
0001
<.
0.63
Yes
5.16
2.49
0001

15 2.9 0.78 .0023

Yes

4.57

1.23

14 0.32 0.55 .5715


16 0.34 0.71 .6358

No
No

1.52
1.86

0.87
1.17

16 0.56 0.45 .2274

No

0.39

1.52

Yes

21.39

10.35

Yes

53.88

92.3

<.
0001
<.
11 73.09 8.62
0001
15 15.87 2.57

CL=confidencelimit.*pvaluesbasedonpairedttest.Significant
improvementswereobservedforecho,breathing,pluggedsensation,
andenviromentalsounds.Noimprovementswerenotedinlyingdown,
sniffing,orapplyingpressure.Themeasuretotalwascalculatedby
summingtheimprovementsforecho,breathing,pluggedsensation,and
enviromentalsoundsbutnotlyingdown,sniffing,orapplyingpressure.
Theoverallmeasurerepresentsestimatedpercentimprovement.Boththe
combinedmeasure(total)andtheoverallpercentmeasureof
improvementshowedimprovementwiththeapplicationofBluTack(p<.
0001).
Table3.ResultsofPairedtTestsforSignificantDifferencesbetweenthe
PreandPostMassLoadedResults

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