Eur Arch Otorhinolaryngol (2017) 274:3585–3591
DOI 10.1007/s00405-017-4691-8
OTOLOGY
Sudden hearing loss: an effectivity comparison of intratympanic
and systemic steroid treatments
Gülce Ermutlu1,3   · Nilda Süslü1 · Taner Yılmaz1 · Sarp Saraç2 
Received: 1 May 2017 / Accepted: 25 July 2017 / Published online: 29 July 2017
© Springer-Verlag GmbH Germany 2017
Abstract  Corticosteroid treatment has been considered the
most effective treatment modality for sudden sensorineu-
ral hearing loss so far. Application route of corticosteroids
may vary. We have designed a prospective randomized case-
controlled clinical trial to evaluate the effectivenesses of the
different application routes of steroids in the treatment of
SSHL. Thirty-five patients were distributed randomly to two
groups which were treated with either ‘oral’ or ‘intratym-
panic’ corticosteroids. Intratympanic steroid administra-
tion was performed three times every other day transtym-
panically. At the end of third month, recovery rate in the
‘intratympanic’ group was 84.2%, whereas in the ‘oral’
group, it was 87.5%. The difference between the recovery
rates was not statistically significant. There were no major
complications related to transtympanic steroid administra-
tion. These findings support that intratympanic steroid ther-
apy is an alternative to systemic steroid therapy in the initial
treatment of sudden hearing loss. In addition, transtympanic
technique is an easy to perform and safe method for deliver-
ing steroids into the inner ear.
Electronic supplementary material  The online version of this
article (doi:10.1007/s00405-017-4691-8) contains supplementary
material, which is available to authorized users.
* Gülce Ermutlu
gulceermutlu@outlook.com
1
Department of Otorhinolaryngology and Head and Neck
Surgery, Hacettepe University, Ankara, Turkey
2
Department of Otorhinolaryngology and Head and Neck
Surgery, Koc University Hospital, İstanbul, Turkey
3
Kağıthane Devlet Hastanesi, Sanayi Mahallesi Sultan Selim
Caddesi, Şahinler Sokak No:23 Kağıthane, İstanbul, Turkey
Keywords  Sudden hearing loss · Intratympanic ·
Corticosteroid · Glucocorticoid · Sensorineural
Introduction
Sudden sensorineural hearing loss (SSHL) is a medical
emergency which is idiopathic in character and defined as
a sensorineural hearing loss (SNHL) of at least 30 decibels
(dB), including at least three consecutive frequencies and
occurring within 72 h. It is a diagnosis of exclusion and is
reported to account for approximately 1% of all cases of
SNHL [1]. Among other causes of the SNHL, SSHL is a cur-
able disease with a favorable prognosis making emergency
care even more important.
Although autoimmunity plays a determining role, it is
considered that other factors (vascular, viral) contribute to
the etiopathogenesis and simultaneously cause distortion
of the inner ear [2]. Hearing restoration is highly possible
especially in patients who are diagnosed within 2 weeks [3].
In addition, a considerable amount of patients (32–65%)
show spontaneous recovery within 2 weeks even when left
untreated [3–5]. It is rather hard to state an effective way of
treatment for a disease which etiopathogenesis is unclear and
may recover spontaneously.
Effectiveness of systemically administered steroids is
controversial; they may not be effective enough at non-
toxic doses because of their limited permeability through
the blood–perilymph barrier [6, 7]. It is possible to deliver
steroids into the inner ear via tympanic cavity. This method
was first used for managing intractable vertigo in patients
with Ménière’s disease [8]. When administered locally ster-
oids may trigger anti-inflammatory mechanisms in the inner
ear. This method with low potential side effects and directly
affecting the inner ear with diffusion through the round
13
Vol.:(0123456789)

3586
window (RW) is a suitable alternative [9]. Initially per-
formed as a salvage procedure for patients who are refrac-
tory to systemic steroid treatment, favorable outcomes of
intratympanic (IT) injection suggest that systemic steroids
may be inadequate to obtain the ideal results and IT treat-
ment might be an alternative in the initial treatment of SSHL
[10, 11].
It is still a point of debate whether outcome of IT treat-
ment is inferior, similar, or superior compared to the con-
ventional methods or being left untreated. The objective of
this study is to compare the efficacy and safety of different
administration routes of steroids in SSHL and to evaluate
the prognostic factors.
Materials and methods
Study design
Following approval from the institutional review board (KA-
130042), patients presenting to the Department of Otorhi-
nolaryngology of Hacettepe University with SSHL were
prospectively followed from June 2013 till January 2014.
Patients were randomly divided into oral steroid (OS) and
intratympanic steroid (ITS) groups based on the drug deliv-
ery method. OS group was considered as the control group,
as well.
Patient selection
All patients in the study population presented with unilateral
SSHL of at least 30 dB including at least three frequencies
and occurring within 72 h. Additional inclusion criteria were
as follows: (1) age between 18 and 80 years, (2) time prior to
treatment not exceeding 7 days, and (3) no history of previ-
ous treatment. Patients with an identifiable cause, a history
of previous otologic surgery on the affected ear, an acute or
chronic otitis media of the affected ear were excluded.
Data collected
A case report form was collected from each patient includ-
ing gender and age of the patient, time prior to treatment,
associated symptoms on admission, patient’s past medical
history of previous ear disease, otoscopic examination, sub-
type of audiometric configuration, level of the hearing loss,
side effects, and complications.
Standard assessment
All patients were evaluated with pure tone audiometry
after a thorough otolaryngologic history and physical
examination. Pure tone thresholds between 125 and 8000
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Eur Arch Otorhinolaryngol (2017) 274:3585–3591
Hertz (Hz) and also tympanometry, speech recognition
thresholds (SRT), word recognition scores (WRS), and
uncomfortable loudness levels (UCL) were evaluated. The
initial audiogram was labeled according to the configura-
tion as flat, up-sloping, and down-sloping. All patients
were examined with a temporal magnetic resonance imag-
ing (MRI) to rule out retrocochlear pathology. All patients
received the standard treatment protocol of our institu-
tion for SSHL; intravenous low molecular weight dextran
(5 cc/kg) for 5–10 days, an oral diuretic agent (acetazola-
mide) for a month, an oral antiviral agent (acyclovir) for
5 days, an oral vasodilator agent (betahistine), and an oral
cytoprotective agent (trimetazidine) for 3 months. Pred-
nisolone was administered for the OS group starting with
a daily divided dose of 1 mg/kg (maximum 80 mg) and
tapering 10 mg every 3 days.
Transtympanic technique
ITS administration was performed three times every other
day using a surgical microscope. Patient was placed with
the head tilted 45° to the opposite side. Local anesthesia
was administered by applying a 10% lidocaine soaked cotton
ball onto the tympanic membrane for approximately 10 min.
Following the creation of an anterosuperior puncture with
a 22-gauge needle for ventilation, a 27-gauge needle was
introduced in the posteroinferior quadrant of the tympanic
membrane to deliver 0.5–0.7  cc dexamethasone (DXM)
(8 mg/2 ml) through the tympanic membrane. The patient
was instructed to remain in the otologic position and to avoid
swallowing or talking for 30 min. The tympanic membrane
was regularly checked until the perforation was healed.
Evaluation of hearing recovery
Follow-up included audiometric testing performed on the
sixth day, fifteenth day, first month, and third month after
initiation of treatment. Pure tone average (PTA) was calcu-
lated as an average of the pure tone thresholds measured at
0.5, 1.0, and 2.0 kHz. Hearing recovery was defined as an
improvement in PTA of at least 10 dB or an increase of at
least 10% points in WRS. Hearing recovery was further clas-
sified into two subcategories as complete or partial recov-
ery based on the criteria recommended by Stachler et al.
[13]. Complete recovery was defined as PTA returning to
within 10 dB of the contralateral ear and recovery of WRS
to within 5–10% of the contralateral ear. Patients not meeting
these criteria were considered partially recovered. In addi-
tion, recovery of a non-serviceable ear due to the episode of
SSHL to a serviceable level with treatment was considered
partial recovery.
Eur Arch Otorhinolaryngol (2017) 274:3585–3591 3587

Table 1  Demographics of the Characteristics OS ITS Total p value χ2 z value

study groups (n = 16) (n = 19) value

Mean age (years) 41.06 49.68 45.74 0.151 1.44

Gender, n (male/female) 9/7 14/5 23/12 0.279 1.172
Mean time prior to treatment (days) 2.69 3.74 3.26 0.102 1.68
Tinnitus (%) 81.2 94.7 88.6 0.312
Level of hearing loss, n (mild/severe) 11/5 12/7 23/12 0.728 0.121

Table 2  Audiometric configurations of the study groups 25

number of paents recovered

p = 0.216 Flat Down-sloping Up-sloping 20
21
χ2 = 3.398
15
OS (n) 9 3 4
ITS (n) 8 1 10
10
Total (n) (%) 17 (48.6) 4 (11.4) 14 (40)
5
4
3
2

Statistical analysis
Chi-square test, Fisher Chi-square test, and Fisher–Free-
man–Halton test were used to compare the hearing recover-
ies of the two groups and to determine the prognostic cri-
teria. Mann–Whitney U test was performed to compare the
quantitative variables in the two groups. SPSS version 21.0
was used to make the analysis. Significance was determined
to be at the confidence level of p < 0.05.
Results
Forty-one consecutive patients with SHL were prospectively
analyzed. Of these, 21 patients received oral steroids and
20 underwent intratympanic injection. Seven of the patients
were excluded after randomization: one patient was diag-
nosed with cochlear hypoplasia and one with multiple scle-
rosis, one patient underwent tympanostomy tube insertion
(for continuing administration of steroids) due to intractable
vertigo, two of the patients withdrew from the study, and two
were lost to follow-up. Thirty-five patients were available
for final analysis, with 19 patients in the ITS group and 16
in the OS group.
Patient demographics
The mean age of the patients was 45.74  years (range
24–80 years). There were 23 men and 12 women. The mean
time prior to treatment was 3.26 days (range 1–7 days).
Eleven of the patients (31.4%) were admitted to the hos-
pital within the first 24 h. The most common associated
symptom was tinnitus (88.6%, n = 31), followed by aural
fullness (57.1%, n = 20). The most common audiometric
0
0 20 40 60 80 100
days
Fig. 1  Improvement in hearing through the follow-up period
configuration was flat type (48.6%, n = 17). Twelve patients
(35.2%) had SHL ranging from mild to severe on the con-
tralateral ear. Prior history of SSHL was present in five
patients (14.7%) and four of them were on the same side. All
these five patients had recovery after treatment. Three of the
eighteen patients in the ITS group had a tympanosclerotic
membrane, while other ears revealed no abnormal findings.
Four (21%) of the patients in the ITS group had transient
vertigo during the procedure.
The two groups were well matched in age and gender,
and there were no statistically significant differences among
the groups with regard to audiometric configuration sub-
types, severity of hearing loss, and time prior to treatment
(Tables 1, 2).
Hearing recovery of the study groups
Overall, 85.7% (n = 30) of the patients had recovery at
the third month follow-up. Complete and partial recovery
rates were 68.6 and 17.1%, respectively. In the first 6 days,
patients with partial recovery constituted 33.3% (7/21) of
the total recovered patients, whereas at the end of the third
month, only 20% (6/30) of the recovered patients had partial
recovery. 60% (n = 21) of the patients had recovery based on
the sixth day audiogram. Recovery magnitude was highest
in the early period and recovery rates tended to decrease as
the follow-up time increased (Fig. 1).

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3588 Eur Arch Otorhinolaryngol (2017) 274:3585–3591

Table 3  Comparison of recovery rates of the study groups at the Table 7  Recovery related to severity of hearing loss
third month
p = 0.038 Improvement (%) Failure (%)
p > 0.99 Failure (%) Improve-
ment(%) Mild hearing loss (<50 dB) 95.7 4.3
(n = 23)
OS 12.5 87.5 Severe hearing loss 66.7 33.3
ITS 15.8 84.2 (≥50 dB) (n = 12)
Total 14.3 85.7

Table 4  Comparison of partial/complete recovery rates at the third of recovered patients was not statistically significant on the
month sixth day, fifteenth day, or first month either (Table 5).
p > 0.05 No recovery (%) Partial recovery Complete
Four patients who were reported as complete recovery at
(%) recovery the third month had profound hearing loss on the contralat-
(%) eral ear, so the criteria used for hearing recovery could not
be applied. Three of them reached the PTA level regarded
OS 12.5 12.5 75
as normal hearing (0–25 dB), and the remaining patient was
ITS 15.8 21.1 63.2
evaluated according to the former audiogram.
Total 14.3 17.1 68.6

Prognostic factors
Table 5  Recovery rates (partial/complete) through the follow-up
period Effect of gender, vertigo at onset, hearing status of the unaf-
Sixth Fifteenth First Third fected ear, and audiometric configuration and severity of
day day month month hearing loss on the prognosis were studied.
OS (n)
There was a trend for more favorable results in women,
 Complete recovery 8 9 10 12
but it was not statistically significant. (p = 0.640).
 Partial recovery 4 4 3 2
Vertigo was present at onset in 17.1% of patients with
 Total 12 13 13 14
a recovery rate of 66.7%. Remaining patients did not have
ITS (n)
symptoms of vertigo and had an overall recovery of 89.7%.
 Complete recovery 6 8 11 12
(p = 0.195). The presence of vertigo at onset did not show
 Partial recovery 3 4 4 4
any significant influence on the outcome.
 Total 9 12 15 16
History of SHL in the contralateral ear did not influence
p value 0.306 0.560 1.0 0.877
the rate of recovery (p > 0.99).
χ2 value 2.763 1.412 0.077 0.614
Though not statistically significant, audiometric configu-
ration seemed to have an effect on prognosis. (p = 0.657)
(Table 6).
Table 6  Recovery related to audiometric configuration Patients with severe hearing loss (greater than or equal
p = 0.657 Improvement (%) Failure (%)
to 50 dB) had a poorer recovery (66.7%) compared to those
χ2 = 1.115 with less than 50 dB loss (95.7%) (p = 0.038) (Table 7).

Flat type (n = 17) 82.4 17.6

Down-sloping type (n = 4) 75
Up-sloping type (n = 14) 92.9
87.5% (n = 14) of the patients had recovery at the third
month follow-up in the OS group, whereas in the ITS
group, recovery rate at the third month was 84.2% (n = 16)
(p > 0.99) (Table 3). Moreover, the number of the patients
with partial or complete recovery in each group revealed
no statistically significant difference at the third month
(p  =  0.877) (Table  4). Comparing the clinical outcome
between groups through the follow-up period, the number
25 Discussion
7.1
SSHL is an idiopathic medical emergency which may occa-
sionally show spontaneous recovery. Even though the inde-
terminate nature of this disease complicates the efforts to
establish an accepted treatment regime, administration of
corticosteroid has been considered the most effective treat-
ment modality. Concerns for potential side effects of sys-
temic steroid use and aim of increased drug concentration
at the site of pathology have led to efforts of delivering cor-
ticosteroids locally. IT technique is an attractive alternative
with potentially low side effects; however, its efficacy as

13
Eur Arch Otorhinolaryngol (2017) 274:3585–3591 3589
an initial treatment modality compared to the conventional
methods is still a point of debate.
Our results have revealed similar recovery rates with
IT and oral steroid administration. This is in accordance
with the majority of the literature which reports no supe-
riority of systemic steroid use over transtympanic appli-
cation [14–16]. Han et al. in their study of 114 patients
reported no significant difference between intratympanic,
intravenous, or enteral treatment [17]. Similarly, Kara et al.
reported recovery rate of 86% in ITS, which was still not
significantly different than the conventional methods [18].
The highest recovery rates with ITS treatment have been
reported by Filipo et al., reaching 91%. However, lack of
a control group in their study prevents a direct compari-
son with systemic steroid use [19]. Studies showing higher
efficacy of a treatment method such as Kakehata et al.’s
method are relatively rare, where they report significantly
higher recovery rates in the ITS group when steroids are
administered following myringotomy or through a tympa-
nostomy tube [20].
Severe hearing loss is related to poor prognosis in gen-
eral [4, 21]. Similarly, improvement in patients with severe
hearing loss was significantly lower in the current study.
In addition, four of the five patients who did not show any
improvement in hearing had severe hearing losses. Up-
sloping type audiometric configuration is considered good
prognostic criteria in the literature [3, 12]. In the current
study, recovery rates of down-sloping type hearing losses
were lower compared to up-sloping type losses, but the
difference was not statistically significant. The absence of
vertigo at onset is thought to be a good predictor of the
outcome [10]. We also observed lower recovery rates in
patients with vertigo at onset, but it was not statistically
significant.
Distinguishing feature of this study is the relatively short
interval between onset of hearing loss and beginning of
treatment. We included patients who admitted within 7 days
from the onset of hearing loss. This interval is generally
accepted as 15 days in the literature but can be as long as
6 weeks [15, 18, 19, 22]. Time to intervention is upmost
important in terms of prognosis; earlier intervention is found
to be related to better results [13, 23]. As recovery may take
place in the late period, we excluded all patients with a his-
tory of any previous treatment for the current attack. We
also excluded the patients with chronic otitis media on the
affected ear because of the fact that RW is thicker in this
patient population [24].
The most common associated symptom in our study was
tinnitus (88.6%) similar to other studies. On the other hand,
only 17.1% of the patients had vertigo at onset which is
lower than average [11, 14, 16, 19, 21, 25].
Intratympanic injection is considered as a safe method.
Several studies reported no major complications due to the
application [10, 14, 17, 19, 26]. High complication rates
of ITS are mostly related to tympanic membrane perfora-
tions due to tympanostomy tube or microcatheter place-
ment. Although rare, membrane perforations do occur
in transtympanic method [16, 27]. To reduce the risk of
membrane perforation, the thinnest needle tip should be
chosen. In the present study we used a 22 gauge needle to
ventilate the middle ear and a 27 gauge needle for instil-
lation. None of the patients experienced transient or per-
manent membrane perforation. In addition, there are some
studies reporting hearing deterioration with IT method, but
these are either cases of simultaneous acute otitis media
or endolymphatic hydrops [18, 26]. In the present study,
we observed transient vertigo in four patients in the ITS
group. No long-term complications were observed in any
of the patients.
There is not an acknowledged ITS treatment protocol so
far. The most common preferred way of delivery is tran-
stympanic route which we also performed in this study
[10–12, 14, 15, 21]. Closure of the perforation takes longer
and risk of persistent membrane perforation is higher when
using other methods for drug delivery (tympanostomy tube
or microcatheter placement…) [20]. It is our belief that
these methods should be preserved for profound hearing
losses. In addition, transtympanic method is cost-efficient
compared to more invasive methods. There are some dis-
advantages as well. The amount of drug that is lost through
the Eustachian tube is not known nor can be controlled. As
a prevention, we asked the patients to remain in the oto-
logic position for 30 min to minimalize this loss. In addi-
tion, false membranes on the RW niche cannot be inter-
vened with this method. Repetitive drug applications are
necessary because of possible RW plugs. For this reason,
we repeated the IT injections for three times. To deliver
the highest dosage possible, we did a ventilation puncture
apart from instillation to relieve the pressure in the middle
ear space.
In the present study, we used 8 mg/2 dl of DXM, because
it is the highest concentration that can be supplied in the
market in our country. The most common preferred agent in
the literature is also DXM followed by methylprednisolone
(MTZ). One disadvantage of MTZ is frequently observed
pain during the procedure which did not occur in our study
or in other studies using DXM [22]. On the other hand,
DXM is thought to be less efficient in ion homeostasis due
to the minor mineralocorticoid efficacy [28]. However, in
a meta-analysis, no statistically significant difference was
determined in using DXM compared to MTZ [29].
Criteria used for evaluating hearing improvement have a
major influence on recovery rates. To date, there is still no
consensus about how much improvement should be consid-
ered success. Results of the studies which use the same crite-
ria for outcome assessment are quite similar despite marked
13

3590
differences in the treatment protocols [26]. Another handicap
is not knowing the former level of hearing of the affected ear
and evaluating recovery according to the opposite ear. In the
current study, we used the criteria recommended by Stachler
et al. for outcome assessment in an attempt to match up with
as much studies as possible [13]. Although rare for SSHL,
recoveries in the late period may influence the outcome. In
a study by Yeo et al., 97% of 156 patients reached their final
hearing level within 3 months [30]. 60% of the patients in
our study had recovery on the sixth day, increased to 85.7%
at the third month. Hence, follow-up period should be kept
long enough to reach ideal outcome.
Various treatment options had been experienced in
the literature other than steroids. In the current study, we
used a protocol including dextran, acetazolamide, acyclo-
vir, betahistine, and trimetazidine added to steroid treat-
ment. However, none of these drugs have been proven to
be effective in the treatment of SSHL [31, 32].
Conclusion
This trial showed that ITS injection can be considered as
an effective treatment modality in the initial treatment
of SSHL. Our results reached the highest recovery rate
among the randomized-controlled trials in the literature
searching the efficacy of intratympanically administered
steroids as a primary treatment modality. Based on the
data in our study, administration of steroids via transtym-
panic method is an easy to perform, safe, and effective
technique. Having said that guidelines about optimal dos-
age and frequency of application must be developed. This
trial demonstrated similar success rates between systemic
and intratympanic administration of steroids. One limita-
tion of the study is the low power of our tests due to the
relatively small number of patients. In addition, due to
the ethical issues, we could not accomplish a placebo-
controlled study. Further studies with larger sample sizes
are needed to answer the question whether ITS injection
is as equally effective as systemic steroid administration
in the primary treatment of SSHL.
Compliance with ethical standards  results. ORL J Otorhinolaryngol Relat Spec 68:247–252
Conflict of interest  The authors declare that they have no conflict
of interest.
Ethical approval  All procedures performed in studies involving
human participants were in accordance with the ethical standards of
the institutional and/or national research committee and with the 1964
Helsinki declaration and its later amendments or comparable ethical
standards.
Informed consent  Informed consent was obtained from all indi-
vidual participants included in the study.
13
Eur Arch Otorhinolaryngol (2017) 274:3585–3591
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