Objective: Cochlear implantation (CI) is an effective treatment for profound deaf patients. To study the cochlear

implant complications in patients at Amir Aalam Hospital.

Methods: The study population involved 177 profoundly deaf patients, implanted within the same cochlear

implant center.

Results: Twenty-four (13.6%) patients experienced complications. Early complications accrued in 9 (37.7%)

patients within the first 24 hours. Eight (4.5%) patients had major complications including facial nerve paralysis,

suture rupture and prosthesis rejection. Prosthesis rejection 6 (30%) was the most frequent major complication.

Minor complications were found in 16 (9%) cases which were managed medically. Older age with CI was

correlated with higher major complications.

Conclusion: In contrast to minor complications, the frequency of major complications in this cohort was higher

than that published by other group

خورسندی, محمدتقی

محمدی, محمدعلی

پیرزاده, احمد

پیرزاده, اکبر

English

ArUMS Digital Repository (سامانه اطلاعات زیست پزشکی و سلامت)

Introduction
Cochlear implantation (CI) is the reference treatment
of profound sensorineural hearing loss. Implantation of
cochlear entails a surgical procedure with the attendant
potential for complications. In response to good results from
implantation, the candidacy criteria have gradually been
relaxed, with the implant devices now being used for children
as young as 12 months.1-3
Not enough data is available about the possible
complications after CI, especially in the developing country
context.4 Complications of CI are not only important from the
standpoint of patient care, but they also add significantly to
length of hospital stay and increase health care costs.5
In this study, we describe the complications in a
cohort of patients consecutively treated in a single center with
CI. The frequency of the implantations in the cohort was
compared with previous studies.
Methods
All consecutive patients referred to the Amir Aalam
Hospital, Iran for the CI from January 1997 to January 2007
Vol. 61, No. 7, July 2011 622
Original Article
Complications related to cochlear implants: experience in Tehran
Akbar Pirzadeh,1 Mohammad Khorsandi,2 Mohammad-Ali Mohammadi,3 Ahmad Pirzadeh4
Department of Surgery School of Medicine,1,4 Department of Nursing, School of Nursing,2
Department of Otolaryngology, School of Medicine,3 Tehran University of Medical Science, Tehran, Iran.
Abstract
Objective: Cochlear implantation (CI) is an effective treatment for profound deaf patients. To study the cochlear
implant complications in patients at Amir Aalam Hospital. 
Methods: The study population involved 177 profoundly deaf patients, implanted within the same cochlear
implant center. 
Results: Twenty-four (13.6%) patients experienced complications. Early complications accrued in 9 (37.7%)
patients within the first 24 hours. Eight (4.5%) patients had major complications including facial nerve paralysis,
suture rupture and prosthesis rejection. Prosthesis rejection 6 (30%) was the most frequent major complication.
Minor complications were found in 16 (9%) cases which were managed medically. Older age with CI was
correlated with higher major complications. 
Conclusion: In contrast to minor complications, the frequency of major complications in this cohort was higher
than that published by other groups.
Keywords: Cochlear implantation, Complications, Iran (JPMA 61:622; 2011).
were included in this study. Data in the CI database were
collected by an ear specialist and a research coordinator at the
hospital. We collected data on patients' characteristics,
indication for CI, and implant related details. We also
collected clinical and implant related events occurring in the
follow-up.
The indication for CI was based on international
recommendations.6All patients were fitted with the MED-EL
C40+ cochlear implant and used the behind-the-ear TEMP+
speech processor. The devices used were the nucleus
(Cochlear Ltd.) or the Clarion (Advanced Bionic Corp.).
Selections of these patients followed the criterion that they
had complete three-year data on the questionnaires. At the
cochlear clinic visits and follow-up contacts after device
implantation, patients were routinely evaluated for any
device-related complications that occurred within 3 years of
the implantation surgery. These complications were
categorized as major or minor based on the consensus of the
ear specialist. Clinical complications were considered to be
major if hospitalization and/for additional surgery were
required. Minor complications were defined as complications
requiring a minor procedure at office sitting or resolved
spontaneously or with medical therapy.
Data were expressed as mean ± standard deviation or
as median as appropriate. Correlation analyses were
performed with the Pearson correlation coefficient method. A
p value <0.05 was considered to indicate a statistically
significant difference. All analyses were carried out using
SPSS for windows version 11.0 (SPSS Inc.). 
Results
The final study cohort consisted of 177 patients, and
their characteristics are shown in Table 1. The patients age at
implantation ranges from 6 months to 60 years with a mean
age at implantation of 3 ± 2 years. There were 96 males and
81 females in the sample. Follow-up data for complications
were available for all patients. The majority of patients had
hereditary deafness, and nearly 89% were below the age of
10. A total of 24 (13.6%) patients experienced related
complications. There was no significant difference in overall
complication rate by gender. Major and minor complications
occurred in 8 (4.5%) and 16 (9%) patients. A large proportion
of complications occurred in the first 24 hours after surgery,
at rate of 37.7% for complications. The most frequent major
complications were prosthesis rejection (5%) (Table 2). The
age of these patients at CI were 1, 2 and 3 years. All of them
had cholesteatoma and a granular reaction to the ear
undergoing implantation 9 months after surgery. Four of these
patients underwent reimplantation with success. Two patients
underwent cochleostomy without reimplantation. The record
causes of prosthesis rejection included wearing a hat which
can cause pressure on flap, previous mastoid surgery or
previous scar. Wearing of a hat (r=0.35, P=0.001) and age at
CI (r=0.31, P=0.02) were positively correlated to prosthesis
rejection. The suture rupture occurred in a 3-year-old girl. She
underwent general anaesthesia and prosthesis was
repositioned and fixed into the cochlear. Apart from local
inflammation, there were no severe infectious complications
(such as meningitis).
Minor complications occurred in 16 patients.
Incisional infections and pocket haematomas that did not
require operative procedure were the most common minor
complications. Partial facial paralysis occurred in a 1-year
age child, which resolved by nerve decompression in two
months. Cutaneous haematoma developed in 5 patients.
Successful outcome was achieved with local dressing and
antibiotic therapy.
The overall outcome of CI was satisfactory. Most
patients could communicate without visual help within 2-3
months and they could hear and talk on the telephone with a
known speech in about a year.
623 J Pak Med Assoc
Table-1: Clinical details of the studied population.
Age, (years) 13±7
Age at implant, (years) 3±2
Gender, female 81 (45.6%)
Clarion device 135 (76%)
Nucleus device 42 (24%)
Hereditary deafness 138 (78%)
Left side implanted, % 90 (57%)
Values are means ± SD, percentage in parenthesis.
Table-2: Frequency of major and minor complications.
Number of patients % patients with
affected complications
Major complications
Within 24 hours
Facial nerve paralysis 1 0.6
>1 week
Suture rupture 1 0.6
Prosthesis rejection 6 3.4
Minor complications
Within 24 hours
Hyperthermia and Tachychardia 1 0.6
Post-surgery haematomas 1 0.6
Respiratory distress 1 0.6
Bleeding and anaemia 1 0.6
Pocket haematoma 1 0.6
Eye inflammation 2 1.2
Bloating 1 0.6
Within first week
Bloating 1 0.6
Abdominal distension 1 0.6
Pocket haematoma 2 1.2
Eye inflammation 2 1.2
>1 week
Incision oedema 2 1.2
Discussion
CI has emerged as an effective therapeutic option
for patients with sensorineural hearing loss. The results of
this study revealed a wide range of complications in
patients implanted at Amir Aalam Hospital. The overall
incidence of CI complications was 13.6% in the studied
population, 4.4% for major and 8.8% for minor
complications. The present results are different from those
of Bhatia et al.7 and Hashemi et al.8 who reported an
incidence of complications of 18% (2.3% major and 16%
minor) and 12.7% (2.7 major and 10% minor)
respectively.9 The present high incidence of complication
also contracts with reports on children in which
complications are observed in up to 3% patients. The
inappropriate recording for these patients could explain
the lower incidence of minor CI complications as
compared with other reports. Previous studies have
reported that flap problems, cholesteatoma and tampon
perfusion were the most common major events.7
Prosthesis rejection is quite an important issue in the
studied population, because it could not be resolved by
revision surgery. Although it was not the aim of our study, we
observed that wearing of hat and age at CI were correlated to
prosthesis rejection. Our results underline the necessity of
reevaluating current eligibility criteria for implant
candidacy.10
The flap failures have been identified as one of the
most common CI complication, which can be resolved by
using post-auricular- instead of C-shaped incision.11
Consistently, all the study patients underwent post-auricular-
shaped incision.
The frequency of major complications is high
enough to require adequate post-surgery monitoring. It is
evident that not all types of complications were reported
by different investigators. These observations suggest
that comparisons among articles should be done with
caution and underlines the lack of extensive experience
with CI.
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Vol. 61, No. 7, July 2011 624


Age at implantation: its importance in pediatric cochlear implantation. Laryngoscope

Cochlear implant flap necrosis: adjunct hyperbaric oxygen therapy for prevention of explantation.

Cochlear implantation in infants less than 12 months of age.

Cochlear implants: current status. Expert Rev Med Devices

Complications in children with long-term cochlear implants.

Costutility analysis of the cochlear implant in children. JAMA

Evidence for the expansion of adult cochlear implant candidacy. Ear Hear

NIH statement on cochlear implants. CMAJ

Surgical complications and their management in a series of 300 consecutive pediatric cochlear implantations. Otol Neurotol

Surgical complications of cochlear implantation.

Trends in Cochlear Implants. Trends Amplif

Complications related to cochlear implants: experience in Tehran

http://eprints.arums.ac.ir/2599/1/Complications.pdf

Complications related to cochlear implants: experience in Tehran

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