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Review article
Operative Unit of Otolaryngology and Otosurgery, Padua University, Via Giustiniani, 2, Padua, Italy
Department of Neurosciences, Padua University, Via Giustiniani, 2, Padua, Italy
ENT Department, Audiology Service, Ferrara University, Cso Giovecca 203, Ferrara, Italy
d
Neuroradiology, Padua University, Via Giustiniani 2, Padua, Italy
e
Department of Neurosciences, Operative Unit of Otolaryngology and Otosurgery, Padua University, Via Giustiniani, 2, Padua, Italy
b
c
A R T I C L E I N F O
A B S T R A C T
Article history:
Received 7 January 2013
Received in revised form 7 March 2013
Accepted 10 March 2013
Available online 8 April 2013
Objectives: Cochlear implantation is a relatively safe procedure with a low complication rate. The overall
rate of complications among cochlear implant patients ranges from 6% to 20%. Major complications are
those that are life-threatening or require surgery, whereas minor complications are those that can be
medically treated. Nonetheless, certain complications, even if highly rare, may require specic
investigations and treatments. Among these rare complications are those with endocochlear
involvement, such as cochleitis or labyrinthitis, with brosis or ossication that could lead to
explantation. The aims of the present study were to report a particular case of post-operative cochleitis
and to review the rate of complications after cochlear implantation, emphasising those conditions with
proven endocochlear involvement.
Methods: We refer to the case of an eight-year-old Italian boy affected by the sudden onset of
headache, ipsilateral otalgia and facial paresis, who presented to our clinic for inexplicable
worsening of the performance of his implant and his residual hearing, six years after surgery. A
complete investigation including (clinical history, routine, autoimmune and serological blood
tests, electrophysiological measurements from the cochlear implant and neuroimaging) was
performed and is herein described. Additionally, a comprehensive review of the literature was
conducted using internet search engines; 274 papers were selected, 88 of which were best suited to
our purposes.
Results: In our case, the progression of the symptoms and the performance decrement required
explantation, followed by a complete recovery. Reviewing the literature revealed only three reports
concerning cases of proven endocochlear phlogosis that required revision surgery. Wound swelling/
infection and vertigo remain the two most common complications of cochlear implantation. Failure
of the device is the third most frequent complication (10.06% of all complications and 1.53% of
cochlear implantations). Other rare conditions (such as granulating labyrinthitis with cochlear
brosis, ossication and erosion, silicone allergy and the formation of a biolm around the internal
device) are possible and unpredictable. Although rare (approximately 1%), such cases may require
explantation.
Conclusions: Despite efforts by both surgeons and manufacturers, device-related and surgical
complications still occur. These and other rare conditions demand specic management, and their
frequency may be underestimated. Further studies are needed to assess more realistic rates of
complications and devise more efcient strategies for early diagnosis and treatment.
2013 Elsevier Ireland Ltd. All rights reserved.
Keywords:
Cochleitis
Endocochlear phlogosis
Implant complications
Granulating labyrinthitis
* Corresponding author at: Operative Unit of Otolaryngology and Otosurgery, Giustiniani, 2, Padua 35128, Italy. Tel.: +39 339 6657486; fax: +39 049 821 1994.
E-mail addresses: alicebenatti@gmail.com (A. Benatti), alessandro.castiglione@unipd.it (A. Castiglione), patrizia.trevisi@unipd.it (P. Trevisi),
roberto.bovo@sanita.padova.it (R. Bovo), monica.rosignoli@unife.it (M. Rosignoli), renzo.manara@sanita.padova.it (R. Manara), alessandromartini@unipd.it (A. Martini).
0165-5876/$ see front matter 2013 Elsevier Ireland Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.ijporl.2013.03.016
886
Contents
1.
2.
3.
4.
5.
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . .
Materials and methods . . . . . . . . . . . . . . . . . .
Clinical, audiological and genetic data .
2.1.
Neuroimaging . . . . . . . . . . . . . . . . . . . .
2.2.
Literature review . . . . . . . . . . . . . . . . .
2.3.
Case report . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Clinical, audiological and genetic data .
3.1.
Neuroimaging . . . . . . . . . . . . . . . . . . . .
3.2.
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . .
References . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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1. Introduction
Cochlear implantation has been established world-wide as a
safe and effective method of rehabilitating profoundly hearingimpaired adults or infants who derive insufcient benets from
hearing aids [1,2]. Medical, surgical and technological advances
in the eld of otology have led to expanding selection criteria and
increasing numbers of cochlear implantations in challenging
cases, with successful outcomes being achieved [36]. Despite
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886
887
887
888
888
888
888
889
889
891
891
Table 1
Literature review of post-operative complications of cochlear implantation; device failures requiring surgery are considered major complications. The percentages refer to the
total number of cases for which data analysis was possible (studies with unspecied and/or unavailable data were excluded from the total number of cases). * = Complications
after surgery in patients with anomalous inner ears. ** = These results must be considered purely indicative because different authors adopted different classication criteria
for major and minor complications; for example, gusher is considered a major complication in some studies and a minor complication in others.
Study
No. of
Cases
No. of complications
(%)
Major complications
(%)
550
438
262
140
177
416
246
505
150
250
434
136
1237
313
80
500
345
268
112
105
300
134
346
176
122
227
315
300
240
158
430
844
135
697
366
100
56
100
11710
92
40
50
18
24
29
28
148
22
33
43
9
149
49
20
79
32
40
18
34
22
37
43
55
76
12
34
11
343
297
42
5
2
1936
49 (8.91%)
12 (2.74%)
1 (0.38%)
11 (7.86%)
8 (4.52%)
6 (1.44%)
21(8.54%)
9 (1.78%)
7 (4.67%)
13 (5.20%)
24 (5.53%)
130 (10.51%)
14 (4.47%)
5 (6.25%)
51 (10.20%)
22 (8.21%)
4 (3.57%)
4 (3.81%)
9 (3.00%)
1 (0.75%)
7 (3.98%)
15 (12.30%)
28 (12.33%)
33 (10.48%)
7 (2.33%)
15 (6.25%)
5 (3.16%)
9 (2.09%)
80 (9.48%)
5 (3.70%)
101 (14.49%)
83 (22.68%)
3 (3.00%)
5 (8.93%)
0
797 ** (7.32% of 10883)
(16.73%)
(9.13%)
(19.08%)
(12.86%)
(13.56%)
(6.97%)
(11.38%)
(29.31%)
(14.67%)
(13.20%)
(9.91%)
(6.62%)
(12.05%)
(15.65%)
(25.00%)
(15.80%)
(9.28%)
(35.71%)
(17.14%)
(9.83%)
(12.50%)
(30.33%)
(18.94%)
(18.3%)
(31.67%)
(7.59%)
(7.91%)
(8.15%)
(49.21%)
(81.15%)
(42.00%)
(8.93%)
(2.00%)
(19.66% of 9849)
Minor complications
(%)
43 (7.82%)
28 (6.39%)
49 (18.70%)
7 (5.00%)
16 (9.04%)
23(5.53%)
7 (2.85%)
139 (27.52%)
15 (10.00%)
20 (8.00%)
19 (4.38%)
19 (1.54%)
35 (11.18%)
15 (18.75%)
28 (5.60%)
36 (32.14%)
14 (13.33%)
15
22
15
48
61
7
25
6
242
214
39
2
1209
(8.52%)
(18.03%)
(6.61%)
(16.00%)
(25.42%)
(4.43%)
(5.81%)
(4.44%)
(34.72%)
(58.47%)
(39.00%)
(2.00%)
** (13.40% of 9022)
Children
(<18 years)
Adults
(>18 years)
19
18
28
45
22
3
6
5
2
157
21
103
9
3
136
(4.34%)
(12.86%)
(11.38%)
(8.91)
(6.62%)
(8.21)
(1.90%)
(1.40%)
(8.93%)
(2.00%)
(6.71% of 2341)
(4.79%)
(20.40%)
(5.70%)
(0.70%)
(8.88% of 1531)
887
Table 2
Complications after/during cochlear implant surgery. The percentages refer to the total number of cases for which data analysis was possible (the studies with unspecied
and/or unavailable data were excluded from the total number of cases); % = percentage of total complications (1083, including unusual complications); %* percentages of total
cochlear implants (7132).
Type of complication
No.
Wound complications
Infections, swelling, haematoma, suture rupture
Subcutaneous haematoma, seroma, emphysema
Keloid
Thin ap
Equilibrium disorders
Vertigo
Nystagmus
Neuritis, labyrinthitis
Device complications
Failure
Gain reduction, Absence of stimulation
Infections
Malpositioning, migration, kinking
Extrusion
Leaks
Gusher
Csf (cerebrospinal uid)
Fistula
Dural tear
Rhinoliquorrea
External, middle ear complications
External, media otitis, tympanic membrane perforation
Cholesteatoma
External auditory canal injury
Acute otomastoiditis
Pocket retraction
Peripheral nerve complications
Temporary facial nerve palsy
Permanent facial nerve palsy
Facial stimulation
Chorda tympani injury
Change in taste
Post-operative pain, transient neuralgia
Alteration in facial sensibility
Other
Worsening/increase/onset of tinnitus
Haemorrhage
Unspecied intraoperative complications
Cerebritis (1 case)/meningitis (7 cases)
Non user
Respiratory distress, laryngospasm
Ocular disorders
Hypertension
Burn
Tachycardia, hyperthermia
Abdominal distension
Unusual complications (Tab 3)
Total
223
153
57
11
2
113
111
1
1
311
109
57
4
102
39
90
62
14
9
4
1
92
58
13
6
14
1
115
46
12
20
20
3
10
4
63
16
13
13
8
5
3
2
1
1
1
1
76
1083
20.59
14.13
5.26
1.02
0.18
10.43
10.25
0.09
0.09
28.72
10.06
5.26
0.37
9.42
3.60
8.31
5.72
1.29
0.83
0.37
0.09
8.49
5.36
1.20
0.55
1.29
0.09
10.62
4.25
1.11
1.85
1.85
0.28
0.92
0.37
5.82
1.48
1.20
1.20
0.74
0.46
0.28
0.18
0.09
0.09
0.09
0.09
7.01
100
3.13
2.15
0.80
0.15
0.03
1.58
1.56
0.01
0.01
4.36
1.53
0.80
0.06
1.43
0.55
1.26
0.87
0.20
0.13
0.06
0.01
1.29
0.81
0.18
0.08
0.20
0.01
1.61
0.64
0.17
0.28
0.28
0.04
0.14
0.06
0.88
0.22
0.18
0.18
0.11
0.07
0.04
0.03
0.01
0.01
0.01
0.01
1.07
15.19
888
Table 3
Unusual post-operative complications of cochlear implantation. The number of cases should be considered an underestimate.? = unavailable or unspecied data.
Unusual post-operative
complications
Cochlear complications
Pneumolabyrinth
Oesteolisys/erosion
Bacterial/fungal biolm
formation
Pneumocoele
Epidural/subdural haematoma
Misplacement into the
carotid canal
Total (%)
No. of
cases
Explantation
3
5
None
4/5
3
19
25
3/3
19/19
14/25
Children
(<18 years)
Adults
(>18 years)
1
3
4/5
4
4
None
None
2
1
8/8
4 (?)
76
References
12 (?)
889
Fig. 1. Audiological data before explantation surgery. Tonal and speech audiometry showed the constant decline of implant benets compared to the good performance
demonstrated at the end of 2011; (a) tonal audiometry results with the left cochlear implant (open set) and residual hearing without the cochlear implant (headphones); (b)
speech audiometry results with the left cochlear implant, using an open set of words, revealed an SRT equal to 25 dB SPL before the onset of symptoms, with worsening
performance in subsequent tests, so that there was a severe discrepancy between the tonal and speech audiometric results (SRT = Speech Recognition Threshold, the lowest
level at which the speech signal can be correctly identied 50% of the time).
fever (38.5 8C) and hyperemia of the external auditory canal and
cheeks. The patient was treated with the oral nonsteroidal antiinammatory drugs cephalosporin and betamethasone for 7 days,
but they produced only a modest and transient benet.
Given the uctuating course of the symptoms, the patient
continued steroid therapy, 30 mg of Deazacort per day, and
experienced partial improvement, but the hearing threshold of his
implant gradually worsened (Fig. 1).
After approximately one month, the patient had thinning or
disruption of the posterior wall of the external auditory canal with
reacutisation of symptoms, likely due to contact with a part of the
internal device array causing a granuloma of approximately
2 mm in diameter in the posterior wall of the external auditory
canal, near the annulus.
A few days later, the patient developed acute left facial nerve
paralysis (grade III on the House-Brackmann scale).
Technical analysis of the device revealed high impedance of 3
apical electrodes (20, 21 and 22) and basal electrode 1. The
external device functioned normally. Subsequently, an integrity
test on the CI24RE cochlear implant was performed by Cochlear
Italia SRL and it was concluded that the receiverstimulator and all
of the electrodes were functioning within the specications
(Normal Device Function) according to the European consensus
statement on cochlear implant failures and explantations [81].
The results of the blood tests were all within the normal ranges
with the exception of the serum biochemistry, which showed an
increase in acute-phase reactants and the presence of IgM and IgG
specic for paramyxovirus type 1 that became negative to
subsequent one month control, exception for (obviously) IgG.
The worsening of his clinical condition, with left facial paralysis
grade IV, fever and persistent tone-speech dissociation, led to
hospitalisation for the removal of the internal device.
The presence of a small granuloma, most likely due to the array
having rotated, was conrmed intraoperatively; the inammatory
reaction was essentially limited to the external auditory canal,
with no evidence of middle ear involvement.
After surgery and antibiotic therapy, complete regression of the
symptoms was achieved. A temporal bone MRI was performed 24 h
after the explantation to evaluate the inner ear and the VII/VIII
890
Fig. 2. Axial temporal bone HRCT scans showing the array position and the
phlogistic ndings in the mastoid and external auditory canal. (A and B) There is no
evidence of electrode extrusion or migration; (C) a granuloma and adjacent eroded
bone (white arrow) are present in the posterior wall of the external auditory canal,
near the tympanic membrane; (D) the mastoid air-cells are full of phlogistic
material.
Fig. 3. The second temporal bone HRCT scan showed: (A and B) slight improvement
of the radiologic inammatory signs and (C and D) hyperdensity of the cochlea
likely attributable to the initial brosis/ossication of the basal and apical turns.
891
Fig. 5. Audiological data after reimplantation surgery in July 2012. Tonal and speech audiometry showed a rapid increase of implant benets reaching the performances of
previous contralateral implanted ear; (a) tonal audiometry with right cochlear implant (open set) and residual hearing without cochlear implant (headphones); (b) the speech
audiometry with right cochlear implant, in an open set words, revealed a SRT equal to 45 dB SPL after 5 months from revision surgery (SRT = Speech Recognition Threshold is
the lowest level at which the speech signal can be correctly identied 50% of the time).
892
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complications in 550 consecutive cochlear implantation, Braz. J. Otorhinolaryngol. 78 (3) (2012) 8085.
[8] M. Ajalloueyan, S. Amirsalari, J. Youse, M.A. Raeessi, S. Radfar, M. Hassanalifard, A
repot of surgical complications in a series of 262 consecutive pediatric cochlear
implantations in Iran, Iran J. Pediatr. 21 (4) (2011) 455460.
[9] E. Lescanne, M. Al Zahrani, D. Bakhos, A. Robier, S. Morinie`re, Revision surgeries
and medical interventions in young cochlear implant recipients, Int. J. Pediatr.
Otorhinolaryngol. 75 (10) (2011) 12211224.
[10] A. Pirzadeh, M. Khorsandi, M.A. Mohammadi, A. Pirzadeh, Complications related
to cochlear implants: experience in Tehran, J. Pak. Med. Assoc. 61 (7) (2011)
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[11] J. Qiu, Y. Chen, P. Tan, J. Chen, Y. Han, L. Gao, et al., Complications and clinical
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