Otology & Neurotology 35:810Y814 Ó 2014, Otology & Neurotology, Inc.

Cochlear Implantation in Patients With Chronic Suppurative Otitis Media Matthew C. Wong, David B. Shipp, Julian M. Nedzelski, Joseph M. Chen, and Vincent Y. W. Lin Department of OtolaryngologyYHead and Neck Surgery, University of Toronto; and Cochlear Implant Program, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.

closure of the external auditory canal followed by cochlear implantation approximately 5 months later. Seven patients were implanted in a single procedure. There were no infections or medical complications after implantation. On average, patients had excellent audiometric scores at 1 year postimplantation (mean sentence test, 79%; SD, 14), and these scores were comparable to our general population (mean sentence test, 71%; SD, 32). Conclusion: Cochlear implant patients with CSOM have no increased risk of postoperative infections or complications. These patients have excellent outcomes with audiometric scores comparable to the general cochlear implant population. Cochlear implantation is a safe and effective treatment for patients with profound hearing loss secondary to CSOM. Key Words: Cochlear implantVChronic suppurative otitis media.

Objective: To determine the safety, efficacy, and outcomes of cochlear implantation in patients with chronic suppurative otitis media (CSOM). Study Design: Retrospective case review. Setting: Tertiary referral center with large cochlear implant program. Patients: Nineteen patients with CSOM who underwent cochlear implantation were identified. Case history, timing of surgical procedures, complications, infections, and postimplant audiometric scores (Hearing in Noise Test [HINT], City University of New York Sentences [CUNY], and Central Institute for the Deaf Sentences [CID]) were evaluated. Main Outcome Measures: Rates of postoperative infections and complications as well as postimplant auditory performance. Results: Twelve patients underwent a staged procedure involving canal wall down mastoidectomy or radical revision mastoidectomy with middle ear and mastoid obliteration and

Otol Neurotol 35:810Y814, 2014.

Cochlear implantation has revolutionized the treatment of patients with severe-to-profound sensorineural hearing loss. The benefits of cochlear implantation have been well documented, with patients experiencing significant improvements in auditory performance and quality of life (1Y3). Patients with severe-to-profound sensorineural hearing loss in association with chronic suppurative otitis media (CSOM) present a challenge to safe implantation. Although this patient population would benefit greatly from cochlear implantation, implantation was previously contraindicated because of concerns of infection and the

possibility of implant extrusion. Intracranial infection is a rare but potentially fatal complication (4). Recently, otologic surgeons have been implanting this population with the caveat that an initial procedure is required to sterilize the mastoid cavity, creating a clean environment for insertion (5Y9). If the infection is quiescent, the implant can be inserted in a single procedure (7Y9). In this study, we aim to investigate the safety, efficacy, and outcomes of cochlear implantation in patients with CSOM.

MATERIALS AND METHODS Address correspondence and reprint requests to Matthew C. Wong, B.Sc., Department of OtolaryngologyYHead and Neck Surgery, Sunnybrook Health Sciences Centre, 2075 Bayview Avenue, Toronto, Ontario, Canada M4N 3M5; E-mail: [email protected] Conflicts of Interest and Source of Funding: None IRB Approval Institution: Sunnybrook Research Ethics Board Principal Investigator: Vincent Lin REB Project PIN: 216-2009

A retrospective chart review of the patients in the Sunnybrook Cochlear Implant Program at the Sunnybrook Health Sciences Centre in Toronto, Canada, was conducted. Patients with CSOM who had undergone cochlear implantation were identified. Case history, cause of hearing loss, sex, date of birth, and current status were recorded. The surgical procedure performed, type of device implanted, timing of procedures, length between stages, and any infections or complications were recorded.

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COCHLEAR IMPLANTATION IN PATIENTS WITH CSOM Postimplantation audiometric test results were documented. Audiometric tests involved Hearing in Noise Test (HINT), City University of New York Sentences (CUNY), and Central Institute for the Deaf Sentences (CID). The speech signal was presented at a constant level of 60 or 65 dB SPL. Tests were performed in quiet. Audiometric scores were evaluated at several periods after implantation.

RESULTS Since 1984, more than 1,000 patients have undergone cochlear implantation at the Sunnybrook Cochlear Implant Program. Nineteen patients were identified with CSOM; 14 of these patients were male, and 5 were female. Median age at time of surgery was 64 years, with a range of 19 to 84 years. Surgeries were carried out between the years of 1996 and 2011. The cause of hearing loss is summarized in Table 1. All 19 patients had either active or inactive CSOM in the ear determined to be most appropriate for implantation. Active CSOM was defined as having a history of CSOM with evidence of purulent discharge with or without cholesteatoma in the 6 months before assessment and surgery. Inactive CSOM was defined as having a history of CSOM with no evidence of purulent discharge or cholesteatoma in the 6 months before assessment and surgery. Some of our patients had multiple pathologies in the implanted ear. One patient with bilateral cochlear otosclerosis also had CSOM in the implanted ear. Three patients with Me´nie`re’s disease in conjunction with CSOM developed hearing loss. The remaining 15 patients developed hearing loss secondary to bilateral CSOM. Surgical management is summarized in Table 2 and Figure 1. Six patients with inactive CSOM without a preexisting radical mastoid cavity (RMC) were implanted in a single procedure. One patient with inactive CSOM and a preexisting RMC underwent canal wall down mastoidectomy with middle ear and mastoid adipose obliteration, blind sac closure of the external auditory canal (EAC), and cochlear implantation in a single procedure. Twelve patients with active CSOM underwent a staged procedure. The first operation consisted of a canal wall down mastoidectomy or radical revision mastoidectomy (RRM) with middle ear and mastoid adipose obliteration and blind sac closure of the EAC. Cochlear implantation was performed 3 to 8 months later. The median length between stages was 5 months. There were no postoperative infections or medical complications in any of the patients. The only complications were a result of a hard failure. Three patients with the same

TABLE 2.

Etiology

No. of patients

Bilateral CSOM Me´nie`re’s Bilateral cochlear otosclerosis CSOM indicates chronic suppurative otitis media.

15 3 1

No. of patients

Staged procedure CWD Mastoidectomy, middle ear/mastoid obliteration, EAC closure; CI RRM; CI Single procedure CI CWD Mastoidectomy, middle ear/mastoid obliteration, EAC closure; CI

12 8 4 7 6 1

CWD indicates canal wall down; CI, cochlear implantation; RRM, radical revision mastoidectomy.

implant device experienced device failure requiring explantation and reimplantation. Device failure was determined to be due to loss of hermetic seal in all 3 cases, commonly known as the vender ‘‘B’’ devices from Advanced Bionics and not related to the initial surgeries. The mean duration to device failure was 6 years (range, 1Y13 yr). Explantation and reimplantation occurred without infection or complications in all 3 cases. Mean postoperative sentence test scores (HINT, CUNY, and CID) are summarized in Table 3. The mean score was 62% (standard deviation [SD], 28) at 3 months, 73% (SD, 15) at 6 months, 79% (SD, 14) at 12 months, and 79% (SD, 18) at 24 months after implantation. The mean maximum score was 88%, with a range of 71% to 100%. The average duration to maximum performance was 18 months, with a range of 3 to 108 months. Postoperative sentence test scores for all patients are shown in Figure 2. In general, patients experienced improvements in hearing performance from 3 to 24 months after implantation. Patients 2, 5, and 15 experienced a decline in hearing performance over 24 months. Patients 7 and 10 were nonusers for unknown reasons and had no audiometric scores recorded. Audiometric scores 1 year after implantation were compared with the general cochlear implant population in our program (Table 4). The mean score for patients with CSOM 1 year after implantation was 79% (SD, 14) compared with 71% (SD, 32) for the general implant population. DISCUSSION In the past, cochlear implantation was contraindicated in patients with CSOM. This was due to concerns that

Time (months)

Etiology of hearing loss

Surgical management

Procedure

TABLE 3. TABLE 1.

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3 6 12 24

Average postoperative sentence test scores (HINT, CUNY, and CID) Range (%)

Mean (%)

Standard deviation

0Y100 43Y100 58Y100 54Y100

62 73 79 79

28 15 14 18

HINT indicates hearing in noise test; CUNY, City University of New York sentences; CID, Central Institute for the Deaf sentences. Otology & Neurotology, Vol. 35, No. 5, 2014

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FIG. 1.

M. C. WONG ET AL.

An outline of the approach used in this series for implanting patients with CSOM.

inserting a foreign device into an infected cavity would result in higher rates of postoperative infections. These infections can be difficult to control and may require explantation (10). In some cases, these infections can even be fatal (4). Previously, patients with CSOM would have been excluded from implantation and left with limited options once they developed profound sensorineural hearing loss. We show in our series that it is possible to implant this patient group with the caveat that patients with active CSOM require an initial mastoidectomy operation to eradicate infection and create a clean environment for implantation. None of the patients in our study experienced any postoperative infections. These findings support studies,

which have reported low incidence of postimplantation infections in CSOM patients, with infection rates comparable to the global cochlear implant population (6Y8,11,12). A study with 13 CSOM patients reported a postimplantation infection rate of 15.4%, compared with a reported rate of 15.7% in the global implant population (7,13). Another study found no complications in 10 CSOM patients who underwent implantation (10). In a recent study by Free et al. (14), 4 patients with inactive CSOM underwent canal wall down mastoidectomy with adipose obliteration and closure of the EAC followed by cochlear implantation in the same procedure. None of these patients had any complications. Studies have also suggested that any postoperative infections that do occur

FIG. 2. Sentence test scores (HINT, CUNY, and CID) over time for all 19 patients in this series. The mean score over time for patients with CSOM is plotted in bold. Otology & Neurotology, Vol. 35, No. 5, 2014

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COCHLEAR IMPLANTATION IN PATIENTS WITH CSOM TABLE 4. One-year postoperative sentence test scores (HINT, CUNY, and CID) for patients with CSOM versus the overall CI population

No. of patients Mean Range Standard deviation

CSOM

Overall CI population

12 79 58Y100 14

711 71 0Y100 32

CSOM indicates chronic suppurative otitis media; HINT, hearing in noise test; CUNY, City University of New York sentences; CID, Central Institute for the Deaf sentences; CI, cochlear implant.

in patients with CSOM can be effectively managed with antibiotics (15). There were no medical complications in our patients. The only complications arose from problems with device hardware. Three patients with the same device experienced device failure because of loss of hermetic seal. This is a well-documented device problem that has significantly decreased in frequency over the past 10 years (16,17). On average, the patients in our study had excellent audiometric outcomes. The audiometric scores at 1 year for our patients with CSOM (mean, 79%; SD, 14) were comparable to our overall cochlear implant population (mean, 71%; SD, 32). Although the difference in sample sizes does not allow for a direct comparison between the 2 populations, our patients performed well on audiometric testing, and our patients with CSOM do not seem to have poorer results than then global cochlear implant population (Table 4). These findings are in agreement with the recent literature. Leung and Briggs (6) reported a mean CUNY score of 64% at 12 months after implantation in 17 patients with CSOM. Olgun et al. (9) also found audiometric outcomes to be comparable to the overall cochlear implant population. The mean sentence test score over time (Table 3 and Fig. 2) suggests that CSOM patients can expect to see the largest improvement in hearing within the first 6 months of implantation, smaller improvements from 6 to 12 months and minimal changes from 12 to 24 months. This trend is similar to the hearing performance over time observed in the global cochlear implant population (2). Although our patients were not routinely tested more than 2 years after implantation, recent studies indicate that audiometric scores remain relatively stable after 2 years (2,18). However, 3 of our patients did not follow the average trend. Patients 2, 5, and 15 reached maximum hearing performance at 3 months after implantation and subsequently experienced a decline in hearing. It should be noted that these were 3 of the oldest patients in our series at time of implantation (68, 79, and 84 years). Implantation in this age group has been found to result in slightly poorer outcomes (3). Because our study spans a large period, patients underwent several different auditory tests (HINT, CUNY, and CID). To be able to compare audiometric results over time for all patients with CSOM, the scores of these 3 tests were assumed to be equivalent.

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The results suggest that the surgical approach used in our series (Fig. 1) provides a safe method for cochlear implantation in patients with CSOM. Other studies with a similar approach have also reported low postoperative infection rates (5Y8). In active CSOM, we recommend a staged procedure. This allows for eradication of infection and provides a clean, dry environment for implantation. In inactive CSOM, patients can be implanted in a single procedure. Interestingly, some studies have reported implanting patients with active CSOM in a single procedure. These studies also report low rates of postoperative infections and complications (19,20). Other studies have also recommended a nonobliterative technique to allow for better radiologic evaluation for potential postoperative cholesteatoma development (5,13). Our series shows that the surgical approach outlined in Figure 1 allows for safe implantation with minimal risk of postoperative infections or complications in patients with CSOM. CONCLUSION Our study implanted patients using a staged procedure in active CSOM and a single procedure in inactive CSOM. This method allowed for safe implantation with no increased risk of postoperative infections or complications. These patients had excellent outcomes with audiometric scores comparable to the general cochlear implant population. Cochlear implantation is a safe and effective treatment for patients with profound hearing loss secondary to CSOM. REFERENCES 1. Chung J, Chueng K, Shipp D, et al. Unilateral multi-channel cochlear implantation results in significant improvement in quality of life. Otol Neurotol 2012;33:566Y71. 2. Ruffin CV, Tyler RS, Witt SA, et al. Long-term performance of Clarion 1.0 cochlear implant users. Laryngoscope 2007;117: 1183Y90. 3. Chatelin V, Kim EJ, Discoll C, et al. Cochlear implant outcomes in the elderly. Otol Neurotol 2004;25:298Y301. 4. Summerfield AQ, Cirstea SE, Roberts KL, et al. Incidence of meningitis and of death from all causes among users of cochlear implants in the United Kingdom. J Public Health 2005;27:55Y61. 5. El-Kashlan HK, Arts HA, Telian SA. Cochlear implantation in chronic suppurative otitis media. Otol Neurotol 2002;23:53Y5. 6. Leung R, Briggs R. Indications for and outcomes of mastoid obliteration in cochlear implantation. Otol Neurotol 2007;28:330Y4. 7. Postelmans JTF, Stokroos RJ, Linmans JJ, Kremer B. Cochlear implantation in patients with chronic otitis media: 7 years’ experience in Maastricht. Eur Arch Otorhinolaryngol 2009;266:1159Y65. 8. Patel AK, Barkdul G, Doherty JK. Cochlear implantation in chronic suppurative otitis media. Oper Tech Otolaryngol 2010;21:254Y60. 9. Olgun L, Batman C, Gultekin G, Kandogan T, Cerci U. Cochlear implantation in chronic otits media. J Laryngol Otol 2005;119: 946Y9. 10. Vaghela HM, Capper R, Gibbin KP. Infections following cochlear implantation. Cochlear Implants Int 2003;4:148Y55. 11. Gray RF, Irving RM. Cochlear implants in chronic suppurative otitis media. Am J Otol 1995;16:682Y6. 12. Axon PR, Mawman DJ, Upile T, Ramsden RT. Cochlear implantation in the presence of chronic suppurative otitis media. J Laryngol Otol 1997;3:228Y32. Otology & Neurotology, Vol. 35, No. 5, 2014

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13. Ovesen T, Johansen LV. Post-operative problems and complications in 313 consecutive cochlear implantations. J Laryngol Otol 2009;123:492Y6. 14. Free RH, Falcioni M, Di Trapani G, et al. The role of subtotal petrosectomy in cochlear implant surgery Y a report of 32 cases and review on indications. Otol Neurotol 2013;34:1033Y40. 15. Hellingman CA, Dunnebier EA. Cochlear implantation in patients with acute or chronic middle ear infectious disease: a review of the literature. Eur Arch Otorhinolaryngol 2009;226:171Y6. 16. Causon A, Verschuur C, Newman TA. Trends in cochlear implant complications: implications for improving long-term outcomes. Otol Neurotol 2013;34:259Y65.

17. Brown KD, Connell SS, Balkany TJ, et al. Incidence and indications for revision cochlear implant surgery in adults and children. Laryngoscope 2008;119:152Y7. 18. Peixoto MC, Spratley J, Oliveira G, et al. Effectiveness of cochlear implants in children: long term results. Int J Pediatr Otorhinolaryngol 2013;77:462Y8. 19. Kojima H, Sakurai Y, Rikitake M, et al. Cochlear implantation in patients with chronic otitis media. Auris Nasus Larynx 2010;37: 415Y21. 20. Basavaraj S, Shanks M, Sivaji N, Allen AA. Cochlear implantation and management of chronic suppurative otitis media: single stage procedure? Eur Arch Otorhinolaryngol 2005;262:852Y5.

Otology & Neurotology, Vol. 35, No. 5, 2014

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Cochlear implantation in patients with chronic suppurative otitis media.

To determine the safety, efficacy, and outcomes of cochlear implantation in patients with chronic suppurative otitis media (CSOM)...
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