Policy Statement—Cochlear Implants in Children: Surgical...

13
Policy Statement—Cochlear Implants in Children: Surgical Site Infections and Prevention and Treatment of Acute Otitis Media and Meningitis abstract The use of cochlear implants is increasingly common, particularly in children younger than 3 years. Bacterial meningitis, often with associated acute otitis media, is more common in children with cochlear implants than in groups of control children. Children with profound deafness who are candidates for cochlear implants should receive all age-appropriate doses of pneumococcal conju- gate and Haemophilus influenzae type b conjugate vaccines and appropriate annual immunization against influenza. In addition, starting at 24 months of age, a single dose of 23-valent pneumococ- cal polysaccharide vaccine should be administered. Before implant surgery, primary care providers and cochlear implant teams should ensure that immunizations are up-to-date, preferably with completion of indicated vaccines at least 2 weeks before implant surgery. Imaging of the temporal bone/inner ear should be per- formed before cochlear implantation in all children with congenital deafness and all patients with profound hearing impairment and a history of bacterial meningitis to identify those with inner-ear mal- formations/cerebrospinal fluid fistulas or ossification of the co- chlea. During the initial months after cochlear implantation, the risk of complications of acute otitis media may be higher than dur- ing subsequent time periods. Therefore, it is recommended that acute otitis media diagnosed during the first 2 months after implan- tation be initially treated with a parenteral antibiotic (eg, ceftriax- one or cefotaxime). Episodes occurring 2 months or longer after implantation can be treated with a trial of an oral antimicrobial agent (eg, amoxicillin or amoxicillin/clavulanate at a dose of ap- proximately 90 mg/kg per day of amoxicillin component), provided the child does not appear toxic and the implant does not have a spacer/positioner, a wedge that rests in the cochlea next to the electrodes present in certain implant models available between 1999 and 2002. “Watchful waiting” without antimicrobial therapy is inappropriate for children with implants with acute otitis media. If feasible, tympanocentesis should be performed for acute otitis me- dia, and the material should be sent for culture, but performance of this procedure should not result in an undue delay in initiating antimicrobial therapy. For patients with suspected meningitis, ce- rebrospinal fluid as well as middle-ear fluid, if present, should be sent for culture. Empiric antimicrobial therapy for meningitis oc- curring within 2 months of implantation should include an agent with broad activity against Gram-negative bacilli (eg, meropenem) plus vancomycin. For meningitis occurring 2 months or longer after implantation, standard empiric antimicrobial therapy for meningi- tis (eg, ceftriaxone plus vancomycin) is indicated. For patients with meningitis, urgent evaluation by an otolaryngologist is indicated for consideration of imaging and surgical exploration. Pediatrics 2010; 126:381–391 Lorry G. Rubin, MD, Blake Papsin, MD and the COMMITTEE ON INFECTIOUS DISEASES AND SECTION ON OTOLARYNGOLOGY–HEAD AND NECK SURGERY KEY WORDS cochlear implant, deafness, meningitis, acute otitis media, vaccination ABBREVIATIONS FDA—Food and Drug Administration CSF— cerebrospinal fluid CI— confidence interval PCV7— heptavalent pneumococcal conjugate vaccine PPSV23—23-valent pneumococcal polysaccharide vaccine PCV13—13-valent pneumococcal conjugate vaccine Hib—Haemophilus influenzae type b conjugate vaccine This document is copyrighted and is property of the American Academy of Pediatrics and its Board of Directors. All authors have filed conflict of interest statements with the American Academy of Pediatrics. Any conflicts have been resolved through a process approved by the Board of Directors. The American Academy of Pediatrics has neither solicited nor accepted any commercial involvement in the development of the content of this publication. www.pediatrics.org/cgi/doi/10.1542/peds.2010-1427 doi:10.1542/peds.2010-1427 All policy statements from the American Academy of Pediatrics automatically expire 5 years after publication unless reaffirmed, revised, or retired at or before that time. PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275). Copyright © 2010 by the American Academy of Pediatrics FROM THE AMERICAN ACADEMY OF PEDIATRICS PEDIATRICS Volume 126, Number 2, August 2010 381 by guest on April 9, 2019 www.aappublications.org/news Downloaded from

Transcript of Policy Statement—Cochlear Implants in Children: Surgical...

Page 1: Policy Statement—Cochlear Implants in Children: Surgical ...pediatrics.aappublications.org/content/pediatrics/early/2010/07/26/... · Surgical Site Infections and Prevention and

Policy Statement—Cochlear Implants in Children:Surgical Site Infections and Prevention andTreatment of Acute Otitis Media and Meningitis

abstractThe use of cochlear implants is increasingly common, particularlyin children younger than 3 years. Bacterial meningitis, often withassociated acute otitis media, is more common in children withcochlear implants than in groups of control children. Childrenwith profound deafness who are candidates for cochlear implantsshould receive all age-appropriate doses of pneumococcal conju-gate and Haemophilus influenzae type b conjugate vaccines andappropriate annual immunization against influenza. In addition,starting at 24 months of age, a single dose of 23-valent pneumococ-cal polysaccharide vaccine should be administered. Before implantsurgery, primary care providers and cochlear implant teamsshould ensure that immunizations are up-to-date, preferably withcompletion of indicated vaccines at least 2 weeks before implantsurgery. Imaging of the temporal bone/inner ear should be per-formed before cochlear implantation in all children with congenitaldeafness and all patients with profound hearing impairment and ahistory of bacterial meningitis to identify those with inner-ear mal-formations/cerebrospinal fluid fistulas or ossification of the co-chlea. During the initial months after cochlear implantation, therisk of complications of acute otitis media may be higher than dur-ing subsequent time periods. Therefore, it is recommended thatacute otitis media diagnosed during the first 2months after implan-tation be initially treated with a parenteral antibiotic (eg, ceftriax-one or cefotaxime). Episodes occurring 2 months or longer afterimplantation can be treated with a trial of an oral antimicrobialagent (eg, amoxicillin or amoxicillin/clavulanate at a dose of ap-proximately 90 mg/kg per day of amoxicillin component), providedthe child does not appear toxic and the implant does not have aspacer/positioner, a wedge that rests in the cochlea next to theelectrodes present in certain implant models available between1999 and 2002. “Watchful waiting” without antimicrobial therapy isinappropriate for children with implants with acute otitis media. Iffeasible, tympanocentesis should be performed for acute otitis me-dia, and thematerial should be sent for culture, but performance ofthis procedure should not result in an undue delay in initiatingantimicrobial therapy. For patients with suspected meningitis, ce-rebrospinal fluid as well as middle-ear fluid, if present, should besent for culture. Empiric antimicrobial therapy for meningitis oc-curring within 2 months of implantation should include an agentwith broad activity against Gram-negative bacilli (eg, meropenem)plus vancomycin. Formeningitis occurring 2months or longer afterimplantation, standard empiric antimicrobial therapy for meningi-tis (eg, ceftriaxone plus vancomycin) is indicated. For patients withmeningitis, urgent evaluation by an otolaryngologist is indicated forconsideration of imaging and surgical exploration. Pediatrics 2010;126:381–391

Lorry G. Rubin, MD, Blake Papsin, MD and the COMMITTEEON INFECTIOUS DISEASES AND SECTION ONOTOLARYNGOLOGY–HEAD AND NECK SURGERY

KEY WORDScochlear implant, deafness, meningitis, acute otitis media,vaccination

ABBREVIATIONSFDA—Food and Drug AdministrationCSF—cerebrospinal fluidCI—confidence intervalPCV7—heptavalent pneumococcal conjugate vaccinePPSV23—23-valent pneumococcal polysaccharide vaccinePCV13—13-valent pneumococcal conjugate vaccineHib—Haemophilus influenzae type b conjugate vaccine

This document is copyrighted and is property of the AmericanAcademy of Pediatrics and its Board of Directors. All authorshave filed conflict of interest statements with the AmericanAcademy of Pediatrics. Any conflicts have been resolved througha process approved by the Board of Directors. The AmericanAcademy of Pediatrics has neither solicited nor accepted anycommercial involvement in the development of the content ofthis publication.

www.pediatrics.org/cgi/doi/10.1542/peds.2010-1427

doi:10.1542/peds.2010-1427

All policy statements from the American Academy of Pediatricsautomatically expire 5 years after publication unless reaffirmed,revised, or retired at or before that time.

PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).

Copyright © 2010 by the American Academy of Pediatrics

FROM THE AMERICAN ACADEMY OF PEDIATRICS

PEDIATRICS Volume 126, Number 2, August 2010 381 by guest on April 9, 2019www.aappublications.org/newsDownloaded from

Page 2: Policy Statement—Cochlear Implants in Children: Surgical ...pediatrics.aappublications.org/content/pediatrics/early/2010/07/26/... · Surgical Site Infections and Prevention and

BACKGROUNDA cochlear implant is an implantedelectronic hearing device designed toproduce useful hearing sensations toa person who is profoundly deaf or se-verely hard of hearing by electricallystimulating nerves inside the innerear. The implant consists of an exter-nal portion that sits behind the ear andinternal components that are surgi-cally placed under the skin and in-serted in the cochlea (Fig 1).1,2 Co-chlear implants are increasingly beingused as a treatment for hearing loss.

By the end of 2005, nearly 15 000 chil-dren and 22 000 adults in the UnitedStates and nearly 100 000 peopleworldwide had received cochlear im-plants for treatment of hearing loss.2

In another important trend, someadults and children are now receivingbilateral cochlear implants.1 Approxi-mately 1 million people in the UnitedStates are potential candidates for co-chlear implants. The current minimumage for placement of cochlear im-plants approved by the US Food andDrug Administration (FDA) is 1 year,

although implants have been placedsuccessfully in infants younger than 1year with profound hearing loss.3–5 It isincreasingly likely that a primary carepediatrician will have 1 or more chil-dren with a cochlear implant in hisor her practice. Potential infectiouscomplications of cochlear implantsinclude postoperative wound anddevice-related infections and bacte-rial meningitis. In childrenwith cochlearimplants, an episode of acute otitis me-dia may lead to inner-ear infection, de-vice infection, device extrusion, device

FIGURE 1Diagram of the implanted cochlear device. External devices pick up, process, and transmit the sound across the skin to a receiver-stimulator implanted inbone. The receiver sends the code down a bundle of wires that passes through the middle ear and continues as the electrode array that is threaded intothe cochlea. (Reprinted with permission from Papsin BC, Gordon KA. N Engl J Med. 2007;357[23]:2380–2387. Copyright © 2007 Massachusetts MedicalSociety. All rights reserved.)

382 FROM THE AMERICAN ACADEMY OF PEDIATRICS by guest on April 9, 2019www.aappublications.org/newsDownloaded from

Page 3: Policy Statement—Cochlear Implants in Children: Surgical ...pediatrics.aappublications.org/content/pediatrics/early/2010/07/26/... · Surgical Site Infections and Prevention and

failure, and/or meningitis. Thus, there isa need for guidelines for prevention, rec-ognition, and management of cochlearimplant–related infections, acute otitismedia, and bacterial meningitis in chil-dren with cochlear implants.

Postoperative Wound Infections

Postoperative surgical site infectionhas been reported in 1% to 12% of pa-tients who have undergone cochlearimplantation.6,7 Major infections mayhave serious consequences, includingloss of the implant, and may occurmore frequently in pediatric patients.6

In 1 case series, 8 of 9 patients withdevice exposure (ie, an opening in theskin overlying the device as a result ofwound infection and resultant wounddehiscence) ultimately required de-vice removal, compared with 3 of 17patients with a wound infection with-out device exposure.7 Although the useof prophylactic perioperative antimi-crobial agents has varied among cen-ters and surgeons, the FDA recom-mended in 2003 that “[h]ealth careproviders should consider prophylac-tic antibiotic treatment periopera-tively in children receiving cochlearimplants.”8 This recommendation wasmade to reduce the risk of meningitisthat occurs in the immediate postoper-

ative period, but it is possible thatthe use of prophylactic antimicrobialagents may also reduce the rate of oc-currence of postoperative wound in-fection, acute otitis media, and implantinfection. Patients with suspectedpostoperative wound infections shouldbe referred urgently to the surgeon whoperformed the implant.

Acute Otitis Media in CochlearImplant Recipients

With an increasing number of childrenyounger than 3 years receiving co-chlear implants, primary care provid-ers are likely to be confronted withchildren with cochlear implants whopresent with acute otitis media. Ratesof morbidity associated with acute oti-tis media may be higher in childrenwith cochlear implants than in otherchildren, because the surgicallyplaced electrode traverses the middleear to the inner ear through the co-chlear wall (cochleostomy) or theround window membrane (Fig 1). Al-though the opening created betweenthe middle and inner ear is generallysealed with fascia or other material, itremains a potential route for acute oti-tis media–causing bacteria in themid-dle ear to spread to the inner ear.Inner-ear infection can result in severe

symptoms including hearing loss at-tributable to damage to auditory pri-mary afferent neurons, vestibular dys-function, and meningitis. In addition,inner-ear infection can result in loss ofthe implant because of implant con-tamination or implant malfunction re-lated to ossification of the cochlea.

Published data concerning the inci-dence and prognosis of acute otitismedia in children with implants arelimited (Table 1).9–13 Theoretically, inthe initial months after placement of acochlear implant, the risk of complica-tions associated with an episode ofacute otitis media may be higher if thecochleostomy, the communication be-tween the middle and inner ear cre-ated during implantation, has nothealed. An animal model has demon-strated that acute otitis media inducedwithin 2 weeks after cochlear implan-tation may result in severe cochleardamage.14 However, postmortem studyof the temporal bone of implant recip-ients 2 to 10 years after implantationdemonstrated that the opening in theround window around the electrodewas sealed with fibrous tissue.15

In the only prospective study of acuteotitis media in implant recipients,Luntz et al9,16 studied 60 children whom

TABLE 1 Acute Otitis Media in Children With Cochlear ImplantsReference (Year) Study

DesignNo. ofPatientsEvaluated

No. of Patients With�1Episode of Acute OtitisMedia in Implanted Ear(Total No. of Episodes ThatOccurred in Either or

Both Ears)

Age atImplantation(Mean Age atImplantation),

y

Length ofFollow-up TimeAfter Implantation(Mean), y

Time Interval FromImplantation toAcute Otitis Media,Range (Mean), mo

Management No. ofEpisodes ofMeningitis

Luntz et al9 (2004) Prospective 60 17 (22) (3.4) 0.25–2.5(1.7) �1, 6 cases Myringotomy and tube placed 0�1, 11 cases All received oral antimicrobial

agents; 46% also receivedparenteral antimicrobialagents

House et al10

(1983)Retrospective 43 NR (4) 2.7–17.5 (8.3) Up to 23⁄4 NR Oral antimicrobial therapy 0

House et al11

(1985)Retrospective 20 8 (13) 2.9–8.7 1–4 (1.3) 1–17 (6.4) Oral antimicrobial therapy NR

Kempf et al12

(2000)Retrospective 366 11 (20) 1–14 �8 NR Route or choice of

antimicrobial agent notspecified; myringotomyperformed in 7 of 20episodes

0

Migirov et al13

(2006)Retrospective 234 47 0.9–16 (4.8) �2 NR Intravenous ceftriaxone for

3–5 d; no myringotomyNR

NR indicates not reported.

FROM THE AMERICAN ACADEMY OF PEDIATRICS

PEDIATRICS Volume 126, Number 2, August 2010 383 by guest on April 9, 2019www.aappublications.org/newsDownloaded from

Page 4: Policy Statement—Cochlear Implants in Children: Surgical ...pediatrics.aappublications.org/content/pediatrics/early/2010/07/26/... · Surgical Site Infections and Prevention and

they categorized as otitis media prone(on the basis of previous history of fre-quent otitismedia; n� 34;mean age atcochlear implant: 48 months) andnon–otitis media prone (n� 26; meanage at cochlear implant: 35 months).Preoperatively, the otitis media–pronegroup underwent ventilation-tubeplacement with or without adenoidec-tomy and, in some cases, additionalmeasures. Patients were required tohave a normal tympanic membraneand no drainage via the ventilationtube for at least 2 weeks before im-plantation. With a mean follow-up pe-riod of 20 months after implantation,at least 1 episode of acute otitis mediahad occurred in 15 (44%) of the 34 oti-tismedia–prone children and 2 (8%) ofthe non–otitis media–prone children.Six (10%) children with implants, 5 ofwhom were in the otitis media–pronegroup, had an episode of acute otitismedia within 1 month of implantation,a finding that supports the assertionthat children are at highest risk ofacute otitis media during the immedi-ate postoperative period. All these ep-isodes of acute otitis media weretreated successfully with oral antimi-crobial agents, typically amoxicillin/clavulanate. Thirteen patients devel-oped acute otitis media later than 1month after implantation; all of themhad installation of a new ventilationtube to establish middle-ear drainage,unless the patient had a preexistingventilation tube, and were treated ini-tially with oral antimicrobial therapy.Six children required hospitalizationand administration of intravenous an-timicrobial therapy because of failureof oral antimicrobial agents and, in 2 ofthese 6 children, acute mastoiditis.

Four retrospective studies of acute oti-tis media in children with implantshave been reported. In 3 studies, theseverity or outcome of acute otitis me-dia was found to be satisfactory whenusing standard treatments (Table

1).10,11,13 In contrast, the fourth study12

revealed that patients with implantswere more likely to require intrave-nous antimicrobial therapy and a myr-ingotomy.12 Furthermore, of the 11 ep-isodes of acute otitis media reportedin this study, 7 patients underwent sur-gical treatment for mastoiditis. Nochild in any of the 4 series was re-ported to have developed bacterialmeningitis. Although these reportsprovide useful insight, they containsignificant limitations, including theretrospective design, possibly leadingto identification and inclusion of onlythe more severe acute otitis media ep-isodes. Another limitation is the lack ofreport of pathogens causing acute oti-tis media episodes.

That no cases of bacterial meningitiswere reported in these case series ofchildren with acute otitis media is notsurprising, given the small number ofcases in these series and a reportedincidence of Streptococcus pneu-moniaemeningitis in children with co-chlear implants of 138 cases per100 000 person-years.17 However, in astudy of bacterial meningitis in chil-dren with implants, for the subgroupof children with bacterial meningitisthat occurred at least 30 days after im-plant surgery (and for whom clinicalinformation was available concerningthe presence of acute otitis media),acute otitis media was present in 13(50%) of 26 patients at the time of pre-sentation with meningitis (althoughwhether acute otitis media was in thesame ear as the implant was not re-ported).17,18 These findings indicatethat, at least in some cases, there maybe a causal relationship betweenacute otitis media and bacterial men-ingitis. Signs of acute otitis mediawere not reported in any of 9 episodesof bacterial meningitis that presentedwithin 30 days of implantation of a co-chlear device. To prevent episodes ofacute otitis media after cochlear im-

plantation, surgeonsmay place tympa-nostomy tubes before or at the time ofimplantation in children with a historyof recurrent acute otitis media or per-sistent middle-ear effusion.16,19 A con-sensus report prepared by 8 cochlearimplant surgeons recommended, onthe basis of theoretical considerationsand a series of otitis media–relatedmeningitis episodes in adults,20 avoid-ance of implantation if middle-ear fluidis present.21 The surgeons stated thatif middle-ear fluid is encountered atthe time of implantation, they recom-mended high-volume irrigation of themiddle ear, administration of topicalantimicrobial agents into the middle-ear space, and systemic therapy withceftriaxone.21

Bacterial Meningitis in CochlearImplant Recipients

Factors independent of cochlear im-plantation may place children withhearing loss at increased risk of bac-terial meningitis.17 Some children havean inner-ear malformation (eg, com-mon cavity malformation) that predis-poses them to bacterial meningitis asa complication of middle- and inner-ear infection. For example, a 6-year-oldchild with Mondini-type malformationand a cochlear implant in the left earplaced 2 years earlier developed rap-idly fatal meningitis.22 Examination ofthe temporal bones at autopsy showedthat acute meningitis was related toright middle-ear infection and suppu-rative labyrinthitis. The left middle earon the side of the implant was unin-fected. Thus, in this case and in a sec-ond case,23 just having an inner-earmalformation, rather than a cochlearimplant, was the risk factor for acuteotitismedia–relatedmeningitis. Bacte-rial meningitis in infants is an impor-tant cause of acquired deafness, whichmay lead to cochlear implantation, andpreimplant meningitis has been identi-fied as a risk factor for postimplantmeningitis.24

384 FROM THE AMERICAN ACADEMY OF PEDIATRICS by guest on April 9, 2019www.aappublications.org/newsDownloaded from

Page 5: Policy Statement—Cochlear Implants in Children: Surgical ...pediatrics.aappublications.org/content/pediatrics/early/2010/07/26/... · Surgical Site Infections and Prevention and

In most cases of meningitis in patientswith an implant, the initial event in thepathogenesis of meningitis is acuteotitis media that occurs in the ipsilat-eral ear, especially when meningitisoccurs more than 30 days after sur-gery. After acute otitis media develops,bacteria can enter the inner earthrough an incompletely sealed co-chleostomy. Pathways of bacterial ac-cess to the cerebrospinal fluid (CSF)from the inner ear include entry intothe labyrinth, infiltration of the co-chlear turns along the electrode enter-ing the Schuknecht bony channels, andfollowing perineural and/or perivascu-lar pathways into the internal auditorycanal to the meninges.21 In patientswith a malformed cochlea in whichthere is a connection to the subarach-noid space, meningitis also can occurvia the cochlear aqueduct. In the ab-sence of a surgical procedure to re-duce such risks, these children remainat increased risk of meningitis aftercochlear implantation. In addition, aspostulated by Arnold et al21 and stud-ied experimentally by Wei et al,25 casesof bacterial meningitis in implant re-cipients may originate via pneumococ-cal bacteremia with hematogenousseeding of the cochlea, such as at asite of tissue necrosis related to theelectrode or positioner (locus minorisresistentiae) with contiguous spreadto the CSF and meninges.

In addition, cochlear implants them-selves increase the risk of bacterialmeningitis, especially during the first 2months after implantation. In a nestedcase-control investigation of US chil-dren younger than 6 years with co-chlear implants and meningitis be-tween 1997 and 2002, 26 children withbacterial meningitis were identifiedamong 4264 children with cochlear im-plants.17 During an additional 2 yearsof follow-up of this cohort, 12 addi-tional episodes of bacterial meningitiswere identified.18 The rate of bacterial

meningitis was 189 cases per 100 000person-years, a more than 30-fold in-creased risk compared with that in theoverall population.17 In a study in Den-mark, the rate of bacterial meningitiswas 43 cases per 100 000 person-yearsin young children with hearing loss(10.4% of the cohort had cochlear im-plants).26 In the same study, young chil-dren with hearing loss and without acochlear implant were at a 4.1-fold in-creased relative risk (95% confidenceinterval [CI]: 1.5–11.0) for developmentof bacterial meningitis compared witha group of children without hearingloss. Within the group of children withimplants in the US study, the risk ofmeningitis was significantly higher forpatients with a particular implantmodel (AB-5100H or AB-5100H-11 [Ad-vanced Bionics, Sylmar, CA]) that in-cluded a positioner (or a so-calledspacer, a wedge that rests in the co-chlea next to the electrodes).17 Duringthe period from 1997 to 2004, only 19%of the cohort of children had a modelwith a positioner, yet these childrenaccounted for 71% of the children withmeningitis. The models with position-ers were available beginning in 1999and were voluntarily recalled in theUnited States in July 2002. In a multi-variate analysis of a case-controlstudy, the odds ratio for meningitis inpatients with an implant with a posi-tioner was 4.5 (95% CI: 1.3–17.9). Al-though the increased risk of meningi-tis in patients with an implant with apositioner continues beyond 24months after implantation,18 to date,elective removal of these implants ortheir positioners is not recommend-ed,18,27 and these implants remain inplace in many patients. In the sameanalysis, an additional risk factor fordevelopment of meningitis was inner-ear malformation with a CSF leak(odds ratio: 9.3 [95% CI: 1.2–94.5]).

Episodes of meningitis in patientswith a cochlear implant may have

a fatal outcome. Of 198 cases ofpostimplant bacterial meningitis inchildren and adults reported to theFDA, the mortality rate in the 184cases for which the outcome of infec-tion was known was 16% (Eric Mann,FDA, personal communication, Feb-ruary 7, 2008). Of 38 children who ex-perienced 41 episodes of meningitisreported by Reefhuis et al17 and Bier-nath et al,18 3 children died.

Streptococcus pneumoniae is themost common pathogen that causesmeningitis in children with cochlearimplants17,18 and in patients with aninner-ear malformation that predis-posed them to bacterial meningitis.28

Pathogens associated with bacterialmeningitis that occurred within 30days of implant surgery were S pneu-moniae in 4 of 9 cases and Acineto-bacter baumannii (2 cases), Esche-richia coli, Haemophilus influenzaetype b, and Enterococcus spp in the re-mainder.17 Of 25 cases that occurredmore than 30 days after implant sur-gery with an identified pathogen, theetiology was S pneumoniae in 80%;nontypeable H influenzae in 12%; Hinfluenzae type b in 4%; and Strepto-coccus pyogenes in 4%.17,18 Neisseriameningitidis (meningococcus) hasnot been reported as an etiology ofmeningitis in children with cochlearimplants (although meningococcalmeningitis has been reported in 2children with congenital malforma-tion of the middle ear26), and avail-able data do not support cochlearimplants as a risk factor for menin-gitis attributable to N meningitidis.As noted earlier, acute otitis mediawas not noted to be present at thetime of diagnosis in any of the casesthat occurred during the first 30days after implantation but wasnoted in 52% of cases that oc-curred more than 30 days afterimplantation.

FROM THE AMERICAN ACADEMY OF PEDIATRICS

PEDIATRICS Volume 126, Number 2, August 2010 385 by guest on April 9, 2019www.aappublications.org/newsDownloaded from

Page 6: Policy Statement—Cochlear Implants in Children: Surgical ...pediatrics.aappublications.org/content/pediatrics/early/2010/07/26/... · Surgical Site Infections and Prevention and

Use of Pneumococcal and Hinfluenzae Type b Vaccines forPrevention of Acute Otitis Mediaand Meningitis

Immunization of the general popula-tion of infants with the primary seriesof heptavalent pneumococcal conju-gate vaccine (PCV7) has resulted in amarked decrease in invasive pneumo-coccal disease, including meningi-tis.29,30 In addition, immunization of in-fants has resulted in an approximately7% reduction in episodes of acute oti-tis media from all etiologies and a 34%reduction in pneumococcal otitis me-dia.31,32 However, 2 randomized double-blind studies of prevention of acute oti-tis media in children 1 to 6 years of ageidentified as otitis prone in which thetreatment group received 1 or 2 dosesof PCV7 followed 6 months later by adose of 23-valent pneumococcal poly-saccharide vaccine (PPSV23) revealedno effect on the rate or severity of epi-sodes of acute otitis media.33,34 Al-though PCV7 results in a reduction innasopharyngeal colonization with vac-cine serotypes, overall carriage ofpneumococci is unchanged as a resultof colonization with nonvaccine sero-types.35 PPSV23, licensed for children 2years of age and older, reduces the in-cidence of invasive pneumococcal dis-ease but does not prevent pneumococ-cal colonization or acute otitis media.36

Therefore, it is uncertain, theoretically,whether PPSV23 in children with im-plants would prevent meningitis at-tributable to pneumococcal infectionsthat originate in the middle earand cause meningitis by contiguousspread of bacteria. There are no dataon the efficacy of PCV7 or PPSV23 inprevention of pneumococcal meningi-tis in children with cochlear implants,but there are immunogenicity data. Asingle dose of PCV7 in children 14months through 5 years of age withcochlear implants induced a substan-tial immune response with mean 12-

fold and 7.8-fold increases in anticap-sular antibody concentration to the 7serotypes in the vaccine in children 14months to 2 years of age and children 2through 5 years of age, respectively.37

Among children 2 through 5 years ofage, a single dose of PCV7 was moreimmunogenic than a single dose ofPPSV23 for the 7 serotypes in PCV7.PPSV23 was immunogenic in childrenolder than 5 years, adolescents, andyoung adults; there was a mean 4.2-fold increase in anticapsular antibodyconcentration to the 7 PCV7 sero-types.37 The distribution of serotypes ofS pneumoniae causing meningitis inimplant recipients is unknown but isassumed to be the same as in childrenwithout cochlear implants. On Febru-ary 24, 2010, a 13-valent pneumococcalconjugate vaccine (PCV13) was li-censed by the FDA on the basis ofsafety and immunogenicity. This vac-cine contains polysaccharides of the 7serotypes in PCV7 and polysaccha-rides from 6 additional serotypes. Ithas not been studied in children withcochlear implants or in children olderthan 71 months. This vaccine replacesPCV7 for all scheduled doses of PCV7 ininfants.38 In addition, a supplementaldose of PCV13 is recommended forchildren 14 months through 18 yearsof age with a cochlear implant.38

H influenzae type b conjugate vaccine(Hib) is highly effective for preventionof invasive disease and colonizationwith this pathogen39,40 and, presum-ably, is effective for prevention ofacute otitis media attributable to H in-fluenzae type b. Cochlear implant re-cipients have anticapsular antibodyconcentrations to H influenzae type bafter immunization that are likely to beprotective.37,41 Hib vaccine does notprevent colonization or infection withnon–serotype b strains; most H influ-enzae strains that cause acute otitismedia are nontypeable strains, aswere the isolates from most cases of

H influenzae meningitis in implantrecipients.17

RECOMMENDATIONS

US Preventive Services Task Force Rat-ings criteria42 were used to assess thestrength of evidence for recommenda-tions. All of the recommendations wereclassified as “I” indicating insufficient ev-idence except where a different rating(ie, ratings A, B, C, or D) is noted after thestatement (see Appendix).

1. Evaluations and ManagementBefore or During Insertion ofCochlear Implant

● Imaging of the temporal bone/innerear should be performed before co-chlear implantation in all childrenwith congenital deafness and all pa-tients with profound hearing impair-ment and a history of bacterial men-ingitis (if not known to have normalhearing before meningitis) to identifythose with inner-ear malformations/CSF fistulas or ossification of the co-chlea. In patients with inner-ear mal-formations that are associated with ahigher likelihood of CSF fistulas aftercochlear implantation (eg, wide ves-tibular aqueduct syndrome or Mon-dini malformation), particular atten-tion must be paid to sealing thecochleostomy during the cochlear im-plant surgery to further lower the riskof developing bacterial meningitis.

● For otitis-prone children or childrenwith persistent middle-ear effusion,tympanostomy tube placementshould be considered before co-chlear implantation.9,16,43

2. Primary and SecondaryPrevention of Meningitis and AcuteOtitis Media

● All children, including those with se-vere hearing impairment or infantswith profound deafness, should re-ceive all doses of PCV13 (or PCV7 ifPCV13 is not yet available) and Hib,according to the routine recom-

386 FROM THE AMERICAN ACADEMY OF PEDIATRICS by guest on April 9, 2019www.aappublications.org/newsDownloaded from

Page 7: Policy Statement—Cochlear Implants in Children: Surgical ...pediatrics.aappublications.org/content/pediatrics/early/2010/07/26/... · Surgical Site Infections and Prevention and

mended schedule (ie, a dose of eachat 2, 4, 6, and 12–15 months of age,except that a dose of Hib is notneeded at 6 months of age ifPRP-OMP [PedvaxHIB or ComVax,Merck, Whitehouse Station, NJ]was given for the first 2 doses)44

(recommendation A).

● Starting at 2 years of age and at least2 months after the last dose of PCV13(or PCV7 if PCV13 is unavailable), adose of PPSV23 should be adminis-tered to (1) children scheduled for co-chlear implantation (orafter cochlearimplantation if not previously admin-istered) and (2) children with aninner-ear malformation with a CSFcommunication45,46 (recommenda-tion B). Formaximal benefit, adminis-tration of the doses of PCV13 andPPSV23 should be completed at least2 weeks before implant surgery. Chil-dren 24 through 71 months of agewho have received 2 or fewer previ-ous doses of PCV13 (or PCV7) before24 months of age should receive 2doses of PCV13 at least 2 monthsapart, and those who have received 3previous doses of PCV13 (or PCV7)should receive 1 dose of PCV13.47

PPSV23 should be administered 2months after completion of the PCV13(PCV7) series. For children older than71 months who have not receivedPCV13, administration of 1 dose ofPCV13 should be considered. All suchchildren should receive PPSV23 (2months after PCV13 if PCV13 is admin-istered) if not previously adminis-tered (recommendation B). Admin-istration of more than 1 dose ofPPSV23 to children with cochlear im-plants is not recommended.

● A single supplemental dose ofPCV13 should be administered tochildren 14 months through 71months of age who have been fullyimmunized with PCV7. A supplemen-tal dose is unnecessary if the fourthdose of pneumococcal conjugate

vaccine given at 12months of age orolder was PCV13.

● A single dose or supplemental dose ofPCV13may be administered to pediat-ric patients 6 through 18 years of agewho have a cochlear implant or arescheduled to receive a cochlear im-plant regardless of previous doses ofPCV7 and PPSV23.

● When assessing a history of previ-ous immunization with pneumococ-cal vaccines, care should be exer-cised to avoid confusing pastimmunization with other vaccinesthat could be considered “meningi-tis vaccines” (ie, Hib and quadriva-lent meningococcal polysaccharideor conjugate vaccines) with dosesof PCV7 and PPSV23.

● Meningococcal conjugate vaccineshould be administered in accor-dance with routine recommenda-tions,48–50 but given current data, co-chlear implant recipients shouldnot be considered a group at highrisk of invasive meningococcal dis-ease. Therefore, children youngerthan 11 years should not be immu-nized routinely.

● In most studies, administration of in-fluenza vaccine to healthy children re-duced the incidence of episodes ofacute otitis media during influenzaseason.51–54 To reduce the number ofepisodes of acute otitismedia, annualadministration of influenza vaccinewith trivalent inactivated vaccine orlive attenuated nasal vaccine (if thechildhasnocondition that constitutesa medical contraindication) to pa-tients with a cochlear implant is rec-ommended, and influenza immuniza-tion of their household contactsshould be strongly considered (rec-ommendation B).

● Tympanostomy tube placement alsoshould be considered if recurrentepisodes of acute otitis media occurafter cochlear implantation.

3. Management of PostoperativeWound Infection or SuspectedCochlear Implant Infection

● Patients with suspected postopera-tive wound infection or suspected im-plant infection should be referredurgently to the surgeon who per-formed the implant procedure.Broad-spectrum antimicrobial ther-apy that includes an agent or agentswith activity against methicillin-susceptible and methicillin-resistantStaphylococcus aureus should beinitiated.

4. Early Diagnosis of Acute OtitisMedia and Meningitis

● Patients and parents should be edu-cated as to symptoms of acute otitismedia andmeningitis and to seek im-mediate medical evaluation for acuteillness with symptoms possiblyattributable to either acute otitismedia (eg, fever or earache) ormeningitis (eg, fever, headache,vomiting, stiff neck, or change inlevel of consciousness).

● Clinicians should consider bacterialmeningitis in the differential diagno-sis of all patients with cochlear im-plants who present with fever with orwithout acute otitismedia on physicalexamination, particularly during thefirst 2 years after implantation in pa-tients with cochlear implants withoutpositioners and indefinitely in pa-tients with cochlear implants placedbetween 1999 and August 2002 withpositioners (Advanced Bionics modelAB-5100H or AB-5100H-11).

5. Management of Acute OtitisMedia in Children With CochlearImplants

● Patients with cochlear implants whoare diagnosedwith acute otitismediashould be started urgently on sys-temic antimicrobial therapy; watchfulwaiting is inappropriate for thesechildren.55 Initial empiric treatment

FROM THE AMERICAN ACADEMY OF PEDIATRICS

PEDIATRICS Volume 126, Number 2, August 2010 387 by guest on April 9, 2019www.aappublications.org/newsDownloaded from

Page 8: Policy Statement—Cochlear Implants in Children: Surgical ...pediatrics.aappublications.org/content/pediatrics/early/2010/07/26/... · Surgical Site Infections and Prevention and

with an oral antimicrobial agent (eg,amoxicillin or amoxicillin/clavulanate,at a dose of 80–90 mg/kg per day) isreasonable if all of the following crite-ria are fulfilled: (1) theepisodeoccurs2 or more months after cochlear im-plantation; (2) the patient does nothave an uncorrected Mondini or sim-ilar inner-ear malformation or CSF/middle-earfistula; (3) thepatientdoesnot appear severely ill and there is noclinical evidence of mastoiditis ormeningitis; and (4) the cochlear im-plant does not have a spacer/posi-tioner (Advanced Bionics model AB-5100H or AB-5100H-11). Patients withacute otitismediawho fulfill these cri-teria are likely to be at a lower risk ofdeveloping inner-ear infection ormeningitis complicating acute otitismedia. If feasible, middle-ear fluidshould be obtained through the tym-panostomy tube or a tympanocente-sis or myringotomy for culture justbefore initiation of antimicrobial ther-apy, but this should not be allowed tocause an undue delay in initiation ofantimicrobial therapy. For patientswith a cochlear implant who do notmeet these criteria (including pa-tients with implants of an unknowntype implanted between 1999 and Au-gust 2002), initial therapy with a par-enteral antimicrobial agent for treat-ment of acute otitis media (eg,ceftriaxone or cefotaxime) is recom-mended. Patients with a cochlear im-plant andacuteotitismedia shouldbeevaluated by an otolaryngologist iftheir condition worsens despite 24hours of antimicrobial therapy. Asample of middle-ear fluid should beobtained for culture, and a myringot-

omy with or without ventilation place-ment should be performed to drainthe middle ear.

6. Management of BacterialMeningitis in Patients With aCochlear Implant

● CSF should be submitted for culture.If present, middle-ear fluid shouldbe obtained and sent for culture.The choice of empiric antimicrobialtherapy for meningitis (eg, ceftriax-one or cefotaxime plus vancomycin)is similar to that for children with-out implants. An exception is forchildren with the onset of meningi-tis during the first 2 weeks after co-chlear implantation; in such cir-cumstances, causal bacteria mayinclude a broader range of patho-gens, including Gram-negativebacilli such as A baumannii andGram-positive bacteria such as En-terococcus spp. Selection of a com-bination of agents that providebroader-spectrum activity againstGram-negative bacilli (eg, mero-penem and vancomycin) should beconsidered. Patients with a cochlearimplant and bacterial meningitisshould be evaluated urgently by anotolaryngologist for consideration ofimaging and surgical exploration.

LEAD AUTHORSLorry G. Rubin, MDBlake Papsin, MD

COMMITTEE ON INFECTIOUS DISEASES,2009–2010Joseph A. Bocchini Jr, MD, ChairpersonJohn S. Bradley, MDMichael T. Brady, MDHenry H. Bernstein, DOCarrie L. Byington, MDMargaret C. Fisher, MDMary P. Glode, MD

Mary Anne Jackson, MDHarry L. Keyserling, MDDavid W. Kimberlin, MDWalter A. Orenstein, MDGordon E. Schutze, MDRodney E. Willoughby Jr, MD

LIAISONSBeth P. Bell, MD – Centers for Disease Controland PreventionRobert Bortolussi, MD – Canadian PaediatricSocietyRichard D. Clover, MD – American Academy ofFamily PhysiciansMarc A. Fischer, MD – Centers for DiseaseControl and PreventionRichard L. Gorman, MD – National Institutes ofHealthLucia Lee, MD – Food and Drug AdministrationR. Douglas Pratt, MD – Food and DrugAdministrationJennifer S. Read, MD, MS, MPH, DTM&H –Eunice Kennedy Shriver National Institute ofChild Health and Human Development,National Institutes of HealthBruce G. Gellin, MD, MPH – National VaccineProgram OfficeJeffrey R. Starke, MD – American ThoracicSocietyJack T. Swanson, MD – AAP Committee onPractice and Ambulatory Medicine

CONSULTANTSH. Cody Meissner, MDLorry G. Rubin, MD

EX OFFICIOLarry K. Pickering, MD – Red Book EditorCarol J. Baker, MD – Red Book Associate EditorSarah S. Long, MD – Red Book Associate Editor

STAFFJennifer Frantz, MPHSECTION ON OTOLARYNGOLOGY–HEADAND NECK SURGERY EXECUTIVECOMMITTEE, 2009–2010Scott R. Schoem, MD, ChairpersonCharles Bower, MDJoshua A. Gottschall, MDDiego Preciado, MD, PhDKristina W. Rosbe, MDSally Richard Shott, MDMark S. Volk, MD, DMD

CONTRIBUTING MEMBERBlake Papsin, MD

STAFFAleksandra Stolic, MPH

REFERENCES

1. Papsin BC, Gordon KA. Cochlear implantsfor children with severe-to-profound hear-ing loss. N Engl J Med. 2007;357(23):2380–2387

2. National Institute on Deafness and OtherCommunication Disorders, National Insti-

tutes of Health. Cochlear implants. Avail-able at: www.nidcd.nih.gov/health/hearing/coch.asp. Accessed April 14, 2009

3. James AL, Papsin BC. Cochlear implant sur-gery at 12 months of age or younger. Laryn-goscope. 2004;114(12):2191–2195

4. Dettman SJ, Pinder D, Briggs RJ, Dowell RC,Leigh JR. Communication development inchildren who receive the cochlear implantyounger than 12 months: risks versus ben-efits. Ear Hear. 2007;28(2 suppl):11S–18S

5. Miyamoto RT, Houston DM, Bergeson T. Co-

388 FROM THE AMERICAN ACADEMY OF PEDIATRICS by guest on April 9, 2019www.aappublications.org/newsDownloaded from

Page 9: Policy Statement—Cochlear Implants in Children: Surgical ...pediatrics.aappublications.org/content/pediatrics/early/2010/07/26/... · Surgical Site Infections and Prevention and

chlear implantation in deaf infants. Laryn-goscope. 2005;115(8):1376–1380

6. Hopfenspirger MT, Levine SC, Rimell FL. In-fectious complications in pediatric co-chlear implants. Laryngoscope. 2007;117(10):1825–1829

7. Cunningham CD III, Slattery WH III, LuxfordWM. Postoperative infection in cochlear im-plant patients. Otolaryngol Head Neck Surg.2004;131(1):109–114

8. US Food and Drug Administration. FDA pub-lic health notification: Continued risk ofbacterial meningitis in children with co-chlear implants with a positioner beyondtwenty-four months post-implantation. Feb-ruary 6, 2006. Available at: www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/UCM062104.Accessed April 14, 2009

9. Luntz M, Teszler CB, Shpak T. Cochlear im-plantation in childrenwith otitismedia: sec-ond stage of a long-term prospective study.Int J Pediatr Otorhinolaryngol. 2004;68(3):273–280

10. House WF, Berliner KI, Eisenberg LS. Experi-ences with the cochlear implant in pre-school children. Ann Otol Rhinol Laryngol.1983;92(6 pt 1):587–592

11. House WF, Luxford WM, Courtney B. Otitismedia in children following the cochlear im-plant. Ear Hear. 1985;6(3 suppl):24S–26S

12. Kempf HG, Stover T, Lenarz T. Mastoiditisand acute otitis media in children with co-chlear implants: recommendations formedical management. Ann Otol Rhinol Lar-yngol Suppl. 2000;185:25–27

13. Migirov L, Yakirevitch A, Henkin Y, Kaplan-Neeman R, Kronenberg. Acute otitis mediaand mastoiditis following cochlear implan-tation. Int J Pediatr Otorhinolaryngol. 2006;70(5):899–903

14. Leake PA, Rebscher SJ, Aird DW. Histopa-thology of cochlear implants: safety consid-erations. In: Schindler RA, Merzenich MN,eds. Cochlear Implants. New York, NY: RavenPress; 1985:55–64

15. Nadol JB Jr, Eddington DK. Histologic evalu-ation of the tissue seal and biologic re-sponse around cochlear implant electrodesin the human. Otol Neurotol. 2004;25(3):257–262

16. Luntz M, Teszler CB, Shpak T, Feiglin H,Farah-Sima’an A. Cochlear implantation inhealthy and otitis-prone children: a pro-spective study. Laryngoscope. 2001;111(9):1614–1618

17. Reefhuis J, Honein MA, Whitney CG, et al.Risk of bacterial meningitis in children withcochlear implants. N Engl J Med. 2003;349(5):435–445

18. Biernath KR, Reefhuis J, Whitney CG, et al.Bacterial meningitis among children withcochlear implants beyond 24 months afterimplantation. Pediatrics. 2006;117(2):284–289

19. Luntz M, Hodges AV, Balkany T, Dolan-Ash S,Schloffman J. Otitis media in children withcochlear implants. Laryngoscope. 1996;106(11):1403–1405

20. Barry D, Delattre J, Vie F, Bedos JP, GehannoP. Otogenic intracranial infections in adults.Laryngoscope. 1999;109(3):483–487

21. Arnold W, Bredberg G, Gstottner W, et al.Meningitis following cochlear implantation:pathomechanisms, clinical symptoms, con-servative and surgical treatments. ORL JOtorhinolaryngol Relat Spec. 2002;64(6):382–389

22. Suzuki C, Sando I, Fagan JJ, Kamerer DB,Knisely AS. Histopathological features of acochlear implant and otogenic meningitisin Mondini dysplasia. Arch OtolaryngolHead Neck Surg. 1998;124(4):462–466

23. Belmont MJ, Arjmand EM. Recurrent acuteotitis media associated meningitis in a pa-tient with a contralateral cochlear implantand bilateral cochleovestibular dysplasia.Int J Pediatr Otorhinolaryngol. 2004;68(8):1091–1093

24. Centers for Disease Control and Prevention.Bacterial meningitis among cochlear im-plant recipients: Canada, 2002.MMWRMorbMortal Wkly Rep. 2006;55(suppl 1):20–24

25. Wei BP, Robins-Browne RM, Shepherd RK,Clark GM, O’Leary SJ. Can we prevent co-chlear implant recipients from developingpneumococcal meningitis? Clin Infect Dis.2008;46(1):e1–e7

26. Parner ET, Reefhuis J, Schendel D, ThomsenJL, Ovesen T, Thorsen P. Hearing loss diag-nosis followed by meningitis in Danish chil-dren, 1995–2004. Otolaryngol Head NeckSurg. 2007;136(3):428–433

27. Whitney CG. Cochlear implants and menin-gitis in children: concise reviews of pediat-ric infectious diseases. Pediatr Infect Dis J.2004;23(8):767–768

28. Ohlms LA, Edwards MS, Mason EO, IgarashiM, Alford BR, Smith RJ. Recurrent meningi-tis and Mondini dysplasia. Arch OtolaryngolHead Neck Surg. 1990;116(5):608–612

29. Whitney CG, Farley MM, Hadler J, et al; ActiveBacterial Core Surveillance of the EmergingInfections Program Network. Decline in in-vasive pneumococcal disease after the in-troduction of protein-polysaccharide conju-gate vaccine. N Engl J Med. 2003;348(18):1737–1746

30. Centers for Disease Control and Prevention.Preventing pneumococcal disease among

infants and young children: recommenda-tions of the Advisory Committee on Immuni-zation Practices (ACIP). MMWR RecommRep. 2000;49(RR-9):1–38

31. Eskola J, Kilpi T, Palmu A, et al; Finnish OtitisMedia Study Group. Efficacy of a pneumo-coccal conjugate vaccine against acute oti-tis media. N Engl J Med. 2001;344(6):403–409

32. Fireman B, Black SB, Shinefield HR, Lee J,Lewis E, Ray P. Impact of the pneumococcalconjugate vaccine on otitis media. PediatrInfect Dis J. 2003;22(1):10–16

33. Veenhoven R, Bogaert D, Uiterwaal C, et al.Effect of conjugate pneumococcal vaccinefollowed by polysaccharide pneumococcalvaccine on recurrent acute otitis media: arandomised study. Lancet. 2003;361(9376):2189–2195

34. van Heerbeek N, Straetemans M, WiertsemaSP, et al. Effect of combined pneumococcalconjugate and polysaccharide vaccinationon recurrent otitis media with effusion. Pe-diatrics. 2006;117(3):603–608

35. O’Brien KL, Dagan R. The potential indirecteffect of conjugate pneumococcal vaccines.Vaccine. 2003;21(17–18):1815–1825

36. American Academy of Pediatrics, Commit-tee on Infectious Diseases. Technicalreport: prevention of pneumococcal infec-tions, including the use of pneumococcalconjugate and polysaccharide vaccines andantibiotic prophylaxis. Pediatrics. 2000;106(2 pt 1):367–376

37. Rose M, Hey C, Kujumdshiev S, Gall V, Schu-bert R, Zielen S. Immunogenicity of pneumo-coccal vaccination of patients with cochlearimplants. J Infect Dis. 2004;190(3):551–557

38. Centers for Disease Control and Prevention.Licensure of a 13-valent pneumococcal con-jugate vaccine (PCV13) and recommenda-tions for use among children: Advisory Com-mittee on Immunization Practices (ACIP),2010. MMWR Morb Mortal Wkly Rep. 2010;59(09):258–261. Available at: www.cdc.gov/mmwr/preview/mmwrhtml/mm5909a2.htm. Accessed June 23, 2010

39. Eskola J, Kayhty H, Takala AK, et al. A ran-domized, prospective field trial of a conju-gate vaccine in the protection of infants andyoung children against invasive Haemophi-lus influenzae type b disease. N Engl J Med.1990;323(20):1381–1387

40. Barbour ML, Mayon-White RT, Coles C, CrookDWM, Moxon ER. The impact of conjugatevaccine on carriage ofHaemophilus influen-zae type b. J Infect Dis. 1995;171(1):93–98

41. Hey C, Rose MA, Kujumdshiev S, GstoettnerW, Schubert R, Zielen S. Does the 23-valentpneumococcal vaccine protect cochlear im-

FROM THE AMERICAN ACADEMY OF PEDIATRICS

PEDIATRICS Volume 126, Number 2, August 2010 389 by guest on April 9, 2019www.aappublications.org/newsDownloaded from

Page 10: Policy Statement—Cochlear Implants in Children: Surgical ...pediatrics.aappublications.org/content/pediatrics/early/2010/07/26/... · Surgical Site Infections and Prevention and

plant recipients? Laryngoscope. 2005;115(9):1586–1590

42. US Department of Health and Human Ser-vices, Agency for Healthcare Research andQuality (AHRC). Grade definitions. Availableat: www.ahrq.gov/clinic/uspstf/grades.htm. Accessed April 14, 2009

43. Papsin BC, Bailey CM, Albert DM, Bellman SC.Otitis media with effusion in paediatric co-chlear implantees: the role of peri-implantgrommet insertion. Int J Pediatr Otorhino-laryngol. 1996;38(1):13–19

44. American Academy of Pediatrics, Commit-tee on Infectious Diseases. Recommendedchildhood and adolescent immunizationschedules–United States, 2008. 2010;125(1):195–196. Available at: http://pediatrics.aappublications.org/cgi/content/full/125/1/195/DC1.

45. Centers for Disease Control and Prevention.Notice to readers: pneumococcal vaccina-tion for cochlear implant recipients.MMWRMorb Mortal Wkly Rep. 2002;51(41):931

46. Centers for Disease Control and Prevention,Advisory Committee on Immunization Prac-tices. Pneumococcal vaccination for co-chlear implant candidates and recipients:updated recommendations of the AdvisoryCommittee on Infectious Practices. MMWR

Morb Mortal Wkly Rep. 2003;52(31):739–740

47. Centers for Disease Control and Prevention,Advisory Committee on Immunization Prac-tices. Update recommendation of the Advi-sory Committee on Immunization Practices(ACIP) for use of 7-valent pneumococcalconjugate vaccine (PCV7) in children aged24–59 months who are not completely vac-cinated.MMWRMorbMortal Wkly Rep. 2008;57(13):343–345

48. American Academy of Pediatrics, Commit-tee on Infectious Diseases. Prevention andcontrol of meningococcal disease: recom-mendations for use of meningococcal vac-cines in pediatric patients. Pediatrics. 2005;116(2):496–505

49. Centers for Disease Control and Prevention,Advisory Committee on Immunization Prac-tices. Notice to readers: revised recommen-dations of the Advisory Committee on Immu-nization Practices to vaccinate all personsaged 11–18 years with meningococcal con-jugate vaccine. MMWR Morb Mortal WklyRep. 2007;56(31):794–795

50. Centers for Disease Control and Prevention.Notice to readers: recommendation fromthe Advisory Committee on ImmunizationPractices (ACIP) for use of quadrivalent me-ningococcal conjugate vaccine (MCV4) in

children aged 2–10 years at increased riskfor invasive meningococcal disease.MMWRMorb Mortal Wkly Rep. 2007;56(48):1265–1266

51. Clements DA, Langdon L, Bland C, Walter E.Influenza A vaccine decreases the incidenceof otitismedia in 6- to 30-month-old childrenin day care. Arch Pediatr AdolescMed. 1995;149(10):1113–1117

52. Heikkinen T, Ruuskanen O, Waris M, ZieglerT, Arola M, Halonen P. Influenza vaccinationin the prevention of acute otitis media inchildren. Am J Dis Child. 1991;145(4):445–448

53. Hoberman A, Greenberg DP, Paradise JL,et al. Effectiveness of inactivated influ-enza vaccine in preventing acute otitismedia in young children: a randomizedcontrolled trial. JAMA. 2003;290(12):1608–1616

54. Ozgur SK, Beyazova U, Kemaloglu YK, et al.Effectiveness of inactivated influenza vac-cine for prevention of otitis media in chil-dren. Pediatr Infect Dis J. 2006;25(5):401–404

55. American Academy of Pediatrics, Subcom-mittee on Management of Acute Otitis Me-dia. Diagnosis and management of acuteotitis media. Pediatrics. 2004;113(5):1451–1465

390 FROM THE AMERICAN ACADEMY OF PEDIATRICS by guest on April 9, 2019www.aappublications.org/newsDownloaded from

Page 11: Policy Statement—Cochlear Implants in Children: Surgical ...pediatrics.aappublications.org/content/pediatrics/early/2010/07/26/... · Surgical Site Infections and Prevention and

APPENDIX Grading of Recommendations

Grade Definition

A Recommended: there is high certainty that the net benefit is substantial.B Recommended: there is high certainty that the net benefit is moderate

or there is moderate certainty that the net benefit is moderate tosubstantial.

C Recommendation against routinely providing: there may beconsiderations that support providing the service in an individualpatient, and there is at least moderate certainty that the net benefit issmall.

D Recommends against the service: there is moderate or high certaintythat the service has no net benefit or that the harms outweigh thebenefits.

I The current evidence is insufficient to assess the balance of benefitsand harms of the recommendation. Evidence is lacking, of poorquality, or conflicting, and the balance of benefits and harms cannotbe determined.

Modified from the US Preventive Services Task Force recommendations categories (available at: www.ahrq.gov/clinic/uspstf/grades.htm).

FROM THE AMERICAN ACADEMY OF PEDIATRICS

PEDIATRICS Volume 126, Number 2, August 2010 391 by guest on April 9, 2019www.aappublications.org/newsDownloaded from

Page 12: Policy Statement—Cochlear Implants in Children: Surgical ...pediatrics.aappublications.org/content/pediatrics/early/2010/07/26/... · Surgical Site Infections and Prevention and

originally published online July 26, 2010; Pediatrics AND SECTION ON OTOLARYNGOLOGY-HEAD AND NECK SURGERY

Lorry G. Rubin, Blake Papsin and the COMMITTEE ON INFECTIOUS DISEASESPrevention and Treatment of Acute Otitis Media and Meningitis

Cochlear Implants in Children: Surgical Site Infections and−−Policy Statement

ServicesUpdated Information &

010-1427http://pediatrics.aappublications.org/content/early/2010/07/26/peds.2including high resolution figures, can be found at:

Permissions & Licensing

http://www.aappublications.org/site/misc/Permissions.xhtmlin its entirety can be found online at: Information about reproducing this article in parts (figures, tables) or

Reprintshttp://www.aappublications.org/site/misc/reprints.xhtmlInformation about ordering reprints can be found online:

by guest on April 9, 2019www.aappublications.org/newsDownloaded from

Page 13: Policy Statement—Cochlear Implants in Children: Surgical ...pediatrics.aappublications.org/content/pediatrics/early/2010/07/26/... · Surgical Site Infections and Prevention and

originally published online July 26, 2010; Pediatrics AND SECTION ON OTOLARYNGOLOGY-HEAD AND NECK SURGERY

Lorry G. Rubin, Blake Papsin and the COMMITTEE ON INFECTIOUS DISEASESPrevention and Treatment of Acute Otitis Media and Meningitis

Cochlear Implants in Children: Surgical Site Infections and−−Policy Statement

http://pediatrics.aappublications.org/content/early/2010/07/26/peds.2010-1427located on the World Wide Web at:

The online version of this article, along with updated information and services, is

1073-0397. ISSN:60007. Copyright © 2010 by the American Academy of Pediatrics. All rights reserved. Print

the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk Grove Village, Illinois,has been published continuously since 1948. Pediatrics is owned, published, and trademarked by Pediatrics is the official journal of the American Academy of Pediatrics. A monthly publication, it

by guest on April 9, 2019www.aappublications.org/newsDownloaded from