Evidence for the expansion of Disclosures · 2018-06-25 · •Rob Labadie, MD, PhD •Matt...
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10/17/17 1 Evidence for the expansion of pediatric cochlear implant candidacy René H. Gifford, PhD Department of Hearing and Speech Sciences Vanderbilt University Medical Center Hear ‘n’ Now Conference October 13, 2017 Disclosures • Audiology Advisory Board – Advanced Bionics – Cochlear Americas • Scientific Advisory Board – Frequency Therapeutics VBWC Pediatric CI Team • Jourdan Holder, AuD • Adrian Taylor, AuD • Christine Brown, AuD • Kelley Corcoran, AuD • Ally Sisler-Dinwiddie, AuD • Lindsey Kanes, MS • Susan Marko, MS • Ciara Alley, MS • Geneine Snell, MS • Delores Smith, MS • Sarah Wilhite, MS • David Haynes, MD • Alejandro Rivas, MD • Marc Bennett, MD • Rob Labadie, MD, PhD • Matt O’Malley, MD • Christopher Wootten, MD • Frank Virgin, MD Evolution of pediatric implant candidacy indications • FDA approval • 6/27/1990: Nucleus 22 (n = 142) • F0/F1/F2-WSP III & Multipeak-MSP • Profound SNHL bilaterally • 2 to 17 years of age • no open set speech recognition • auditory oral education program Pediatric Cochlear Implant Criteria • based primarily on the audiogram and auditory progress (or lack thereof…) • varies with age • each manufacturer outlines slightly different criteria • Many clinicians are uncomfortable recommending CI for children who do not meet all criteria. Current CI criteria for children
Transcript of Evidence for the expansion of Disclosures · 2018-06-25 · •Rob Labadie, MD, PhD •Matt...
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Evidencefortheexpansionofpediatric cochlearimplantcandidacy
RenéH.Gifford,PhDDepartmentofHearingandSpeechSciences
VanderbiltUniversityMedicalCenter
Hear‘n’NowConferenceOctober13,2017
Disclosures• AudiologyAdvisoryBoard
–AdvancedBionics–CochlearAmericas
• ScientificAdvisoryBoard– FrequencyTherapeutics
VBWCPediatricCITeam• JourdanHolder,AuD• AdrianTaylor,AuD• ChristineBrown,AuD• KelleyCorcoran,AuD• AllySisler-Dinwiddie,AuD• LindseyKanes,MS• SusanMarko,MS• CiaraAlley,MS• Geneine Snell,MS• DeloresSmith,MS• SarahWilhite,MS
• DavidHaynes,MD• AlejandroRivas,MD• MarcBennett,MD• RobLabadie,MD,PhD• MattO’Malley,MD• ChristopherWootten,MD• FrankVirgin,MD
Evolution of pediatric implant candidacy indications
• FDA approval
• 6/27/1990: Nucleus 22 (n = 142)• F0/F1/F2-WSP III & Multipeak-MSP
• Profound SNHL bilaterally
• 2 to 17 years of age
• no open set speech recognition
• auditory oral education program
Pediatric Cochlear Implant Criteria• based primarily on the audiogram and auditory progress
(or lack thereof…)
• varies with age
• each manufacturer outlines slightly different criteria
• Many clinicians are uncomfortable recommending CI for children who do not meet all criteria.
Current CI criteria for children
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AB, Cochlear, & MED-EL: profound bilateral SNHL
Degree of hearing loss< 2 years
Cochlear: severe-to-profound bilateral SNHL
Degree of hearing loss> 2 years
AB & MED-EL: profound bilateral SNHL
Cochlear, AB & MED-EL: little to no progress with appropriately fitted HAs
e.g., IT-MAIS, MAIS, LittlEARS
Auditory progress with HAs:Younger children
Cochlear: ≤ 30% word recognition (MLNT or LNT)
Auditory progress with HAs:Older children
AB: < 12% word recognition (PBK) or < 30% HINT-C sentence recognition
MED-EL: < 20% word recognition (MLNT or LNT)
Childrenmustmiss70to88%ofthesignaltoqualify.
Evidencefortheexpansion ofpediatriccochlearimplantcandidacy
Carlsonetal.(2015).Otol Neurotol.36(1):43-50.
HYPOTHESIS:Childrenwhoarenon-traditionalCIcandidates,butarenotmakingprogresswithappropriatelyfittedHAsandinterventionwilldemonstratesignificantbenefitfromcochlearimplantationasdefinedbyimprovementin:
1) Speechperceptionand/or2) Auditoryskilldevelopment
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Studyinclusioncriteria
CIrecipients<18yearsofagewithSNHLandoneorbothofthefollowing:
• <70dBHLPTAforchildrenbetween2and17yearsofageor<90dBHLPTAforthoseunder24months
• Ageappropriatewordand/orsentencerecognitionscores>30%inthebest-aidedcondition
Carlsonetal.(2015).Primaryoutcomemeasures
Pre- &post-CIresultsforageappropriatematerials:
• SpeechrecognitiontestsintheCIear,contralateralearandbest-aidedconditions• NUCHIPs,MLNT,LNT,CNC• HINT-C,BabyBio,AzBio
• Parentalquestionnairesgaugingauditoryskillsdevelopment• IT-MAIS/MAIS,LittlEARS,PEACH
Carlsonetal.(2015).
Carlsonetal.(2015).Participants
• 51patients(across2centers)• 39unilateral,12bilateral
• Meanageofimplantation:8.3years• Range:7.0monthsto17.6years
• MeandurationofCIexperienceatreportedfollow-up:17.1months• Range:2.5to46.5months
• Allwereimplantedwiththemostrecenttechnology• AB:13,Cochlear:44,MED-EL:6
Carlsonetal.(2015).Participants
Carlsonetal.(2015).Participants Speech perception testing: PREOP
Carlsonetal.(2015).
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63-percentage point improvement
40-percentage point improvement
Carlsonetal.(2015).
No decline in performance
27-percentage point improvement
Carlsonetal.(2015).
Carlsonetal.(2015).
Mean improvement in total language: 9.9 points (p = 0.024)
Carlsonetal.(2015)Follow-up• ExpansionofCarlsonetal.(2015)• ExcludedchildrenwithANSD,CND,andSSD• n=65• Atleast3monthsofCIexperience(averagefollow-up=12.78months;range=3- 24months)
• Comparedpre- andpost- operativespeechrecognitionscores– Participantsweretestedpost-operativelywiththesameormoredifficultspeechmaterialsthantheyweretestedwithpre-operatively
CI ear only
Word Recognition
CI ear only
Word Recognition
F(1,23) = 70.6, p < 0.001
Mean benefit: 41-percentage points
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Word Recognition
CI ear +best aided
Mean benefit: 14-percentage points
F(1,15) = 3.596, p = 0.077
CI ear only
Sentence Recognition
F(1,18) = 56.05, p < 0.001
Mean benefit: 46-percentage points
Sentence recognition
CI ear +best aidedF(1,17) = 30.49, p < 0.001
Mean benefit: 20-percentage points
Carlson et al. (2015) & follow-up study
SUMMARY• Childrenw/lessseverehearinglossesthanspecifiedbyFDAlabeling,gainsignificantbenefitfromCI
• Allbut2demonstratedequivocalorsignificantlybetteroutcomes
• 2childrenshowedadecrementinbest-aidedcondition(words)
• These2childrendemonstratedbenefitforsentences.• Wehavenotseenadefinitivepointofdiminishingreturns.• Alarge-scalereassessmentofpeds CIcandidacyiswarrantedtoallowmorechildrenaccesstothebenefitsofCI.
Leighetal.(2016).IntlJAudiol,55:S9–S18
STUDYOVERVIEW:• retrospectivestudy• n=140children• sensoryhearingloss,noadditionaldisabilities• 78CIrecipients—allimplanted<3years• 62hearingaid(HA)users
RESEARCHQUESTIONS:1) WhichchildrenaretrulyCIcandidates?2) Whatistheoptimalageforimplantation?
Leighetal.(2016).IntlJAudiol,55:S9–S18
STUDYOVERVIEW:• retrospectivestudy• n=140children• SNHL,noadditionaldisabilities• 78CIrecipients—allimplanted<3years• 62hearingaid(HA)users
RESEARCHQUESTIONS:1) WhichchildrenaretrulyCIcandidates?2) Whatistheoptimalageforimplantation?
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EXPERIMENT1:audiometriccriteriaforimplantation
• CIgroup:CI<2.5years• HAgroup:HAfitting<2.5yearsofage• Monosyllabicwordrecognitionat5yearsofage
Leighetal.(2016).IntlJAudiol,55:S9–S18
n = 17
n = 21
n = 38
n = 78
Leighetal.(2016).IntlJAudiol,55:S9–S18
Leighetal.(2016).IntlJAudiol,55:S9–S18
phon
emes
LowerlimitofIQR
Quadraticregression
Leighetal.(2016).IntlJAudiol,55:S9–S18
EXPERIMENT2:optimalageatimplantation
• 32CIrecipients• Allimplanted<2.5years• Languageassessedpostoperativelyat1,2,3,and5yearspost-activation• RossettiInfant-ToddlerLanguageScale(RITLS)• PeabodyPictureVocabularyTest(PPVT)
Leighetal.(2016).IntlJAudiol,55:S9–S18SUMMARY
• ChildrenwithPTA≥65dBHLwillhaveahigherlikelihoodofexhibitingimprovementwithCIvs.HA
• Equivalenttoadultindications• ModeratetoprofoundSNHL
• Childrentendtobeexhibitlanguagedelayappxequivalenttothedurationofauditorydeprivation(priortoCI)
• Earlierisbetteràminimizeoreliminatedelay!
Leighetal.(2016).IntlJAudiol,55:S9–S18
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Other studiesDettman etal.(2004)ArchOtolaryngol HeadNeckSurg,
130:612-618.
Leighetal.(2011).EarHear, 32,313-22.
Cadieux etal.(2013).Otol Neurotol,34:408-15.
Hassepass etal.(2013).Otol Neurotol,34:53-60.
Vincenti etal.(2014).ItalJPediatr,40:72.
Fitzpatricketal.(2015).EarHear,36:688-94.
Dettman etal.(2016).Otol Neurotol.37:e82-95.
Implanting children under 12 months of age
Amajorconcernistheissueofspecificity:theriskofimplantingachildwithout SNHL
Anesthesiaconcernsandcomplications:incidenceofmorbidity,mortality,andlife-threateningadverseeventsinchildren<12monthswassignificantlyhigherthanchildrenolderthan1yearofage
Cosetti andRoland(2010).TrendsAmplif,14:46-57
Anesthesiaconcernsandcomplications:
§ Theseconcerns—frompriorpapers—weremostlydueto:
§ lackoffasting§ veryyoungage(<1month)§ emergencysurgery
Cosetti andRoland(2010).TrendsAmplif,14:46-57
Multiplestudiesdemonstratenogreateranestheticriskforchildren<12monthsforCIsurgery.
BertramandLenarz,2004;JamesandPapsin,2004;Coletti etal.,2005;Miyamotoetal.,2005;Waltzman andRoland,2005;Dettmanetal.,2007;Valenciaetal.,2008;Miyamotoetal.,2008
Cosetti andRoland(2010).TrendsAmplif,14:46-57 Recall that audiometric criteria for
pediatric CI…
- most stringent for youngest children
- our youngest language learners
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Age at implantation matters
• Word segmentation abilities develop rapidly between 7.5 and 10.5 months (Jusczyk, 2002).
• Infants can link sound patterns with meaning by6 months (mommy, daddy, no, bye bye, etc.)
• 8 months of age: 60+ words/concepts
PediatricCochlearImplantCriteria
• 8-month olds: long-term storage of words (up to 2 weeks)
• important prerequisite for learning language!
• Houston et al., 2009, 2012; Bergeson et al., 2010: children implanted < 12 months à significantly better word learning abilities
Age at implantation matters
PediatricCochlearImplantCriteria
• Tomblin et al. (2005): children implanted b/tw 10-15 months had significantly better expressive language
• Hearing and/or language learning opportunities likely begin BEFORE birth (DeCasper et al., 1980, 1986; Kisilevsky et al., 2003; Moon et al., 2013; Partanen et al., 2013)
Age at implantation matters
PediatricCochlearImplantCriteria
Age matters! But current CI criteria are strictest for the
youngest children.
Dettman etal.(2016).Otol Neurotol,37:e82–e95.
• 3AustralianCIcenters,n=125• prospectiveassessment:speechperception,language,&speechproduction
• Assessmenttimepoints:schoolentry&lateprimary/earlysecondary
Dettman etal.(2016).Otol Neurotol,37:e82–e95.
Age normative range
Group 1: implanted < 12 months
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Age normative range
Dettman etal.(2016).Otol Neurotol,37:e82–e95.
Tobey et al. (2013). Intl J Audiol, 52: 219–229.
n = 160
CI in 1st
year of life
Age normative range
Dashed lines: 95% confidence limits
Tobey et al. (2013). Intl J Audiol, 52: 219–229.
Age normative range
Receptive Language
Tobey et al. (2013). Intl J Audiol, 52: 219–229.
Age normative range
Expressive Language
Outcomes for children implanted < 12 months
Houston and Miyamoto (2010). Otol Neurotol, 31:1248-1253.Bergeson et al., (2010). Restorative Neurology and
Neuroscience, 28: 157–165Houston et al., (2012). Developmental Science. 15(3):448-61
Houston et al. (2012). J Am Acad Audiol. 23(6):446-63.Leigh et al. (2013). Otol Neurotol, 34(3):443-50.Holman et al. (2013). Otol Neurotol, 34(2):251-8.Dettman et al. (2016). Otol Neurotol, 37:e82–e95.
Guerzoni et al (2016). Laryngoscope, 126:2098–2105
Casestudy
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Case1
• 4.5-yearoldmale• Termbirth,nocomplications• Nofamilyhistoryofhearingloss• FailedNBHS• Bilateralmoderate-to-severeSNHLidentifiedat2
months• FittedwithHAsat3monthsofage• 2youngersiblings
Case1ABR estimates
Case112 months
Case14 years
Case1 Case1
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Case1 Case1
• CIinRIGHTear3monthsafterCIworkup• 1monthbefore5th birthday
• CI512
Case1 BabyBioCase1
BabyBioCase1
• current CI criteria for children are set too low• re: audiogram, function, and age
• pediatric criteria are much more stringent than labeled adult criteria (even more so than Medicare!)
• requiring children with the best, appropriatelyfitted HAs to miss 70 to 88% of the signal!
• and…that’s in the quiet sound booth
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Crukley et al. (2011). J Educat Audiol, 17: 23-35.
• CIs provide auditory access to HF information that HAs just cannot provide for those with sev-to-profound SNHL
•…this is critical because children are learning language!
• Pay attention to auditory and language progress with appropriately fitted HAs
• more valuable than audiogram
Questions?Comments?
