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?

rene.gifford@Vanderbilt.edu