candidacy and outcomes for cis and hybrids

HollyTeagle,AuD,AssociateProfessorUniversityofNorthCarolina–ChapelHill

Candidacy and Outcomes for CIs and Hybrids

ClinicalOutcomes

CIMakers

HistoricalExpansionofFDAGuidelines• ManufacturerssubmittechnologyforapprovaltotheFDA-mustbesafeandeffecDve

•  Clinicaloutcomessupporttheseclaims

•  PaDentsuccessencouragesexpansionintechnologyandpracDces

Criteriain1985• Adults18yrs+• ONSETofhearingloss

PostlinguisDc

• DEGREEofhearinglossProfound

• WORDRECOGNITION

0%Pre-Operative

Aided Speech Testing

Word Test

Hearing Aid: 0%

AB = Hearing Aid Both Ears

Criteriain1990•  Adults18yrs+•  Children2yrs+•  ONSETofhearingloss

PostlinguisDcadults

Pre&PostLinguisDckids•  DEGREEofhearingloss

Profound•  WORDRECOGNITION

0%Pre-Operative

Aided Speech Testing

Word Test

Hearing Aid: 0%

AB = Hearing Aid Both Ears

Criteriain1998•  Adults18yrs+•  Children18mos+•  ONSETOFHEARINGLOSS

Pre&PostLinguisDc•  DEGREEOFLOSS

SeveretoProfoundAdults

ProfoundChildren• WORDRECOGNITION

40%orlessPre-Operative

Aided Speech Testing

Word Test

Hearing Aid: 38%

AB = Hearing Aid Both Ears

Criteriain2000•  Adults18yrs+Children12mo+•  ONSETOFHEARINGLOSS

Pre&PostLinguisDc•  DEGREEOFLOSS

SeveretoProfoundAdults

ProfoundChildren•  WORDRECOGNITION

Sentencesscore50%orlessineartobeimplanted,

<60%inbestaidedcondiQon

Pre-Operative

Aided Speech Testing

Sentence Test

Hearing Aid: 46%

AB = Hearing Aid Both Ears

Criteriain2014•  AdultsonlyforHybrid•  DEGREEOFLOSSHybrid/Electro-AcousDc:NormaltoModerateinlowfrequenciesS/Pmidtohighfrequencies(2devices:CochlearandMED-EL)•  WORDRECOGNITIONCNCwordscore>10%butlessthan60%ineartobeimplanted;<80%CNCwordsincontralateralear

Pre-Operative

Aided Speech Testing

Word Test

Hearing Aid: 54% LE

72% RE

WhyhaveFDAGuidelinesexpanded?•  CItechnologyandclinicaloutcomesimproved•  AdultsandchildrenwithS/PhearinglosshavebeVeroutcomeswithCIsthanwithhearingaids

•  TesDngpreviouslyonlyusedsentencescores;nowincreasinglyusingsinglewordtestscoresandhearinginnoise(morepeoplearecandidates)

•  ResearchdemonstratescandidatesdobeVerwithmoreresidualhearingandshorterperiodsofdeafness

CochlearNucleusHybridMedElEAS

Whywasthisexpansionappropriate?

•  FDAapprovalofahybriddevicesignifiesrecogniDonthat:

•  CIHybridelectrodemorelikelytoresultinmorepreservedresidualhearingthantradiDonalCIelectrode

•  OpeneddoorforpaDentswithgreaterpre-operaDvehearingtoreceiveHybridCI

•  StudiesshowhybridhearingprovidesimprovedspeechrecogniDoninnoisecomparedtotradiDonalCIs,leadingtogreateraVenDonbeingpaidtotesDnginnoise

CIOutcomes•  TremendousvariabilityinoutcomesduetoheterogeneouspopulaDonBasedonapublishedmeta-analysis(Gaylor,etal.,2013)

•  StaDsDcallysignificantimprovementinmeanspeechscoresasmeasuredbyopen-setsentenceormulD-syllablewordtests;

•  SignificantimprovementinQOLaaerunilateralimplantaDon•  BilateralimplantaDonshowedimprovementincommunicaDon-relatedoutcomescomparedwithunilateralimplantaDon

•  BilateralimplantaDonprovidesaddiDonalimprovementsinsoundlocalizaDoncomparedwithunilateraldeviceuse.

Pre-Operative

Aided Speech Testing

Word Test

Hearing Aid: 16%

AB = Hearing Aid Both Ears

Post-Operative

Aided Speech Testing

Word Test

CI Right 80%

CI Left 84%

CR = Cochlear Implant Right Ear

CL = Cochlear Implant Left Ear

•  EASOutcomes–SingleCenterStudy

Adunka et al (2013)

Post-Operative -2 years

Aided Speech Testing

Word Test

EAS 90%

CL = Cochlear Implant Left Ear

Pre-Operative

Aided Speech Testing

Word Test

Hearing Aid: 26%

AL = Hearing Aid Left Ear

MedicareandCochlearImplants

MedicareandCochlearImplantaQon•  Federallyfundedhealthinsuranceprogramforpeople65+

• Medicarehasit’sowncriteriaforCICoverage•  Limitedbenefitfromhearingaidswith40%orlesswordsinsentencesinbestaidedineartobeimplanted

• Clinicaltrialallowsupto50%ineartobeimplantedand60%bilaterally

ResearchProject:MedicareCED• ACIAsponsoreddevelopmentofCoveragewithEvidenceDevelopmentstudyapprovedbyMedicare

•  Studyisregisteredonclinicaltrials.gov• hVps://clinicaltrials.gov/ct2/show/NCT02075229• Purpose:ToevaluatesafetyandefficacyofCIsforolderadultsusingexpandedCMScriteria

•  Ifapproved,CMSandFDAguidelineswillbemoreequivalent

CentersinvolvedintheMedicaidStudy

PaQentEligibilityMedicareExpansionStudy•  65yearsofageorolder•  Bilateralmoderate-to-profoundsensorineuralhearinglossinlowfrequencies(upto1000Hz)andprofoundsensorineuralhearinglossinhighfrequencies(3000Hzandabove)

•  Bestaidedsentencescoreinquietbetween40-60%correctonrecordedHINTsentences

•  ScoresexceedcurrentMedicareguidelinebutmeetFDA•  SpokenEnglishasprimarylanguage•  CogniDveabilitytouseauditorycluesandwillingnesstoundergorehabilitaDon

•  NomedicalcontraindicaDonsforsurgery

EvaluaDonofRevisedIndicaDonsforCochlearImplantCandidacyfortheAdultCMSPopulaDon:Resultstodate

HowtogoforwardifyouthinkyoumaybeacandidatefortheMedicareClinicalTrial

•  Manyaudiologistsarehesitanttoreferbasedonearlycandidacycriteriaandunfamiliarityw/CI

•  YourcandidacyisunknownunDlyou’vebeentestedataCIcenter•  StudyaudiologistswillreviewyouraudiogrambeforetheapttodetermineifanevaluaDonisrecommended

•  TypicallypeoplearehappytheywentforanevaluaDon,eveniftheyarenotacandidate,astheyreceiveinformaDon

•  UnlikeahearingevaluaDon,tesDngforCIcandidacyistypicallycoveredbyhealthinsurance(includingMedicare)

Haveyoubeentoldyou’re“notdeafenough”eventhoughyouhavedifficultyhearing?

• Wecanreviewyouraudiogramandgiveyouanideaifyoumightwanttoexplorecandidacyatacenternearyou

•  StudypersonnelcanreviewyourmostrecentaudiogrampriortovisiDng

•  InsurancecoverageisthesameasunderMedicare(thoughitwillnotcovertravel)

• MayreturntoalocalCIcenteraaerfirstyear

BenefitsReportedbyPaQents• RicherrelaDonshipwithfamilyandfriends•  IncreasedconfidenceandeaseofcommunicaDonathomeandwork

• MoresocialopportuniDes• GreateremploymentopportuniDes•  Improvementinqualityoflife

Whyisitwrongtowait?• ToomanypeoplearewaiDng…theaveragedelaybetweenonsetofsevere/profoundhearinglossandCIis10years

• DuraDonofdeafnessisoneofthemostsignificantpredictorsofoutcomeswithaCI:shorterduraDonofdeafnessresultsinbeVeroutcomes

References •  GaylorJM,RamanG,ChungM,LeeJ,RaoM,LauJPoeDS(2013).CochlearimplantaDoninadults:asystemaDcreviewandmeta-analysis.JAMAOtolaryngolHeadNeckSurg.139(3):265-72.

•  AdunkaOF,DillionMT,AdunkaMC,KingER,PillsburgyHC,BuchmanCA(2013).HearingpreservaDonandspeechpercepDonoutcomeswithelectric-acousDcsDmulaDonaaer12monthsoflisteningexperience.Laryngoscope.123(10):2509-15.

•  CMSSTUDYINFORMATIONCONTACT:DonnaSorkin/dsorkin@acialliance.org