candidacy and outcomes for cis and hybrids
TRANSCRIPT
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/[email protected]