cochlear implanta/on in adults with single-sided deafnesss: … · 2018-04-03 · • 1...
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CochlearImplanta/oninAdultswithSingle-SidedDeafnesss:Updatefroma
NorthAmericanClinicalTrial
NicholasA.Dewyer,MD;KevinWong,BA;SullivanSmith,BS;SamuelBarber,MD;DanielJ.
Lee,MD
RuthY.Litovsky,PhD;KengMoua,ShellyGodar,AlanKan,SaraMisurelli
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Disclosures
• DanielLeeisapaidconsultantfor:– AuregenBiotherapeu7cs– Storz– FrequencyTherapeu7cs
• RuthLitovskyhasconsultedforCochlearCorp.• ThistrialisfinanciallysupportedbyMed-El
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Single-SidedDeafness(SSD)
• 36,000–72,000newcasesperyearinUS1• Func7onaldeficits2– Soundlocaliza7on– Speech-in-noise– Tinnitus– ReducedQOL– Fearoflosingremaininghearing
1. Baguleyetal.,ClinOtolaryngol,2006.2. Finkeetal.,IntJAudiol,2017.
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TreatmentsforSSD
• Listeningstrategies
• CROS
• BoneConduc7onImplant
• CochlearImplant– NotFDA-approvedforSSD
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PreviousTrialsofCIforSSD
• MostlydoneoutsideofUS• Improvementsin:– Tinnitus– Speech-in-noise– Soundlocaliza7on– Qualityoflife
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CochlearImplanta7onfortheTreatmentofSingle-SidedDeafness(NCT02532972)
• Prospec7ve,single-arm,inves7ga7onaldeviceexemp7on• Med-ElMAESTROCIwithFlex28electrodearray• Keyinclusioncriteria:– ≥18-years-old– ≥70dBat500,1000,2000Hzinoneearand≤35dBincontralateralear
– Subjec7vereportsof7nnitus– Noretro-cochlearpathologyonCT/MRI
• Currentlyrecrui7ngsubjects
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CIfortheTreatmentofSSD:OutcomeMeasures
Pre-opand3,6,and12monthspost-ac/va/on:
• Soundfieldthresholds• Wordrecogni7on• Subjec7vemeasures
– Tinnitussuppression– Qualityoflife
• SF-36• HHI/THI• APHAB• SpeechandSpa7alQuali7esofHearing
Pre-opand12monthspost-ac/va/on:• Soundlocaliza7on• Speech-in-noise
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What’sNotableaboutthisTrial?
• PerformedinUS• Plantoenroll20subjects• Thoroughaudiologicalandsurveyassessments• Sophis7catedsoundlocaliza7onandspeech-in-noisetes7ng– Trackingmovingsoundsource
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SoundLocaliza7onTes7ng
• Sta7onarysoundloca7on• Star7onaryvs.movingsound• Movingsounddirec7onandexcursion
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StudyProgress
• 9subjectsenrolledandimplanted(Nov2016–Dec2017)– Agerange:26–67years– Dura7onofdeafness:2.7[1–7]years– E7ologies• 7idiopathicsuddenSNHL• 1Ménière’sdisease• 1post-trauma7c
• 1subjectwithdrewaler3months($)• 1subjectwithTMperfora7onbetween3-6monthspost-op
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InsurancePaidforTrialCIs
• 8/9subjectshadCIpaidforbyinsurance– Averageco-pay$2,333– UnitedHealth,BlueCross,Aetna,Cigna
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PreliminaryResults
0 3 6 9 1 20
2 0
4 0
6 0
8 0
W R S in C I e a r
m o n th s p o s t-o p
CN
C (
%)
0 3 6 9 1 20
2 0
4 0
6 0
8 0
1 0 0
T in n itu s
m o n th s p o s t-o p
Tin
nitu
s H
an
dic
ap
In
ven
tory
(T
HI)
0 3 6 9 1 20
2 0
4 0
6 0
8 0
1 0 0
S u b je c tiv e H e a rin g H a n d ic a p
m o n th s p o s t-o p
He
ari
ng
Ha
nd
ica
p I
nve
nto
ry (
HH
I)
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PreliminaryDatafromUW-Madison
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PreliminaryDatafromUW-Madison
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ThankYou