CochlearImplanta/oninAdultswithSingle-SidedDeafnesss:Updatefroma

NorthAmericanClinicalTrial

NicholasA.Dewyer,MD;KevinWong,BA;SullivanSmith,BS;SamuelBarber,MD;DanielJ.

Lee,MD

RuthY.Litovsky,PhD;KengMoua,ShellyGodar,AlanKan,SaraMisurelli

Disclosures

•  DanielLeeisapaidconsultantfor:– AuregenBiotherapeu7cs– Storz– FrequencyTherapeu7cs

•  RuthLitovskyhasconsultedforCochlearCorp.•  ThistrialisfinanciallysupportedbyMed-El

Single-SidedDeafness(SSD)

•  36,000–72,000newcasesperyearinUS1•  Func7onaldeficits2– Soundlocaliza7on– Speech-in-noise– Tinnitus– ReducedQOL– Fearoflosingremaininghearing

1.  Baguleyetal.,ClinOtolaryngol,2006.2.  Finkeetal.,IntJAudiol,2017.

TreatmentsforSSD

•  Listeningstrategies

•  CROS

•  BoneConduc7onImplant

•  CochlearImplant– NotFDA-approvedforSSD

PreviousTrialsofCIforSSD

•  MostlydoneoutsideofUS•  Improvementsin:– Tinnitus– Speech-in-noise– Soundlocaliza7on– Qualityoflife

CochlearImplanta7onfortheTreatmentofSingle-SidedDeafness(NCT02532972)

•  Prospec7ve,single-arm,inves7ga7onaldeviceexemp7on•  Med-ElMAESTROCIwithFlex28electrodearray•  Keyinclusioncriteria:– ≥18-years-old– ≥70dBat500,1000,2000Hzinoneearand≤35dBincontralateralear

– Subjec7vereportsof7nnitus– Noretro-cochlearpathologyonCT/MRI

•  Currentlyrecrui7ngsubjects

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

What’sNotableaboutthisTrial?

•  PerformedinUS•  Plantoenroll20subjects•  Thoroughaudiologicalandsurveyassessments•  Sophis7catedsoundlocaliza7onandspeech-in-noisetes7ng– Trackingmovingsoundsource

SoundLocaliza7onTes7ng

•  Sta7onarysoundloca7on•  Star7onaryvs.movingsound•  Movingsounddirec7onandexcursion

StudyProgress

•  9subjectsenrolledandimplanted(Nov2016–Dec2017)– Agerange:26–67years– Dura7onofdeafness:2.7[1–7]years– E7ologies•  7idiopathicsuddenSNHL•  1Ménière’sdisease•  1post-trauma7c

•  1subjectwithdrewaler3months($)•  1subjectwithTMperfora7onbetween3-6monthspost-op

InsurancePaidforTrialCIs

•  8/9subjectshadCIpaidforbyinsurance– Averageco-pay$2,333– UnitedHealth,BlueCross,Aetna,Cigna

PreliminaryResults

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PreliminaryDatafromUW-Madison

PreliminaryDatafromUW-Madison

ThankYou