Lumity CI Study - Clinical Evaluation of Next Generation Cochlear Implant Sound Processor
Evaluation of Advanced Bionics Next Generation CI Sound Processor Programmed With Target CI v.1.6 Fitting Software in Adult Users of the HiResolution™ Bionic Ear System
This is a prospective within-subjects repeated-measures study that will enroll 18 bilateral adult users implanted with a HiResolution Bionic Ear System (HiRes 90KTM, HiRes 90K TM Advantage, HiResTM Ultra, HiResTM Ultra 3D and CII with HiFocus electrode).
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
The overall goal of this clinical study is to demonstrate the safety and efficacy of next generation sound processor in users of the HiResolution Bionic Ear System. Speech understanding outcomes are expected to be similar with the new sound processor as compared to the Naída CI M90 processor. Therefore, the study uses a non-inferiority design to demonstrate non-inferiority of the next generation processor, relative to the currently approved Naída CI M90 for sentence understanding in quiet and in noise. Additionally, the features on the new device will be evaluated to demonstrate spatial situational awareness using a localization tasks.
Studietype
Registrering (Faktiske)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Ability to provide Informed Consent
- 18 years of age or older
- Bilateral users of a HiResolution™ Bionic Ear System (HiRes 90K™, HiRes 90K™ Advantage, HiRes™ Ultra, HiRes™ Ultra 3D and CII with HiFocus electrode)
- Willingness to participate in all scheduled procedures outlined in the study investigational plan
- Minimum of 6 months of CI experience for each ear
- At least moderate open-set speech recognition abilities with implant in each individual implanted ear, as defined by achieving a score of ≥ 50% words correct in the AzBio Sentence Test in quiet using a Naída CI M90 research processor
- English language proficiency, as determined by the investigator
- Willingness to use a behind-the-ear research processor for the duration of the study
Exclusion Criteria:
- Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the investigator
- Unwillingness or physical / cognitive inability of subject to comply with all investigational requirements as determined by the investigator
- < 50% words correct AzBio Sentence Test in quiet in either ear using the Naída CI M90 research processor
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Bilateral Users of a HiResolution Bionic Ear System
Control Device followed by experimental Device. |
Device: Naida M90 sound processor programmed with Target CI v1.5 software Device: Next generation sound processor programmed with investigation software |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Speech Recognition in Quiet
Tidsramme: 1 Day
|
The primary objective is to demonstrate that speech recognition in quiet on a Next Generation CI sound processor is no worse than speech recognition in quiet on the currently approved Naída CI M90 processor for speech understanding in quiet. Scores are expressed as a percentage of words correct from 0% to 100% with higher scores indicating a better outcome. During the test the subject will be presented with a minimum of 133 words up to a maximum 159. |
1 Day
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CR0124
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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