A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults

Sponsor
Cochlear
Study ID
NCT07338864
Status
Not Yet Recruiting

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Conditions

  • Hearing Implants
  • Hearing Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cochlear Nucleus Nexa Cochlear implant (CI1032) — DEVICE
    Participants will be implanted with a CI1032 cochlear implant as determined by the treating clinician
  • Cochlear Nucleus Nexa Cochlear implant (CI1022) — DEVICE
    Participants will be implanted with a CI1022 cochlear implant as determined by the treating clinician
  • Cochlear Nucleus Nexa Cochlear implant (CI1012) — DEVICE
    Participants will be implanted with a CI1012 cochlear implant as determined by the treating clinician

Study Details

The aim of this clinical investigation is to demonstrate the performance, clinical benefit and safety of commercial cochlear implant systems. Speech performance and subjective hearing results, and comparison with cochlear implant results available in literature, is intended to demonstrate the performance and clinical benefit of the cochlear implant systems investigated in this study.

Key Dates

First listed
Jan 14, 2026
Start date
May 31, 2026
Status verified
Mar 2026
Primary completion
May 31, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
66 participants (estimated)

Arms

  • Arm: Cochlear implant (CI1032)
    Participants implanted with a CI1032
  • Arm: Cochlear implant (CI1022)
    Participants implanted with a CI1022
  • Arm: Cochlear implant (CI1012)
    Participants implanted with a CI1012

Primary Outcome Measure

Mean within-participant change in the word recognition score in quiet [ Time Frame: Preimplantation to 6 months post-activation ]

Central Contacts

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