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A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults

Study acronym: ELEVATE
StatusActive, Not Recruiting
PhaseNot applicable
SponsorCochlear
Started
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Record History

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  1. Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 5 of 7 entries
    • Site details revised at 11 of 11 sites
  2. Site details revised at 2 of 11 sitesv12
  3. Site details revised at 1 of 11 sitesv11
  4. Site details revised at 1 of 11 sitesv10
  5. Start date changed from estimate of Apr 2026 to Apr 3, 2026
    • Site details revised at 6 of 11 sites
    v9
Show 4 earlier versionsHide 4 earlier versions
  1. Site details revised at 1 of 11 sitesv8
  2. Site details revised at 1 of 11 sitesv7
  3. Site details revised at 1 of 11 sitesv6
  4. Re-verified, no change to tracked fieldsv5
  1. Recruitment opened
    • Study sites revised (11)
    v4
  2. Site contacts updated at 1 of 11 sitesv3
  3. Study sites: 1 to 11v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Cochlear
28 trials monitored
See all monitored trials
This pivotal study examines the clinical efficacy and safety of an investigational totally implantable cochlear implant (TICI) system. The system includes a microphone placed under the skin to detect speech and sound from the environment, providing the option to hear without any visible external parts. This study will involve adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve (the nerve that carries sound signals from the ear to the brain). Participants will complete hearing tests and questionnaires to evaluate how well the system works and how it affects their daily life.
Trial Details
NCT Number NCT07287124
Lead Sponsor Cochlear
Conditions
(from sponsor)		 Hearing Loss, Bilateral Sensorineural
Related terms Hearing Loss
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov