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

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

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  1. Re-verified, no change to tracked fieldsv10
  2. Trial status changed: Recruiting → Active, Not Recruiting
    • Site details revised at 8 of 8 sites
    v9
  3. Site details revised at 2 of 8 sitesv8
  4. Site details revised at 1 of 8 sitesv7
  5. Site details revised at 1 of 8 sitesv6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 5 to 8v5
  2. Secondary endpoints: details revised at 2 of 8 entriesv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2025 to Dec 1, 2025
    • Site details revised at 5 of 5 sites
    v3
  4. Secondary endpoints revised (8)v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 clinical study examines the performance of an investigational totally implantable cochlear implant (TICI) system. The system includes an implantable microphone under the skin to detect speech and sound from the environment allowing the option to hear without the need of an external sound processor. This implant will be tested in 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). The study participants will undergo a series of tests that include testing their implant and their hearing. They will also complete questionnaires to see how they rate their hearing and overall general health.
Trial Details
NCT Number NCT07139327
Lead Sponsor Cochlear
Conditions
(from sponsor)		 Hearing Loss, Bilateral Sensorineural
Related terms Hearing Loss, Hearing Loss, Sensorineural
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov