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Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population

Study acronym: ACE
StatusActive, Not Recruiting
PhaseNot applicable
SponsorCochlear
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date changed from estimate of Apr 2026 to Apr 16, 2026v12
  2. Re-verified, no change to tracked fieldsv11
  3. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 11 to 9
    • Primary completion date: Dec 2025 to Apr 2026
    • Study completion date: Jun 2028 to Oct 2028
    v10
  4. Site details revised at 1 of 11 sitesv9
  5. Site details revised at 1 of 11 sitesv8
Show 6 earlier versionsHide 6 earlier versions
  1. Site details revised at 1 of 11 sitesv7
  2. Site details revised at 2 of 11 sitesv6
  3. Study sites: 10 to 11
    • Collaborators: 2 to 4
    v5
  4. Start date changed from estimate of Aug 2024 to Sep 17, 2024
    • Site details revised at 3 of 10 sites
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jul 2024 to Aug 2024
    • Site details revised at 10 of 10 sites
    v3
  6. Start date: May 2024 to Jul 2024
    • Study sites: 8 to 10
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study aims to evaluate the safety and efficacy of cochlear implantation for adults with bilateral sensorineural hearing loss who currently do not meet the FDA-approved indications for cochlear implantation. Following cochlear implantation, participants will complete speech perception assessments and questionnaires over the course of seven visits.
Trial Details
NCT Number NCT06293482
Lead Sponsor Cochlear
Collaborators: NAMSA, LWB Consulting, Althea Anagnostopoulos Harrington, MV Clinical Research, LLC
Conditions
(from sponsor)		 Hearing Loss, Sensorineural, Hearing Loss, Bilateral
Related terms Hearing Loss, Bilateral, Hearing Loss, Sensorineural
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov