Clinical Trial

Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population

Study acronym: ACE
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2024-02-28; most recent amendment 2026-06-01.
Status change: Recruiting → Active, Not Recruiting 2025-10-08
Status change: Not Yet Recruiting → Recruiting 2024-08-12
Trial Details
NCT Number NCT06293482
Lead Sponsor Cochlear
Collaborators: NAMSA, LWB Consulting, Althea Anagnostopoulos Harrington, MV Clinical Research, LLC
Conditions Hearing Loss, Sensorineural, Hearing Loss, Bilateral
Enrollment 50 participants
Start Date 2024-09-17
Primary Completion 2026-04-16 (estimated)
Study Completion 2028-10 (estimated)
Updated on ClinicalTrials.gov 2026-06-03