Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population
ACE
A Pivotal, Prospective, Open-label, Multi-center Study of Safety and Effectiveness of Cochlear Implantation in an Expanded Population of Adults With Bilateral Sensorineural Hearing Loss
1 other identifier
interventional
50
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2024
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2024
CompletedFirst Posted
Study publicly available on registry
March 5, 2024
CompletedStudy Start
First participant enrolled
September 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
ExpectedApril 13, 2026
April 1, 2026
1.5 years
February 28, 2024
April 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of device and procedure-related adverse events and serious adverse events
Events will be summarized by type, frequency, and severity.
6-months post-activation
Mean change on aided word recognition in the unilateral CI alone listening condition at 6 months post-activation compared to pre-operative baseline in the unilateral aided listening condition for the ear to be implanted
The CNC word recognition test (for English speakers) and Spanish Bisyllabic word test (for Spanish speakers) will be administered in quiet at a level equal to 60dBA in the sound field. The tests will be scored as total number of words correct, which will be expressed as a percentage correct for this study.
Pre-operative baseline, 6 months post-activation
Mean change on AzBio sentences in noise at 6 months post-activation in the everyday listening condition compared to pre-operative performance in the everyday listening condition
The AzBio sentence test (for English speakers) and the Spanish AzBio sentence test (for Spanish speakers) will be utilised. These are validated tests to assess the open-set sentence recognition in quiet or in the presence of competing noise. For this study, the target sentences will be presented at a fixed level of 65dBA starting at a +10 dB signal-to-noise ratio using multi-talker babble as the competing signal. Each word in the sentence counts towards the overall score, which will be expressed as a percent correct for this study.
Pre-operative baseline, 6 months post-activation
Secondary Outcomes (7)
Number of device and procedure related adverse events and serious adverse events
36-Months post-activation
Proportion of participants who demonstrate a change score of +1 or greater on the Speech, Spatial and Qualities of Hearing Scale (SSQ12) at 6-months post-activation compared to preoperative baseline
Pre-operative baseline, 6 months post-activation
Mean change on the Tinnitus Handicap Inventory (THI) score at 6-months post-activation compared to preoperative baseline will exceed a 7-point improvement
Pre-operative baseline, 6 months post-activation
Mean change on aided word recognition in the unilateral CI alone listening condition at 3 months post activation compared to pre-operative baseline in the unilateral aided listening condition for the ear to be implanted
Pre-operative baseline, 3 months post-activation
Mean change on AzBio sentences in noise at 3 months post-activation in the everyday listening condition compared to pre-operative performance in the everyday listening condition
Pre-operative baseline, 3 months post-activation
- +2 more secondary outcomes
Study Arms (1)
Cochlear™ Nucleus® System
EXPERIMENTALParticipants will be implanted with a commercially approved Cochlear™ Nucleus® implant.
Interventions
The Cochlear™ Nucleus ® System is a commercially available system intended for restoration of hearing sensation through electrical stimulation of the auditory nerve in adult patients with bilateral symmetrical sensorineural hearing loss.
Eligibility Criteria
You may qualify if:
- Individuals 18 or older at the time of consent
- Meets the following audiometric criteria for the ear to be implanted: clinically established sensorineural hearing loss (SNHL) defined by a four frequency pure tone average (PTA) at 500, 1000, 2000, \& 4000 Hz of: ≥60 dB HL and compromised functional hearing in the aided condition defined as \<50% correct on a word recognition test
- Meets the following audiometric criteria for the non-implanted contralateral ear: clinically established SNHL defined by a four frequency PTA at 500, 1000, 2000, \& 4000 Hz of \>30 dB HL
- Candidate is a fluent speaker in the language used to assess speech perception performance as determined by the investigator.
- Willing and able to provide written informed consent.
You may not qualify if:
- Meets current indications on audiometric thresholds for traditional adult CI candidates (i.e., bilateral moderate to profound hearing loss in the low frequencies and profound \[≥ 90 dB HL\] hearing loss in the mid to high speech frequencies)
- Absence of cochlea development or a cochlear nerve
- Presence of active middle ear infection in the ear to be implanted
- Tympanic membrane perforation in the presence of active middle ear disease in the ear to be implanted
- Medical or psychological conditions that contraindicate general anaesthesia, surgery, or participation in the clinical investigation.
- Existing contralateral cochlear implant or medical plan to implant a contralateral cochlear implant during the clinical investigation.
- Pregnant or breastfeeding women. Women who plan to become pregnant during the course of the clinical investigation.
- Unrealistic expectations on the part of the participant, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the investigator.
- Additional disabilities that may affect the participant's participation of safety during the clinical investigation.
- Unable or unwilling to comply with all of the requirements of the clinical investigation as determined by the investigator.
- Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- Employees of Cochlear.
- Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cochlearlead
- NAMSAcollaborator
- LWB Consultingcollaborator
- Althea Anagnostopoulos Harringtoncollaborator
- MV Clinical Research, LLCcollaborator
Study Sites (9)
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
Centre for Neurosciences
Tucson, Arizona, 85718, United States
Pacific Neuroscience Institute
Santa Monica, California, 90404, United States
University of Miami
Coral Gables, Florida, 33146, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Midwest Ear Institute
Kansas City, Missouri, 64111, United States
New York University
New York, New York, 10016, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Pennsylvania Hospitals
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2024
First Posted
March 5, 2024
Study Start
September 17, 2024
Primary Completion
April 1, 2026
Study Completion (Estimated)
October 1, 2028
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.