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Procedure

Cochlear™ Nucleus® System for Sensorineural Hearing Loss (ACE Trial)

N/A
Waitlist Available
Research Sponsored by Cochlear
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36-months post-activation
Awards & highlights

ACE Trial Summary

This trial will assess if cochlear implants are safe and effective for adults with hearing loss in both ears who don't currently meet the criteria for cochlear implantation. Participants will undergo the procedure and then

Who is the study for?
This trial is for adults with bilateral sensorineural hearing loss who don't currently qualify for cochlear implants under FDA guidelines. Participants will be assessed over seven visits after receiving the implant.Check my eligibility
What is being tested?
The study is testing the Cochlear™ Nucleus® System to see if it's safe and works well in improving hearing for those who have significant hearing loss but aren't eligible for current treatments.See study design
What are the potential side effects?
Potential side effects of cochlear implantation may include infection, ringing in the ears, dizziness, taste disturbances, numbness around the ear, and device failure or complications.

ACE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36-months post-activation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36-months post-activation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
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
Number of device and procedure-related adverse events and serious adverse events
Secondary outcome measures
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
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
Mean change on the Tinnitus Handicap Inventory (THI) score at 6-months post-activation compared to preoperative baseline will exceed a 7-point improvement
+4 more

ACE Trial Design

1Treatment groups
Experimental Treatment
Group I: Cochlear™ Nucleus® SystemExperimental Treatment1 Intervention
Participants will be implanted with a commercially approved Cochlear™ Nucleus® implant.

Find a Location

Who is running the clinical trial?

LWB ConsultingUNKNOWN
CochlearLead Sponsor
89 Previous Clinical Trials
5,981 Total Patients Enrolled
NAMSAOTHER
46 Previous Clinical Trials
18,782 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the anticipated results that researchers hope to achieve through this experimental investigation?

"The principal aim of this clinical investigation, to be evaluated approximately 6 months after initiation, is the average alteration in aided word recognition under unilateral CI alone auditory settings at the 6-month juncture following activation contrasted against the pre-surgical baseline while utilizing a singular assisted hearing setting for the ear slated for implantation. Additional aspirations involve determining the percentage of individuals exhibiting an increment score of +1 or more on the Speech, Spatial and Qualities of Hearing Scale (SSQ12) at 6 months post-activation relative to their initial state before surgery. The SSQ12 serves as a self-reported survey devised to gauge audiological"

Answered by AI

How many medical facilities are currently conducting this research trial?

"Patient enrollment is open at prestigious institutions such as New york University in New York, Florida's University of Miami in Coral Gables, and the Barrow Neurological Institute in Phoenix, Arizona. Additionally, recruitment is ongoing at 8 other healthcare facilities."

Answered by AI

Are there ongoing efforts to actively enroll participants for this clinical trial?

"Per clinicaltrials.gov, this particular research endeavor is not presently seeking subjects. Originally shared on May 1st, 2024, it was last revised on February 28th of the same year. Although recruitment has ceased for this trial, there are currently 170 other studies actively enrolling participants."

Answered by AI

Who else is applying?

What site did they apply to?
Midwest Ear Institute
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

because I have hearing loss in the right side.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population
2024. "Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06293482.
All > Sensorineural Hearing Loss
~33 spots leftby Dec 2025
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