Cochlear Implants for Hearing Loss (ACE Trial)

N/A

Recruiting

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

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36-months post-activation

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

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