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Electrocochleography for Hearing Loss (AB-ECOG Trial)

N/A

Waitlist Available

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No cochlear abnormality that might prevent full insertion of the CI electrode array

Must not have

Chronic otitis media

Malformed cochlea

Timeline

Screening 3 weeks

Treatment Varies

Follow Up to be collected at post-op clinical visits until 12 months post-op

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how the inner ear responds to sound delivered via a cochlear implant during/after surgery, to help understand how well it performs.

Who is the study for?

This trial is for individuals aged one year and older who meet the standard requirements for cochlear implant surgery, have a specific level of hearing loss, and no ear abnormalities that would interfere with the implant. It's not suitable for those with auditory neuropathy, chronic ear infections, malformed cochlea, ear tubes in place or past middle ear surgeries.

What is being tested?

The study is examining how well the inner ear responds to sounds during and after cochlear implant surgery using a technique called Electrocochleography. This could help understand the effectiveness of cochlear implants post-operation.

What are the potential side effects?

Since this trial involves standard surgical procedures for cochlear implants rather than testing new medications, side effects are likely related to typical risks associated with such surgeries like infection risk or issues related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My inner ear can fully accommodate a cochlear implant electrode.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have long-term ear infections.

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I have a malformed cochlea.

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I have had surgery or injury to my middle ear.

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I have been diagnosed with auditory neuropathy spectrum disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ to be performed within one month of cochlear implantation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~to be performed within one month of cochlear implantation

This trial's timeline: 3 weeks for screening, Varies for treatment, and to be performed within one month of cochlear implantation for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The CI electrode's scalar position as indicated by post-operative computed tomography (CT)

Secondary study objectives

Post-operative hearing performance

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2: Audible ECochG Response OnExperimental Treatment1 Intervention

This condition will have the audible ECochG response on and available to the surgeon. In this condition, the surgeon perform a conventional electrode insertion while listening to the running ECochG signal for drop in amplitude (suggesting impending trauma). If no drop is detected, insertion will proceed to the full electrode length according to the standard-of-care. If an ECochG amplitude drop is observed, the surgeon will place this observation in its clinical context and evaluate insertion parameters, (i.e., insertion vector, insertion speed, etc.), customary practice with conventional CI surgery, but here supplemented by the ECochG response. In the case of an ECochG amplitude drop that does not recover, the standard-of-care practice of achieving a full electrode insertion will be followed.

Group II: Arm 1: Audible ECochG Response OffExperimental Treatment1 Intervention

Arm 1: Audible ECochG Response Off This condition is identical to the current standard-of-care for conventional CI surgery used worldwide. The surgeon will perform his or her electrode insertion without ECochG monitoring. Minute manipulations of the electrode are a normal part of conventional electrode insertion; manipulations such as redirecting the insertion vector or slowing down insertion speed will be made, as deemed necessary by the surgeon. A full electrode insertion will be performed, as appropriate. The ECochG responses will be recorded, but the surgeon will be blinded to this information during surgery.

0 / 5Eligibility criteria met