Electrocochleography for Hearing Loss
(AB-ECOG Trial)

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Medical College of Wisconsin

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?The purpose of this study is to see how the inner ear responds to sound delivered to the ear canal during and after your cochlear implant surgery. This information may be helpful in telling us how well a cochlear implant performs after surgery.

Eligibility Criteria

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.

Inclusion Criteria

You can hear sounds at certain frequencies with a volume of 80 decibels or less.

No additional handicap that would prevent study procedures from being followed

I am at least one year old.

+2 more

Exclusion Criteria

I have long-term ear infections.

I have a malformed cochlea.

You have ear tubes in your ears.

+2 more

Participant Groups

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.

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.