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Procedure

Electrocochleography Monitoring for Hearing Loss Preservation During Cochlear Implant Surgery

N/A

Recruiting

Led By Amanda Ortmann, PhD

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

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

Must have

Severe to profound mid to high-frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, and 4000 Hz ≥75 dB HL) in the ear to be implanted

Limited benefit from conventional amplification in the best aided condition as defined by test scores

Must not have

Unwillingness or inability to comply with all investigational requirements including the randomization process

Medical condition contraindicated for surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, 12, 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a monitoring system during cochlear implant surgery can help preserve residual hearing.

Who is the study for?

This trial is for adults aged 18-79 with severe to profound sensorineural hearing loss who have had limited benefit from hearing aids. They must be proficient in English, willing to complete study visits, and not have prelingual deafness or inner ear abnormalities. Candidates should not have had a previous cochlear implant and must be getting an implant from Cochlear Limited or Advanced Bionics AG.

What is being tested?

The study tests if using electrocochleography during cochlear implant surgery can help preserve residual hearing. It's a randomized trial across multiple centers where participants are chosen by chance to receive this monitoring technique while being implanted.

What are the potential side effects?

While the document does not specify side effects related to electrocochleography, typical risks of cochlear implants include loss of residual hearing, infection, tinnitus, nerve injury, dizziness or balance problems.

Eligibility Criteria

Inclusion Criteria

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

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I have severe hearing loss in the high-frequency range in one ear.

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Hearing aids don't help me much, according to tests.

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I have severe hearing loss in the high-frequency range in one ear.

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I am between 18 and 79 years old with hearing loss that occurred after learning to speak.

Exclusion Criteria

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

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I am willing and able to follow all study requirements.

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I have a health condition that makes surgery unsafe for me.

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I have been diagnosed with auditory neuropathy spectrum disorder.

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I have a nerve-related ear condition, like a tumor or stroke.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, 12, 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6, 12, 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 12, 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Preservation Advantage

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

Active Control

Group I: ECochG monitoringExperimental Treatment1 Intervention

For those randomized to the experimental group, the CI surgery will proceed in a standard fashion. However, the surgeon will utilize ECochG-guided monitoring by placing the external device coil and processor over the receiver/stimulator of the implanted components. Also, a sound applicator (i.e. speaker) will be placed in the external auditory canal by the surgeon. During electrode insertion the surgeon will utilize the ECochG feedback to adjust insertion if needed. That is, once the electrode has been inserted at least 75% (75% of the electrode contacts inside the cochlea), the surgeon may proceed to full insertion if indicated during ECochG feedback or may modify and/or cease electrode insertion if indicated by the ECochG feedback in attempts to preserve RH.

Group II: Control GroupActive Control1 Intervention

For those randomized to the control group, they will receive their CI per the standard of care. That is, all procedures that take place during a routine CI surgery will be the same for those in the control group. As such, no ECochG monitoring will be performed. However, all study surgeons will be asked to adhere to soft surgical principles (non-traumatic cochlear opening, slow electrode insertions) to enhance HP outcomes even in the absence of intraoperative ECochG monitoring. Further, the standard of care for cochlear implantation is to perform full electrode insertions with all electrode contacts inside of the cochlea. Thus, for subjects in the control group, surgeons will be asked to perform full electrode insertions.

0 / 8Eligibility criteria met