Cochlear Implant for Unilateral Hearing Loss

N/A

Recruiting

Led By Jill B Firszt, PhD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

Better ear SSD: PTA at .5, 1, 2, 4 kHz ≤ 25 dB HL; CNC word score at 60 dB SPL ≥ 70%; Stable hearing for the past 6-month period

At least 4 years of age and up to 14 years, 11 months of age and able to complete all investigational procedures

Must not have

Exclusions for cochlear implantation and the CI phase of the study: Cochlear malformation or obstruction that would preclude full insertion of the electrode array in the ear to be implanted

Hearing loss of neural or central origin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 visits pre-implant over a minimum of 4 months and the 3, 6, 9, 12, and 15 month post-implant visits

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a cochlear implant (CI) performs better than a hearing aid (HA) for children with either asymmetric hearing loss (AHL) or single-sided deafness (SSD). The study also looks at whether using a CI in combination with a hearing aid (bimodal hearing) is more effective than using a hearing aid alone.

Who is the study for?

This trial is for children aged 4 to nearly 15 with asymmetric hearing loss (AHL) or single-sided deafness (SSD). They must have a certain level of hearing loss in one ear and be currently using a hearing aid. The better ear must meet specific hearing criteria, depending on whether it's AHL or SSD. Participants need stable hearing, fluency in English, and parents willing to comply with study requirements.

What is being tested?

The study tests how well children with AHL or SSD hear before and after getting a cochlear implant compared to their current performance with a hearing aid. It also looks at the benefits of having both a cochlear implant in one ear and either normal hearing or using a hearing aid in the other.

What are the potential side effects?

While not explicitly listed here, common side effects from cochlear implants can include discomfort around the implant site, ringing in the ears (tinnitus), dizziness, changes in taste sensation, and device malfunction.

Eligibility Criteria

Inclusion Criteria

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

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My hearing in my better ear is good and stable for the last 6 months.

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I am between 4 and 14 years old and can follow the study's procedures.

Exclusion Criteria

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

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My ear structure allows for full cochlear implant electrode insertion.

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I have hearing loss that is not due to ear damage.

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

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I cannot complete all required study procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 visits pre-implant over a minimum of 4 months and the 3, 6, 9, 12, and 15 month post-implant visits

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 visits pre-implant over a minimum of 4 months and the 3, 6, 9, 12, and 15 month post-implant visits

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 visits pre-implant over a minimum of 4 months and the 3, 6, 9, 12, and 15 month post-implant visits for reporting.