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Cochlear Implant Settings for Childhood Hearing Loss

N/A

Waitlist Available

Led By Lisa Park, AuD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

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

Must have

Spoken English as the primary language (speech perception testing conducted in English)

Aged 5 through 17 years

Must not have

Anatomical considerations that necessitated surgical modifications such as ossification, incomplete insertion, or placement in scala vestibuli

Cochlear nerve deficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post-stimulation

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating whether speech perception is better in pediatric cochlear implant (CI) recipients with functional pre-operative hearing when they use the hearing aid alone or combined electric-acoustic stimulation. Two cohorts of CI recipients aged 6 through 17 years will be evaluated.

Who is the study for?

This trial is for children aged 5-17 with certain types of hearing loss who speak English and have realistic expectations. They must be able to participate in tests, have adequate language skills, and received a specific cochlear implant. Those with oral motor delays, cochlear nerve issues, or cognitive impairments that prevent testing are excluded.

What is being tested?

The study compares speech perception in kids with pre-operative low frequency hearing using two methods: one group uses a hearing aid alone (HA-alone), the other combines this with electric-acoustic stimulation (EAS). The goal is to see which method better supports speech understanding.

What are the potential side effects?

While not explicitly stated, potential side effects may include discomfort from wearing devices, possible changes in residual hearing levels due to device use or surgery-related complications.

Eligibility Criteria

Inclusion Criteria

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

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I primarily speak and understand English.

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I am between 5 and 17 years old.

Exclusion Criteria

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

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My surgery was adjusted due to specific physical conditions.

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I have a problem with the nerve that connects my ear to my brain.

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I cannot complete certain tests due to behavioral or thinking problems.

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I struggle to understand speech because of difficulty moving my mouth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post stimulation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post stimulation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post stimulation 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 BKB-SIN SNR-50 Scores

Mean CNC Word Scores

Secondary study objectives

Articulation Scores

Expressive Language Scores

Mean Pediatric SSQ Scores

+1 more

Other study objectives

Percent correct in prosodic identification scores, comparing EAS to CI-Alone conditions in Arm 1 participants

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: FES ArmExperimental Treatment1 Intervention

Subjects with pre-operative low frequency hearing who receive a CI and present with a post-operative LFPTA of \> 75 dB HL. Electric Acoustic Speech Processor: Full-electric stimulation (FES) fitting

Group II: EAS ArmExperimental Treatment1 Intervention

Subjects who receive a CI and present with a post-operative LFPTA of ≤ 75 dB HL. Electric Acoustic Speech Processor: Electric-acoustic stimulation (EAS) fitting.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Electric Acoustic Speech Processor: Electric-acoustic stimulation fitting

2018

N/A

~30

Electric Acoustic Speech Processor: Full-electric stimulation fitting

2018

N/A

~30