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Procedure

Cochlear Implant + Hearing Aid for Hearing Loss

N/A
Recruiting
Led By Rene H Gifford, PhD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willingness to use EAS technology in the implanted ear(s) to be verified via data logging from cochlear implant and hearing aid software
Adults aged 18+ years with either normal hearing (n=40) or at least 1 CI and binaural low-frequency acoustic hearing (n=40)
Must not have
MoCA or HI-MoCA score < 26 for adult participants
Timeline
Screening 3 weeks
Treatment Varies
Follow Up this will be measured at multiple time points including at or within 1 month of eas activation (adults & peds), 6 months (adults & peds), 12 months (adults & peds, and 24 months (peds)
Awards & highlights
No Placebo-Only Group

Summary

This trial studies the benefits of cochlear implants for hearing impaired adults and children, restoring their ability to hear with electric & acoustic hearing in the same ear.

Who is the study for?
This trial is for children (5-17 years) and adults (18+ years) with hearing loss who can benefit from a cochlear implant combined with a hearing aid in the same ear. Participants must have some low-frequency hearing left, be willing to use EAS technology, and have typical cognitive abilities. Adults should not have single-sided deafness or any confounding diagnoses like autism or general cognitive impairment.
What is being tested?
The study tests Electric Acoustic Stimulation (EAS), which combines a cochlear implant with a hearing aid in one ear, aiming to improve speech understanding and spatial hearing. It will compare the benefits of EAS in both children and adults against those using only standard cochlear implants.
What are the potential side effects?
While specific side effects are not listed for this trial, generally speaking, risks may include surgical complications from the cochlear implant procedure, skin irritation from wearing devices, potential over-amplification of sound causing discomfort or additional hearing damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to use and track my hearing aid and cochlear implant usage.
Select...
I am over 18 and have normal hearing or use a cochlear implant with some natural hearing.
Select...
I have a cochlear implant and hearing loss in both ears.
Select...
I am a child aged 5-17 with normal hearing or have a cochlear implant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cognitive test score is below 26.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~this will be measured at multiple time points including at or within 1 month of eas activation (adults & peds), 6 months (adults & peds), 12 months (adults & peds, and 24 months (peds)
This trial's timeline: 3 weeks for screening, Varies for treatment, and this will be measured at multiple time points including at or within 1 month of eas activation (adults & peds), 6 months (adults & peds), 12 months (adults & peds, and 24 months (peds) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in BEL sentence score demonstrating EAS benefit for speech recognition in noise (CIHA+HA - CI+HA)
Change in BKB-SIN score demonstrating EAS benefit for speech recognition in noise (CIHA+HA - CI+HA)
Secondary study objectives
EAS benefit for minimal audible angle (MAA) (CIHA+HA - CI+HA)
ILD sensitivity
ITD sensitivity

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Pediatric use of EASExperimental Treatment1 Intervention
Clinical intervention; Children with CI and the fitting of electric and acoustic stimulation (EAS) technology in the implanted ear(s).
Group II: Adult use of EASExperimental Treatment1 Intervention
Clinical intervention; Adults with CI and the fitting of electric and acoustic stimulation (EAS) technology in the implanted ear(s).
Group III: Children with Normal HearingActive Control1 Intervention
Children with normal hearing; acoustic only
Group IV: Adults with Normal HearingActive Control1 Intervention
Adult with normal hearing; acoustic only

Find a Location

Who is running the clinical trial?

National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
353 Previous Clinical Trials
181,317 Total Patients Enrolled
1 Trials studying Neonatal Hearing Loss
236 Patients Enrolled for Neonatal Hearing Loss
Vanderbilt University Medical CenterLead Sponsor
902 Previous Clinical Trials
938,341 Total Patients Enrolled
Rene H Gifford, PhDPrincipal InvestigatorVanderbilt University Medical Center

Media Library

Electric and acoustic stimulation (EAS) technology (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05923203 — N/A
Neonatal Hearing Loss Research Study Groups: Children with Normal Hearing, Adult use of EAS, Pediatric use of EAS, Adults with Normal Hearing
Neonatal Hearing Loss Clinical Trial 2023: Electric and acoustic stimulation (EAS) technology Highlights & Side Effects. Trial Name: NCT05923203 — N/A
Electric and acoustic stimulation (EAS) technology (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05923203 — N/A
~103 spots leftby Jun 2028
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