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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

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.

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I am over 18 and have normal hearing or use a cochlear implant with some natural hearing.

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I have a cochlear implant and hearing loss in both ears.

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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:

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My cognitive test score is below 26.

Timeline

Screening ~ 3 weeks3 visits

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)

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

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Deafness and Other Communication Disorders (NIDCD)NIH

348 Previous Clinical Trials

180,577 Total Patients Enrolled

Vanderbilt University Medical CenterLead Sponsor

888 Previous Clinical Trials

934,774 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

Cochlear Implants Research Study Groups: Children with Normal Hearing, Adult use of EAS, Pediatric use of EAS, Adults with Normal Hearing

Cochlear Implants 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

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