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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)
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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
Find a Location
Who is running the clinical trial?
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
330 Previous Clinical Trials
178,311 Total Patients Enrolled
56 Trials studying Hearing Loss
19,993 Patients Enrolled for Hearing Loss
Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
672,033 Total Patients Enrolled
5 Trials studying Hearing Loss
94 Patients Enrolled for Hearing Loss
Rene H Gifford, PhDPrincipal InvestigatorVanderbilt University Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to use and track my hearing aid and cochlear implant usage.I am over 18 and have normal hearing or use a cochlear implant with some natural hearing.I have a cochlear implant and hearing loss in both ears.If you have a cochlear implant, the hearing in your non-implanted ear must be at least mildly impaired. Participants with normal hearing in one ear will not be included.My cognitive test score is below 26.Everyone's thinking and memory skills need to be at the same level, and adults also need to pass a test to check their memory and thinking skills.If you have a cochlear implant, the hearing test results for low-pitched sounds must be less than or equal to 80 decibels in both ears.Your nonverbal intelligence score is less than 85.You have a condition like autism, hearing nerve problems, a brain disorder, or difficulty thinking clearly that might affect the study results.I am a child aged 5-17 with normal hearing or have a cochlear implant.
Research Study Groups:
This trial has the following groups:- Group 1: Children with Normal Hearing
- Group 2: Adult use of EAS
- Group 3: Pediatric use of EAS
- Group 4: Adults with Normal Hearing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate figure of individuals participating in this research?
"Indeed, clinicaltrials.gov attests that this clinical trial is presently in the process of recruiting participants. The investigation was initially posted on July 20th 2023 and revised most recently on July 31st 2023. At least 160 patients are sought from 1 site for enrollment."
Answered by AI
Are there any openings for participation in this research endeavor?
"Affirmative. Clinicaltrials.gov hosts data that suggests this medical study has been recruiting patients since its posting on July 20th, 2023 with the latest edits made to it being on July 31st of the same year. Currently, 160 participants are required from a single clinical site."
Answered by AI
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