Understanding how cochlear implants affect hearing in children and adults
Development and Assessment of Listener-tailored Programming for Cochlear Implant Listeners
This study is trying to see how cochlear implants help both children and adults hear better and how they adjust to the changes over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 3 Months and up |
| Sex | All |
| Sponsor | Massachusetts Eye and Ear Infirmary Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT05867173 on ClinicalTrials.gov |
What this trial studies
This project aims to explore the effects of cochlear implants on the auditory system in both children and adults. It focuses on improving programming methods for cochlear implants and studying the adaptation process of listeners to new programming over time. By analyzing how cochlear implants influence speech perception outcomes, the study seeks to enhance clinical practices and ultimately improve hearing results for users. The research involves experimental speech processing strategies tailored to individual needs.
Who should consider this trial
Good fit: Ideal candidates include adults and children aged 6 months and older who are native speakers of American English and use specific cochlear implant models.
Not a fit: Patients who cannot provide informed consent or do not meet specific inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved hearing outcomes for cochlear implant users.
How similar studies have performed: Other studies have shown promise in improving cochlear implant outcomes through tailored programming approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Research Subjects with a Cochlear Implant ADULTS Inclusion Criteria * Adult at least 18 years old * Native speakers of American English * Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer), Cochlear, or MED-EL CHILDREN Inclusion Criteria * Children at least 3 months old * Native speakers of American English * Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer), Cochlear, or MED-EL * For both children and adults with a cochlear implant, some study criteria might pertain to a subset of subjects, such as a specific age at which the subjects developed a hearing loss, or was implanted. Exclusion Criteria: Exclusion for all Cochlear Implant Subjects: * Inability to provide informed consent * Does not meet the inclusion criteria for a specific study protocol, such as age of onset of hearing loss, age of cochlear implantation, duration of deafness, number of active electrodes in the cochlear implant device * Unable to carry out the study protocol or tasks required in the study Exclusion for all Normal Hearing Subjects: * Inability to provide informed consent * Hearing loss, or significant history of hearing related issues * Unable to carry out the study protocol or tasks required in the study
Where this trial is running
Boston, Massachusetts and 1 other locations
- Mass Eye and Ear — Boston, Massachusetts, United States (Recruiting)
- Boston Children's Hospital — Waltham, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Julie Arenberg — Massachusetts Eye and Ear
- Study coordinator: Julie Arenberg
- Email: julie_arenberg@meei.harvard.edu
- Phone: 617-807-7904
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.