Comparing two fitting strategies for cochlear implants in patients with hearing loss
Comparison of Speech Understanding Between a Tonotopy-based Bimodal Fitting and a Default Bimodal Fitting in Newly Cochlear-implanted Patients: a Double-blind Randomized Crossover Study.
This study is testing two different ways to set up cochlear implants for people with hearing loss to see which one helps them understand speech better in noisy places.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MED-EL Elektromedizinische Geräte GesmbH Industry-sponsored |
| Locations | 1 site (Saint-Etienne) |
| Trial ID | NCT05955469 on ClinicalTrials.gov |
What this trial studies
This study aims to compare a tonotopy-based fitting strategy (TFS4) with a conventional fitting strategy (FS4) in patients receiving cochlear implants combined with hearing aids. The primary focus is on assessing speech recognition in noisy environments, while secondary objectives include evaluating performance in quiet settings and overall auditory skills. The study seeks to address the variability in outcomes experienced by bimodal users by optimizing the frequency matching between the cochlear implant and the hearing aid. Participants will undergo both fitting strategies to determine which provides better auditory outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are French speakers and meet the criteria for cochlear implantation.
Not a fit: Patients with retro-cochlear pathologies or significant residual hearing in the contralateral ear may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance speech recognition and overall auditory experience for patients using cochlear implants and hearing aids.
How similar studies have performed: While there is variability in outcomes for bimodal users, this approach is innovative and aims to improve existing fitting strategies, suggesting potential for success based on previous findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient (\>= 18 years old) speaking French * Patient who fulfils the criteria for cochlear implantation Exclusion Criteria: * retro-cochlear pathology: auditory neuropathy, vestibular schwannoma * patient with residual hearing \< 70 dB hearing level (HL) at 500 Hz and 1000 Hz on the contralateral ear
Where this trial is running
Saint-Etienne
- CHU Saint-Etienne — Saint-Etienne, France (Recruiting)
Study contacts
- Principal investigator: Alexandre Karkas, Pr — Centre Hospitalier Universitaire de Saint Etienne
- Study coordinator: Vincent Péan, PhD
- Email: vincent.pean@medel.com
- Phone: 0603592974
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.