Comparing two fitting strategies for cochlear implants in patients with hearing loss
Comparison of a Bimodal Fitting With Synchronization and a Conventional Bimodal Fitting in Newly Implanted Cochlear Patient. Prospective Monocentric Randomized Double-blind Crossover Study.
This study is testing two different ways to set up cochlear implants and hearing aids together to see which helps adults with hearing loss hear better in noisy situations.
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 (Nice) |
| Trial ID | NCT05898659 on ClinicalTrials.gov |
What this trial studies
This study aims to compare two tonotopy-based fitting strategies for bimodal hearing, which involves using a cochlear implant alongside a hearing aid. One strategy includes synchronization between the devices, while the other does not. The primary focus is on evaluating the accuracy of sound localization, speech perception in noise, and overall auditory skills experienced by the subjects. The study will involve adult patients who meet the criteria for cochlear implantation and have experienced total hearing loss for less than five years.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who speak French and meet the criteria for cochlear implantation.
Not a fit: Patients with retro-cochlear pathology 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 sound localization and speech perception for patients using cochlear implants and hearing aids.
How similar studies have performed: Previous studies on bimodal hearing strategies have shown promising results, indicating potential benefits in sound perception and quality of life.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient (\>= 18 years old) speaking French * Patient who fulfils the criteria for cochlear implantation * Total hearing loss for less than 5 years Exclusion Criteria: * retro-cochlear pathology: auditory neuropathy, vestibular schwannoma * patient with residual hearing \< 70 dB hearing level (HL) at 250 Hz and 500 Hz and \< 80 dB HL at 1000 Hz on the contralateral ear
Where this trial is running
Nice
- CHU Nice — Nice, France (Recruiting)
Study contacts
- Principal investigator: Nicolas Guevara, Pr — Nice University Hospital
- 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.