Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Comparing two fitting strategies for cochlear implants in patients with hearing loss

Official title: Comparison of a Bimodal Fitting With Synchronization and a Conventional Bimodal Fitting in Newly Implanted Cochlear Patient. Prospective Monocentric Randomized Double-blind Crossover Study.

Run by MED-EL Elektromedizinische Geräte GmbH · NCT05898659 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment20 (estimated)
SponsorMED-EL Elektromedizinische Geräte GmbH
Industry-sponsored
Locations1 site (Nice)
StatusRecruiting
StartedOctober 17, 2023
Main results expectedDecember 15, 2026
Study endsDecember 15, 2026
Registry record updatedJanuary 14, 2026
Trial IDNCT05898659 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older who speak French and meet the criteria for cochlear implantation.

Probably not a fit

Patients with retro-cochlear pathology or significant residual hearing in the contralateral ear may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Previous studies on bimodal hearing strategies have shown promising results, indicating potential benefits in sound perception and quality of life.

Who can join: the full rules

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 it's running

  • 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.