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 Speech Understanding Between a Tonotopy-based Bimodal Fitting and a Default Bimodal Fitting in Newly Cochlear-implanted Patients: a Double-blind Randomized Crossover Study.

Run by MED-EL Elektromedizinische Geräte GmbH · NCT05955469 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment20 (estimated)
SponsorMED-EL Elektromedizinische Geräte GmbH
Industry-sponsored
Locations1 site (Saint-Etienne)
StatusRecruiting
StartedNovember 5, 2024
Main results expectedJanuary 1, 2027
Study endsJanuary 1, 2027
Registry record updatedJanuary 20, 2026
Trial IDNCT05955469 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

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

Probably not a fit

Patients with retro-cochlear pathologies 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 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.

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 gone: 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.

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

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 it's running

  • 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

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.