Ireland
--:--IST
Recruiting Not applicable

Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting

NCT05955469 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-11-05
Last updated
2026-01-20

Condition(s) studied

Sensorineural Hearing Loss, BilateralBilateral Hearing Loss

Investigational drug(s) / intervention(s)

FS4 then TFS4 (cochlear implant)TFS4 then FS4 (cochlear implant)

FS4 then TFS4 (cochlear implant): Cochlear implant with default fitting then with tonotopy-based fitting

TFS4 then FS4 (cochlear implant): Cochlear implant with tonotopy-based fitting then with default fitting

Study summary

Main objective:

For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy (TFS4) to a default fitting strategy (FS4) for the speech recognition in noise.

Secondary objectives:

Comparison of TFS4 to FS4 for speech recognition in quiet. Comparison of TFS4 to FS4 for the auditory skills experienced by the subject.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Speech recognition in noise — at 6 weeks post-activation
    The speech recognition in noise is evaluated with the French Matrix test (Framatrix) \[S. Jansen et al. Comparison of three types of French speech-in-noise tests: a multi-center study. Int J Audiol, 51 (3) (2012), pp. 164-173\].
  • Speech recognition in noise — at 12 weeks post-activation
    The speech recognition in noise is evaluated with the French Matrix test (Framatrix) \[S. Jansen et al. Comparison of three types of French speech-in-noise tests: a multi-center study. Int J Audiol, 51 (3) (2012), pp. 164-173\].

Trial sites (1)

FacilityCityRegionStatus
CHU Saint-Etienne Saint-Etienne France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05955469 on ClinicalTrials.gov ↗ ← All trials in France