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

NCT05955469 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-01-20

No results posted yet for this 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.

Conditions

  • Sensorineural Hearing Loss, Bilateral
  • Bilateral Hearing Loss

Interventions

DEVICE

FS4 then TFS4 (cochlear implant)

Cochlear implant with default fitting then with tonotopy-based fitting

DEVICE

TFS4 then FS4 (cochlear implant)

Cochlear implant with tonotopy-based fitting then with default fitting

Sponsors & Collaborators

  • MED-EL Elektromedizinische Geräte GesmbH

    lead INDUSTRY

Principal Investigators

  • Alexandre Karkas, Pr · Centre Hospitalier Universitaire de Saint Etienne

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-05
Primary Completion
2027-01-01
Completion
2027-01-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05955469 on ClinicalTrials.gov