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

October 18, 2023 updated by: MED-EL Elektromedizinische Geräte GesmbH

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction:

Cochlear implantation allows the rehabilitation of profound bilateral deafness, restoring speech perception and verbal communication when the traditional hearing aid no longer provides satisfactory hearing gain. A cochlear implant includes an electrode array and its functioning is based on the principle of cochlear tonotopy: Each electrode encodes a frequency spectrum according to its position in the cochlea (high frequencies are assigned to the basal electrodes and low frequencies to the apical electrodes). The cochlear implant thus breaks down the frequency spectrum into a number of frequency bands via bandpass filters corresponding to the number of electrodes in the implant. During the fitting these bands can be modified by the audiologist.

Bimodal hearing refers to the use of a CI in one ear with a HA on the contralateral side. This association allows for adults and children a better perception of speech in quiet and in noise, a better perception of music, hearing comfort, better sound quality, better localization of sound and, consequently, a better quality of life compared to unilateral CI alone. However, there is great variability in the integration process; while some bimodal users show substantial benefits, others receive little or no benefit.

This variability could be due to the mismatch of frequencies (tonotopic shift) between the CI and the contralateral HA.

Recently MED-EL has developed an "anatomy-based fitting" (ABF) strategy based on the tonotopy that allows, from a postoperative scanner, to calculate the theoretical characteristic frequency of neurons stimulated by each electrode contact and to transmit this information to the fitting software of the CI.

This strategy (TFS4) could therefore allow a better integration of information in bimodal hearing and in particular improve the speech recognition in noise compared to a default strategy (FS4).

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.

Plan of the study:

It is a prospective open monocentric randomized crossover study: Measures will be done on the patient at 6 weeks and 12 weeks post-activation.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FS4 then TFS4
Cochlear Implant with FS4 first during 6 weeks then with TFS4 during 6 weeks
Device: FS4 then TFS4 (cochlear implant)
Cochlear implant with default fitting then with tonotopy-based fitting
Active Comparator: TFS4 then FS4
Cochlear Implant with TFS4 first during 6 weeks then with FS4 during 6 weeks
Device: TFS4 then FS4 (cochlear implant)
Cochlear implant with tonotopy-based fitting then with default fitting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech recognition in noise
Time Frame: 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].
at 6 weeks post-activation
Speech recognition in noise
Time Frame: 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].
at 12 weeks post-activation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech recognition in quiet
Time Frame: at 6 weeks post-activation
Cochlear list of Lafon: list of 51 phonems (17 words). Speech recognition score on 50.
at 6 weeks post-activation
Speech recognition in quiet
Time Frame: at 12 weeks post-activation
Cochlear list of Lafon: list of 51 phonems (17 words). Speech recognition score on 50.
at 12 weeks post-activation
Auditory skills experienced by the patient
Time Frame: at 6 weeks post-activation
Auditory skills experienced by the patient are evaluated with the short form of the French version of the speech spatial qualities scale (SSQ) with of 15 questions describing various real-world auditory situations [Moulin et al. Ear & Hearing 2019;40;938-950].
at 6 weeks post-activation
Auditory skills experienced by the patient
Time Frame: at 12 weeks post-activation
Auditory skills experienced by the patient are evaluated with the short form of the French version of the speech spatial qualities scale (SSQ) with of 15 questions describing various real-world auditory situations [Moulin et al. Ear & Hearing 2019;40;938-950].
at 12 weeks post-activation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MED-EL Elektromedizinische Geräte GesmbH

Investigators

  • Principal Investigator: Alexandre Karkas, Pr, Centre Hospitalier Universitaire de Saint Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2023

Primary Completion (Estimated)

September 15, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

July 13, 2023

First Submitted That Met QC Criteria

July 13, 2023

First Posted (Actual)

July 21, 2023

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEDEL_COTONBIM_StEtienne_study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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