Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting With or Without Synchronization

January 12, 2026 updated by: MED-EL Elektromedizinische Geräte GesmbH

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

Main objective:

For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy with synchronization between HA and CI (ABFS) to a tonotopy based fitting strategy without synchronization (ABFnoS) for the accuracy of sound localization.

Secondary objectives:

Comparison of ABFS to ABFnoS for the bias of sound localization. Comparison of ABFS to ABFnoS for speech perception in noise. Comparison of ABFS to ABFnoS 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.

MED-EL has developed a fitting strategy (ABF) that allows, from a post-operative 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.

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 different processing times between CI and contralateral HA.

Recently, MED-EL (Austria) has developed a new approach to synchronize the treatment time of the CI with that of the contralateral HA via the fitting software. This new approach takes into account the different treatment times between CI and contralateral HA and allows synchronization between the 2 systems (CI and HA).

This strategy (ABFS) could therefore allow a better integration of information in bimodal hearing and in particular improve the sound localization compare to a strategy without synchronization (ABFnoS).

Main objective:

For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy with synchronization between HA and CI (ABFS) to a tonotopy based fitting strategy without synchronization (ABFnoS) for the accuracy of sound localization.

Secondary objectives:

Comparison of ABFS to ABFnoS for the bias of sound localization. Comparison of ABFS to ABFnoS for speech perception in noise. Comparison of ABFS to ABFnoS 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
  • 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

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: ABFnoS then ABFS
Cochlear Implant with ABFnoS first during 6 weeks then with ABFS during 6 weeks
Device: ABFnoS then ABFS (Cochlear implant)
Cochlear implant with tonotopy-based fitting without synchronization with the contralateral hearing-aid then with synchronization with the contralateral hearing-aid
Active Comparator: ABFS then ABFnoS
Cochlear Implant with ABFS first during 6 weeks then with ABFnoS during 6 weeks
Device: ABFS then ABFnoS (Cochlear implant)
Cochlear implant with tonotopy-based fitting with synchronization with the contralateral hearing-aid then without synchronization with the contralateral hearing-aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of sound localization
Time Frame: at 6 weeks post-activation
The accuracy of sound localization will be achieved with a sound localization test in the horizontal plane with 7 loudspeakers (HP) spaced 30° apart and arranged in a ½ circle from -90° to +90° at 1m around the patient.
at 6 weeks post-activation
Accuracy of sound localization
Time Frame: at 12 weeks post-activation
The accuracy of sound localization will be achieved with a sound localization test in the horizontal plane with 7 loudspeakers (HP) spaced 30° apart and arranged in a ½ circle from -90° to +90° at 1m around the patient.
at 12 weeks post-activation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bias of sound localization
Time Frame: at 6 weeks post-activation
The bias of sound localization will be achieved with a sound localization test in the horizontal plane with 7 loudspeakers (HP) spaced 30° apart and arranged in a ½ circle from -90° to +90° at 1m around the patient.
at 6 weeks post-activation
Bias of sound localization
Time Frame: at 12 weeks post-activation
The bias of sound localization will be achieved with a sound localization test in the horizontal plane with 7 loudspeakers (HP) spaced 30° apart and arranged in a ½ circle from -90° to +90° at 1m around the patient.
at 12 weeks post-activation
Speech recognition in noise
Time Frame: at 6 weeks post-activation

The speech recognition in noise is evaluated with the French-language VRB (vocale rapide dans le bruit) test [Leclerc et al., Eur Ann Otorhinolaryngol Head Neck Dis

. 2018 Oct;135(5):315-319.]. It is a sentence test with target words. The speech level is at 65 dB sound pressure level (SPL) and the signal-to-noise ratio varies from 18 dB to -3 dB by 3 dB step.
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-language VRB (vocale rapide dans le bruit) test [Leclerc et al., Eur Ann Otorhinolaryngol Head Neck Dis

. 2018 Oct;135(5):315-319.]. It is a sentence test with target words. The speech level is at 65 dB SPL and the signal-to-noise ratio varies from 18 dB to -3 dB by 3 dB step.
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 French version of the speech spatial qualities scale (SSQ) with of 49 questions describing various real-world auditory situations..
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 French version of the speech spatial qualities scale (SSQ) with of 49 questions describing various real-world auditory situations..
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: Nicolas Guevara, Pr, Nice University Hospital

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 17, 2023

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

June 2, 2023

First Submitted That Met QC Criteria

June 2, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED_EL_REG_BIMOD_Nice_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.

Clinical Trials on Sensorineural Hearing Loss, Bilateral

Clinical Trials on ABFnoS then ABFS (Cochlear implant)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe