Speech Perception of a Tonotopy-based Fitting for Cochlear Implant Recipients for 6 Months With Conventional Setting

April 30, 2026 updated by: MED-EL Elektromedizinische Geräte GesmbH

Contribution to Speech Perception of a Tonotopy-based Fitting for Patients With Cochlear Implants for 6 Months With a Conventional Setting: Prospective Cross-sectional Study

Main objective:

Compare speech recognition in noise with tonotopic fitting (FS4T) and with conventional non-tonotopic fitting (FS4noT) in adult patients implanted for 6 months with a MED-EL cochlear implant with FS4noT strategy.

Secondary objectives:

Comparison of FS4noT and FS4T settings

  • for speech recognition in quiet
  • for subjective auditory spatial perception

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. The fitting software developed by the manufacturers proposed a default fitting with a lower limit between 100 and 250 Hz according to the brands and an upper limit of about 8500 Hz. The frequency bands assigned to each electrode follow a logarithmic scale with the high frequencies for the basal electrodes and the low frequencies for the apical electrodes. This distribution takes into account the number of active electrodes but does not take into account the anatomy and the natural cochlear tonotopy specific to each patient. Several studies have analyzed the anatomical variations of the cochlear dimensions: size of the cochlea and the ratio between the contact surfaces of the electrodes with the cochlea are variable from one patient to another. The insertion depth during surgery is also variable due to parameters related to the patients as well as to the operator, which seems to impact the understanding of speech in noise. Mathematical algorithms have recently been developed to estimate the cochlear tonotopy of each patient from a CT scan assessment. CT imaging of the implanted ear combined with 3D reconstruction software, provides cochlear length measurements. Using this approach it is possible to measure the position of each electrode relative to the cochlear apex. Recently, MED-EL (Austria) has developed a new approach based on CT-scan and tuning of the frequencies associated with each electrode using anatomical information of position of the electrodes in the cochlea: this fitting is called anatomy-based fitting (ABF).

Recently [Jiam et al. 2016, 2019] showed that a frequency fitting based on the tonotopy of the electrodes allowed to obtain a better perception of pitch after 30 minutes of acclimatization. In a prospective randomized crossover study with a wearing time of 6 weeks on new cochlear implantees, Creff et al. (2023, 2024) obtained very significantly superior results with a tonotopic setting compared to a classic setting (HDCIS) for speech recognition tests in noise and for musical perception. However, even if the tonotopic setting appears particularly promising over a period of 6 weeks, it is possible that the difference diminishes over time (Mertens et al.,2021). Brain plasticity could partially or completely compensate for the mismatch after a few months/years of CI use (Svirsky et al. 2004; Reiss et al. 2007, 2014). However, this adaptation may remain incomplete or prolong the acclimatization period even after numerous rehabilitation sessions (Sagi et al. 2010; Svirsky et al. 2015; Tan et al. 2017; Dorman et al. 2022). Further studies on the use of tonotopy-based fitting and its effects on speech understanding, also in experienced CI users, are therefore needed.

Main objective:

Compare speech recognition in noise with tonotopic fitting (FS4T) and with conventional non-tonotopic fitting (FS4noT) in adult patients implanted for 6 months with a MED-EL cochlear implant with FS4noT strategy.

Secondary objectives:

Comparison of FS4noT and FS4T settings

  • for speech recognition in quiet
  • for subjective auditory spatial perception

Plan of the study: It is a prospective open monocentric transversal study.

Study Type

Interventional

Enrollment (Estimated)

25

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

  • France
      • Limoges, France, 87000
        • Recruiting
        • CHU
        • Contact:

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ABF arm
At 6 month post-activation: tonotopic fitting FS4T the participant wears FS4T during 6 weeks.
Other: Tonotopic cochlear implant fitting FS4T
Comparison of FS4T and FS4noT
Other Names:
  • No tonotopic cochlear implant fitting FS4noT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech recognition in noise
Time Frame: 6 weeks after FS4T fitting

Framatrix test. Speech and noise in front the participant (at 1m). Noise level: 65 dB SPL. Speech level: adaptive with the answers of the participant. Result: speech-to-noise ratio (speech reception threshold, SRT50) for 50% of intelligibility in noise.

Test with FS4T and with FS4noT
6 weeks after FS4T fitting

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech recognition in quiet
Time Frame: 6 weeks after FS4T fitting

Two lists of 10 disyllabic words (Fournier lists) at 65 dB SPL. The participant has to repeat the word emitted. Result: score on 20.

Test with FS4T and with FS4noT.
6 weeks after FS4T fitting
Subjective auditory spatial perception
Time Frame: At FS4T fitting and 6 weeks after FS4T fitting

Questionnaire SSQi15 (" Speech, Spatial, and Qualities of hearing scale ", SSQ). The questionnaire consists of 15 questions describing various real-world hearing situations.

The subject answers each question with a score on a visual analogue scale graduated from 0 (worse) to 10 (better) ranging from "not at all" (0) to "yes perfectly" (10).

The result obtained is composed of

  • a total average score equal to the sum of the scores of all the questions divided by the total number of questions.
  • 3 average sub-scores describing 3 subscales: Speech hearing with 5 questions Spatial hearing with 5 questions Quality of hearing with 5 questions. Questionnaire with FS4T (at FS4T fitting) and with FS4noT (6 weeks after FS4T fitting)
At FS4T fitting and 6 weeks after FS4T fitting

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: Karine Aubry, Pr, University Hospital, Limoges

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)

January 1, 2025

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

December 4, 2024

First Submitted That Met QC Criteria

December 6, 2024

First Posted (Actual)

December 9, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEDEL_ABF6m_Limoges_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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