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NCT Number: NCT05955469

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location status: Recruiting

Location contact

Alexandre Karkas, Pr

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FS4 then TFS4 (cochlear implant)

Device

Cochlear implant with default fitting then with tonotopy-based fitting

TFS4 then FS4 (cochlear implant)

Device

Cochlear implant with tonotopy-based fitting then with default fitting

Primary outcomes

  1. 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].

  2. 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].

Secondary outcomes

  1. 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.

  2. 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.

  3. 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].

  4. 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].

Study contacts

Contact information is provided by the study sponsor or research team.

Vincent Péan, PhD

CONTACT

[email protected]

0603592974 ext. +33

Sponsors and collaborators

Lead sponsor

MED-EL Elektromedizinische Geräte GesmbH

Industry

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 21, 2023
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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