Menu
Recruiting NCT06737185

Comparison of Speech Understanding Between Tonotopy-based Fitting and Setting Based on Evolutionary Algorithms

No phase Interventional Sensorineural Hearing Loss, Bilateral

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EAFS4T: modification with evolutionary algorithm of tonotopic-based fitting.
Who it may be relevant to
Registry conditions: Sensorineural Hearing Loss, Bilateral. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison of Speech Understanding Between Tonotopy-based Fitting and Evolutionary Algorithm-based Setting: a Prospective Cross-sectional Study

Overview

Main objective: Compare speech recognition in noise with tonotopic setting (FS4T) and with tonotopic fitting modified by evolutionary algorithm (EAFS4T) in adult patients implanted for 6 months or more with a MED-EL cochlear implant with FS4T. Secondary objectives: Comparison of FS4T and EAFS4T settings * for speech recognition in quiet * for subjective auditory spatial perception * for subjective auditory and musical perception

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.

A tonotopy-based fitting allows for better results in pitch perception or speech perception in noise or musical perception. However, there is a large variability in the results observed between patients. This variability could be due to the individual characteristics of the listeners (neuronal survival, current propagation and spread, duration of deafness, lack of cortical plasticity).

A modification of frequency allocations in the setting could take into account this individual variability and improve speech discrimination and music perception. Saadoun et al. (2022) studied on 27 subjects the effect of an adjustment of frequency allocation by an evolutionary algorithm (EA) approach and showed an improvement in speech perception in noise compared to a default setting (not based on tonotopy) for patients implanted for more than 6 months in a bimodal situation (with a contralateral prosthesis). We therefore propose to use evolutionary algorithms to modify the tonotopy-based fitting and improve the perception in noise of implanted patients.

Main objective:

Compare speech recognition in noise with tonotopic setting (FS4T) and tonotopic fitting modified by evolutionary algorithm (EAFS4T) in adult patients implanted for 6 months or more with a MED-EL cochlear implant with FS4T.

Secondary objectives:

Comparison of FS4T and EAFS4T settings

* for speech recognition in quiet * for subjective auditory spatial perception * for subjective auditory and musical perception

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

Interventions

  • Other EAFS4T: modification with evolutionary algorithm of tonotopic-based fitting
    Comparison of FS4T and EAFS4T

Primary outcome measures

  • Speech recognition in noise [Time frame: 6 weeks after EAFS4T fitting]
Secondary outcome measures (4)
  • Speech recognition in quiet [Time frame: 6 weeks after EAFS4T fitting]
  • Subjective auditory spatial perception [Time frame: at EAFS4T fitting (6 months after cochlear implant activation) and 6 weeks after EAFS4T fitting]
  • Subjective assessment of auditory perception [Time frame: at EAFS4T fitting (6 months after cochlear implant activation) and 6 weeks after EAFS4T fitting]
  • Subjective assessment of musical perception [Time frame: at EAFS4T fitting (6 months after cochlear implant activation) and 6 weeks after EAFS4T fitting]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CHU — Dijon

Identifiers

NCT: NCT06737185 · MEDEL_algoevIC_Dijon_study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗