Sensorineural Hearing Loss, BilateralNCT06737185
Comparison of Speech Understanding Between Tonotopy-based Fitting and Setting Based on Evolutionary Algorithms
A study testing EAFS4T: modification with evolutionary algorithm of tonotopic-based fitting in people with Sensorineural Hearing Loss, Bilateral, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sensorineural Hearing Loss, Bilateral
- What is being tested?
- EAFS4T: modification with evolutionary algorithm of tonotopic-based fitting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2025to 15 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient (>= 18 years old) speaking French
- Patient who fulfils the criteria for cochlear implantation
Who cannot join
- retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU
Dijon, 21000
Alexis BOZORG GRAYELI, Pr, 0380293758, alexis.bozorggrayeli@chu-dijon.fr
About this study
Official title: Comparison of Speech Understanding Between Tonotopy-based Fitting and Evolutionary Algorithm-based Setting: a Prospective Cross-sectional Study
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
Read the 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.
- Conditions
- Sensorineural Hearing Loss, Bilateral
- Being tested
- EAFS4T: modification with evolutionary algorithm of tonotopic-based fitting
- Keywords
- cochlear implant, evolutionary algorithms, tonotopy-based fitting
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EAFS4T: modification with evolutionary algorithm of tonotopic-based fittingOther
Also called FS4T: tonotopic-based fitting
Comparison of FS4T and EAFS4T
| Study group | Role | What they receive |
|---|---|---|
| EA arm | Other | at 6 month post-activation: evolutionary algorithms to modify the tonotopy-based fitting FS4T to give EAFS4T fitting.
Participant wears EAFS4T during 6 weeks. Receives: Other: EAFS4T: modification with evolutionary algorithm of tonotopic-based fitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech recognition in noise
HINT-5 min test. Noise level: 60 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 EAFS4T and with FS4T.
Measured: 6 weeks after EAFS4T fitting
Secondary outcomes (4)
Speech recognition in quiet
One list of 10 disyllabic words (Fournier lists) at 65 dB SPL. The participant has to repeat the word emitted.
Result: score on 10. Test with EAFS4T and with FS4T
Measured: 6 weeks after EAFS4T fitting
Subjective auditory spatial perception
SSQi15 questionnaire (" 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 to 10 ranging from "not at all" to "yes perfectly".
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 EAFS4T fitting) and with EAFS4T (6 weeks after EAFS4T fitting)
Measured: at EAFS4T fitting (6 months after cochlear implant activation) and 6 weeks after EAFS4T fitting
Subjective assessment of auditory perception
Assessment of sound quality in silence and in noise with 4 statements. Likert scale from 1 to 5. Score on 20.
Likert scale with FS4T (at EAFS4T fitting) and with EAFS4T (6 weeks after EAFS4T fitting)
Measured: at EAFS4T fitting (6 months after cochlear implant activation) and 6 weeks after EAFS4T fitting
Subjective assessment of musical perception
Six questions from the Munich Music Self-Questionnaire [Stark et al. 2003]. Questionnaire with FS4T (at EAFS4T fitting) and with EAFS4T (6 weeks after EAFS4T fitting)
Measured: at EAFS4T fitting (6 months after cochlear implant activation) and 6 weeks after EAFS4T fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start15 Jan 2025
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorineural Hearing Loss, BilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexis BOZORG GRAYELI, Pr, Principal investigator, Centre Hospitalier Universitaire Dijon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737185
- Sponsor's protocol ID
- MEDEL_algoevIC_Dijon_study
- Status last verified
- Apr 2026
- First submitted
- 5 Dec 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Speech Understanding Between Tonotopy-based Fitting and Evolutionary Algorithm-based Setting: a Prospective Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06737185
- Acronym / sponsor ID
- MEDEL_algoevIC_Dijon_study
- Conditions
- Sensorineural Hearing Loss, Bilateral
- Keywords
- cochlear implant, evolutionary algorithms, tonotopy-based fitting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2028 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EA arm | Other | Other: EAFS4T: modification with evolutionary algorithm of tonotopic-based fittingat 6 month post-activation: evolutionary algorithms to modify the tonotopy-based fitting FS4T to give EAFS4T fitting. Participant wears EAFS4T during 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patient (>= 18 years old) speaking French
- Patient who fulfils the criteria for cochlear implantation
Key exclusion criteria (1 listed)
- retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EAFS4T: modification with evolutionary algorithm of tonotopic-based fittingAlso: FS4T: tonotopic-based fittingComparison of FS4T and EAFS4T | Other | EA arm |
Primary outcome
Speech recognition in noise
Time frame: 6 weeks after EAFS4T fitting
HINT-5 min test. Noise level: 60 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 EAFS4T and with FS4T.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexis BOZORG GRAYELI, Pr principal investigator
Centre Hospitalier Universitaire Dijon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EAFS4T: modification with evolutionary algorithm of tonotopic-based fitting in people with Sensorineural Hearing Loss, Bilateral, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincent Péan, PhD (603592974 ext. +33, vincent.pean@medel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech recognition in noise (time frame: 6 weeks after EAFS4T fitting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.