Sensorineural Hearing Loss, BilateralNCT05955469
Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting
A study testing FS4 then TFS4 (cochlear implant) and TFS4 then FS4 (cochlear implant) in people with Sensorineural Hearing Loss, Bilateral and Bilateral Hearing Loss, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sensorineural Hearing Loss, Bilateral, Bilateral Hearing Loss
- What is being tested?
- FS4 then TFS4 (cochlear implant) and TFS4 then FS4 (cochlear implant)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2024to 1 Jan 2027
- 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
- patient with residual hearing < 70 dB hearing level (HL) at 500 Hz and 1000 Hz on the contralateral ear
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 Saint-Etienne
Saint-Etienne, 42055
Alexandre Karkas, Pr, alexandre.karkas@chu-st-etienne.fr
About this study
Official 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.
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.
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.
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.
- Being tested
- FS4 then TFS4 (cochlear implant), TFS4 then FS4 (cochlear implant)
- Keywords
- Cochlear implant, Bimodal fitting, Anatomy-based fitting
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| FS4 then TFS4 | Active comparator | Cochlear Implant with FS4 first during 6 weeks then with TFS4 during 6 weeks Receives: Device: FS4 then TFS4 (cochlear implant) |
| TFS4 then FS4 | Active comparator | Cochlear Implant with TFS4 first during 6 weeks then with FS4 during 6 weeks Receives: Device: TFS4 then FS4 (cochlear implant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech recognition in noise
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].
Measured: at 6 weeks post-activation
Speech recognition in noise
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].
Measured: at 12 weeks post-activation
Secondary outcomes (4)
Speech recognition in quiet
Cochlear list of Lafon: list of 51 phonems (17 words). Speech recognition score on 50.
Measured: at 6 weeks post-activation
Speech recognition in quiet
Cochlear list of Lafon: list of 51 phonems (17 words). Speech recognition score on 50.
Measured: at 12 weeks post-activation
Auditory skills experienced by the patient
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].
Measured: at 6 weeks post-activation
Auditory skills experienced by the patient
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].
Measured: at 12 weeks post-activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start5 Nov 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (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
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment Two arms A and B: Arm A: Bimodal patient's fitting with default fitting (FS4) --\> 6 weeks use --\> tests and bimodal patient's fitting with tonotopy-based fitting (TFS4) --\> 6 weeks use --\> tests; Arm B: Bimodal patient's fitting with TFS4 --\> 6 weeks use --\> tests and bimodal patient's fitting with FS4 --\> 6 weeks use --\> tests
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexandre Karkas, Pr, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955469
- Sponsor's protocol ID
- MEDEL_COTONBIM_StEtienne_study
- Status last verified
- Jan 2026
- First submitted
- 13 Jul 2023
- Last updated
- 20 Jan 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 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT05955469
- Acronym / sponsor ID
- MEDEL_COTONBIM_StEtienne_study
- Keywords
- Cochlear implant, Bimodal fitting, Anatomy-based fitting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 21 Jul 2023 (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:
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.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Crossover Assignment Two arms A and B: Arm A: Bimodal patient's fitting with default fitting (FS4) --> 6 weeks use --> tests and bimodal patient's fitting with tonotopy-based fitting (TFS4) --> 6 weeks use --> tests; Arm B: Bimodal patient's fitting with TFS4 --> 6 weeks use --> tests and bimodal patient's fitting with FS4 --> 6 weeks use --> tests
| Arm | Type | Receives |
|---|---|---|
| FS4 then TFS4 | Active comparator | Device: FS4 then TFS4 (cochlear implant)Cochlear Implant with FS4 first during 6 weeks then with TFS4 during 6 weeks |
| TFS4 then FS4 | Active comparator | Device: TFS4 then FS4 (cochlear implant)Cochlear Implant with TFS4 first during 6 weeks then with FS4 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 (2 listed)
- 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
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 |
|---|---|---|
| FS4 then TFS4 (cochlear implant)Cochlear implant with default fitting then with tonotopy-based fitting | Device | FS4 then TFS4 |
| TFS4 then FS4 (cochlear implant)Cochlear implant with tonotopy-based fitting then with default fitting | Device | TFS4 then FS4 |
Primary outcome
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].
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].
4 secondary outcomes
Speech recognition in quiet
Time frame: at 6 weeks post-activation
Speech recognition in quiet
Time frame: at 12 weeks post-activation
Auditory skills experienced by the patient
Time frame: at 6 weeks post-activation
Auditory skills experienced by the patient
Time frame: at 12 weeks post-activation
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 20 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Sensorineural Hearing Loss, Bilateral
Active, not recruiting
Clinical Utility of Residual Hearing in the Cochlear Implant Ear
Hearing Loss, Sensorineural, Hearing Loss
Active, not recruiting
A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
Hearing Loss, Bilateral Sensorineural
RecruitingPhase 3
Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss
Sensorineural Hearing Loss, Bilateral
Active, not recruiting
A Pivotal Study to Evaluate the Efficacy and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
Hearing Loss, Bilateral Sensorineural
RecruitingPhase 1/2
Open-label Study of SKY-GJB2 in Pediatric Subjects With GJB2-mediated Hearing Loss
GJB2-mediated Hearing Loss, GJB2 Gene Mutation
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.
Alexandre Karkas, Pr principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FS4 then TFS4 (cochlear implant) and TFS4 then FS4 (cochlear implant) in people with Sensorineural Hearing Loss, Bilateral and Bilateral Hearing Loss, 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 2 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 20 Jan 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 (0603592974 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: at 6 weeks post-activation). The study lists 2 primary outcomes in all. 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 20 Jan 2026.