Sensorineural Hearing Loss, BilateralNCT05898659
Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting With or Without Synchronization
A study testing ABFnoS then ABFS (Cochlear implant) and ABFS then ABFnoS (Cochlear implant) in people with Sensorineural Hearing Loss, Bilateral, 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 with synchronization between HA and CI (ABFS) to a tonotopy based fitting strategy without synchronization (ABFnoS) for the accuracy of sound localization. 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?
- ABFnoS then ABFS (Cochlear implant) and ABFS then ABFnoS (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
- 17 Oct 2023to 15 Dec 2026
- 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
- Total hearing loss for less than 5 years
Who cannot join
- retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
- patient with residual hearing < 70 dB hearing level (HL) at 250 Hz and 500 Hz and < 80 dB HL at 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 Nice
Nice, 06103
Nicolas Guevara, Pr, guevara.n@chu-nice.fr
About this study
Official title: Comparison of a Bimodal Fitting With Synchronization and a Conventional Bimodal Fitting in Newly Implanted Cochlear Patient. Prospective Monocentric Randomized Double-blind Crossover Study.
Main objective:
For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy with synchronization between HA and CI (ABFS) to a tonotopy based fitting strategy without synchronization (ABFnoS) for the accuracy of sound localization.
Secondary objectives:
Comparison of ABFS to ABFnoS for the bias of sound localization. Comparison of ABFS to ABFnoS for speech perception in noise. Comparison of ABFS to ABFnoS 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.
MED-EL has developed a fitting strategy (ABF) that allows, from a post-operative 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.
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 different processing times between CI and contralateral HA.
Recently, MED-EL (Austria) has developed a new approach to synchronize the treatment time of the CI with that of the contralateral HA via the fitting software. This new approach takes into account the different treatment times between CI and contralateral HA and allows synchronization between the 2 systems (CI and HA).
This strategy (ABFS) could therefore allow a better integration of information in bimodal hearing and in particular improve the sound localization compare to a strategy without synchronization (ABFnoS).
Main objective:
For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy with synchronization between HA and CI (ABFS) to a tonotopy based fitting strategy without synchronization (ABFnoS) for the accuracy of sound localization.
Secondary objectives:
Comparison of ABFS to ABFnoS for the bias of sound localization. Comparison of ABFS to ABFnoS for speech perception in noise. Comparison of ABFS to ABFnoS 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.
- Conditions
- Sensorineural Hearing Loss, Bilateral
- Being tested
- ABFnoS then ABFS (Cochlear implant), ABFS then ABFnoS (Cochlear implant)
- Keywords
- cochlear implant, bimodal fitting, 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.
ABFnoS then ABFS (Cochlear implant)Device
Cochlear implant with tonotopy-based fitting without synchronization with the contralateral hearing-aid then with synchronization with the contralateral hearing-aid
ABFS then ABFnoS (Cochlear implant)Device
Cochlear implant with tonotopy-based fitting with synchronization with the contralateral hearing-aid then without synchronization with the contralateral hearing-aid
| Study group | Role | What they receive |
|---|---|---|
| ABFnoS then ABFS | Active comparator | Cochlear Implant with ABFnoS first during 6 weeks then with ABFS during 6 weeks Receives: Device: ABFnoS then ABFS (Cochlear implant) |
| ABFS then ABFnoS | Active comparator | Cochlear Implant with ABFS first during 6 weeks then with ABFnoS during 6 weeks Receives: Device: ABFS then ABFnoS (Cochlear implant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of sound localization
The accuracy of sound localization will be achieved with a sound localization test in the horizontal plane with 7 loudspeakers (HP) spaced 30° apart and arranged in a ½ circle from -90° to +90° at 1m around the patient.
Measured: at 6 weeks post-activation
Accuracy of sound localization
The accuracy of sound localization will be achieved with a sound localization test in the horizontal plane with 7 loudspeakers (HP) spaced 30° apart and arranged in a ½ circle from -90° to +90° at 1m around the patient.
Measured: at 12 weeks post-activation
Secondary outcomes (6)
Bias of sound localization
The bias of sound localization will be achieved with a sound localization test in the horizontal plane with 7 loudspeakers (HP) spaced 30° apart and arranged in a ½ circle from -90° to +90° at 1m around the patient.
Measured: at 6 weeks post-activation
Bias of sound localization
The bias of sound localization will be achieved with a sound localization test in the horizontal plane with 7 loudspeakers (HP) spaced 30° apart and arranged in a ½ circle from -90° to +90° at 1m around the patient.
Measured: at 12 weeks post-activation
Speech recognition in noise
The speech recognition in noise is evaluated with the French-language VRB (vocale rapide dans le bruit) test [Leclerc et al., Eur Ann Otorhinolaryngol Head Neck Dis
. 2018 Oct;135(5):315-319.]. It is a sentence test with target words. The speech level is at 65 dB sound pressure level (SPL) and the signal-to-noise ratio varies from 18 dB to -3 dB by 3 dB step.
Measured: at 6 weeks post-activation
Speech recognition in noise
The speech recognition in noise is evaluated with the French-language VRB (vocale rapide dans le bruit) test [Leclerc et al., Eur Ann Otorhinolaryngol Head Neck Dis
. 2018 Oct;135(5):315-319.]. It is a sentence test with target words. The speech level is at 65 dB SPL and the signal-to-noise ratio varies from 18 dB to -3 dB by 3 dB step.
Measured: at 12 weeks post-activation
Auditory skills experienced by the patient
Auditory skills experienced by the patient are evaluated with the French version of the speech spatial qualities scale (SSQ) with of 49 questions describing various real-world auditory situations..
Measured: at 6 weeks post-activation
Auditory skills experienced by the patient
Auditory skills experienced by the patient are evaluated with the French version of the speech spatial qualities scale (SSQ) with of 49 questions describing various real-world auditory situations..
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 posted12 Jun 2023
- Study start17 Oct 2023
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (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
- Two arms A and B: Arm A: Bimodal patient's fitting with tonotopy-based fitting without synchronization (ABFnoS) --\> 6 weeks use --\> tests and bimodal patient's fitting with tonotopy-based fitting with synchronization (ABFS) --\> 6 weeks use --\> tests; Arm B: Bimodal patient's fitting with ABFS --\> 6 weeks use --\> tests and bimodal patient's fitting with ABFnoS --\> 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
- Nicolas Guevara, Pr, Principal investigator, Nice University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898659
- Sponsor's protocol ID
- MED_EL_REG_BIMOD_Nice_study
- Status last verified
- Jan 2026
- First submitted
- 2 Jun 2023
- Last updated
- 14 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 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Bimodal Fitting With Synchronization and a Conventional Bimodal Fitting in Newly Implanted Cochlear Patient. Prospective Monocentric Randomized Double-blind Crossover Study.
- ClinicalTrials.gov ID
- NCT05898659
- Acronym / sponsor ID
- MED_EL_REG_BIMOD_Nice_study
- Conditions
- Sensorineural Hearing Loss, Bilateral
- Keywords
- cochlear implant, bimodal fitting, tonotopy-based fitting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 12 Jun 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 with synchronization between HA and CI (ABFS) to a tonotopy based fitting strategy without synchronization (ABFnoS) for the accuracy of sound localization.
Secondary objectives:
Comparison of ABFS to ABFnoS for the bias of sound localization. Comparison of ABFS to ABFnoS for speech perception in noise. Comparison of ABFS to ABFnoS 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.
MED-EL has developed a fitting strategy (ABF) that allows, from a post-operative 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.
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 different processing times between CI and contralateral HA.
Recently, MED-EL (Austria) has developed a new approach to synchronize the treatment time of the CI with that of the contralateral HA via the fitting software. This new approach takes into account the different treatment times between CI and contralateral HA and allows synchronization between the 2 systems (CI and HA).
This strategy (ABFS) could therefore allow a better integration of information in bimodal hearing and in particular improve the sound localization compare to a strategy without synchronization (ABFnoS).
Main objective:
For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy with synchronization between HA and CI (ABFS) to a tonotopy based fitting strategy without synchronization (ABFnoS) for the accuracy of sound localization.
Secondary objectives:
Comparison of ABFS to ABFnoS for the bias of sound localization. Comparison of ABFS to ABFnoS for speech perception in noise. Comparison of ABFS to ABFnoS 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
- Two arms A and B: Arm A: Bimodal patient's fitting with tonotopy-based fitting without synchronization (ABFnoS) --> 6 weeks use --> tests and bimodal patient's fitting with tonotopy-based fitting with synchronization (ABFS) --> 6 weeks use --> tests; Arm B: Bimodal patient's fitting with ABFS --> 6 weeks use --> tests and bimodal patient's fitting with ABFnoS --> 6 weeks use --> tests
| Arm | Type | Receives |
|---|---|---|
| ABFnoS then ABFS | Active comparator | Device: ABFnoS then ABFS (Cochlear implant)Cochlear Implant with ABFnoS first during 6 weeks then with ABFS during 6 weeks |
| ABFS then ABFnoS | Active comparator | Device: ABFS then ABFnoS (Cochlear implant)Cochlear Implant with ABFS first during 6 weeks then with ABFnoS 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 (3 listed)
- Adult patient (>= 18 years old) speaking French
- Patient who fulfils the criteria for cochlear implantation
- Total hearing loss for less than 5 years
Key exclusion criteria (2 listed)
- retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
- patient with residual hearing < 70 dB hearing level (HL) at 250 Hz and 500 Hz and < 80 dB HL at 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 |
|---|---|---|
| ABFnoS then ABFS (Cochlear implant)Cochlear implant with tonotopy-based fitting without synchronization with the contralateral hearing-aid then with synchronization with the contralateral hearing-aid | Device | ABFnoS then ABFS |
| ABFS then ABFnoS (Cochlear implant)Cochlear implant with tonotopy-based fitting with synchronization with the contralateral hearing-aid then without synchronization with the contralateral hearing-aid | Device | ABFS then ABFnoS |
Primary outcome
Accuracy of sound localization
Time frame: at 6 weeks post-activation
The accuracy of sound localization will be achieved with a sound localization test in the horizontal plane with 7 loudspeakers (HP) spaced 30° apart and arranged in a ½ circle from -90° to +90° at 1m around the patient.
Accuracy of sound localization
Time frame: at 12 weeks post-activation
The accuracy of sound localization will be achieved with a sound localization test in the horizontal plane with 7 loudspeakers (HP) spaced 30° apart and arranged in a ½ circle from -90° to +90° at 1m around the patient.
6 secondary outcomes
Bias of sound localization
Time frame: at 6 weeks post-activation
Bias of sound localization
Time frame: at 12 weeks post-activation
Speech recognition in noise
Time frame: at 6 weeks post-activation
Speech recognition in noise
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 14 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.
Nicolas Guevara, Pr principal investigator
Nice University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABFnoS then ABFS (Cochlear implant) and ABFS then ABFnoS (Cochlear implant) 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 3 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 14 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?
Accuracy of sound localization (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 14 Jan 2026.