Sensorineural Hearing Loss, BilateralNCT04591093
Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy
A study testing FineHearing Strategy with 10 more apical electrodes or with 10 more basal electrodes activated in people with Sensorineural Hearing Loss, Bilateral, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in France.
Trial summary
Main objective: Investigate on new cochlear implanted patients whether the FineHearing strategy of the MED-EL cochlear implant gives better results on musical perception if the depth of stimulation (stimulation or not of the apical areas) is greater. 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?
- FineHearing Strategy with 10 more apical electrodes or with 10 more basal electrodes activated
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2021to 30 Sep 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
- Patient with a postoperative insertion angle of the apical electrode > 450°
- Patient with 12 active electrodes on the day of activation.
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
GH Pitié-Salpêtrière, APHP 6
Paris, 75651 Paris Cedex 13
Isabelle Mosnier, Dr, (+33) 1 42 16 26 06, isabelle.mosnier@aphp.fr
About this study
Official title: Study of Musical Perception and Post-operative Auditory Performance as a Function of the Depth of Stimulation in Subjects Implanted With a MED-EL Cochlear Implant and Using a FineHearing Strategy Single-center Randomized Cross-over Study
Main objective:
Investigate on new cochlear implanted patients whether the FineHearing strategy of the MED-EL cochlear implant gives better results on musical perception if the depth of stimulation (stimulation or not of the apical areas) is greater.
Secondary objectives:
Evaluate the effect of stimulation depth on vocal audiometric results, results of differential frequency threshold test and on qualitative sound perception.
Read the detailed description
Introduction:
Conventional stimulation strategies in cochlear implants (e.g. ACE, CIS) use the place of the electrode to code the frequency by sending low frequency information on the apical electrodes and high frequency information on the basal electrodes. The stimulation rate of the electrodes is constant.
The pitch is only partially transmitted by these conventional strategies which would explain the poor results of cochlear implants in the perception of music.
In the FineHearing strategy of the MED-EL implant, the rate of stimulation on the low-frequency electrodes is related to the frequency of the sound and makes it possible to code the frequency information temporally.
Rader \& al. 2016 have studied the contribution of adding to the tonotopic coding of the frequency (classical strategy) a temporal coding of the information by varying the stimulation rate. The results obtained show that providing this frequency information by time coding makes it possible to obtain perceived pitch much closer to the expected pitch (of normal-hearing) and less variability, especially at low frequencies. With fixed stimulation rate (classical strategy) low frequencies are poorly coded, whereas with the variable stimulation rate they are better coded.
In addition, Landsberger et al. [2018] studied in six subjects with a MED-EL implant the perception of a temporal coding according to the position of the electrodes with a long insertion: middle or apical position. The results seem to show that the temporal coding of the frequency would be more reliable than the spatial coding (related to the position of the electrode) at the apex, and the reverse on the electrodes in the middle position.
Studies have shown that the FineHearing strategy can provide benefits over the classic HDCIS strategy in tasks involving the fundamental F0 such as speech recognition in noise (after a certain learning time) [Kleine Punte \& al. 2014 ; Vermeire \& al. 2010], the perception of music [Roy \& al. 2015 ; Roy \& al. 2016] or the perceived quality of pitch [Müller \& al. 2012].
The results obtained seem to depend on the position of the electrode: a deep insertion to reach the apical zone of the cochlea would allow better coding of the information.
MED-EL's FineHearing coding strategy with stimulation of the apical areas of the cochlea (long insertion of electrodes) could therefore allow better transmission of musical pitch and in particular improve the subjective quality of music compared to the same stimulation strategy without reaching the apical areas (short insertion).
Objective of the study: The objective of the study is to evaluate if the FineHearing strategy of MED-EL with stimulation of the apical zones allows to better transmit musical pitch and in particular to improve the subjective quality of the music compared to the same stimulation strategy without apical stimulation.
Main objective:
Show that the FineHearing strategy of MED-EL with stimulation of the apical zones allows to obtain a better perceptual quality of music in newly implanted cochlear patients than the same strategy without apical stimulation.
Secondary objectives:
- Evaluate differential frequency thresholds and correlation with qualitative perceptions of music.
- Evaluate the effect of the stimulation of the apical zones on the results of speech audiometry with the FineHearing strategy.
- Evaluate the effect of the stimulation of the apical zones on the subjective quality of sounds by questionnaire with the FineHearing strategy.
Plan of study:
it is a Single-center, randomized, double-blind, cross-over study
- Conditions
- Sensorineural Hearing Loss, Bilateral
- Being tested
- FineHearing Strategy with 10 more apical electrodes or with 10 more basal electrodes activated
- Keywords
- cochlear implant, stimulation strategy, sound coding strategy
- 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.
FineHearing Strategy with 10 more apical electrodes or with 10 more basal electrodes activatedDevice
Cochlear implant with FineHearing Strategy with 10 more apical electrodes activated or with 10 more basal electrodes activated
| Study group | Role | What they receive |
|---|---|---|
| CI with FineHearing with 10 more apical electrodes activated then 10 more basal electrodes activated | Active comparator | Cochlear implant with FineHearing Strategy with 10 more apical electrodes activated first during 1 month then FineHearing Strategy with 10 more basal electrodes activated during 1 month Receives: Device: FineHearing Strategy with 10 more apical electrodes or with 10 more basal electrodes activated |
| CI with FineHearing with 10 more basal electrodes activated then 10 more apical electrodes activated | Active comparator | Cochlear implant with FineHearing Strategy with 10 more basal electrodes activated first during 1 month then FineHearing Strategy with 10 more apical electrodes activated during 1 month Receives: Device: FineHearing Strategy with 10 more apical electrodes or with 10 more basal electrodes activated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative measure of music with direct audio link
The Gabrielsson scale (1988) is used to evaluate perceived sound quality as a multidimensional phenomenon, that is composed of a number of separate perceptual dimensions. Eight perceptual dimensions are evaluated: clarity, fullness, brightness vs dullness, hardness/sharpness vs softness, spaciousness, nearness, extraneous sounds, loudness.
Visual analog scales (VAS) are used for each dimension and the patient has to score the dimension on a 10 cm VAS (between 0 to 10).
The test is performed with a direct audio link to the CI.
Measured: at 1 month post-activation
Qualitative measure of music with direct audio link
The Gabrielsson scale (1988) is used to evaluate perceived sound quality as a multidimensional phenomenon, that is composed of a number of separate perceptual dimensions. Eight perceptual dimensions are evaluated: clarity, fullness, brightness vs dullness, hardness/sharpness vs softness, spaciousness, nearness, extraneous sounds, loudness.
Visual analog scales (VAS) are used for each dimension and the patient has to score the dimension on a 10 cm VAS (between 0 to 10).
The test is performed with a direct audio link to the CI.
Measured: at 2 months post-activation
Secondary outcomes (8)
Qualitative measure of music
The Gabrielsson scale (1988) is used to evaluate perceived sound quality as a multidimensional phenomenon, that is composed of a number of separate perceptual dimensions. Eight perceptual dimensions are evaluated: clarity, fullness, brightness vs dullness, hardness/sharpness vs softness, spaciousness, nearness, extraneous sounds, loudness.
Visual analog scales (VAS) are used for each dimension and the patient has to score the dimension on a 10 cm VAS (between 0 to 10).
The test is performed in free field without any contralateral aid.
Measured: at 1 month post-activation
Qualitative measure of music
The Gabrielsson scale (1988) is used to evaluate perceived sound quality as a multidimensional phenomenon, that is composed of a number of separate perceptual dimensions. Eight perceptual dimensions are evaluated: clarity, fullness, brightness vs dullness, hardness/sharpness vs softness, spaciousness, nearness, extraneous sounds, loudness.
Visual analog scales (VAS) are used for each dimension and the patient has to score the dimension on a 10 cm VAS (between 0 to 10).
The test is performed in free field without any contralateral aid.
Measured: at 2 months post-activation
Speech recognition in quiet
The speech recognition in quiet is evaluated with 3 monosyllabic list of 17 words at 60 dB SPL. The patient has to recognize 17 words and 51 phonemes. The words and phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 for the words and the phonemes (or 0% and 100%).
Measured: at 1 month post-activation
Speech recognition in quiet
The speech recognition in quiet is evaluated with 3 monosyllabic list of 17 words at 60 dB SPL. The patient has to recognize 17 words and 51 phonemes. The words and phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 for the words and the phonemes (or 0% and 100%).
Measured: at 2 months post-activation
Differential frequency threshold
This test aimed to determine the smallest perceptible difference in F0 between two stimuli for various baseline values of F0. An adaptive procedure is used.
Measured: at 1 month post-activation
Differential frequency threshold
This test aimed to determine the smallest perceptible difference in F0 between two stimuli for various baseline values of F0. An adaptive procedure is used.
Measured: at 2 months post-activation
Sound quality
The HISQUI questionnaire will be used to evaluate the sound quality. The HISQUI questionnaire (Hearing Implant Sound Quality Index) is a questionnaire on the perceptual quality of sounds given a score (maximum=203) for each patient which indicates how he/she perceives the sound quality with his/her hearing implant in the everyday life.
Measured: at 1 month post-activation
Sound quality
The HISQUI questionnaire will be used to evaluate the sound quality. The HISQUI questionnaire (Hearing Implant Sound Quality Index) is a questionnaire on the perceptual quality of sounds given a score (maximum=203) for each patient which indicates how he/she perceives the sound quality with his/her hearing implant in the everyday life.
Measured: at 2 months post-activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start10 Jul 2021
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 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
- Crossover Assignment two arms A and B: Arm A: patient's fitting with strategy FS4 and 10 more apical electrodes activated--\> 1 month use --\> tests and patient's fitting with strategy FS4 and 10 more basal electrodes --\> 1 month use --\> tests Arm B: patient's fitting with strategy FS4 and 10 more basal electrodes activated --\> 1 month use --\> tests and patient's fitting with strategy FS4 and 10 more apical electrodes --\> 1 month use --\> tests
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Isabelle Mosnier, Dr, Principal investigator, Service ORL, UF Implants auditifs et explorations fonctionnelles GH Pitié-Salpêtrière, APHP 6 Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591093
- Sponsor's protocol ID
- MED-EL_FS_stimdepth_frenchstud
- Status last verified
- Nov 2025
- First submitted
- 11 Oct 2020
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Musical Perception and Post-operative Auditory Performance as a Function of the Depth of Stimulation in Subjects Implanted With a MED-EL Cochlear Implant and Using a FineHearing Strategy Single-center Randomized Cross-over Study
- ClinicalTrials.gov ID
- NCT04591093
- Acronym / sponsor ID
- MED-EL_FS_stimdepth_frenchstud
- Conditions
- Sensorineural Hearing Loss, Bilateral
- Keywords
- cochlear implant, stimulation strategy, sound coding strategy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2021 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 19 Oct 2020 (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:
Investigate on new cochlear implanted patients whether the FineHearing strategy of the MED-EL cochlear implant gives better results on musical perception if the depth of stimulation (stimulation or not of the apical areas) is greater.
Secondary objectives:
Evaluate the effect of stimulation depth on vocal audiometric results, results of differential frequency threshold test and on qualitative sound perception.
Detailed description
Introduction:
Conventional stimulation strategies in cochlear implants (e.g. ACE, CIS) use the place of the electrode to code the frequency by sending low frequency information on the apical electrodes and high frequency information on the basal electrodes. The stimulation rate of the electrodes is constant.
The pitch is only partially transmitted by these conventional strategies which would explain the poor results of cochlear implants in the perception of music.
In the FineHearing strategy of the MED-EL implant, the rate of stimulation on the low-frequency electrodes is related to the frequency of the sound and makes it possible to code the frequency information temporally.
Rader \& al. 2016 have studied the contribution of adding to the tonotopic coding of the frequency (classical strategy) a temporal coding of the information by varying the stimulation rate. The results obtained show that providing this frequency information by time coding makes it possible to obtain perceived pitch much closer to the expected pitch (of normal-hearing) and less variability, especially at low frequencies. With fixed stimulation rate (classical strategy) low frequencies are poorly coded, whereas with the variable stimulation rate they are better coded.
In addition, Landsberger et al. [2018] studied in six subjects with a MED-EL implant the perception of a temporal coding according to the position of the electrodes with a long insertion: middle or apical position. The results seem to show that the temporal coding of the frequency would be more reliable than the spatial coding (related to the position of the electrode) at the apex, and the reverse on the electrodes in the middle position.
Studies have shown that the FineHearing strategy can provide benefits over the classic HDCIS strategy in tasks involving the fundamental F0 such as speech recognition in noise (after a certain learning time) [Kleine Punte \& al. 2014 ; Vermeire \& al. 2010], the perception of music [Roy \& al. 2015 ; Roy \& al. 2016] or the perceived quality of pitch [Müller \& al. 2012].
The results obtained seem to depend on the position of the electrode: a deep insertion to reach the apical zone of the cochlea would allow better coding of the information.
MED-EL's FineHearing coding strategy with stimulation of the apical areas of the cochlea (long insertion of electrodes) could therefore allow better transmission of musical pitch and in particular improve the subjective quality of music compared to the same stimulation strategy without reaching the apical areas (short insertion).
Objective of the study: The objective of the study is to evaluate if the FineHearing strategy of MED-EL with stimulation of the apical zones allows to better transmit musical pitch and in particular to improve the subjective quality of the music compared to the same stimulation strategy without apical stimulation.
Main objective:
Show that the FineHearing strategy of MED-EL with stimulation of the apical zones allows to obtain a better perceptual quality of music in newly implanted cochlear patients than the same strategy without apical stimulation.
Secondary objectives:
- Evaluate differential frequency thresholds and correlation with qualitative perceptions of music.
- Evaluate the effect of the stimulation of the apical zones on the results of speech audiometry with the FineHearing strategy.
- Evaluate the effect of the stimulation of the apical zones on the subjective quality of sounds by questionnaire with the FineHearing strategy.
Plan of study:
it is a Single-center, randomized, double-blind, cross-over study
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: patient's fitting with strategy FS4 and 10 more apical electrodes activated--> 1 month use --> tests and patient's fitting with strategy FS4 and 10 more basal electrodes --> 1 month use --> tests Arm B: patient's fitting with strategy FS4 and 10 more basal electrodes activated --> 1 month use --> tests and patient's fitting with strategy FS4 and 10 more apical electrodes --> 1 month use --> tests
| Arm | Type | Receives |
|---|---|---|
| CI with FineHearing with 10 more apical electrodes activated then 10 more basal electrodes activated | Active comparator | Device: FineHearing Strategy with 10 more apical electrodes or with 10 more basal electrodes activatedCochlear implant with FineHearing Strategy with 10 more apical electrodes activated first during 1 month then FineHearing Strategy with 10 more basal electrodes activated during 1 month |
| CI with FineHearing with 10 more basal electrodes activated then 10 more apical electrodes activated | Active comparator | Device: FineHearing Strategy with 10 more apical electrodes or with 10 more basal electrodes activatedCochlear implant with FineHearing Strategy with 10 more basal electrodes activated first during 1 month then FineHearing Strategy with 10 more apical electrodes activated during 1 month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient (≥ 18 years old) speaking French
- Patient who fulfils the criteria for cochlear implantation
- Patient with a postoperative insertion angle of the apical electrode > 450°
- Patient with 12 active electrodes on the day of activation.
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 |
|---|---|---|
| FineHearing Strategy with 10 more apical electrodes or with 10 more basal electrodes activatedCochlear implant with FineHearing Strategy with 10 more apical electrodes activated or with 10 more basal electrodes activated | Device | CI with FineHearing with 10 more apical electrodes activated then 10 more basal electrodes activated, CI with FineHearing with 10 more basal electrodes activated then 10 more apical electrodes activated |
Primary outcome
Qualitative measure of music with direct audio link
Time frame: at 1 month post-activation
The Gabrielsson scale (1988) is used to evaluate perceived sound quality as a multidimensional phenomenon, that is composed of a number of separate perceptual dimensions. Eight perceptual dimensions are evaluated: clarity, fullness, brightness vs dullness, hardness/sharpness vs softness, spaciousness, nearness, extraneous sounds, loudness. Visual analog scales (VAS) are used for each dimension and the patient has to score the dimension on a 10 cm VAS (between 0 to 10). The test is performed with a direct audio link to the CI.
Qualitative measure of music with direct audio link
Time frame: at 2 months post-activation
The Gabrielsson scale (1988) is used to evaluate perceived sound quality as a multidimensional phenomenon, that is composed of a number of separate perceptual dimensions. Eight perceptual dimensions are evaluated: clarity, fullness, brightness vs dullness, hardness/sharpness vs softness, spaciousness, nearness, extraneous sounds, loudness. Visual analog scales (VAS) are used for each dimension and the patient has to score the dimension on a 10 cm VAS (between 0 to 10). The test is performed with a direct audio link to the CI.
8 secondary outcomes
Qualitative measure of music
Time frame: at 1 month post-activation
Qualitative measure of music
Time frame: at 2 months post-activation
Speech recognition in quiet
Time frame: at 1 month post-activation
Speech recognition in quiet
Time frame: at 2 months post-activation
Differential frequency threshold
Time frame: at 1 month post-activation
Differential frequency threshold
Time frame: at 2 months post-activation
Sound quality
Time frame: at 1 month post-activation
Sound quality
Time frame: at 2 months 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 19 Nov 2025.
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.
Isabelle Mosnier, Dr principal investigator
Service ORL, UF Implants auditifs et explorations fonctionnelles GH Pitié-Salpêtrière, APHP 6 Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FineHearing Strategy with 10 more apical electrodes or with 10 more basal electrodes activated 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 4 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 19 Nov 2025. 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 ((+33) 603592974, vincent.pean@medel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative measure of music with direct audio link (time frame: at 1 month 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 19 Nov 2025.