Sensorineural Hearing Loss, BilateralNCT03694704
Study of Auditory Performance on Prosodic Tests in Cochlear Implanted Subjects Using a Fine Structure Strategy
A study testing FineHearing strategy in people with Sensorineural Hearing Loss, Bilateral, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in France.
Trial summary
Main objective: Investigate how the FineHearing strategy of the MED-EL cochlear implant can extract prosody based solely on the frequency of the voice fundamental (F0) in speech Secondary objectives: Evaluate the time evolution of the results of prosodic tests Evaluate the time evolution of the results of differential… 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2019to 28 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient with MED-EL cochlear implant (Sonnet / Synchrony)
- Adult patient (≥ 18 years old) speaking French
- Patient having an estimate of the optimal size of the electrode for its cochlea with the MED-EL software before their implantation.
- Patient with post-implant audiometry thresholds without cochlear implant > 80 dB HL on 250 Hz, 500 Hz and 1000 Hz frequencies (no residual hearing)
- Patient with vocal audiometry in quiet on Fournier's disyllabic words ≥ 70% at 6 months post-activation
Who cannot join
- Retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Auditory Performance on Postoperative Prosodic Tests in Subjects Implanted With a MED-EL Cochlear Implant and Using a FineHearing Strategy. Prospective Longitudinal Multicentric Study
Main objective:
Investigate how the FineHearing strategy of the MED-EL cochlear implant can extract prosody based solely on the frequency of the voice fundamental (F0) in speech
Secondary objectives:
Evaluate the time evolution of the results of prosodic tests Evaluate the time evolution of the results of differential frequency threshold test Evaluate the time evolution of vocal audiometric tests in silence and noise Evaluate the correlation between prosodic test results and frequency differential threshold results
Read the detailed description
Introduction:
Prosodie is the study of the phenomena of accentuation and intonation (variation of pitch, duration and intensity) allowing the conveyance of information related to the sense such as the relief, but also the assertion, interrogation, injunction, exclamation ...
It has a role at the grammatical, emotional and pragmatic levels of communication by informing about the emotional state of the speaker (sad / happy), about sex and identity, about the type of statement (question / affirmation) and about the borders in the sentences.
The auditory cues that play a role in the perception of prosody include changes in the fundamental frequency F0 (ie vibrational frequency of the speaker's vocal cords) during a speech, the duration of the syllables, or the rate or intensity of the speech. [Di Christo 2013] The cochlear implant is a device for auditory rehabilitation. Its principle is to transform the analog signals recorded by a microphone into digital signals that directly stimulate the fibers of the auditory nerve through electrodes inserted into the cochlea. [HAS 2012, HAS 2007, http://www.has-sante.fr] Cochlear implants are indicated in cases of severe or profound sensorineural deafness.
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. [Wilson \& Dorman 2008] The pitch is only partially transmitted by these conventional strategies [Moore 2003; Oxenham 2008] which would explain the poor results of cochlear implants in the perception of music [Bruns \& al. 2016; Galvin III \& al. 2009; Veekmans \& al. 2009; Cooper \& al. 2008] and prosody [Kalathottukaren \& al. 2015 ; Meister et al. 2011; Meister et al. 2009].
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.
The FineHearing coding strategy of MED-EL with long insertion of electrode could therefore make it possible to better transmit the prosody and specifically to better extract the fundamental frequency F0 of the voice.
Objective of the study The objective of the study is to evaluate if the FineHearing strategy of the MED-EL implant allows to better transmit the prosody and specifically by the fundamental frequency of the voice (F0).
Main objective:
Show that the MED-EL FineHearing strategy (with deep insertion of the electrode) allows to extract prosody cues based only on the fundamental frequency F0.
Secondary objectives:
- evaluate differential frequency thresholds and correlation with prosodic performance
- Evaluate the positioning of the electrode array and its effect on prosodic performance
Plan of study:
It is a prospective open multicenter longitudinal study: measures will be done on the patient at 6 and 12 month post-activation.
- Conditions
- Sensorineural Hearing Loss, Bilateral
- Being tested
- FineHearing strategy
- 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 strategyDevice
Cochlear implant with FineHearing strategy
| Study group | Role | What they receive |
|---|---|---|
| CI with FineHearing Strategy | Experimental | cochlear implant with FineHearing strategy Receives: Device: FineHearing strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosodic test
Two versions, question and statement, of each of 12 sentences were recorded. The final 24 stimuli were constructed so that members of a question/statement pair were acoustically identical until the final syllable leaving pitch as the only salient cue for discrimination. the 24 sentences were presented in random order to the patient and he has to say if it is a question or a statement. Each good answer is scored 1 yielding a total between 0 and 24
Measured: at 12 month post-activation
Secondary outcomes (5)
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 6 month post-activation
Prosodic test
Two versions, question and statement, of each of 12 sentences were recorded. The final 24 stimuli were constructed so that members of a question/statement pair were acoustically identical until the final syllable leaving pitch as the only salient cue for discrimination. the 24 sentences were presented in random order to the patient and he has to say if it is a question or a statement. Each good answer is scored 1 yielding a total between 0 and 24
Measured: at 6 month post-activation
Vocal audiometry in quiet and noise
Word recognition test in quiet with 10 words. Each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
Signal to noise ratio (SRT50) to have 50% of sentence recognition in noise. Measure of the speech reception threshold (i.e. the speech intensity in dB SPL) for 50% (SRT50) of comprehension of sentences free field with the cochlear implant.
Measured: at 6 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 12 month post-activation
Vocal audiometry in quiet and noise
Word recognition test in quiet with 10 words. Each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
Signal to noise ratio (SRT50) to have 50% of sentence recognition in noise. Measure of the speech reception threshold (i.e. the speech intensity in dB SPL) for 50% (SRT50) of comprehension of sentences free field with the cochlear implant.
Measured: at 12 month post-activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start28 Feb 2019
- Primary completion28 Apr 2022 (estimated)
- Study completion28 Apr 2022 (estimated)
Why it stopped: COVID-19
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mathieu Marx, Pr, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694704
- Sponsor's protocol ID
- MED-EL_FS_prosody_french_study
- Status last verified
- May 2022
- First submitted
- 26 Sep 2018
- Last updated
- 16 May 2025
- 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 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Auditory Performance on Postoperative Prosodic Tests in Subjects Implanted With a MED-EL Cochlear Implant and Using a FineHearing Strategy. Prospective Longitudinal Multicentric Study
- ClinicalTrials.gov ID
- NCT03694704
- Acronym / sponsor ID
- MED-EL_FS_prosody_french_study
- Conditions
- Sensorineural Hearing Loss, Bilateral
- Keywords
- cochlear implant, stimulation strategy, sound coding strategy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 28 Apr 2022 (estimated)
- Study completion
- 28 Apr 2022 (estimated)
- First posted
- 3 Oct 2018 (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 how the FineHearing strategy of the MED-EL cochlear implant can extract prosody based solely on the frequency of the voice fundamental (F0) in speech
Secondary objectives:
Evaluate the time evolution of the results of prosodic tests Evaluate the time evolution of the results of differential frequency threshold test Evaluate the time evolution of vocal audiometric tests in silence and noise Evaluate the correlation between prosodic test results and frequency differential threshold results
Detailed description
Introduction:
Prosodie is the study of the phenomena of accentuation and intonation (variation of pitch, duration and intensity) allowing the conveyance of information related to the sense such as the relief, but also the assertion, interrogation, injunction, exclamation ...
It has a role at the grammatical, emotional and pragmatic levels of communication by informing about the emotional state of the speaker (sad / happy), about sex and identity, about the type of statement (question / affirmation) and about the borders in the sentences.
The auditory cues that play a role in the perception of prosody include changes in the fundamental frequency F0 (ie vibrational frequency of the speaker's vocal cords) during a speech, the duration of the syllables, or the rate or intensity of the speech. [Di Christo 2013] The cochlear implant is a device for auditory rehabilitation. Its principle is to transform the analog signals recorded by a microphone into digital signals that directly stimulate the fibers of the auditory nerve through electrodes inserted into the cochlea. [HAS 2012, HAS 2007, http://www.has-sante.fr] Cochlear implants are indicated in cases of severe or profound sensorineural deafness.
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. [Wilson \& Dorman 2008] The pitch is only partially transmitted by these conventional strategies [Moore 2003; Oxenham 2008] which would explain the poor results of cochlear implants in the perception of music [Bruns \& al. 2016; Galvin III \& al. 2009; Veekmans \& al. 2009; Cooper \& al. 2008] and prosody [Kalathottukaren \& al. 2015 ; Meister et al. 2011; Meister et al. 2009].
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.
The FineHearing coding strategy of MED-EL with long insertion of electrode could therefore make it possible to better transmit the prosody and specifically to better extract the fundamental frequency F0 of the voice.
Objective of the study The objective of the study is to evaluate if the FineHearing strategy of the MED-EL implant allows to better transmit the prosody and specifically by the fundamental frequency of the voice (F0).
Main objective:
Show that the MED-EL FineHearing strategy (with deep insertion of the electrode) allows to extract prosody cues based only on the fundamental frequency F0.
Secondary objectives:
- evaluate differential frequency thresholds and correlation with prosodic performance
- Evaluate the positioning of the electrode array and its effect on prosodic performance
Plan of study:
It is a prospective open multicenter longitudinal study: measures will be done on the patient at 6 and 12 month post-activation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CI with FineHearing Strategy | Experimental | Device: FineHearing strategycochlear implant with FineHearing strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with MED-EL cochlear implant (Sonnet / Synchrony)
- Adult patient (≥ 18 years old) speaking French
- Patient having an estimate of the optimal size of the electrode for its cochlea with the MED-EL software before their implantation.
- Patient with post-implant audiometry thresholds without cochlear implant > 80 dB HL on 250 Hz, 500 Hz and 1000 Hz frequencies (no residual hearing)
- Patient with vocal audiometry in quiet on Fournier's disyllabic words ≥ 70% at 6 months post-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 strategyCochlear implant with FineHearing strategy | Device | CI with FineHearing Strategy |
Primary outcome
Prosodic test
Time frame: at 12 month post-activation
Two versions, question and statement, of each of 12 sentences were recorded. The final 24 stimuli were constructed so that members of a question/statement pair were acoustically identical until the final syllable leaving pitch as the only salient cue for discrimination. the 24 sentences were presented in random order to the patient and he has to say if it is a question or a statement. Each good answer is scored 1 yielding a total between 0 and 24
5 secondary outcomes
Differential frequency threshold
Time frame: at 6 month post-activation
Prosodic test
Time frame: at 6 month post-activation
Vocal audiometry in quiet and noise
Time frame: at 6 month post-activation
Differential frequency threshold
Time frame: at 12 month post-activation
Vocal audiometry in quiet and noise
Time frame: at 12 month post-activation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- 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. This study is not recruiting at the moment.
Mathieu Marx, Pr principal investigator
University Hospital, Toulouse
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 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 5 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: withdrawn, as of the sponsor's last update on 16 May 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosodic test (time frame: at 12 month post-activation). 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 16 May 2025.