Sensorineural Hearing Loss, BilateralNCT05230498
Study of Sound and Speech Perception in New Cochlear Implanted Subjects Using or Not an Anatomy-based Fitting
A study testing anatomy-based fitting then default fitting and default fitting then anatomy-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 the recognition of environmental sounds with an anatomy-based fitting and with a default fitting adult patients newly implanted with a MED-EL cochlear implant. 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?
- anatomy-based fitting then default fitting and default fitting then anatomy-based fitting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2022to 15 Nov 2024
- 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
- 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.
About this study
Official title: Comparison of an Anatomy-based Fitting and a Conventional Fitting in Newly Implanted Cochlear Patients. Prospective Monocentric Randomized Double-blind Crossover Study.
Main objective:
Compare the recognition of environmental sounds with an anatomy-based fitting and with a default fitting adult patients newly implanted with a MED-EL cochlear implant.
Secondary objectives:
Compare speech recognition in quiet with an anatomy-based fitting and with a default fitting in adult patients newly implanted with a MED-EL cochlear implant.
Compare speech recognition in noise with an anatomy-based fitting and with a default fitting in adult patients newly implanted with a MED-EL cochlear implant.
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.
Main objective:
Compare the recognition of environmental sounds with an anatomy-based fitting and with a default fitting adult patients newly implanted with a MED-EL cochlear implant.
Secondary objectives:
Compare speech recognition in quiet with an anatomy-based fitting and with a default fitting in adult patients newly implanted with a MED-EL cochlear implant.
Compare speech recognition in noise with an anatomy-based fitting and with a default fitting in adult patients newly implanted with a MED-EL cochlear implant.
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
- anatomy-based fitting then default fitting, default fitting then anatomy-based fitting
- Keywords
- cochlear implant strategy, anatomy-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.
anatomy-based fitting then default fittingDevice
Cochlear implant with anatomy-based fitting then default fitting
default fitting then anatomy-based fittingDevice
Cochlear implant with anatomy-based fitting then default fitting
| Study group | Role | What they receive |
|---|---|---|
| Cochlear Implant (CI) with default fitting then anatomy-based fitting | Active comparator | Cochlear Implant with default fitting first during 6 weeks then with anatomy-based fitting during 6 weeks Receives: Device: default fitting then anatomy-based fitting |
| Cochlear Implant (CI) with anatomy-based fitting then default fitting | Active comparator | Cochlear Implant with anatomy-based fitting during 6 weeks then with default fitting during 6 weeks Receives: Device: anatomy-based fitting then default fitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recognition of Environmental sounds
The environmental sound recognition is evaluated with the Environmental Sound Identification Test (TISE, Treville-Protain et al. 2019). The patient has to recognize 24 environmental sounds. Each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
Measured: at 6 weeks post-activation
Recognition of Environmental sounds
The environmental sound recognition is evaluated with the Environmental Sound Identification Test (TISE, Treville-Protain et al. 2019). The patient has to recognize 24 environmental sounds. Each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
Measured: at 12 weeks post-activation
Secondary outcomes (4)
Speech recognition in quiet
The speech recognition in quiet is evaluated with 3 lists of 10 disyllabic words. The patient has to recognize 30 words. Each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
Measured: at 6 weeks post-activation
Speech recognition in quiet
The speech recognition in quiet is evaluated with 3 lists of 10 disyllabic words. The patient has to recognize 30 words. Each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
Measured: at 12 weeks post-activation
Speech recognition in noise
The speech recognition in noise is evaluated with the French-language "Rapid speech in noise" (VRB) test (Leclerc et al. 2018). The speech level is at 65 dB SPL. The patient has to recognize 3 target words by sentence. The 8 sentences are played with signal-to-noise ratios between +18 dB and -3 dB by steps of 3 dB. The SRT50 (threshold for 50% intelligibility in noise) is obtained by SRT50 = 19,5 - R, with R = number of correct answers (on 24).
Measured: at 6 weeks post-activation
Speech recognition in noise
The speech recognition in noise is evaluated with the French-language VRB test (Leclerc et al. 2018). The speech level is at 65 dB SPL. The patient has to recognize 3 target words by sentence. The 8 sentences are played with signal-to-noise ratios between +18 dB and -3 dB by steps of 3 dB. The SRT50 (threshold for 50% intelligibility in noise) is obtained by SRT50 = 19,5 - R, with R=number of correct answers (on 24).
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 posted9 Feb 2022
- Study start15 Feb 2022
- Primary completion15 Nov 2024
- Study completion15 Nov 2024
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: patient's fitting with default fitting --\> 6 weeks use --\> tests and patient's fitting with anatomy-based fitting --\> 6 weeks use --\> tests Arm B: patient's fitting with anatomy-based fitting --\> 6 weeks use --\> tests and patient's fitting with default fitting --\> 6 weeks use --\> tests
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Damien Bonnard, Dr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230498
- Sponsor's protocol ID
- MEDEL_anatfit_Bordeaux_study
- Status last verified
- Dec 2024
- First submitted
- 28 Jan 2022
- Last updated
- 5 Dec 2024
- 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 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of an Anatomy-based Fitting and a Conventional Fitting in Newly Implanted Cochlear Patients. Prospective Monocentric Randomized Double-blind Crossover Study.
- ClinicalTrials.gov ID
- NCT05230498
- Acronym / sponsor ID
- MEDEL_anatfit_Bordeaux_study
- Conditions
- Sensorineural Hearing Loss, Bilateral
- Keywords
- cochlear implant strategy, anatomy-based fitting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 9 Feb 2022 (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 the recognition of environmental sounds with an anatomy-based fitting and with a default fitting adult patients newly implanted with a MED-EL cochlear implant.
Secondary objectives:
Compare speech recognition in quiet with an anatomy-based fitting and with a default fitting in adult patients newly implanted with a MED-EL cochlear implant.
Compare speech recognition in noise with an anatomy-based fitting and with a default fitting in adult patients newly implanted with a MED-EL cochlear implant.
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.
Main objective:
Compare the recognition of environmental sounds with an anatomy-based fitting and with a default fitting adult patients newly implanted with a MED-EL cochlear implant.
Secondary objectives:
Compare speech recognition in quiet with an anatomy-based fitting and with a default fitting in adult patients newly implanted with a MED-EL cochlear implant.
Compare speech recognition in noise with an anatomy-based fitting and with a default fitting in adult patients newly implanted with a MED-EL cochlear implant.
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: patient's fitting with default fitting --> 6 weeks use --> tests and patient's fitting with anatomy-based fitting --> 6 weeks use --> tests Arm B: patient's fitting with anatomy-based fitting --> 6 weeks use --> tests and patient's fitting with default fitting --> 6 weeks use --> tests
| Arm | Type | Receives |
|---|---|---|
| Cochlear Implant (CI) with default fitting then anatomy-based fitting | Active comparator | Device: default fitting then anatomy-based fittingCochlear Implant with default fitting first during 6 weeks then with anatomy-based fitting during 6 weeks |
| Cochlear Implant (CI) with anatomy-based fitting then default fitting | Active comparator | Device: anatomy-based fitting then default fittingCochlear Implant with anatomy-based fitting during 6 weeks then with default fitting 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 |
|---|---|---|
| anatomy-based fitting then default fittingCochlear implant with anatomy-based fitting then default fitting | Device | Cochlear Implant (CI) with anatomy-based fitting then default fitting |
| default fitting then anatomy-based fittingCochlear implant with anatomy-based fitting then default fitting | Device | Cochlear Implant (CI) with default fitting then anatomy-based fitting |
Primary outcome
Recognition of Environmental sounds
Time frame: at 6 weeks post-activation
The environmental sound recognition is evaluated with the Environmental Sound Identification Test (TISE, Treville-Protain et al. 2019). The patient has to recognize 24 environmental sounds. Each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
Recognition of Environmental sounds
Time frame: at 12 weeks post-activation
The environmental sound recognition is evaluated with the Environmental Sound Identification Test (TISE, Treville-Protain et al. 2019). The patient has to recognize 24 environmental sounds. Each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
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
Speech recognition in noise
Time frame: at 6 weeks post-activation
Speech recognition in noise
Time frame: at 12 weeks post-activation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- 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.
Damien Bonnard, Dr principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anatomy-based fitting then default fitting and default fitting then anatomy-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: finished, as of the sponsor's last update on 5 Dec 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recognition of Environmental sounds (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 5 Dec 2024; AzTrials last refreshed its copy on 1 Nov 2026.