Severe to Profound Sensorineural Hearing LossCRSOSICNCT07371299
Correlations Between Subjective and Objective Responses to Cochlear Implant Stimulation
An observational study of Severe to Profound Sensorineural Hearing Loss, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Cochlear implants have been used for several decades, with major technological advances. However, adjustment can be difficult for patients who have to get used to a new sound that is electrical rather than acoustic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe to Profound Sensorineural Hearing Loss
- What is being tested?
- Objective electrophysiological measures (eCAP, eABR, eSRT)
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2026to Oct 2029
- Phase
- Observational
- 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
Study population: Adult patients who are going to receive or have received a cochlear implant.
Who may be able to join
- Incident case cohort:
- Age ≥ 18 years (18 years or older)
- Scheduled for first-time unilateral cochlear implantation within the next 3 months
- Informed about the study and did not object (non-opposition)
- Cross-sectional sample of prevalent cases:
- Age ≥ 18 years (18 years or older)
Show all 9Show fewer
- Underwent unilateral cochlear implantation more than 1 year ago
- Has used the implant for more than 1 year (interval between implantation surgery and study inclusion > 1 year)
- Informed about the study and did not object (non-opposition)
Who cannot join
- Exclusion Criteria - applies to both the incident case cohort and the cross-sectional sample of prevalent cases:
- Prior middle or inner ear surgery
- Cognitive impairment or insufficient comprehension of French that would prevent understanding of study procedures or accurate measurement of comfort thresholds during programming
- Peripheral facial palsy
- Bilateral cochlear implantation
- Patient under legal guardianship/court-ordered protection
Show all 11Show fewer
- Additional exclusion - cross-sectional sample of prevalent cases only:
- More than half of the electrodes not inserted (i.e., <50% electrode insertion)
- Secondary exclusion criteria - Incident case cohort:
- More than half of the electrodes not inserted (<50% electrode insertion)
- Postoperative peripheral facial nerve palsy following the implantation surgery
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Multimodal Objective Measures Help Cochlear Implant Programming: Cross-sectional and Prospective Study Focusing on the Correlations Between eSRT, Behavioural and Other Objective Responses (eABR, eCAP)
Cochlear implants have been used for several decades, with major technological advances. However, adjustment can be difficult for patients who have to get used to a new sound that is electrical rather than acoustic. In general, adjustment is based on the patient's responses: the patient must inform the technician of their sensations in order to determine the sound level that is comfortable for them (MCL: maximum comfortable level).
The adjustment therefore depends on a subjective assessment. The aim of the adjustments is to make the sound pleasant while increasing the stimulation level to the maximum tolerated level in order to achieve good listening dynamics. Objective indicators would therefore be useful in improving the accuracy of the adjustments. The objective measurements that can be taken are:
- Electrical compound action potentials (eCAP)
- Electrical auditory brainstem response (eABR)
- Electrical stapedius reflex threshold (eSRT).
Read the detailed description
Observational study of adult patients who are going to receive or have received a cochlear implant. In fact, two groups of patients will be studied:
Incident case cohort: patients included in the cohort will be followed for one year after surgery.
Data will be collected at each postoperative follow-up visit (M1, M3, M6, M9, M12) to monitor their progress. Each objective measurement will be taken on at least three electrodes: on the left, right, and central electrodes. Data will be collected at each postoperative follow-up visit (M1, M3, M6, M9, M12) in order to monitor their progress. Each objective measurement will be taken on at least three electrodes: on the basal, median, and apical parts of the electrode array. Stimulation will be configured using the software normally used to adjust the implant.
Responses are collected:
- for eCAPs: via the same software
- for eABRs: using an auditory evoked potential recording device synchronized with the implant stimulations
- for eSRTs: using a tympanometer with the probe inserted into the external auditory canal on the same side or the opposite side to the stimulation. Cross-sectional sample of prevalent cases: The same measurements will be taken in patients who had a cochlear implant some time ago (evaluation more than one year after surgery). The measurements will be taken only once during their annual check-up. This population will enable us to compare data from patients who have recently had an implant with data from a population that already has a minimum of experience and adaptation to the implant.
- Being tested
- Objective electrophysiological measures (eCAP, eABR, eSRT)
- Keywords
- Cochlear implants, Cochlear implant stimulation, Electrical compound action potentials (eCAP), Electrical auditory brainstem response (eABR), electrical stapedius reflex threshold (eSRT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Objective electrophysiological measures (eCAP, eABR, eSRT)Diagnostic test
Non-invasive electrophysiological recordings obtained during/after routine cochlear-implant programming, using standard clinical equipment: eCAP via CI software, eABR via an evoked-potential system synchronized with the implant, and eSRT via tympanometry. No investigational device or randomization. Measurements are collected for observational correlations with behavioral levels. Schedule: incident cohort at M1, M3, M6, M9, M12; prevalent cohort single annual visit.
| Study group | Role | What they receive |
|---|---|---|
| Incident CI Cohort (Prospective Adults) | Adults ≥18 scheduled for first-time unilateral cochlear implantation within 3 months; followed post-op at M1, M3, M6, M9, M12. Objective measures on ≥3 electrodes (basal, middle, apical): eCAP via CI software; eABR via evoked-potential system; eSRT via tympanometer. No experimental intervention (routine programming only). Main interest: associations between objective metrics and behavioral MCL, with key analyses at M6 and M12. Receives: Diagnostic Test: Objective electrophysiological measures (eCAP, eABR, eSRT) | |
| Prevalent CI Cohort (Cross-Sectional Adults) | Adults ≥18 with unilateral cochlear implant use ≥12 months; single annual follow-up visit. Same objective measures (eCAP, eABR, eSRT) on ≥3 electrodes using standard clinical equipment; no intervention. Purpose: cross-sectional correlations and comparison with the incident cohort. Receives: Diagnostic Test: Objective electrophysiological measures (eCAP, eABR, eSRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The MCL threshold, the objective response threshold (eSRT), the eSRT response
"The MCL threshold, expressed in CU (charge unit) units, corresponds to the maximum level of stimulation of the implant required to obtain a sound level considered comfortable by the patient. It will be recorded at each post-operative check-up (M1, M3, M6, M9, and M12).
The objective response threshold (eSRT), expressed in CU units, corresponds to the minimum level of implant stimulation required to elicit a stapedial reflex. It will be recorded at each post-operative assessment (M1, M3, M6, M9, and M12).
The eSRT response will be collected using a tympanometry probe (commonly used to measure ear impedance in patients during a standard hearing assessment) in the patient's external auditory canal, ipsilateral or contralateral to the implanted side. The tympanometer will continuously record ear impedance during electrical stimulation until a significant variation is obtained, indicating the presence of the stapedial reflex."
Measured: 15 months
Secondary outcomes (10)
Correlation between behavioral MCL and eABR threshold
Pearson/Spearman correlation between Maximum Comfortable Level (MCL, charge units [CU]) and electrically evoked Auditory Brainstem Response (eABR) threshold (CU); measured on ≥3 electrodes (basal, middle, apical) using standard CI programming and evoked-potential equipment.
Measured: Month 6 and Month 12 post-operative follow-up visits (incident cohort)
Correlation between behavioral MCL and eCAP threshold
Pearson/Spearman correlation between MCL (CU) and electrically evoked Compound Action Potential (eCAP) threshold (CU); measured on ≥3 electrodes (basal, middle, apical) via implant software.
Measured: M1, M3, M6, M9, M12 post-operative visits (incident cohort).
Correlation between eSRT and eABR thresholds
Pearson/Spearman correlation between electrically evoked Stapedius Reflex Threshold (eSRT, CU) and eABR threshold (CU); ≥3 electrodes per visit.
Measured: M6 and M12 post-operative visits (incident cohort).
Correlation between eSRT and eCAP thresholds
Pearson/Spearman correlation between eSRT (CU) and eCAP threshold (CU); ≥3 electrodes per visit.
Measured: M1, M3, M6, M9, M12 post-operative visits (incident cohort).
Correlation between eABR and eCAP thresholds
Pearson/Spearman correlation between eABR and eCAP thresholds (both in CU); ≥3 electrodes per visit.
Measured: Month 6 and Month 12 after cochlear implantation (incident cohort)
Agreement between intraoperative eSRT by tympanometer vs visual stapedius reflex
Association between peri-operative eSRT measured objectively with a tympanometer and the surgeon's visual observation of stapedius movement (yes/no).
Measured: ntraoperative (single time point during CI surgery).
Probe frequencies eliciting eSRT
Distribution of probe frequencies (226, 678, 1000 Hz) that yield an eSRT response; eSRT level recorded for each tested frequency.
Measured: Post-operative follow-up visits at Month 1, Month 3, Month 6, Month 9, and Month 12 (incident cohort), and 1 year or more after cochlear implantation (prevalent cohort)
Longitudinal profile of objective thresholds (eSRT/eABR/eCAP)
Trajectory of eSRT, eABR, and eCAP thresholds over the first post-operative year, summarized graphically and descriptively.
Measured: From Month 1 to Month 12 after cochlear implantation (incident cohort)
Cross-sectional associations among MCL and objective measures in prevalent users
Correlations between MCL and eSRT/eABR/eCAP, and pairwise correlations among objective measures, in adults with ≥12 months of CI use.
Measured: At the annual follow-up visit, at least 12 months after cochlear implant surgery.
Between-cohort comparison of correlation coefficients (prevalent vs incident) Description: Comparison of correlation coefficients for each pair (MCL-eSRT, MCL-eABR, MCL-eCAP, eSRT-eABR, eSRT-eCAP, eABR-eCAP) between the prevalent cross-section and the in
Between-cohort comparison of correlation coefficients (prevalent vs incident) Description: Comparison of correlation coefficients for each pair (MCL-eSRT, MCL-eABR, MCL-eCAP, eSRT-eABR, eSRT-eCAP, eABR-eCAP) between the prevalent cross-section and the incident cohort.
Measured: Incident cohort: post-operative follow-up visits from Month 1 through Month 12. Prevalent cohort: annual follow-up visit, at least 12 months after cochlear implant surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe to Profound Sensorineural Hearing LossStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Cochlear
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371299
- Sponsor's protocol ID
- APHP250486
- Other IDs
- 2025-A01446-43
- Acronym
- CRSOSIC
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 27 Jan 2026
- 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 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Objective Measures Help Cochlear Implant Programming: Cross-sectional and Prospective Study Focusing on the Correlations Between eSRT, Behavioural and Other Objective Responses (eABR, eCAP)
- ClinicalTrials.gov ID
- NCT07371299
- Acronym / sponsor ID
- CRSOSIC / APHP250486
- Keywords
- Cochlear implants, Cochlear implant stimulation, Electrical compound action potentials (eCAP), Electrical auditory brainstem response (eABR), electrical stapedius reflex threshold (eSRT)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Cochlear
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 27 Jan 2026 (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.
Cochlear implants have been used for several decades, with major technological advances. However, adjustment can be difficult for patients who have to get used to a new sound that is electrical rather than acoustic. In general, adjustment is based on the patient's responses: the patient must inform the technician of their sensations in order to determine the sound level that is comfortable for them (MCL: maximum comfortable level).
The adjustment therefore depends on a subjective assessment. The aim of the adjustments is to make the sound pleasant while increasing the stimulation level to the maximum tolerated level in order to achieve good listening dynamics. Objective indicators would therefore be useful in improving the accuracy of the adjustments. The objective measurements that can be taken are:
- Electrical compound action potentials (eCAP)
- Electrical auditory brainstem response (eABR)
- Electrical stapedius reflex threshold (eSRT).
Detailed description
Observational study of adult patients who are going to receive or have received a cochlear implant. In fact, two groups of patients will be studied:
Incident case cohort: patients included in the cohort will be followed for one year after surgery.
Data will be collected at each postoperative follow-up visit (M1, M3, M6, M9, M12) to monitor their progress. Each objective measurement will be taken on at least three electrodes: on the left, right, and central electrodes. Data will be collected at each postoperative follow-up visit (M1, M3, M6, M9, M12) in order to monitor their progress. Each objective measurement will be taken on at least three electrodes: on the basal, median, and apical parts of the electrode array. Stimulation will be configured using the software normally used to adjust the implant.
Responses are collected:
- for eCAPs: via the same software
- for eABRs: using an auditory evoked potential recording device synchronized with the implant stimulations
- for eSRTs: using a tympanometer with the probe inserted into the external auditory canal on the same side or the opposite side to the stimulation. Cross-sectional sample of prevalent cases: The same measurements will be taken in patients who had a cochlear implant some time ago (evaluation more than one year after surgery). The measurements will be taken only once during their annual check-up. This population will enable us to compare data from patients who have recently had an implant with data from a population that already has a minimum of experience and adaptation to the implant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incident CI Cohort (Prospective Adults) | – | Diagnostic Test: Objective electrophysiological measures (eCAP, eABR, eSRT)Adults ≥18 scheduled for first-time unilateral cochlear implantation within 3 months; followed post-op at M1, M3, M6, M9, M12. Objective measures on ≥3 electrodes (basal, middle, apical): eCAP via CI software; eABR via evoked-potential system; eSRT via tympanometer. No experimental intervention (routine programming only). Main interest: associations between objective metrics and behavioral MCL, with key analyses at M6 and M12. |
| Prevalent CI Cohort (Cross-Sectional Adults) | – | Diagnostic Test: Objective electrophysiological measures (eCAP, eABR, eSRT)Adults ≥18 with unilateral cochlear implant use ≥12 months; single annual follow-up visit. Same objective measures (eCAP, eABR, eSRT) on ≥3 electrodes using standard clinical equipment; no intervention. Purpose: cross-sectional correlations and comparison with the incident cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who are going to receive or have received a cochlear implant.
Key inclusion criteria (9 listed)
- Age ≥ 18 years (18 years or older)
- Scheduled for first-time unilateral cochlear implantation within the next 3 months
- Informed about the study and did not object (non-opposition)
- Age ≥ 18 years (18 years or older)
- Underwent unilateral cochlear implantation more than 1 year ago
Key exclusion criteria (11 listed)
- Exclusion Criteria - applies to both the incident case cohort and the cross-sectional sample of prevalent cases:
- Prior middle or inner ear surgery
- Cognitive impairment or insufficient comprehension of French that would prevent understanding of study procedures or accurate measurement of comfort thresholds during programming
- Peripheral facial palsy
- Bilateral cochlear implantation
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 |
|---|---|---|
| Objective electrophysiological measures (eCAP, eABR, eSRT)Non-invasive electrophysiological recordings obtained during/after routine cochlear-implant programming, using standard clinical equipment: eCAP via CI software, eABR via an evoked-potential system synchronized with the implant, and eSRT via tympanometry. No investigational device or randomization. Measurements are collected for observational correlations with behavioral levels. Schedule: incident cohort at M1, M3, M6, M9, M12; prevalent cohort single annual visit. | Diagnostic test | Incident CI Cohort (Prospective Adults), Prevalent CI Cohort (Cross-Sectional Adults) |
Primary outcome
The MCL threshold, the objective response threshold (eSRT), the eSRT response
Time frame: 15 months
"The MCL threshold, expressed in CU (charge unit) units, corresponds to the maximum level of stimulation of the implant required to obtain a sound level considered comfortable by the patient. It will be recorded at each post-operative check-up (M1, M3, M6, M9, and M12). The objective response threshold (eSRT), expressed in CU units, corresponds to the minimum level of implant stimulation required to elicit a stapedial reflex. It will be recorded at each post-operative assessment (M1, M3, M6, M9, and M12). The eSRT response will be collected using a tympanometry probe (commonly used to measure ear impedance in patients during a standard hearing assessment) in the patient's external auditory canal, ipsilateral or contralateral to the implanted side. The tympanometer will continuously record ear impedance during electrical stimulation until a significant variation is obtained, indicating the presence of the stapedial reflex."
10 secondary outcomes
Correlation between behavioral MCL and eABR threshold
Time frame: Month 6 and Month 12 post-operative follow-up visits (incident cohort)
Correlation between behavioral MCL and eCAP threshold
Time frame: M1, M3, M6, M9, M12 post-operative visits (incident cohort).
Correlation between eSRT and eABR thresholds
Time frame: M6 and M12 post-operative visits (incident cohort).
Correlation between eSRT and eCAP thresholds
Time frame: M1, M3, M6, M9, M12 post-operative visits (incident cohort).
Correlation between eABR and eCAP thresholds
Time frame: Month 6 and Month 12 after cochlear implantation (incident cohort)
Agreement between intraoperative eSRT by tympanometer vs visual stapedius reflex
Time frame: ntraoperative (single time point during CI surgery).
Probe frequencies eliciting eSRT
Time frame: Post-operative follow-up visits at Month 1, Month 3, Month 6, Month 9, and Month 12 (incident cohort), and 1 year or more after cochlear implantation (prevalent cohort)
Longitudinal profile of objective thresholds (eSRT/eABR/eCAP)
Time frame: From Month 1 to Month 12 after cochlear implantation (incident cohort)
Cross-sectional associations among MCL and objective measures in prevalent users
Time frame: At the annual follow-up visit, at least 12 months after cochlear implant surgery.
Between-cohort comparison of correlation coefficients (prevalent vs incident) Description: Comparison of correlation coefficients for each pair (MCL-eSRT, MCL-eABR, MCL-eCAP, eSRT-eABR, eSRT-eCAP, eABR-eCAP) between the prevalent cross-section and the in
Time frame: Incident cohort: post-operative follow-up visits from Month 1 through Month 12. Prevalent cohort: annual follow-up visit, at least 12 months after cochlear implant surgery.
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 27 Jan 2026.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe to Profound Sensorineural Hearing Loss, run by Assistance Publique - Hôpitaux de Paris.
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 9 inclusion and 11 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: opening soon, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Antoine PAUL, PhD (+33145213128, antoine.paul@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The MCL threshold, the objective response threshold (eSRT), the eSRT response (time frame: 15 months). 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 27 Jan 2026.