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NCT Number: NCT07371299

Correlations Between Subjective and Objective Responses to Cochlear Implant Stimulation

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).

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Key information

Conditions

Severe to Profound Sensorineural Hearing Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)
  • 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)

Exclusion criteria

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

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

Treatment and study plan

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.

Primary outcomes

  1. 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."

Secondary outcomes

  1. Correlation between behavioral MCL and eABR threshold

    Time frame: Month 6 and Month 12 post-operative follow-up visits (incident cohort)

    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.

  2. Correlation between behavioral MCL and eCAP threshold

    Time frame: M1, M3, M6, M9, M12 post-operative visits (incident cohort).

    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.

  3. Correlation between eSRT and eABR thresholds

    Time frame: M6 and M12 post-operative visits (incident cohort).

    Pearson/Spearman correlation between electrically evoked Stapedius Reflex Threshold (eSRT, CU) and eABR threshold (CU); ≥3 electrodes per visit.

  4. Correlation between eSRT and eCAP thresholds

    Time frame: M1, M3, M6, M9, M12 post-operative visits (incident cohort).

    Pearson/Spearman correlation between eSRT (CU) and eCAP threshold (CU); ≥3 electrodes per visit.

  5. Correlation between eABR and eCAP thresholds

    Time frame: Month 6 and Month 12 after cochlear implantation (incident cohort)

    Pearson/Spearman correlation between eABR and eCAP thresholds (both in CU); ≥3 electrodes per visit.

  6. Agreement between intraoperative eSRT by tympanometer vs visual stapedius reflex

    Time frame: ntraoperative (single time point during CI surgery).

    Association between peri-operative eSRT measured objectively with a tympanometer and the surgeon's visual observation of stapedius movement (yes/no).

  7. 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)

    Distribution of probe frequencies (226, 678, 1000 Hz) that yield an eSRT response; eSRT level recorded for each tested frequency.

  8. Longitudinal profile of objective thresholds (eSRT/eABR/eCAP)

    Time frame: From Month 1 to Month 12 after cochlear implantation (incident cohort)

    Trajectory of eSRT, eABR, and eCAP thresholds over the first post-operative year, summarized graphically and descriptively.

  9. 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.

    Correlations between MCL and eSRT/eABR/eCAP, and pairwise correlations among objective measures, in adults with ≥12 months of CI use.

  10. 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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Antoine PAUL, PhD

CONTACT

[email protected]

+33145213128

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Cochlear

Registry information

Official study 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)

Acronym: CRSOSIC

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jan 27, 2026
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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