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Correlations Between Subjective and Objective Responses to Cochlear Implant Stimulation

NCT07371299 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-01-27

No results posted yet for this study

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. 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).

Conditions

  • Severe to Profound Sensorineural Hearing Loss

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Cochlear

    collaborator INDUSTRY

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2029-10-31
Completion
2029-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07371299 on ClinicalTrials.gov