Electrophysiological Study of Interindividual Differences in Speech-understanding Among Cochlear Implant Patients

Differences in speech-understanding and the quality of the subjective perception among cochlear implant patients (Digisonic SP) depends on numerous factors. The electrical field distribution (interaction between electrodes) could also explain the disparity of the performances? The objective of our study was to quantify the influence of the electrical field interactions between the channels of stimulation according to the vocal performances of the implanted subjects, for various subjective levels of electric stimulation.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Subject of French language
Subject with a moderate bilateral sensorineural hearing loss, severe to profound
Sensorineural hearing loss post-lingual (after onset of language acquisition)
Subject paired with the implant Neurelec (Appendix 1) for more than 9 months
Subject has received an appropriate setting under usual clinical follow-up
Elderly 18 to 75 years
Subject giving consent

Exclusion criteria

Sensorineural hearing loss pre-lingual
Deafness following a meningitis, or neurodegenerative diseases
Illiteracy
Pregnant women
Subject blind
Subject enjoying a measure of legal protection
Subject incapable of giving consent
Subject vulnerable

Treatment and study plan

Electrophysiological study of the interindividual variability of vocal performance

Other

Primary outcomes

Quantify the interactions between electrical stimulation channels based vocal performance of implanted subjects, for different subjective levels of electrical stimulation.

Time frame: At the inclusion - Day 0

The vocal performance will be noted in percentage of voice recognition in the silence and in the noise.

And the electric interaction between the channels of stimulations will be estimated by the measure of the refractory period of the circuits of the hearing system with the PEAEP after stimulations of electrodes of intermediate situation in the cochlée (electrodes 11, 12 and 13)

Secondary outcomes

Comparative study of PEAEP (Auditory Evoked Potentials Early electric) in vocal performance

Time frame: At the inclusion - Day 0

Collection of the PEAEP after stimulation of 4 different electrodes distributed on the totality of door-electrode: generally, electrodes 4, 7, 10 and 13 will be stimulated. The amplitudes and the latencies of the waves II, III and V will be analyzed and compared with the vocal performances.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2014
First posted: Mar 6, 2013
Registry last updated: Jun 16, 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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Completed