Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy

NCT04591093 | Recruiting

• 1 other identifier: MED-EL_FS_stimdepth_frenchstud
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Main objective: Investigate on new cochlear implanted patients whether the FineHearing strategy of the MED-EL cochlear implant gives better results on musical perception if the depth of stimulation (stimulation or not of the apical areas) is greater. Secondary objectives: Evaluate the effect of stimulation depth on vocal audiometric results, results of differential frequency threshold test and on qualitative sound perception.

Conditions

Sensorineural Hearing Loss, Bilateral

Keywords

cochlear implant; stimulation strategy; sound coding strategy

Outcome Measures

Primary Outcomes (2)

• Qualitative measure of music with direct audio link

  The Gabrielsson scale (1988) is used to evaluate perceived sound quality as a multidimensional phenomenon, that is composed of a number of separate perceptual dimensions. Eight perceptual dimensions are evaluated: clarity, fullness, brightness vs dullness, hardness/sharpness vs softness, spaciousness, nearness, extraneous sounds, loudness. Visual analog scales (VAS) are used for each dimension and the patient has to score the dimension on a 10 cm VAS (between 0 to 10). The test is performed with a direct audio link to the CI.

  at 1 month post-activation

• Qualitative measure of music with direct audio link

  The Gabrielsson scale (1988) is used to evaluate perceived sound quality as a multidimensional phenomenon, that is composed of a number of separate perceptual dimensions. Eight perceptual dimensions are evaluated: clarity, fullness, brightness vs dullness, hardness/sharpness vs softness, spaciousness, nearness, extraneous sounds, loudness. Visual analog scales (VAS) are used for each dimension and the patient has to score the dimension on a 10 cm VAS (between 0 to 10). The test is performed with a direct audio link to the CI.

  at 2 months post-activation

Secondary Outcomes (8)

• Qualitative measure of music

  at 1 month post-activation

• Qualitative measure of music

  at 2 months post-activation

• Speech recognition in quiet

  at 1 month post-activation

• Speech recognition in quiet

  at 2 months post-activation

• Differential frequency threshold

  at 1 month post-activation

Study Arms (2)

CI with FineHearing with 10 more apical electrodes activated then 10 more basal electrodes activated

ACTIVE COMPARATOR

Cochlear implant with FineHearing Strategy with 10 more apical electrodes activated first during 1 month then FineHearing Strategy with 10 more basal electrodes activated during 1 month

Device: FineHearing Strategy with 10 more apical electrodes or with 10 more basal electrodes activated

CI with FineHearing with 10 more basal electrodes activated then 10 more apical electrodes activated

ACTIVE COMPARATOR

Cochlear implant with FineHearing Strategy with 10 more basal electrodes activated first during 1 month then FineHearing Strategy with 10 more apical electrodes activated during 1 month

Device: FineHearing Strategy with 10 more apical electrodes or with 10 more basal electrodes activated

Interventions

FineHearing Strategy with 10 more apical electrodes or with 10 more basal electrodes activated DEVICE

Cochlear implant with FineHearing Strategy with 10 more apical electrodes activated or with 10 more basal electrodes activated

CI with FineHearing with 10 more apical electrodes activated then 10 more basal electrodes activated; CI with FineHearing with 10 more basal electrodes activated then 10 more apical electrodes activated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient (≥ 18 years old) speaking French
• Patient who fulfils the criteria for cochlear implantation
• Patient with a postoperative insertion angle of the apical electrode \> 450°
• Patient with 12 active electrodes on the day of activation.

You may not qualify if:

• Retro-cochlear pathology: auditory neuropathy, vestibular schwannoma

Sponsors & Collaborators

• MED-EL Elektromedizinische Geräte GesmbH: lead

Study Sites (1)

GH Pitié-Salpêtrière, APHP 6

Paris, 75651 Paris Cedex 13, France

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

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

Study Officials

• Isabelle Mosnier, Dr

  Service ORL, UF Implants auditifs et explorations fonctionnelles GH Pitié-Salpêtrière, APHP 6 Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Péan, PhD

CONTACT

(+33) 603592974; vincent.pean@medel.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind study: the patient and the investigator don't know the strategy
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Crossover Assignment two arms A and B: Arm A: patient's fitting with strategy FS4 and 10 more apical electrodes activated--\> 1 month use --\> tests and patient's fitting with strategy FS4 and 10 more basal electrodes --\> 1 month use --\> tests Arm B: patient's fitting with strategy FS4 and 10 more basal electrodes activated --\> 1 month use --\> tests and patient's fitting with strategy FS4 and 10 more apical electrodes --\> 1 month use --\> tests

Study Record Dates

• First Submitted: October 11, 2020
• First Posted: October 19, 2020
• Study Start: July 10, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

FR (1)