Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting With or Without Synchronization

NCT05898659 | Recruiting

• 1 other identifier: MED_EL_REG_BIMOD_Nice_study
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Main objective: For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy with synchronization between HA and CI (ABFS) to a tonotopy based fitting strategy without synchronization (ABFnoS) for the accuracy of sound localization. Secondary objectives: Comparison of ABFS to ABFnoS for the bias of sound localization. Comparison of ABFS to ABFnoS for speech perception in noise. Comparison of ABFS to ABFnoS for the auditory skills experienced by the subject.

Conditions

Sensorineural Hearing Loss, Bilateral

Keywords

cochlear implant; bimodal fitting; tonotopy-based fitting

Outcome Measures

Primary Outcomes (2)

• Accuracy of sound localization

  The accuracy of sound localization will be achieved with a sound localization test in the horizontal plane with 7 loudspeakers (HP) spaced 30° apart and arranged in a ½ circle from -90° to +90° at 1m around the patient.

  at 6 weeks post-activation

• Accuracy of sound localization

  The accuracy of sound localization will be achieved with a sound localization test in the horizontal plane with 7 loudspeakers (HP) spaced 30° apart and arranged in a ½ circle from -90° to +90° at 1m around the patient.

  at 12 weeks post-activation

Secondary Outcomes (6)

• Bias of sound localization

  at 6 weeks post-activation

• Bias of sound localization

  at 12 weeks post-activation

• Speech recognition in noise

  at 6 weeks post-activation

• Speech recognition in noise

  at 12 weeks post-activation

• Auditory skills experienced by the patient

  at 6 weeks post-activation

Study Arms (2)

ABFnoS then ABFS

ACTIVE COMPARATOR

Cochlear Implant with ABFnoS first during 6 weeks then with ABFS during 6 weeks

Device: ABFnoS then ABFS (Cochlear implant)

ABFS then ABFnoS

ACTIVE COMPARATOR

Cochlear Implant with ABFS first during 6 weeks then with ABFnoS during 6 weeks

Device: ABFS then ABFnoS (Cochlear implant)

Interventions

ABFnoS then ABFS (Cochlear implant) DEVICE

Cochlear implant with tonotopy-based fitting without synchronization with the contralateral hearing-aid then with synchronization with the contralateral hearing-aid

ABFnoS then ABFS

ABFS then ABFnoS (Cochlear implant) DEVICE

Cochlear implant with tonotopy-based fitting with synchronization with the contralateral hearing-aid then without synchronization with the contralateral hearing-aid

ABFS then ABFnoS

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
• Total hearing loss for less than 5 years

You may not qualify if:

• retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
• patient with residual hearing \< 70 dB hearing level (HL) at 250 Hz and 500 Hz and \< 80 dB HL at 1000 Hz on the contralateral ear

Sponsors & Collaborators

• MED-EL Elektromedizinische Geräte GesmbH: lead

Study Sites (1)

CHU Nice

Nice, 06103, France

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

Cochlear Implants

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

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Study Officials

• Nicolas Guevara, Pr

  Nice University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Péan, PhD

CONTACT

0603592974; 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 fitting.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two arms A and B: Arm A: Bimodal patient's fitting with tonotopy-based fitting without synchronization (ABFnoS) --\> 6 weeks use --\> tests and bimodal patient's fitting with tonotopy-based fitting with synchronization (ABFS) --\> 6 weeks use --\> tests; Arm B: Bimodal patient's fitting with ABFS --\> 6 weeks use --\> tests and bimodal patient's fitting with ABFnoS --\> 6 weeks use --\> tests

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 12, 2023
• Study Start: October 17, 2023
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)