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

Sponsor

MED-EL Elektromedizinische Geräte GesmbH (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05898659

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sensorineural Hearing Loss, Bilateral	Device: ABFnoS then ABFS (Cochlear implant) Device: ABFS then ABFnoS (Cochlear implant)	N/A

Detailed Description

Introduction: Cochlear implantation allows the rehabilitation of profound bilateral deafness, restoring speech perception and verbal communication when the traditional hearing aid no longer provides satisfactory hearing gain.

A cochlear implant includes an electrode array and its functioning is based on the principle of cochlear tonotopy: Each electrode encodes a frequency spectrum according to its position in the cochlea (high frequencies are assigned to the basal electrodes and low frequencies to the apical electrodes). The cochlear implant thus breaks down the frequency spectrum into a number of frequency bands via bandpass filters corresponding to the number of electrodes in the implant. During the fitting these bands can be modified by the audiologist.

MED-EL has developed a fitting strategy (ABF) that allows, from a post-operative scanner, to calculate the theoretical characteristic frequency of neurons stimulated by each electrode contact and to transmit this information to the fitting software of the CI.

Bimodal hearing refers to the use of a CI in one ear with a HA on the contralateral side.

This association allows for adults and children a better perception of speech in quiet and in noise, a better perception of music, hearing comfort, better sound quality, better localization of sound and, consequently, a better quality of life compared to unilateral CI alone. However, there is great variability in the integration process; while some bimodal users show substantial benefits, others receive little or no benefit.

This variability could be due to different processing times between CI and contralateral HA.

Recently, MED-EL (Austria) has developed a new approach to synchronize the treatment time of the CI with that of the contralateral HA via the fitting software. This new approach takes into account the different treatment times between CI and contralateral HA and allows synchronization between the 2 systems (CI and HA).

This strategy (ABFS) could therefore allow a better integration of information in bimodal hearing and in particular improve the sound localization compare to a strategy without synchronization (ABFnoS).

Main objective:

Secondary objectives:

Plan of the study:

It is a prospective open monocentric randomized crossover study: Measures will be done on the patient at 6 weeks and 12 weeks post-activation.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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 --> testsTwo 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

Masking:

Double (Participant, Investigator)

Masking Description:

Double blind study: The patient and the investigator don't know the fitting.

Primary Purpose:

Other

Official Title:

Comparison of a Bimodal Fitting With Synchronization and a Conventional Bimodal Fitting in Newly Implanted Cochlear Patient. Prospective Monocentric Randomized Double-blind Crossover Study.

Anticipated Study Start Date :

Jun 15, 2023

Anticipated Primary Completion Date :

Dec 15, 2024

Anticipated Study Completion Date :

Jun 15, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ABFnoS then ABFS Cochlear Implant with ABFnoS first during 6 weeks then with ABFS during 6 weeks	Device: ABFnoS then ABFS (Cochlear implant) Cochlear implant with tonotopy-based fitting without synchronization with the contralateral hearing-aid then with synchronization with the contralateral hearing-aid
Active Comparator: ABFS then ABFnoS Cochlear Implant with ABFS first during 6 weeks then with ABFnoS during 6 weeks	Device: ABFS then ABFnoS (Cochlear implant) Cochlear implant with tonotopy-based fitting with synchronization with the contralateral hearing-aid then without synchronization with the contralateral hearing-aid

Arm

Intervention/Treatment

Active Comparator: ABFnoS then ABFS

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

Device: ABFnoS then ABFS (Cochlear implant)

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

Active Comparator: ABFS then ABFnoS

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

Device: ABFS then ABFnoS (Cochlear implant)

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

Outcome Measures

Primary Outcome Measures

Accuracy of sound localization [at 6 weeks post-activation]
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.
Accuracy of sound localization [at 12 weeks post-activation]
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.

Secondary Outcome Measures

Bias of sound localization [at 6 weeks post-activation]
The bias 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.
Bias of sound localization [at 12 weeks post-activation]
The bias 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.
Speech recognition in noise [at 6 weeks post-activation]
The speech recognition in noise is evaluated with the French-language VRB (vocale rapide dans le bruit) test [Leclerc et al., Eur Ann Otorhinolaryngol Head Neck Dis . 2018 Oct;135(5):315-319.]. It is a sentence test with target words. The speech level is at 65 dB sound pressure level (SPL) and the signal-to-noise ratio varies from 18 dB to -3 dB by 3 dB step.
Speech recognition in noise [at 12 weeks post-activation]
The speech recognition in noise is evaluated with the French-language VRB (vocale rapide dans le bruit) test [Leclerc et al., Eur Ann Otorhinolaryngol Head Neck Dis . 2018 Oct;135(5):315-319.]. It is a sentence test with target words. The speech level is at 65 dB SPL and the signal-to-noise ratio varies from 18 dB to -3 dB by 3 dB step.
Auditory skills experienced by the patient [at 6 weeks post-activation]
Auditory skills experienced by the patient are evaluated with the French version of the speech spatial qualities scale (SSQ) with of 49 questions describing various real-world auditory situations..
Auditory skills experienced by the patient [at 12 weeks post-activation]
Auditory skills experienced by the patient are evaluated with the French version of the speech spatial qualities scale (SSQ) with of 49 questions describing various real-world auditory situations..

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult patient (>= 18 years old) speaking French
Patient who fulfils the criteria for cochlear implantation
Total hearing loss for less than 5 years

Exclusion Criteria:

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