Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting

Sponsor

MED-EL Elektromedizinische Geräte GesmbH (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05955469

Collaborator

(none)

Enrollment

Location

Arms

27.6

Anticipated Duration (Months)

0.7

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 (TFS4) to a default fitting strategy (FS4) for the speech recognition in noise.

Secondary objectives:

Comparison of TFS4 to FS4 for speech recognition in quiet. Comparison of TFS4 to FS4 for the auditory skills experienced by the subject.

Condition or Disease	Intervention/Treatment	Phase
Sensorineural Hearing Loss, Bilateral Bilateral Hearing Loss	Device: FS4 then TFS4 (cochlear implant) Device: TFS4 then FS4 (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.

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 the mismatch of frequencies (tonotopic shift) between the CI and the contralateral HA.

Recently MED-EL has developed an "anatomy-based fitting" (ABF) strategy based on the tonotopy that allows, from a postoperative 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.

This strategy (TFS4) could therefore allow a better integration of information in bimodal hearing and in particular improve the speech recognition in noise compared to a default strategy (FS4).

Main objective:

For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy (TFS4) to a default fitting strategy (FS4) for the speech recognition in noise.

Secondary objectives:

Comparison of TFS4 to FS4 for speech recognition in quiet. Comparison of TFS4 to FS4 for the auditory skills experienced by the subject.

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:

Crossover Assignment Two arms A and B: Arm A: Bimodal patient's fitting with default fitting (FS4) --> 6 weeks use --> tests and bimodal patient's fitting with tonotopy-based fitting (TFS4) --> 6 weeks use --> tests; Arm B: Bimodal patient's fitting with TFS4 --> 6 weeks use --> tests and bimodal patient's fitting with FS4 --> 6 weeks use --> testsCrossover AssignmentTwo arms A and B:Arm A: Bimodal patient's fitting with default fitting (FS4) --> 6 weeks use --> tests and bimodal patient's fitting with tonotopy-based fitting (TFS4) --> 6 weeks use --> tests; Arm B: Bimodal patient's fitting with TFS4 --> 6 weeks use --> tests and bimodal patient's fitting with FS4 --> 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 Speech Understanding Between a Tonotopy-based Bimodal Fitting and a Default Bimodal Fitting in Newly Cochlear-implanted Patients: a Double-blind Randomized Crossover Study.

Anticipated Study Start Date :

Sep 15, 2023

Anticipated Primary Completion Date :

Sep 15, 2025

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: FS4 then TFS4 Cochlear Implant with FS4 first during 6 weeks then with TFS4 during 6 weeks	Device: FS4 then TFS4 (cochlear implant) Cochlear implant with default fitting then with tonotopy-based fitting
Active Comparator: TFS4 then FS4 Cochlear Implant with TFS4 first during 6 weeks then with FS4 during 6 weeks	Device: TFS4 then FS4 (cochlear implant) Cochlear implant with tonotopy-based fitting then with default fitting

Arm

Intervention/Treatment

Active Comparator: FS4 then TFS4

Cochlear Implant with FS4 first during 6 weeks then with TFS4 during 6 weeks

Device: FS4 then TFS4 (cochlear implant)

Cochlear implant with default fitting then with tonotopy-based fitting

Active Comparator: TFS4 then FS4

Cochlear Implant with TFS4 first during 6 weeks then with FS4 during 6 weeks

Device: TFS4 then FS4 (cochlear implant)

Cochlear implant with tonotopy-based fitting then with default fitting

Outcome Measures

Primary Outcome Measures

Speech recognition in noise [at 6 weeks post-activation]
The speech recognition in noise is evaluated with the French Matrix test (Framatrix) [S. Jansen et al. Comparison of three types of French speech-in-noise tests: a multi-center study. Int J Audiol, 51 (3) (2012), pp. 164-173].
Speech recognition in noise [at 12 weeks post-activation]
The speech recognition in noise is evaluated with the French Matrix test (Framatrix) [S. Jansen et al. Comparison of three types of French speech-in-noise tests: a multi-center study. Int J Audiol, 51 (3) (2012), pp. 164-173].

Secondary Outcome Measures

Speech recognition in quiet [at 6 weeks post-activation]
Cochlear list of Lafon: list of 51 phonems (17 words). Speech recognition score on 50.
Speech recognition in quiet [at 12 weeks post-activation]
Cochlear list of Lafon: list of 51 phonems (17 words). Speech recognition score on 50.
Auditory skills experienced by the patient [at 6 weeks post-activation]
Auditory skills experienced by the patient are evaluated with the short form of the French version of the speech spatial qualities scale (SSQ) with of 15 questions describing various real-world auditory situations [Moulin et al. Ear & Hearing 2019;40;938-950].
Auditory skills experienced by the patient [at 12 weeks post-activation]
Auditory skills experienced by the patient are evaluated with the short form of the French version of the speech spatial qualities scale (SSQ) with of 15 questions describing various real-world auditory situations [Moulin et al. Ear & Hearing 2019;40;938-950].

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

Exclusion Criteria:

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