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

Sensorineural Hearing Loss, Bilateral Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05955469
• Other study ID #: MEDEL_COTONBIM_StEtienne_study
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: October 2023
• Source: MED-EL Elektromedizinische Geräte GesmbH
• Contact: Vincent Péan, PhD
• Phone: 0603592974
• Email: vincent.pean[@]medel.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 1, 2026
• Est. primary completion date: September 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bilateral Hearing Loss
• Deafness
• Hearing Loss
• Hearing Loss, Bilateral
• Hearing Loss, Sensorineural
• Seizures
• Sensorineural Hearing Loss, Bilateral

Intervention

Device:
• FS4 then TFS4 (cochlear implant)
Cochlear implant with default fitting then with tonotopy-based fitting
• TFS4 then FS4 (cochlear implant)
Cochlear implant with tonotopy-based fitting then with default fitting

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
MED-EL Elektromedizinische Geräte GesmbH

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speech recognition in noise	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].	at 6 weeks post-activation
Primary	Speech recognition in noise	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].	at 12 weeks post-activation
Secondary	Speech recognition in quiet	Cochlear list of Lafon: list of 51 phonems (17 words). Speech recognition score on 50.	at 6 weeks post-activation
Secondary	Speech recognition in quiet	Cochlear list of Lafon: list of 51 phonems (17 words). Speech recognition score on 50.	at 12 weeks post-activation
Secondary	Auditory skills experienced by the patient	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].	at 6 weeks post-activation
Secondary	Auditory skills experienced by the patient	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].	at 12 weeks post-activation