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

Sensorineural Hearing Loss, Bilateral Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05898659
• Other study ID #: MED_EL_REG_BIMOD_Nice_study
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2023
• Est. completion date: June 15, 2025

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 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.

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:

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.

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: June 15, 2025
• Est. primary completion date: December 15, 2024
• 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

• 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

Related Conditions & MeSH terms

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

Intervention

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
• 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

Locations

Country	Name	City	State
France	CHU Nice	Nice

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	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
Primary	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	Bias of sound localization	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.	at 6 weeks post-activation
Secondary	Bias of sound localization	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.	at 12 weeks post-activation
Secondary	Speech recognition in noise	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.	at 6 weeks post-activation
Secondary	Speech recognition in noise	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.	at 12 weeks post-activation
Secondary	Auditory skills experienced by the patient	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..	at 6 weeks post-activation
Secondary	Auditory skills experienced by the patient	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..	at 12 weeks post-activation