Clinical trial NCT05955469: Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sensorineural Hearing Loss, Bilateral
Bilateral Hearing Loss
Keywords: Cochlear implant
Bimodal fitting
Anatomy-based fitting
Lead sponsor: MED-EL Elektromedizinische Geräte GesmbH
Sponsor class: INDUSTRY
First posted: 2023-07-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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 --\> tests
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Speech recognition in noise
timeFrame: at 6 weeks post-activation
measure: Speech recognition in noise
timeFrame: at 12 weeks post-activation
Secondary outcomes:
measure: Speech recognition in quiet
timeFrame: at 6 weeks post-activation
measure: Speech recognition in quiet
timeFrame: at 12 weeks post-activation
measure: Auditory skills experienced by the patient
timeFrame: at 6 weeks post-activation
measure: Auditory skills experienced by the patient
timeFrame: at 12 weeks post-activation
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: Centre Hospitalier Universitaire de Saint Etienne
name: Alexandre Karkas, Pr
role: PRINCIPAL_INVESTIGATOR
References: