Study of Quality Perception on Music in New Cochlear Implanted Subjects Using or Not a Fine Structure Strategy

MED-EL

Status: Completed

Conditions: Sensorineural Hearing Loss, Bilateral

Treatments: Device: FineHearing strategy or HDCIS strategy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03993899

MED_EL_FS_music_Rennes_study

Details and patient eligibility

About

Main objective:

Show the superiority of Fine Structure (FS4) strategy compared to Continuous Interleaved Sampling (HDCIS) strategy on the qualitative preference for the listening of musical pieces.

Secondary objectives

• Show the superiority of FS4 strategy compared to the HDCIS strategy on the perception of musical elements (contour test).
• Analyze the link between the results of musical perception tests and the subjective preference of musical listening.
• Show the non inferiority of FS4 strategy compared to the HDCIS strategy on the perception of speech elements.
• Analyze the link between the results of musical perception tests and the results of the perception of speech elements.
• Analyze the qualitative multidimensional perception with HDCIS and FS4

Full description

Introduction:

At present, most people with modern cochlear implant systems can understand speech using the device alone, at least under favorable listening conditions.

In recent years, research has increasing focussed on how implant users perceive sounds other than speech. In particular, music perception is of interest.

A review of the literature on musical perception with traditional implants, coding only the temporal envelope [McDermott 2004], revealed the following elements:

• On average, implant users perceive the rhythm approximately as well as listeners with normal hearing
• With technically sophisticated multi-channel sound processors, melody recognition, especially without rhythmic or verbal cues, is poor.
• The perception of timbre, especially the sounds of musical instruments, is generally unsatisfactory.
• Implant users tend to rate the quality of musical sounds as less enjoyable than listeners with normal hearing And studies show that the fine structure of sound is the main vector of information for music and the location of sounds. [Smith et al. 2002] It therefore seems necessary to focus on the contribution of the coding of the fine temporal structure of sound to the cochlear implant.

Main objective:

Show the superiority of FS4 strategy compared to HDCIS strategy on the qualitative preference for the listening of musical pieces.

Secondary objectives:

• Show the superiority of FS4 strategy compared to the HDCIS strategy on the perception of musical elements (contour test).
• Analyze the link between the results of musical perception tests and the subjective preference of musical listening.
• Show the non inferiority of FS4 strategy compared to the HDCIS strategy on the perception of speech elements.
• Analyze the link between the results of musical perception tests and the results of the perception of speech elements.
• Analyze the qualitative multidimensional perception with HDCIS and FS4

Plan of the study:

It is a prospective open monocentric randomized crossover study: measures will be done on the patient at 15 days and 30 days post-activation.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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19 participants in 2 patient groups

Cochlear implant (CI) with FineHearing Strategy then HDCIS

Active Comparator group

Description:

cochlear implant with FineHearing strategy first during 15 days then with HDCIS strategy during 15 days

Treatment:

Device: FineHearing strategy or HDCIS strategy

CI with HDCIS Strategy then FS4

Active Comparator group

Description:

cochlear implant with HDCIS strategy first during 15 days then with FS4 strategy during 15 days

Treatment:

Device: FineHearing strategy or HDCIS strategy