Impact of Microphone Positioning on Auditory Performance in Cochlear Implant Users

NCT ID: NCT04677517

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-06-01

Brief Summary

The construction of our auditory space requires several prerequisites, including localization abilities in 3D (azimuth, elevation and distance). These abilities rely on the proper development and functionality of the auditory system to extract various acoustic cues from our environment. Extraction and analysis of these auditory cues are based on the synchronous use of ears, called binaurality. Other natural behaviours are useful to precisely determine the location of a sound source: visual information and head movements.

The slightest anatomical-functional change (e.g. unilateral hearing loss, malformation of the pinna) can disturb spatial hearing abilities. Many patients with hearing loss are fitted with a hearing aid (HA) or a cochlear implant (CI) to ensure the best speech understanding. However, this auditory rehabilitation remains insufficient to restore a good perception of spatial hearing. One of the key point to improve sound localization seems to be microphone positioning on hearing aids. Several questions remain on the optimal microphone positioning.

Conditions

Cochlear Prosthesis Implantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Implanted patients

All the participants are patients with post-lingual deafness and fitted with cochlear implants

Group Type: EXPERIMENTAL

Modification of active microphone positioning

Intervention Type: DEVICE

Patient will pass the experimental tests described above with 3 different active microphone positions :

• on the cochlear implant processor;
• on the antenna
• in front of the external ear canal

Patient will pass the tests 1 week after each microphone position change, so that they can get used to the new position in their everyday life.

SPHERE protocol

Intervention Type: BEHAVIORAL

Patient's 3D localization in noise will be assessed thnks to a 3D localization system called SPHERE based on virtual reality.

Data from spatial hearing perception will be recorded in three-dimensional space (azimuth, elevation, and depth). First, the pointing error will be computed separately for azimuth, elevation, and depth, in terms of constant error (absolute and signed) and variable error. Then, these separate errors will be combined into a cumulative error "3d-D" (the 3d-D value), hence summarizing all three space dimensions, and taking into account absolute and variable error in one measure.

French Matrix Test

Intervention Type: BEHAVIORAL

This test assesses the intelligibility threshold defined as the noise level (in decibels) for which the subject can repeat 50% of the words heard (in dichotic listening), resulting in an Speech Recognition Threshold (SRT) value

Quality of life questionnaire

Intervention Type: BEHAVIORAL

The Speech, Spatial and Qualities of Hearing Scale short-form with 15 items (SSQ15) questionnaire is performed in order to evaluate auditory abilities of patients in different daily life situations.

Likert scale

Intervention Type: BEHAVIORAL

This subjective evaluation will be added to evaluate difficulties and self-confidence felt by participants during the SPHERE protocol and the French Matrix Test.

Interventions

Modification of active microphone positioning

Patient will pass the experimental tests described above with 3 different active microphone positions :

• on the cochlear implant processor;
• on the antenna
• in front of the external ear canal

Patient will pass the tests 1 week after each microphone position change, so that they can get used to the new position in their everyday life.

Intervention Type: DEVICE

SPHERE protocol

Patient's 3D localization in noise will be assessed thnks to a 3D localization system called SPHERE based on virtual reality.

Data from spatial hearing perception will be recorded in three-dimensional space (azimuth, elevation, and depth). First, the pointing error will be computed separately for azimuth, elevation, and depth, in terms of constant error (absolute and signed) and variable error. Then, these separate errors will be combined into a cumulative error "3d-D" (the 3d-D value), hence summarizing all three space dimensions, and taking into account absolute and variable error in one measure.

Intervention Type: BEHAVIORAL

French Matrix Test

This test assesses the intelligibility threshold defined as the noise level (in decibels) for which the subject can repeat 50% of the words heard (in dichotic listening), resulting in an Speech Recognition Threshold (SRT) value

Intervention Type: BEHAVIORAL

Quality of life questionnaire

The Speech, Spatial and Qualities of Hearing Scale short-form with 15 items (SSQ15) questionnaire is performed in order to evaluate auditory abilities of patients in different daily life situations.

Intervention Type: BEHAVIORAL

Likert scale

This subjective evaluation will be added to evaluate difficulties and self-confidence felt by participants during the SPHERE protocol and the French Matrix Test.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 18 to 75 inclusive
• Regular follow-up in the Ear Nose and Throat department of the Edouard Herriot hospital in Lyon
• Post-lingual deafness
• Fitted with two Advanced Bionics (AB) cochlear implants (Naïda Q70 or Naïda Q90 processor) Or fitted with one AB cochlear implant and a contralateral hearing aid
• Fitted with the latest implant for more than 1 year
• Normal or corrected vision
• Able to understand experimental instructions
• Affiliated with a social security scheme

Exclusion Criteria

• Oculomotor disorder
• Bilateral vestibular areflexia
• Adult subject to a legal protection measure (guardianship, curatorship)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric TRUY, Professor

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Hôpital Edouard Herriot - service ORL

Lyon, , France

Countries

France

Other Identifiers

69HCL20_1013

Identifier Type: -

Identifier Source: org_study_id