Sound Perception Study of Hearing-impaired People With Hearing Aids (ETERNEL)

ÉTude de la pERception soNorE de Personnes maLentendantes équipées d'Aides Auditives

The aim of the ETERNEL project will be to study the influence of the perception of a single sound timbre on the understanding of a complex sound scene in hearing-impaired people with hearing aids. This will be done by quantifying the inability to manage a complex sound scene as a function of the timbre of the sounds making it up. The more a sound interferes with understanding the complex sound scene, the more salient that sound is considered to be. In this way, the investigators can determine which timbre dimensions make sounds particularly salient for the hearing impaired.

Study Overview

• Status: Recruiting
• Conditions: Auditory Perception
• Intervention / Treatment: Behavioral: Influence of the parameters of the sound timbre on the perception of a sound; Behavioral: Complex sound scene comprehension test; Behavioral: Complex sound scene comprehension test with hearing aids

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Céline Quinsac; Phone Number: +33 0176535029; Email: celine.quinsac@pasteur.fr
• Study Contact Backup: Name: Armand Schwarz; Email: armand.schwarz@pasteur.fr

Study Locations

• France
  • Paris, France
    • Recruiting
    • CeRIAH
    • Contact: Paul Avan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

For all participants:

• Age between 60 and 75
• Native French speaker
• Have given their consent to take part in the study.
• Declare that they have an active social life or hobbies that stimulate their cognitive abilities
• Have a MOCA score above 26
• No tympano-ossicular dysfunction.
• Voice in noise audiometry results showing normal results.

For participants with impaired hearing :

• Pure tone audiometry showing audiograms of type N3 or N4 and symmetrical between the two ears.
• Report having experienced problems with abnormally prominent sound.

For participants with normal hearing:

- Pure tone audiometry showing audiograms with losses of less than 30 dBHl.

Exclusion Criteria:

• Be under guardianship or curatorship,
• Be deprived of liberty by judicial or administrative decision, or be under legal protection.
• Bear the consequences of an ear infection and/or have a history of an ENT disease that permanently affects hearing or balance (vestibular schwannoma, Ménière's disease, sudden or fluctuating deafness, congenital hypoacusis).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Normal Hearing participants	Behavioral: Influence of the parameters of the sound timbre on the perception of a sound; The experiment consists of evaluating the sound level of n complex stimuli, then equalising them in loudness, in order to measure a loudness curve in function of timbre descriptors. The stimuli will then be listened to again in pairs. The task is there to compare the stimuli using a VAS to indicate how different the two sounds are.; Behavioral: Complex sound scene comprehension test; The experiment consists in identifying the parameters of the sound timbre that most disturb the understanding of complex sound scenes, by asking the participants to identify sounds whose timbre has been modified.
Experimental: Hearing-impaired with hearing aids	Behavioral: Influence of the parameters of the sound timbre on the perception of a sound; The experiment consists of evaluating the sound level of n complex stimuli, then equalising them in loudness, in order to measure a loudness curve in function of timbre descriptors. The stimuli will then be listened to again in pairs. The task is there to compare the stimuli using a VAS to indicate how different the two sounds are.; Behavioral: Complex sound scene comprehension test; The experiment consists in identifying the parameters of the sound timbre that most disturb the understanding of complex sound scenes, by asking the participants to identify sounds whose timbre has been modified.; Behavioral: Complex sound scene comprehension test with hearing aids; The experiment will be identical to intervention 2. This time, the modification of the stimulus timbres will focus on the most problematic dimensional modifications, i.e. those where the difference between normal-hearing and hearing-impaired listeners is greatest. We will then modify the signal processing parameters of the hearing aid simulator (for example, the size of the averaging window or the gain balance of the filters), to observe their impact on the salience of certain stimuli.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of correct answers in melody comparison tasks in the hearing-impaired group compared with the normal-hearing group,	3-hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterisation of the dissimilarity between pairs of stimuli measured by a continuous perceptual scale	Continuous perceptual scale ranging from very dissimilar to very similar	3-hours
Evaluation of the perceived loudness level of a set of stimuli, measured using scales of magnitude.	11-point Likert scale	3-hours
Comparison between the results of speech audiometry in noise, i.e number of words correctly repeated, with native settings versus settings minimising the discomfort of salient sounds for each participant with hearing loss.	the comparison will focus on the number of words correctly repeated on the 1st visit (with native settings) versus the last visit (with settings minimising the discomfort)	up to 24 months

Collaborators and Investigators

• Sponsor: Institut Pasteur
• Collaborators: Institut de l'Audition
• Investigators: Principal Investigator: Paul Avan, CeRIAH

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Equipment and Supplies; Electrical Equipment and Supplies; Wearable Electronic Devices; Sensory Aids; Hearing Aids
• Other Study ID Numbers: 2024-040; 2024-A01112-45 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No