Real-time Artificial Intelligence-based Speech Enhancement Methods for Hearing Aid Improvement (REFINED)

Pasteur Institute

Status

Enrolling

Conditions

Deafness Neurosensory

Treatments

Other: audiological measurements

Other: Evaluation of the denoising methods REFINED

Other: Objective and subjective audiological measurements

Study type

Interventional

Funder types

Industry

Identifiers

NCT05985473

2023-A00140-45 (Other Identifier)

2022-016

Details and patient eligibility

About

Individuals with Auditory Neuropathy Spectrum Disorders (ANSD) represent 1-10% of adults with hearing loss. These individuals have little or no benefit from current hearing aids because ANSD is a continuum of hearing impairments due to synaptic or neural dysfunction in the peripheral and central parts of the auditory pathways, which impairs temporal information processing without necessarily affecting auditory sensitivity. There is a need to find ad-hoc denoising methods, based on the expert knowledge of audiologists, to improve the noise comprehension performance of these patients. Implemented denoising methods, based on artificial intelligence, will also greatly benefit more standard hearing loss cases.

Full description

Longitudinal study consisting of multiple visits with multiple examinations over a total duration of approximately 3 years per ANSD participant and 1 year per normal hearing participant.

normal hearing participant : year 1 : Inclusion visit, Phenotyping visit (Audiological tests), Follow-up Visit 1 (Noise Comprehension Tests)
ANSD participant : year 1 : Inclusion visit, Phenotyping visit (Audiological tests), Follow-up Visit 1 (Noise Comprehension Tests) year 2 : Follow-up Visit 2 (Noise Comprehension Tests) year 3 : Follow-up Visit 3 (Noise Comprehension Tests)

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

For all participants:

Age greater than or equal to 18 years,
French mother tongue,
Have an average tonal hearing loss (calculated according to the BIAP method) < 30 dB HL, on headphones, for each ear,
Be professionally active, not be pre-retired and not be unemployed
Be affiliated with a social security plan,

For participants with TSNA:

Have degraded comprehension in noise (threshold of Intelligibility in Noise > 3 dB compared to the norm).

For controls:

Have normal comprehension in noise (Intelligibility in Noise threshold ≤ 3 dB from the norm).

Exclusion criteria

For all participants:

Have a conductive or mixed hearing loss, which is when the hearing loss affects both the outer and/or middle ear and the inner ear.
Have an asymmetric hearing loss, i.e. a difference in average hearing loss between the left and right ear greater than 30 dB,
Have sequelae of ear infections and/or a history of ENT disease that permanently affects hearing (vestibular schwannoma, Meniere's disease, sudden or fluctuating deafness, congenital hypoacusis)
Being under guardianship,
Being deprived of liberty by judicial or administrative decision, or being subject to legal protection.