The Influence of the Individual Auditory-cognitive Need on the Aided Benefit Using Different Feature Settings

University Ghent

Status: Completed

Conditions: Speech Intelligibility; Hearing Loss, Sensorineural

Treatments: Behavioral: Audiological Assessment; Other: Real ear measurement; Device: Hearing aid feature adjustment (frequency compression) of the following hearing aids: Phonak Audéo Paradise/Lumity 70; Behavioral: Questionnaires; Behavioral: Cognition; Device: Hearing aid feature adjustment (noise reduction) of the following hearing aids: Phonak Audéo Paradise/Lumity 70; Behavioral: Cognitive screening and vision screening

Study type: Interventional

Funder types: Other

Identifiers

NCT06420037

ONZ-2023-0437

Details and patient eligibility

About

The goal of this clinical trial is to optimize hearing aid benefit based on the individual auditory-cognitive need using different hearing aid features in first-time hearing aid users between 45-80 years old with bilateral Phonak Audéo Paradise/Lumity 70/90 hearing aids. The main questions it aims to answer are:

Does cognitive functioning affect hearing aid benefit? How can hearing aid fitting be optimized based on the individual auditory-cognitive profile?

The hypothesis posits that cognitive abilities influence the effectiveness of hearing aids, alongside hearing status. Furthermore, if features of hearing aids improve speech understanding and listening effort, it is proposed that individuals with lower cognitive functioning will experience heightened benefits from hearing aids.

The study will consist of three groups: one control group and two groups where one different feature will be modified.

Participants will be tested at baseline measurement, including:

• screening tests
• audiological tests
• questionnaires
• cognitive tests
• real-ear-measurement

Following this, participants will be divided in one of the three groups, after which speech audiometry will be repeated. After a 4-week acclimatization period, the second measurement will take place, repeating speech audiometry and questionnaires. Subsequently, the hearing aid settings will be restored to their initial configuration.

Enrollment: 32 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Dutch-speaking individuals aged between 45-80 years old
• individuals with normal vision (with glasses or lenses if needed)
• individuals with age-related hearing loss
• individuals with bilateral hearing aids (Phonak Audéo Paradise/Lumity 70)
• individuals who are capable to give consent to participate in the study themselves

Exclusion criteria

• user of cochlear implants
• use of influencing medication (for example: Rilatin and antidepressants)
• learning disabilities (for example: dyslexia and dyscalculia)
• (history of) neurological problems (brain tumor, epilepsy, history of stroke, ...)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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32 participants in 3 patient groups

Individuals between 45-80 years with bilateral hearing aids (control group)

Other group

Description:

Within this control group, no changes will be made to the hearing aid settings. However, they undergo all other tests of the test protocol.

Treatment:

Behavioral: Cognitive screening and vision screening

Behavioral: Cognition

Behavioral: Questionnaires

Other: Real ear measurement

Behavioral: Audiological Assessment

Individuals between 45-80 years with bilateral hearing aids (frequency compression)

Experimental group

Description:

Within this experimental group, a slight modification (which differs between groups) will be made to the basic hearing aid setting.

Treatment:

Behavioral: Cognitive screening and vision screening

Behavioral: Cognition

Behavioral: Questionnaires

Device: Hearing aid feature adjustment (frequency compression) of the following hearing aids: Phonak Audéo Paradise/Lumity 70

Other: Real ear measurement

Behavioral: Audiological Assessment

Individuals between 45-80 years with bilateral hearing aids (noise reduction)

Experimental group

Description:

Within this experimental group, a slight modification (which differs between groups) will be made to the basic hearing aid setting.

Treatment:

Behavioral: Cognitive screening and vision screening

Behavioral: Cognition

Device: Hearing aid feature adjustment (noise reduction) of the following hearing aids: Phonak Audéo Paradise/Lumity 70

Behavioral: Questionnaires

Other: Real ear measurement

Behavioral: Audiological Assessment