NCT06420037

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University Ghent · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Speech Intelligibility
• Hearing Loss, Sensorineural

Interventions

Type	Name	Description
DEVICE	Hearing aid feature adjustment (frequency compression) of the following hearing aids: Phonak Audéo Paradise/Lumity 70	Upon enrollment, each participant will be allocated to one of three research groups and participants will remain unaware of their group assignment. This groups will undergo a slight modification, namely frequency compression turned off, to the basic setting.
DEVICE	Hearing aid feature adjustment (noise reduction) of the following hearing aids: Phonak Audéo Paradise/Lumity 70	Upon enrollment, each participant will be allocated to one of three research groups and participants will remain unaware of their group assignment. This groups will undergo a slight modification, namely noise reduction turned off, to the basic setting.
BEHAVIORAL	Cognitive screening and vision screening	The Dutch Montreal Cognitive Assessment will be assessed. The Snellen Eye Test will be used to screen for normal or corrected-to-normal vision.
BEHAVIORAL	Audiological Assessment	Three audiological tests are included: 1) Tympanometry to assess the middle ear status, 2) Pure-tone audiometry with headphone to evaluate the hearing thresholds, 3) Speech audiometry in free field to assess the ability to understand spoken sentences in quiet and in the presence of background noise.
BEHAVIORAL	Questionnaires	Three questionnaires are included: 1. The HAVICOP questionnaire to assess the hearing-related quality of life (Ceuleers, D., Baudonck, N., Keppler, H., Kestens, K., Dhooge, I., \& Degeest, S. (2023). Development of the hearing-related quality of life questionnaire for auditory-visual, cognitive and psychosocial functioning (hAVICOP). Journal of communication disorders, 101, 106291.) 2. the FAS (fatigue assessment scale) to assess how you usually feel 3. the EEAS (extended effort assessment scale) to assess how you experience listening in everyday life.
BEHAVIORAL	Cognition	Four cognitive functions, important for speech understanding, will be assessed both audibly and visually: divided attention, working memory, processing speed, and cognitive flexibility and inhibition.
OTHER	Real ear measurement	This test will give an objective assessment of the hearing aids' configuration.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-10-04
• Completion: 2024-10-04
• First posted: 2024-05-17
• Last updated: 2025-11-18

Locations

1 site across 1 country: Belgium