An interventional study of Hearing aid feature adjustment (frequency compression) of the following hearing aids: Phonak Audéo Paradise/Lumity 70 and Hearing aid feature adjustment (noise reduction) of the following hearing aids: Phonak Audéo Paradise/Lumity 70 in Speech Intelligibility and Hearing Loss, Sensorineural, sponsored by University Ghent. Completed at 1 site in Belgium. Open to participants aged 45 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by University Ghent · Not applicable, Interventional, and Other
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:
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.
371 studies on the registry are indexed under Hearing Loss, Sensorineural; 111 are open to participants now.
This study's enrollment of 32 is close to the median of 32 across 264 interventional studies indexed under Hearing Loss, Sensorineural.
Browse Hearing Loss, Sensorineural studies →University Ghent is the lead sponsor of 345 studies on the registry; 85 are open to participants now.
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Exclusion Criteria:
Within this control group, no changes will be made to the hearing aid settings. However, they undergo all other tests of the test protocol.
Behavioral: Cognitive screening and vision screening · Behavioral: Audiological Assessment · Behavioral: Questionnaires · Behavioral: Cognition · Other: Real ear measurement
Within this experimental group, a slight modification (which differs between groups) will be made to the basic hearing aid setting.
Device: Hearing aid feature adjustment (frequency compression) of the following hearing aids: Phonak Audéo Paradise/Lumity 70 · Behavioral: Cognitive screening and vision screening · Behavioral: Audiological Assessment · Behavioral: Questionnaires · Behavioral: Cognition · Other: Real ear measurement
Within this experimental group, a slight modification (which differs between groups) will be made to the basic hearing aid setting.
Device: Hearing aid feature adjustment (noise reduction) of the following hearing aids: Phonak Audéo Paradise/Lumity 70 · Behavioral: Cognitive screening and vision screening · Behavioral: Audiological Assessment · Behavioral: Questionnaires · Behavioral: Cognition · Other: Real ear measurement
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.
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.
The Dutch Montreal Cognitive Assessment will be assessed. The Snellen Eye Test will be used to screen for normal or corrected-to-normal vision.
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.
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.
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.
This test will give an objective assessment of the hearing aids' configuration.
Speech reception threshold
Based on the results of the speech understanding task, the speech reception threshold will give an indication of the ability to understand spoken sentences in quiet and noise.
Time frame: This outcome measure will be assessed twice during the initial measurement (both +/- 10 minutes) and once during the second measurement (+/- 10 minutes).
Hearing related quality of life
Thirty-five sentences should be responded using a VAS (0-100). Mean scores will be calculated for each subdomain separately (auditory-visual, cognitive, and psychosocial functioning) as well as combined within a total score; the worse one's hearing-related quality of life, the lower the score.
Time frame: This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 10 minutes).
Fatigue assessment
Ten sentences should be responded based on five categories, ranging from Never to Always: 1 = Never; 2 = Sometimes; 3 = Frequently; 4 = Often; and 5 = Always.
Time frame: This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 5 minutes).
Effort assessment
Ten sentences should be responded using a VAS (0-100). Mean scores will be calculated for each sentence. The lower the score, the lower the effort.
Time frame: This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 5 minutes).
Cognitive functioning (auditory and visual)
Cognitive functions such as 'divided attention', 'working memory', 'processing speed', and 'flexibility and inhibition' will be assessed both audibly and visually. Mean scores and average reaction times will be computed.
Time frame: These outcome measures will be assessed once during the first measurement (+/- 55 minutes).
Real ear measurement
Test to obtain an objective understanding of the current settings of the hearing aids.
Time frame: This outcome measure will be assessed once during the first measurement (+/- 15-20 minutes).
Screening of mild cognitive impairment (MoCA) and vision
The result (max 30) on the MoCA will be calculated.
Time frame: This outcome measure will be assessed once during the first measurement (+/- 5-10 minutes).
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Speech Intelligibility
University Ghent