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Completed

NCT Number: NCT06420037

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

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.

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Key information

Conditions

Speech Intelligibility Behavior Communication Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Speech Verbal Behavior

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Ghent

Ghent, East-Flanders, 9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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, ...)

Treatment and study plan

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

Device

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.

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

Device

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.

Cognitive screening and vision screening

Behavioral

The Dutch Montreal Cognitive Assessment will be assessed. The Snellen Eye Test will be used to screen for normal or corrected-to-normal vision.

Audiological Assessment

Behavioral

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.

Questionnaires

Behavioral

Three questionnaires are included:

  • 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.)
  • the FAS (fatigue assessment scale) to assess how you usually feel
  • the EEAS (extended effort assessment scale) to assess how you experience listening in everyday life.

Cognition

Behavioral

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.

Real ear measurement

Other

This test will give an objective assessment of the hearing aids' configuration.

Primary outcomes

  1. Speech reception threshold

    Time frame: This outcome measure will be assessed twice during the initial measurement (both +/- 10 minutes) and once during the second measurement (+/- 10 minutes).

    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.

Secondary outcomes

  1. Hearing related quality of life

    Time frame: This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 10 minutes).

    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.

  2. Fatigue assessment

    Time frame: This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 5 minutes).

    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.

  3. Effort assessment

    Time frame: This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 5 minutes).

    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.

  4. Cognitive functioning (auditory and visual)

    Time frame: These outcome measures will be assessed once during the first measurement (+/- 55 minutes).

    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.

  5. Real ear measurement

    Time frame: This outcome measure will be assessed once during the first measurement (+/- 15-20 minutes).

    Test to obtain an objective understanding of the current settings of the hearing aids.

  6. Screening of mild cognitive impairment (MoCA) and vision

    Time frame: This outcome measure will be assessed once during the first measurement (+/- 5-10 minutes).

    The result (max 30) on the MoCA will be calculated.

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 17, 2024
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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