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Physiological, Behavioural and Subjective Measures of Listening Effort

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Sonova

Status

Completed

Conditions

Hearing Loss

Treatments

Device: Hearing Aid with NR(1)
Device: Hearing Aid without NR enabled
Device: Hearing Aid with NR(2)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03761927
Sonova2018_36

Details and patient eligibility

About

Participants will perform two different listening tasks: (1) listening to, and repeating back, sentence lists presented in noise, and (2) listening to short radio excerpts and answering subsequent comprehension questions. At the same time participants are required to perform a manual target-tracking task on a touch screen. During this study, continuous, non-invasive physiological measurements (heart rate, skin conductance and hemoencephalography) will be made from participants. Using this paradigm we will be assessing the effect of different hearing aid processing algorithms on listening effort. The study takes the form of a three factor (listening task x algorithm x signal-to-noise ratio), within-subjects design. Each participant performs each listening task (about 4min long each) with each algorithm (reference, noise reduction I, noise reduction II), at two signal-to-noise ratios (+4 decibel and 0 decibel) twice (test-retest).

Enrollment

17 patients

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy outer ear (without previous surgical procedures)
  • Ability to fill in a questionnaire conscientiously
  • Informed Consent as documented by signature
  • Minimum 1 year hearing aid experience
  • Moderate-Severe (N3-N5) hearing loss or Normal Hearing

Exclusion criteria

  • Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
  • Limited mobility and not in the position to attend weekly appointments
  • Inability to produce a reliable hearing test result
  • Massively limited dexterity
  • Known psychological problems
  • Known central hearing disorders

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

17 participants in 3 patient groups

Hearing Aid without NR enabled.
Active Comparator group
Description:
Hearing Aid without Noise Reduction (NR) enabled serves as reference condition.
Treatment:
Device: Hearing Aid without NR enabled
Hearing Aid with NR(1)
Experimental group
Description:
Hearing Aid with Noise Reduction I (NR) enabled.
Treatment:
Device: Hearing Aid with NR(1)
Hearing Aid with NR(2)
Experimental group
Description:
Hearing Aid with Noise Reduction II (NR) enabled.
Treatment:
Device: Hearing Aid with NR(2)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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