Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2020_09
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sonova AG
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Differences in Event-related-skin-conductance
Study Overview
Brief Summary
Participants will perform two different listening tasks: (1) listening to, and repeating back, sentence lists presented in noise, and (2) Subjective rating of effort & performance following each condition. During this study, continuous, non-invasive physiological measurements (skin conductance, changes in pupil dilation) will be recorded 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 one factor (algorithm), within-subjects design.
Each participant performs the Speech perception task with each algorithm (reference, noise reduction I, noise reduction II, noise reduction III), at two individualized signal-to-noise ratios (SRT90 and SRT50). Additionally subjective performance ratings in real-life will be collected.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Hearing Aid without NR(0) enabled
Hearing Aid without Noise Reduction (NR 0) enabled serves as reference condition.
Intervention: Hearing Aid without NR enabled (Device)
Hearing Aid with NR (1)
Hearing Aid with Noise Reduction I (NR) enabled.
Intervention: Hearing Aid with NR(1) (Device)
Hearing Aid with NR(2)
Hearing Aid with Noise Reduction II (NR) enabled.
Intervention: Hearing Aid with NR(2) (Device)
Hearing Aid with NR(3)
Hearing Aid with Noise Reduction III (NR) enabled.
Intervention: Hearing Aid with NR(3) (Device)
Outcomes
Primary Outcomes
Differences in Event-related-skin-conductance
Time Frame: 6 weeks
Skin conductance will be recorded from participants during the performance of the auditory task. Analyses will be carried out on the skin conductance response recorded during a time window following each auditory stimulus. It is planned to analyze event-related skin conductance response amplitudes \& latencies (micro-Siemens \& milliseconds).
Differences in Event-related-pupil-dilation (ERPDs)
Time Frame: 6 weeks
Pupil dilations will be recorded from the participant during the performance of the auditory tasks. Analyses will be carried out relative to the pre-trial baseline (measured one second prior to the onset of the stimulus), in order to account for differences in baseline physiological activity. It is planned to analyze event-related-pupil-dilations. We use the unit: pixels. The size of a pixel in 1mm\^2 is relative to the distance between the eye and the camera. Even though participants heads were placed on a chin rest that was always the same distance from the camera, the distance between the individual eye and the camera can still be different due to differences in participants' anatomies. Thus, pupil dilation are often reported relative to an individuals' baseline, for example as percent change relative to the baseline. Therefore, we use the unit: pixels, as the use of mm\^2 may be inaccurate.
Secondary Outcomes
- Oldenburg Sentence Test(6 weeks)
- Sound Quality Ratings(6 weeks)
- Spectro-temporal-modulation Detection Thresholds (STM)(6 weeks)