Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2019_33
- Conditions
- Hearing Loss
- Interventions
- Device: Hearing Aid without Reverberation Canceller (RevC).Device: Hearing Aid Reverberation Canceller enabled (RevC_1)
- Registration Number
- NCT04167735
- Lead Sponsor
- Sonova AG
- Brief Summary
Participants will complete a listening task in a simulated reverberant environment. Participants are seated and instructed to look at a fixation cross while a sentence is played. Sentences are varied with respect to their speech rate. While listening to the sentences participant's pupil dilation is measured by means of pupillometry which is a non-invasive physiological measurement. Participants are asked to repeat back the sentences loud. At fixed intervals, subjective ratings are collected by asking participants to move an on-screen slider using a game controller. Two hearing aid programs will be compared, one intended for speech perception in quiet and the other to reduce reverberation in reverberant environments. The study is designed as factorial, with 2 speech rates, 2 room simulations and 2 hearing aid programs. The same conditions will be re-tested once after a minimum of one day. A pilot study will determine appropriate speech rates by applying a different factorial, with 4 speech rates, 2 room simulations and 1 hearing aid program. Participants complete all conditions (within-subjects) in one experimental sessions that lasts around 1 hour.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- Healthy outer ear (without previous surgical procedures)
- Ability to fill in a questionnaire conscientiously
- Informed Consent as documented by signature
- Mild-Moderate/Severe (N2-N4) hearing loss
- 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
- Limited ability to describe listening impressions/experiences and the use of the hearing aid
- Inability to produce a reliable hearing test result
- Massively limited dexterity
- Known psychological problems
- Known central hearing disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Hearing Aid without Reverberation Canceller (no_RevC) Hearing Aid without Reverberation Canceller (RevC). Hearing Aid without Reverberation Canceller (RevC) : Hearing Aid Reverberation Canceller enabled (RevC_1) Hearing Aid Reverberation Canceller enabled (RevC_1) Hearing Aid Reverberation Canceller enabled (RevC_1)
- Primary Outcome Measures
Name Time Method Changes in Event-related-pupil-dilations (ERPDs) 4 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.
- Secondary Outcome Measures
Name Time Method subjective rating 4 weeks Subjective ratings: using a game controller, participants rate the difficulty of the sentences and listening effort on a visual analog scale. The scale is continuous and ranges from minimal to maximal difficulty/effort. The position of the cursor on the scale is then used to calculate a percentage from 0-100% difficulty/effort.
Oldenburg sentence test 4 weeks 1. Words recalled correctly: words repeated back by participants are logged and the percentage of words recalled correctly calculated.
Trial Locations
- Locations (1)
Sonova AG
🇨ðŸ‡Stäfa, Switzerland