Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hearing Loss
- Sponsor
- Sonova AG
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Changes in Event-related-pupil-dilations (ERPDs)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
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
- •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
Outcomes
Primary Outcomes
Changes in Event-related-pupil-dilations (ERPDs)
Time Frame: 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 Outcomes
- subjective rating(4 weeks)
- Oldenburg sentence test(4 weeks)