Real-Ear Measurement (REM) and Test Box System Integration Into Fitting Software
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Validation Studies
- Sponsor
- Phonak AG, Switzerland
- Enrollment
- 205
- Locations
- 1
- Primary Endpoint
- Procedure time (min) of fitting workflow including Real Ear measurement
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
Integration of the REM-verification within the fitting workflow will enable the hearing care professional to easily run real ear measurements. The purpose of the two study parts is to prove that an integrated cooperative system, consisting of fitting software and measurement system, matches desired responses for certain stimuli faster, more reliably and more precisely at the ear drums of hearing instrument wearers than current best practice processes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clean and healthy ear canal, eardrum and pinna
- •Ability to keep current position (of head and body) during a period of about 5 minutes while seated.
Exclusion Criteria
- •Ear infections
- •Ear wax in the ear
- •Hyperacusis
- •Pacemaker
- •Disability to keep position.
Outcomes
Primary Outcomes
Procedure time (min) of fitting workflow including Real Ear measurement
Time Frame: 2 month
In addition to the outcome measurement "time" (in minutes) further outcome measurements can be obtained due to the performed real ear measurement procedure itself. Data that give information pertaining to test reliability (in dB) and precision of hearing aid fitting (in dB).
Distance (mm) from probe tube to eardrum measurement
Time Frame: 1 month
Precise of the Probe Tube placement
Secondary Outcomes
- Subjective rating of unpleasantness (0 = not unpleasant at all, 10 = very unpleasant)(1 month)
- Questionnaire about perceived annoyance(2 month)