Real-Ear Measurement (REM) and Test Box System Integration Into Fitting Software

Not Applicable

Completed

• Conditions: Validation Studies
• Interventions: Device: Real-Ear Measurement system integrated in hearing aid fitting software

• Registration Number: NCT02555462
• Lead Sponsor: Phonak AG, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-14
• Study First Submitted QC: 2015-09-18
• Study First Posted: 2015-09-21
• Primary Completion: 2016-03
• Study Completion: 2016-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-03
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

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
• Tremor
• Disability to keep position.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Real-Ear Measurement	Real-Ear Measurement system integrated in hearing aid fitting software	The study arm goes through a comparative test run followed by a comparative hearing aid fitting.

Primary Outcome Measures

Name	Time	Method
Distance (mm) from probe tube to eardrum measurement	1 month	Precise of the Probe Tube placement
Procedure time (min) of fitting workflow including Real Ear measurement	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).

Secondary Outcome Measures

Name	Time	Method
Questionnaire about perceived annoyance	2 month	Perceived annoyance of the hearing care professional and the test subject measured with a questionnaire including rating scales for stessful and boring.
Subjective rating of unpleasantness (0 = not unpleasant at all, 10 = very unpleasant)	1 month	Pleasantness during the probe tube placement

Trial Locations

Locations (1)

Phonak AG; 🇨🇭 Stäfa, Zürich, Switzerland