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

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.

Study Overview

• Status: Completed
• Conditions: Validation Studies
• Intervention / Treatment: Device: Real-Ear Measurement system integrated in hearing aid fitting software

• Study Type: Interventional
• Enrollment (Anticipated): 205
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich
    • Stäfa, Zürich, Switzerland, 8712
      • Phonak AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 67 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Real-Ear Measurement; The study arm goes through a comparative test run followed by a comparative hearing aid fitting.	Device: Real-Ear Measurement system integrated in hearing aid fitting software; The subjects individual response of the ear canal gets measured with the help of a probe tube and a following hearing aid fitting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance (mm) from probe tube to eardrum measurement	Precise of the Probe Tube placement	1 month
Procedure time (min) of fitting workflow including Real Ear measurement	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).	2 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Phonak AG, Switzerland

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: September 14, 2015
• First Submitted That Met QC Criteria: September 18, 2015
• First Posted (Estimate): September 21, 2015

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: April 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: KEK-ZH-NR.2015-0099