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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Validation Studies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Real-Ear Measurement

The study arm goes through a comparative test run followed by a comparative hearing aid fitting.

Group Type EXPERIMENTAL

Real-Ear Measurement system integrated in hearing aid fitting software

Intervention Type DEVICE

The subjects individual response of the ear canal gets measured with the help of a probe tube and a following hearing aid fitting.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.