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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02555462

Enrollment

205

Registered

2015-09-21

Start date

2015-09-30

Completion date

2016-12-31

Last updated

2017-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Validation Studies

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.

Interventions

DEVICEReal-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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 67 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Subjective rating of unpleasantness (0 = not unpleasant at all, 10 = very unpleasant)	1 month	Pleasantness during the probe tube placement
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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026