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OpenTrials
Completed

NCT Number: NCT02555462

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.

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Key information

Conditions

Validation Studies

Age range

16 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Phonak AG

Stäfa, Canton of Zurich, 8712, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Real-Ear Measurement system integrated in hearing aid fitting software

Device

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

Primary outcomes

  1. Distance (mm) from probe tube to eardrum measurement

    Time frame: 1 month

    Precise of the Probe Tube placement

  2. 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).

Secondary outcomes

  1. Subjective rating of unpleasantness (0 = not unpleasant at all, 10 = very unpleasant)

    Time frame: 1 month

    Pleasantness during the probe tube placement

  2. Questionnaire about perceived annoyance

    Time frame: 2 month

    Perceived annoyance of the hearing care professional and the test subject measured with a questionnaire including rating scales for stessful and boring.

Sponsors and collaborators

Lead sponsor

Phonak AG, Switzerland

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 21, 2015
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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