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

Validation Studies Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02555462
• Other study ID #: KEK-ZH-NR.2015-0099
• Status: Completed
• Phase: N/A
• First received: September 14, 2015
• Last updated: April 3, 2017
• Start date: September 2015
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: Phonak AG, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: December 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 67 Years

Eligibility

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.

Related Conditions & MeSH terms

• Validation Studies

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Phonak AG	Stäfa	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Phonak AG, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance (mm) from probe tube to eardrum measurement	Precise of the Probe Tube placement	1 month
Primary	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	Subjective rating of unpleasantness (0 = not unpleasant at all, 10 = very unpleasant)	Pleasantness during the probe tube placement	1 month
Secondary	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