This trial has been completed.

Condition validation studies
Treatment real-ear measurement system integrated in hearing aid fitting software
Sponsor Phonak AG, Switzerland
Start date September 2015
End date March 2016
Trial size 205 participants
Trial identifier NCT02555462, KEK-ZH-NR.2015-0099


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Primary purpose other
Masking no masking
The study arm goes through a comparative test run followed by a comparative hearing aid fitting.
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.

Primary Outcomes

Distance (mm) from probe tube to eardrum measurement
time frame: 1 month
Procedure time (min) of fitting workflow including Real Ear measurement
time frame: 2 month

Secondary Outcomes

Subjective rating of unpleasantness (0 = not unpleasant at all, 10 = very unpleasant)
time frame: 1 month
Questionnaire about perceived annoyance
time frame: 2 month

Eligibility Criteria

All participants from 16 years up to 67 years old.

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.

Trial information was received from ClinicalTrials.gov and was last updated in April 2017.
Information provided to ClinicalTrials.gov by Phonak AG, Switzerland.