Quality Control of CE-Certified Phonak Hearing Aids - 2018_42
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03938753|
Recruitment Status : Completed
First Posted : May 6, 2019
Last Update Posted : May 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss Sensorineural Hearing Loss||Device: Audéo M90-T||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Quality Control of CE-Certified Phonak Hearing Aids - 2018_42|
|Actual Study Start Date :||January 9, 2019|
|Actual Primary Completion Date :||February 7, 2019|
|Actual Study Completion Date :||February 28, 2019|
Experimental: Phonak Audéo M90-T
The Phonak Audéo M90-T is a Receiver-in-the-canal Hearing aid with direct connectivity functionality and a T-Coil from Phonak which will be fitted to the participants individual Hearing loss.
Device: Audéo M90-T
Receiver in the canal (RIC) Hearing aid form Phonak which will be fitted to the participants individual Hearing loss.
- Subjective perception of the T-Coil Sound Quality [ Time Frame: 4 weeks ]The primary objective of this study is to measure that the overall sound Quality of the T-Coil program [subjective satisfaction rating on a scale from 0%-100% in 1% steps] of the investigational device is rated as at least as 60% or better [60% is the border between 'ok' and 'satisfied'] after a test period with daily life situations.
- Program switch-back workflow into T-Coil program [ Time Frame: 4 weeks ]The number of incorrect switch-back occurences will be measured under laboratory conditions. A switch-back workflow is defined as the correct (re)activation of the T-Coil program, after an automatic program change into a streaming program. Due to an incoming phone call or due a start of audio streaming via Bluetooth, the investigational device will automatically switch into a streaming program. As soon as the Bluetooth stream stops, the investigation device must automatically toggle back into the T-Coil program (switch-back workflow).
- Observation of the system stability [ Time Frame: 4 weeks ]Another objective of this study is the monitoring of the system stability during daily life situations. The investigational device will be worn for 4 weeks in home trial. Each investigational device will track the system stability in the background (unnoticeable for the HI-wearer). A log file of the system stability can be read out by the investigator. The system stability will be calculated by the amount of tracked system artefacts in relation to the overall wearing time. System artefacts are not or only hardly noticeable for the HI wearer, so that these system artefacts can only be tracked by reading out the data logging of the investigational device.
- Sound Quality rating of T-Coil program under lab conditions [ Time Frame: 4 weeks ]Another objective is the subjective perception of the Sound Quality of the T-Coil under laboratory condition. Subjects will rate the perceived Sound Quality of an audio file streamed via T-Coil on a scale from 'not at all' to 'excellent'.
- Subjective perception of audio artefacts in T-Coil program [ Time Frame: 4 weeks ]Another objective is to count the number of reports from subjects regarding audible artefacts in the T-Coil program after a home trial phase of 4 weeks. Audible artefacts are defined as any disturbing unnatural sounds which interfere with a streamed signal via T-Coil. Artefacts will be noted on a client questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03938753
|Stäfa, Zürich, Switzerland, 8712|