Back to resultsQuality Control of CE-Certified Phonak Hearing Aids - 2018_42
Primary Purpose
Hearing Loss, Sensorineural Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Audéo M90-T
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- Adult hearing impaired persons (minimum age: 18 years, moderate to severe Hearing loss)
- Good written and spoken (Swiss) German language skills
- Healthy outer ear
- Ability to fill in a questionnaire (p/eCRF) conscientiously
- Willingness to wear Receiver in the canal hearing aids
- Informed Consent as documented by signature
- Owning a compatible smartphone
Exclusion Criteria:
- Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
- Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
- Limited ability to describe listening impressions/experiences and the use of the hearing aid
- Inability to produce a reliable hearing test result
- Known psychological problems
- Central hearing disorders
Sites / Locations
- Sonova AG
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Phonak Audéo M90-T
Arm Description
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.
Outcomes
Primary Outcome Measures
Subjective perception of the T-Coil Sound Quality
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.
Secondary Outcome Measures
Program switch-back workflow into T-Coil program
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03938753
Brief Title
Quality Control of CE-Certified Phonak Hearing Aids - 2018_42
Official Title
Quality Control of CE-Certified Phonak Hearing Aids - 2018_42
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 9, 2019 (Actual)
Primary Completion Date
February 7, 2019 (Actual)
Study Completion Date
February 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
Detailed Description
In this study one CE-labeled Phonak Receiver-in-the-canal (RIC) devices is investigated. The experimental device will be investigated regarding Sound Quality perception ot the T-Coil program. A secondary objective of this study is the investigation of the Overall system stability in daily life situations. The experimental device contains direct connectivity functionality and a T-Coil. The combination of a wireless chip for Bluetooth streaming and a T-Coil in one housing can cause audible artifacts on the T-Coil, which shall be investigated within this study. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural Hearing Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phonak Audéo M90-T
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Audéo M90-T
Intervention Description
Receiver in the canal (RIC) Hearing aid form Phonak which will be fitted to the participants individual Hearing loss.
Primary Outcome Measure Information:
Title
Subjective perception of the T-Coil Sound Quality
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Program switch-back workflow into T-Coil program
Description
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).
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Observation of the system stability
Description
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.
Time Frame
4 weeks
Title
Sound Quality rating of T-Coil program under lab conditions
Description
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'.
Time Frame
4 weeks
Title
Subjective perception of audio artefacts in T-Coil program
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult hearing impaired persons (minimum age: 18 years, moderate to severe Hearing loss)
Good written and spoken (Swiss) German language skills
Healthy outer ear
Ability to fill in a questionnaire (p/eCRF) conscientiously
Willingness to wear Receiver in the canal hearing aids
Informed Consent as documented by signature
Owning a compatible smartphone
Exclusion Criteria:
Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
Limited ability to describe listening impressions/experiences and the use of the hearing aid
Inability to produce a reliable hearing test result
Known psychological problems
Central hearing disorders
Facility Information:
Facility Name
Sonova AG
City
Stäfa
State/Province
Zürich
ZIP/Postal Code
8712
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Quality Control of CE-Certified Phonak Hearing Aids - 2018_42
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