Back to resultsQuality Control of CE-Certified Phonak Hearing Aids - 2016_37
Primary Purpose
Hearing Loss, Bilateral Sensorineural, Progressive
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Hearing Aid (Successor of Phonak Virto V)
Hearing Aid (Phonak Virto V)
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss, Bilateral Sensorineural, Progressive
Eligibility Criteria
Inclusion Criteria:
- Adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids
- Good written and spoken (Swiss) German language skills
- Healthy outer ear
- Ability to fill in a questionnaire (p/eCRF) conscientiously
- Informed Consent as documented by signature
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
- Massively limited dexterity
- Known psychological problems
- Central hearing disorders
Sites / Locations
- Sonova AG
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Successor of Phonak Virto V
Phonak Virto V
Arm Description
The successor of Phonak's Virto V will be fitted to the participants individual hearing loss.
Phonak Virto V will be fitted to the participants individual hearing loss.
Outcomes
Primary Outcome Measures
Speech intelligibility in noise as signal to noise ratio in dB (dB SNR)
The data, serving as primary outcomes are collected in a series of lab appointments. The speech intelligibility in noise will be assessed with the aid of the german Oldenburg sentence test. The result is the signal to noise ratio in dB (dB SNR). Descriptive statistics will be executed in the form of determining the median and quartiles. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued.
Secondary Outcome Measures
Speech intelligibility in percent in a quiet listening situation
The data, serving as secondary outcomes are collected in a series of lab appointments. The speech intelligibility in quiet will be assessed with the aid of the german rhyme test "Einsilber-Reimtest nach von Wallenberg und Kollmeier" (WaKo). The result is the speech intelligibility in percent. Descriptive statistics will be executed in the form of determining the median and quartiles. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued.
Zero-defect performance in daily life
The data, serving as secondary outcomes are collected in a series of home trials taking place between the lab trial appointments. The zero-defect performance in daily life (that means: no interruptions, distortions, artefacts, feedback, system noise or other malfunctions) will be assessed with the aid of quantitative questionnaires. The results are "Yes/No" replies and open-ended.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03108768
Brief Title
Quality Control of CE-Certified Phonak Hearing Aids - 2016_37
Official Title
Quality Control of CE-Certified Phonak Hearing Aids - 2016_37
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
April 3, 2017 (Actual)
Primary Completion Date
June 14, 2017 (Actual)
Study Completion Date
June 14, 2017 (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
A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch. The aim of the investigation series is to ensure zero-defect overall performance of the new hearing systems as well as maximum benefit for the participant with the devices in comparison to previously outstanding Phonak Hearing Systems.
Detailed Description
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 in the way as planned for this study ("phase of final inspection"). This will be a controlled, single blinded and randomised active comparator 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, Bilateral Sensorineural, Progressive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Phonak Virto V and the successor of Phonak Virto V will be fitted to the participants individual hearing loss.
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Successor of Phonak Virto V
Arm Type
Experimental
Arm Description
The successor of Phonak's Virto V will be fitted to the participants individual hearing loss.
Arm Title
Phonak Virto V
Arm Type
Active Comparator
Arm Description
Phonak Virto V will be fitted to the participants individual hearing loss.
Intervention Type
Device
Intervention Name(s)
Hearing Aid (Successor of Phonak Virto V)
Intervention Description
The successor of Phonak's In-The-Ear (ITE) hearing aid Virto V will be fitted to the participants individual hearing loss.
Intervention Type
Device
Intervention Name(s)
Hearing Aid (Phonak Virto V)
Intervention Description
Phonak's In-The-Ear (ITE) hearing aid Virto V will be fitted to the participants individual hearing loss.
Primary Outcome Measure Information:
Title
Speech intelligibility in noise as signal to noise ratio in dB (dB SNR)
Description
The data, serving as primary outcomes are collected in a series of lab appointments. The speech intelligibility in noise will be assessed with the aid of the german Oldenburg sentence test. The result is the signal to noise ratio in dB (dB SNR). Descriptive statistics will be executed in the form of determining the median and quartiles. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued.
Time Frame
Three weeks
Secondary Outcome Measure Information:
Title
Speech intelligibility in percent in a quiet listening situation
Description
The data, serving as secondary outcomes are collected in a series of lab appointments. The speech intelligibility in quiet will be assessed with the aid of the german rhyme test "Einsilber-Reimtest nach von Wallenberg und Kollmeier" (WaKo). The result is the speech intelligibility in percent. Descriptive statistics will be executed in the form of determining the median and quartiles. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued.
Time Frame
One week
Title
Zero-defect performance in daily life
Description
The data, serving as secondary outcomes are collected in a series of home trials taking place between the lab trial appointments. The zero-defect performance in daily life (that means: no interruptions, distortions, artefacts, feedback, system noise or other malfunctions) will be assessed with the aid of quantitative questionnaires. The results are "Yes/No" replies and open-ended.
Time Frame
Three 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) with and without (experience with) hearing aids
Good written and spoken (Swiss) German language skills
Healthy outer ear
Ability to fill in a questionnaire (p/eCRF) conscientiously
Informed Consent as documented by signature
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
Massively limited dexterity
Known psychological problems
Central hearing disorders
Facility Information:
Facility Name
Sonova AG
City
Stafa
State/Province
Zürich
ZIP/Postal Code
8712
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Quality Control of CE-Certified Phonak Hearing Aids - 2016_37
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