Back to resultsQuality Control of CE-Certified Phonak Hearing Aids - 2017_13
Primary Purpose
Hearing Loss, Bilateral Sensorineural, Progressive
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Line extension of the Phonak Audéo B product family
Phonak Audéo B
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
Line extension of the Phonak Audéo B hearing aid
Phonak Audéo B hearing aid
Arm Description
The line extension of the Phonak Audéo B product family will be fitted to the participants individual hearing loss.
Phonak Audéo B will be fitted to the participants individual hearing loss.
Outcomes
Primary Outcome Measures
Usability (phone calls)
The data, serving as primary outcomes are collected in a lab appointment. The participants will be asked to accept, reject and hang up phone calls with the aid of the push button of the hearing aid. The usability will be subjectively assessed by the participants and additionally by the investigators on given scales. Descriptive statistics will be executed. 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
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.
Speech intelligibility in noise as signal to noise ratio in dB (dB SNR)
The data, serving as secondary 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03131557
Brief Title
Quality Control of CE-Certified Phonak Hearing Aids - 2017_13
Official Title
Quality Control of CE-Certified Phonak Hearing Aids - 2017_13
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 12, 2017 (Actual)
Primary Completion Date
July 18, 2017 (Actual)
Study Completion Date
July 18, 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
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 usability, 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 Audéo B and a line extension of the Phonak Audéo B hearing aid product family will be fitted to the participants individual hearing loss.
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Line extension of the Phonak Audéo B hearing aid
Arm Type
Experimental
Arm Description
The line extension of the Phonak Audéo B product family will be fitted to the participants individual hearing loss.
Arm Title
Phonak Audéo B hearing aid
Arm Type
Active Comparator
Arm Description
Phonak Audéo B will be fitted to the participants individual hearing loss.
Intervention Type
Device
Intervention Name(s)
Line extension of the Phonak Audéo B product family
Intervention Description
The line extension of the Phonak Audéo B product family will be fitted to the participants individual hearing loss.
Intervention Type
Device
Intervention Name(s)
Phonak Audéo B
Intervention Description
Phonak Audéo B will be fitted to the participants individual hearing loss.
Primary Outcome Measure Information:
Title
Usability (phone calls)
Description
The data, serving as primary outcomes are collected in a lab appointment. The participants will be asked to accept, reject and hang up phone calls with the aid of the push button of the hearing aid. The usability will be subjectively assessed by the participants and additionally by the investigators on given scales. Descriptive statistics will be executed. 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
Secondary Outcome Measure Information:
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
Title
Speech intelligibility in noise as signal to noise ratio in dB (dB SNR)
Description
The data, serving as secondary 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
One week
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simone Ebbing, B.Sc.
Organizational Affiliation
Sonova AG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sonova AG
City
Stafa
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 - 2017_13
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