Back to resultsQuality Control of CE-Certified Phonak Hearing Aids - 2017_27
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
Sponsored by
About this trial
This is an interventional other 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
- Smartphone user
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 Type
Experimental
Arm Label
Audéo B hearing aid line extension
Arm Description
The line extension of the Phonak Audéo B product family will be fitted to the participants individual hearing loss.
Outcomes
Primary Outcome Measures
Stable performance in daily life
The data, serving as primary outcomes are collected in a series of home trials, taking place between the lab trial appointments. The stable performance in daily life (that means: no significant interruptions, distortions, artefacts, feedback, system noise or other malfunctions) will be assessed with the aid of quantitative questionnaires. 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.
Phone call - Sound Quality
The data serving as primary outcomes are collected in a lab appointment. The participants will be asked to have a phone call with the investigator in the lab. The sound quality 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03253003
Brief Title
Quality Control of CE-Certified Phonak Hearing Aids - 2017_27
Official Title
Quality Control of CE-Certified Phonak Hearing Aids - 2017_27
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
August 7, 2017 (Actual)
Primary Completion Date
August 25, 2017 (Actual)
Study Completion Date
August 25, 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 a stable overall performance of the new hearing systems, a good sound quality during phone calls as well as maximum benefit for the participant with the devices.
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 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
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A line extension of the Phonak Audéo B hearing aid product family will be fitted to the participants individual hearing loss.
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Audéo B hearing aid line extension
Arm Type
Experimental
Arm 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)
Line extension of the Phonak Audéo B product family
Intervention Description
The line extension of Phonak Audéo B product family will be fitted to the participants individual hearing loss.
Primary Outcome Measure Information:
Title
Stable performance in daily life
Description
The data, serving as primary outcomes are collected in a series of home trials, taking place between the lab trial appointments. The stable performance in daily life (that means: no significant interruptions, distortions, artefacts, feedback, system noise or other malfunctions) will be assessed with the aid of quantitative questionnaires. 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
Three weeks
Title
Phone call - Sound Quality
Description
The data serving as primary outcomes are collected in a lab appointment. The participants will be asked to have a phone call with the investigator in the lab. The sound quality 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
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
Smartphone user
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
Stäfa
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 - 2017_27
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