Back to resultsQuality Control of CE-Certified Phonak Hearing Aids - 2017_37
Primary Purpose
Hearing Loss, Sensorineural
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Successor of Phonak Audéo B-Direct
Phonak Audéo B-Direct
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss, Sensorineural
Eligibility Criteria
Inclusion Criteria:
- Adult hearing impaired persons (minimum age: 18 years) with at least 3 months 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 Audéo B-Direct
Phonak Audéo B-Direct
Arm Description
The successor of Phonak Audéo B-Direct will be fitted to the participants individual hearing loss.
The Phonak Audéo B-Direct will be fitted to the participants individual hearing loss.
Outcomes
Primary Outcome Measures
Spontaneous acceptance of the initial pre-calculation (first fit)
The data, serving as primary outcomes are collected in the first study appointment. The spontaneous acceptance of the initial pre-calculation (also called 'first fit') in regard to loudness and sound quality will be assessed with the aid of a systematic interview in lab.
Secondary Outcome Measures
Listening effort in noisy listening environment
The data, serving as secondary outcomes are collected in the second study appointment. The listening effort in noisy listening environments will be assessed under controlled conditions in lab with the aid of the Adaptive Categorial Listening Effort Scaling Test (ACALES). The result shows the listening effort on a scale from 'no effort - extreme effort' at different signal to noise ratios.
Speech intelligibility in noisy listening environment
The data, serving as secondary outcomes are collected in the third study appointment. The speech intelligibility in noise will be assessed with the aid of the german Oldenburg sentence test (OLSA) under controlled conditions in lab. The result is the signal to noise ratio in dB (dB SNR).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03379766
Brief Title
Quality Control of CE-Certified Phonak Hearing Aids - 2017_37
Official Title
Quality Control of CE-Certified Phonak Hearing Aids - 2017_37
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
February 2, 2018 (Actual)
Study Completion Date
February 2, 2018 (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 and functions. 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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Successor of Phonak Audéo B-Direct
Arm Type
Experimental
Arm Description
The successor of Phonak Audéo B-Direct will be fitted to the participants individual hearing loss.
Arm Title
Phonak Audéo B-Direct
Arm Type
Active Comparator
Arm Description
The Phonak Audéo B-Direct will be fitted to the participants individual hearing loss.
Intervention Type
Device
Intervention Name(s)
Successor of Phonak Audéo B-Direct
Intervention Description
The successor of Phonak Audéo B-Direct will be fitted to the participants indivudal hearing loss.
Intervention Type
Device
Intervention Name(s)
Phonak Audéo B-Direct
Intervention Description
The Phonak Audéo B-Direct will be fitted to the participants individual hearing loss.
Primary Outcome Measure Information:
Title
Spontaneous acceptance of the initial pre-calculation (first fit)
Description
The data, serving as primary outcomes are collected in the first study appointment. The spontaneous acceptance of the initial pre-calculation (also called 'first fit') in regard to loudness and sound quality will be assessed with the aid of a systematic interview in lab.
Time Frame
One week
Secondary Outcome Measure Information:
Title
Listening effort in noisy listening environment
Description
The data, serving as secondary outcomes are collected in the second study appointment. The listening effort in noisy listening environments will be assessed under controlled conditions in lab with the aid of the Adaptive Categorial Listening Effort Scaling Test (ACALES). The result shows the listening effort on a scale from 'no effort - extreme effort' at different signal to noise ratios.
Time Frame
One week
Title
Speech intelligibility in noisy listening environment
Description
The data, serving as secondary outcomes are collected in the third study appointment. The speech intelligibility in noise will be assessed with the aid of the german Oldenburg sentence test (OLSA) under controlled conditions in lab. The result is the signal to noise ratio in dB (dB SNR).
Time Frame
One week
Other Pre-specified Outcome Measures:
Title
TV streaming
Description
The data, serving as other outcomes are collected within home trials with the test hearing aids, which take place between the weekly study appointments. The participants will be asked to assess the streamed signals in regard to any disturbing artefacts (e. g. fluctuation of volume or sound quality). In case that the participants experienced such artefacts, they will be asked to rate how bothersome these artefacts were (on a 10-point scale from 'not at all - extremely'). These ratings will be aggregated to arrive at one reported value.
Time Frame
Three weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult hearing impaired persons (minimum age: 18 years) with at least 3 months 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
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_37
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