Back to resultsQuality Control of CE-Certified Phonak Hearing Aids - 2019_19
Primary Purpose
Hearing Loss, Sensorineural Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Phonak Bolero M90-M
Roger Select
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, mild to moderate Hearing loss) without hearing aid experience
- 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
- owning a compatible smartphone
- Hearing loss in range of N2-N3 (ISO 60118-15)
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 2
Arm Type
Experimental
Active Comparator
Arm Label
Phonak Bolero M90-M
Roger Select
Arm Description
The Phonak Bolero M90-M is a Behind-the-Ear Hearing aid with direct connectivity functionality from Phonak which will be fitted to the participants individual Hearing loss
The Roger Select is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid.
Outcomes
Primary Outcome Measures
Speech intelligibility in noise
The primary objective of this study is to investigate the speech intelligibility in noise of the investigational device alone versus the active comparator. Speech understanding in noise will be evaluated with an objective and validated test procedure, the Outcome measure will be the value of speech intelligibility in percentage at a certain signal to noise ratio.
Secondary Outcome Measures
Subjective Sound quality perception
The secondary objective of this study is to investigate the overall sound quality perception of the investigational device for daily real life situations. The sound quality perception will be measured with a subjective satisfaction rating scale ranging from 0% to 100%.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03992989
Brief Title
Quality Control of CE-Certified Phonak Hearing Aids - 2019_19
Official Title
Quality Control of CE-Certified Phonak Hearing Aids - 2019_19
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 3, 2019 (Actual)
Primary Completion Date
July 6, 2019 (Actual)
Study Completion Date
July 6, 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 Behind-the-ear (BTE) devices is investigated including CE-labeled compatible accessories. The experimental device will be investigated regarding its performance of speech understanding in noise with and without an accessory existing of an external microphone to pick sound at a certain target. 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. Another objective of this study is the investigation of the subjective occlusion effect of different acoustic couplings. 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
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phonak Bolero M90-M
Arm Type
Experimental
Arm Description
The Phonak Bolero M90-M is a Behind-the-Ear Hearing aid with direct connectivity functionality from Phonak which will be fitted to the participants individual Hearing loss
Arm Title
Roger Select
Arm Type
Active Comparator
Arm Description
The Roger Select is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid.
Intervention Type
Device
Intervention Name(s)
Phonak Bolero M90-M
Intervention Description
The Phonak Bolero M90-M is a Behind-the-Ear Hearing aid with direct connectivity functionality from Phonak which will be fitted to the participants individual Hearing loss
Intervention Type
Device
Intervention Name(s)
Roger Select
Intervention Description
The Roger Select is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid.
Primary Outcome Measure Information:
Title
Speech intelligibility in noise
Description
The primary objective of this study is to investigate the speech intelligibility in noise of the investigational device alone versus the active comparator. Speech understanding in noise will be evaluated with an objective and validated test procedure, the Outcome measure will be the value of speech intelligibility in percentage at a certain signal to noise ratio.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Subjective Sound quality perception
Description
The secondary objective of this study is to investigate the overall sound quality perception of the investigational device for daily real life situations. The sound quality perception will be measured with a subjective satisfaction rating scale ranging from 0% to 100%.
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Subjective occlusion effect
Description
Another objective of this study is to investigate the subjectively perceived occlusion effect of the own voice by the use of the investigational device. The subjective occlusion effect will be investigated with subjective ratings scales for the dimensions 'dullness of own voice' and 'naturalness of own voice'
Time Frame
4 weeks
Title
Sound quality for streamed audio signals
Description
Another objective of this study is to evaluate the subjectively perceived sound quality of streamed audio signals [via bluetooth streaming] with the help of a subjective rating scale
Time Frame
1 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, mild to moderate Hearing loss) without hearing aid experience
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
owning a compatible smartphone
Hearing loss in range of N2-N3 (ISO 60118-15)
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 - 2019_19
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