Back to resultsQuality Control of CE-Certified Phonak Hearing Aids - 2018_07
Primary Purpose
Hearing Loss, Sensorineural
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Extension of Virto B-Titanium
Virto B-Titanium
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 or 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
- willingness to wear custom made Hearing aids
- Informed Consent as documented by signature
- Benefit with TFG tool at least on one ear
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
- Limited dexterity (not able to change a 10size Hearing aid battery)
- no Benefit of the TFG tool on both ears
- 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
Device: Extension of Phonak Virto B-Titanium
Device: Phonak Virto B-Titanium
Arm Description
The extension of Phonak Virto B-Titanium will be fitted to the participants individual Hearing loss.
The Phonak Virto B-Titanium will be fitted to the participants individual Hearing loss.
Outcomes
Primary Outcome Measures
Visibility and Wearing Comfort
The primary objective of this study is to evaluate if Virto B-Titanium hearing aids measured with the Titanium FitGuide (TFG) (extension of Virto B-Titanium) are less visible (deeper) than modeling without TFG (Virto B-Titanium) while maintaining wearing comfort on adult participants (new and existing users) with mild to moderately-severe hearing loss (M and P receiver ).
Secondary Outcome Measures
Measurement of acoustic Feedback Thresholds
Secondary objective is to compare the acoustic feedback thresholds of the TFG- and without TFG- modeled devices in regard of an adequate sealing effect of the respective devices. Thereby, feedback thresholds, measured with the Phonak Target fitting software, must be comparable to average feedback threshold values of the respective shell forms (IIC / CIC). Acceptable feedback thresholds must guarantee an insertion gain [in dB SPL] of at least 20 dB in a specific frequency range.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03555084
Brief Title
Quality Control of CE-Certified Phonak Hearing Aids - 2018_07
Official Title
Quality Control of CE-Certified Phonak Hearing Aids - 2018_07
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 22, 2018 (Actual)
Primary Completion Date
June 22, 2018 (Actual)
Study Completion Date
June 22, 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, functions and wearing comfort. 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
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Device: Extension of Phonak Virto B-Titanium
Arm Type
Experimental
Arm Description
The extension of Phonak Virto B-Titanium will be fitted to the participants individual Hearing loss.
Arm Title
Device: Phonak Virto B-Titanium
Arm Type
Active Comparator
Arm Description
The Phonak Virto B-Titanium will be fitted to the participants individual Hearing loss.
Intervention Type
Device
Intervention Name(s)
Extension of Virto B-Titanium
Intervention Description
In ear Hearing aid device individually modeled to ear canal geometry to compensate an individual Hearing loss.
Intervention Type
Device
Intervention Name(s)
Virto B-Titanium
Intervention Description
In ear Hearing aid device individually modeled to ear canal geometry to compensate an individual Hearing loss.
Primary Outcome Measure Information:
Title
Visibility and Wearing Comfort
Description
The primary objective of this study is to evaluate if Virto B-Titanium hearing aids measured with the Titanium FitGuide (TFG) (extension of Virto B-Titanium) are less visible (deeper) than modeling without TFG (Virto B-Titanium) while maintaining wearing comfort on adult participants (new and existing users) with mild to moderately-severe hearing loss (M and P receiver ).
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Measurement of acoustic Feedback Thresholds
Description
Secondary objective is to compare the acoustic feedback thresholds of the TFG- and without TFG- modeled devices in regard of an adequate sealing effect of the respective devices. Thereby, feedback thresholds, measured with the Phonak Target fitting software, must be comparable to average feedback threshold values of the respective shell forms (IIC / CIC). Acceptable feedback thresholds must guarantee an insertion gain [in dB SPL] of at least 20 dB in a specific frequency range.
Time Frame
3 weeks
Other Pre-specified Outcome Measures:
Title
TFG Fitrate
Description
Another objective is to investigate whether at least 50% of the screened population will get a deeper fitted device by the use of the TFG tool, proven by modelling software
Time Frame
3 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 or 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
willingness to wear custom made Hearing aids
Informed Consent as documented by signature
Benefit with TFG tool at least on one ear
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
Limited dexterity (not able to change a 10size Hearing aid battery)
no Benefit of the TFG tool on both ears
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 - 2018_07
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