Quality Control of CE-Certified Phonak Hearing Aids - 2018_07
1 other identifier
interventional
16
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2018
CompletedStudy Start
First participant enrolled
May 22, 2018
CompletedFirst Posted
Study publicly available on registry
June 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 22, 2018
CompletedSeptember 17, 2018
September 1, 2018
1 month
May 7, 2018
September 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 ).
3 weeks
Secondary Outcomes (1)
Measurement of acoustic Feedback Thresholds
3 weeks
Other Outcomes (1)
TFG Fitrate
3 weeks
Study Arms (2)
Device: Extension of Phonak Virto B-Titanium
EXPERIMENTALThe extension of Phonak Virto B-Titanium will be fitted to the participants individual Hearing loss.
Device: Phonak Virto B-Titanium
ACTIVE COMPARATORThe Phonak Virto B-Titanium will be fitted to the participants individual Hearing loss.
Interventions
In ear Hearing aid device individually modeled to ear canal geometry to compensate an individual Hearing loss.
In ear Hearing aid device individually modeled to ear canal geometry to compensate an individual Hearing loss.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sonova AGlead
Study Sites (1)
Sonova AG
Stäfa, Canton of Zurich, 8712, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2018
First Posted
June 13, 2018
Study Start
May 22, 2018
Primary Completion
June 22, 2018
Study Completion
June 22, 2018
Last Updated
September 17, 2018
Record last verified: 2018-09