Quality Control of CE-Certified Phonak Hearing Aids - 2017_37
1 other identifier
interventional
20
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 and functions. 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 Jan 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
December 13, 2017
CompletedFirst Posted
Study publicly available on registry
December 20, 2017
CompletedStudy Start
First participant enrolled
January 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2018
CompletedMarch 9, 2018
March 1, 2018
25 days
December 13, 2017
March 8, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
One week
Secondary Outcomes (2)
Listening effort in noisy listening environment
One week
Speech intelligibility in noisy listening environment
One week
Other Outcomes (1)
TV streaming
Three weeks
Study Arms (2)
Successor of Phonak Audéo B-Direct
EXPERIMENTALThe successor of Phonak Audéo B-Direct will be fitted to the participants individual hearing loss.
Phonak Audéo B-Direct
ACTIVE COMPARATORThe Phonak Audéo B-Direct will be fitted to the participants individual hearing loss.
Interventions
The successor of Phonak Audéo B-Direct will be fitted to the participants indivudal hearing loss.
The Phonak Audéo B-Direct will be fitted to the participants individual hearing loss.
Eligibility Criteria
You may qualify if:
- 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
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
- Massively limited dexterity
- 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
December 13, 2017
First Posted
December 20, 2017
Study Start
January 8, 2018
Primary Completion
February 2, 2018
Study Completion
February 2, 2018
Last Updated
March 9, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share