Quality Control of CE-Certified Phonak Hearing Aids - 2016_05
1 other identifier
interventional
30
1 country
1
Brief Summary
A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of hearing participants to grant quality control prior to product launch. The aim of the investigation series is to ensure zero-defect overall performance of the new hearing systems as well as maximum benefit for the participant with the devices in comparison to previously outstanding Phonak Hearing Systems.
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 Nov 2016
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
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2016
CompletedFirst Posted
Study publicly available on registry
November 1, 2016
CompletedStudy Start
First participant enrolled
November 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2017
CompletedMarch 1, 2017
February 1, 2017
3 months
October 26, 2016
February 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Zero-defect performance in daily life
The data, serving as primary outcomes are collected in a series of home trials taking place between the lab trial appointments. The zero-defect performance in daily life (that means: no interruptions, distortions, artefacts, feedback, system noise or other malfunctions) will be assessed with the aid of quantitative questionnaires. The results are "Yes/No" replies and open-ended.
Four weeks
Secondary Outcomes (3)
Speech intelligibility in noise as signal to noise ration in dB (dB SNR)
Two weeks
Visibility
Four weeks
Wearing Comfort
Four weeks
Other Outcomes (1)
Initial first fit acceptance (pre-calculation) in lab
Two weeks
Interventions
Successor of Phonak Virto V90-10 NW O
Eligibility Criteria
You may qualify if:
- Adult hearing impaired persons (minimum age: 18 years) with and 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
- 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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2016
First Posted
November 1, 2016
Study Start
November 8, 2016
Primary Completion
February 20, 2017
Study Completion
February 20, 2017
Last Updated
March 1, 2017
Record last verified: 2017-02