Study Stopped
PMCF data, originally planned to be collected withthis study, are collected using another methodology
Quality Control of CE-Certified Phonak Hearing Aids - 2019_23
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Phonak Hearing Devices pass through different development and study phases. At an early stage, feasibiltiy 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 interpendency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, resulting from the pre-validation studies, they get optimized. Prior to product launch, the Phonak Hearing Systems get reviewed by a final quality control in terms of clinical trials. This is a pre-validation study, investigating improved algorithms, features, functions and wearing comfort. This will be a clinical investigation 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
Started Aug 2019
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
August 6, 2019
CompletedFirst Posted
Study publicly available on registry
August 7, 2019
CompletedStudy Start
First participant enrolled
August 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2019
CompletedSeptember 20, 2019
September 1, 2019
17 days
August 6, 2019
September 18, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Successful creation of a Custom Sceario (%)
Endusers of the phoneApp are able to add a custum scenario to the app.
4 weeks
Successful answering of conference call (%)
Endusers of the phoneApp are able to answering the conference call?
2 weeks
Study Arms (1)
Phone Application
EXPERIMENTALInterventions
Phone application is developed to adjust hearing aids. It incorporates functionalities like volume control and program change.
Eligibility Criteria
You may qualify if:
- experienced hearing aid users (minimum age: 18 years, moderate to moderate/severe hearing loss)
- modern subjects with an affinity to new technology
- willingness and interest in testing Apps
- owning a compatible smartphone
- Healthy outer ear
- willingness to wear behind the ear hearing aids
- Informed Consent as documented by signature
You may not qualify if:
- the audiogramm is not in the fitting range of the intended hearing aid
- limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
- participant is not able to describe experiences and hearing impressions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sonova AGlead
Study Sites (1)
Sonova AG
Stäfa, 8712, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2019
First Posted
August 7, 2019
Study Start
August 20, 2019
Primary Completion
September 6, 2019
Study Completion
September 6, 2019
Last Updated
September 20, 2019
Record last verified: 2019-09