Quality Control of CE-Certified Phonak Hearing Aids - 2019_34
1 other identifier
interventional
13
1 country
1
Brief Summary
Phonak Hearing Devices pass through different development and study phases. 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, 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 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
participants targeted
Target at below P25 for not_applicable
Started Nov 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
Study Start
First participant enrolled
November 11, 2019
CompletedFirst Submitted
Initial submission to the registry
December 3, 2019
CompletedFirst Posted
Study publicly available on registry
December 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2020
CompletedMarch 3, 2020
February 1, 2020
2 months
December 3, 2019
February 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Rating of the subjective comfort for the old and the new setting
Rating of the comfort, regarding to the loudness, with the old and the new setting of the external microphone (%)
6 weeks
Secondary Outcomes (3)
Evaluation of the speech intelligibility in noise
2 weeks
Subjective Sound Quality rating
6 weeks
Subjective rating of natural sounds
6 weeks
Study Arms (2)
external microphone old
OTHERexternal microphone new
OTHERInterventions
External microphone is developed for direct transmission of speech into the hearing aids for better speech intelligibility, especially in noise.
Eligibility Criteria
You may qualify if:
- experienced hearing aid user
- severe hearing loss
- willingness and interest in testing an external microphone healthy outer ear
- willingness to wear behind the ear hearing aids
- Informed Consent as documented by signature
You may not qualify if:
- the audiogram 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
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2019
First Posted
December 5, 2019
Study Start
November 11, 2019
Primary Completion
January 17, 2020
Study Completion
January 17, 2020
Last Updated
March 3, 2020
Record last verified: 2020-02