- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03379766
Quality Control of CE-Certified Phonak Hearing Aids - 2017_37
March 8, 2018 updated by: Sonova AG
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zürich
-
Stäfa, Zürich, Switzerland, 8712
- Sonova AG
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Successor of Phonak Audéo B-Direct
The successor of Phonak Audéo B-Direct will be fitted to the participants individual hearing loss.
|
The successor of Phonak Audéo B-Direct will be fitted to the participants indivudal hearing loss.
|
ACTIVE_COMPARATOR: Phonak Audéo B-Direct
The Phonak Audéo B-Direct will be fitted to the participants individual hearing loss.
|
The Phonak Audéo B-Direct will be fitted to the participants individual hearing loss.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spontaneous acceptance of the initial pre-calculation (first fit)
Time Frame: One week
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Listening effort in noisy listening environment
Time Frame: One week
|
The data, serving as secondary outcomes are collected in the second study appointment.
The listening effort in noisy listening environments will be assessed under controlled conditions in lab with the aid of the Adaptive Categorial Listening Effort Scaling Test (ACALES).
The result shows the listening effort on a scale from 'no effort - extreme effort' at different signal to noise ratios.
|
One week
|
Speech intelligibility in noisy listening environment
Time Frame: One week
|
The data, serving as secondary outcomes are collected in the third study appointment.
The speech intelligibility in noise will be assessed with the aid of the german Oldenburg sentence test (OLSA) under controlled conditions in lab.
The result is the signal to noise ratio in dB (dB SNR).
|
One week
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TV streaming
Time Frame: Three weeks
|
The data, serving as other outcomes are collected within home trials with the test hearing aids, which take place between the weekly study appointments.
The participants will be asked to assess the streamed signals in regard to any disturbing artefacts (e. g. fluctuation of volume or sound quality).
In case that the participants experienced such artefacts, they will be asked to rate how bothersome these artefacts were (on a 10-point scale from 'not at all - extremely').
These ratings will be aggregated to arrive at one reported value.
|
Three weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 8, 2018
Primary Completion (ACTUAL)
February 2, 2018
Study Completion (ACTUAL)
February 2, 2018
Study Registration Dates
First Submitted
December 13, 2017
First Submitted That Met QC Criteria
December 19, 2017
First Posted (ACTUAL)
December 20, 2017
Study Record Updates
Last Update Posted (ACTUAL)
March 9, 2018
Last Update Submitted That Met QC Criteria
March 8, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sonova2017_37
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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