A Comparative Clinical Investigation of Two Hearing Instrument Digital Signal Processing
NCT ID: NCT04374851
Last Updated: 2021-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
19 participants
INTERVENTIONAL
2020-08-03
2020-11-30
Brief Summary
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Detailed Description
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For this study, Bernafon AG will carry out testing with participants with hearing loss to validate the performance of a new digital signal processing (DSP). System testing of the DSP shows an improved signal, yet it must be tested with humans to be sure of an improvement in real-life situations. The current study will compare the new DSP to the one that is used in the Bernafon hearing aids that are CE- marked and currently available on the market. The goal is to determine whether the new DSP is better in real-life situations than the current system.
Primary Endpoint: The primary objective is to assess the new DSP system with various hearing losses and levels of amplification. Speech testing will be used to analyse the speech perception of participants.
Secondary Endpoint: The secondary objective is to verify the overall performance of the new device. Acceptable noise levels will be measured as well as further speech testing. Questionnaires will be used to measure subjective responses to the performance.
Other Endpoints: The subjective performance of an optimized fitting versus a standard fitting and the acceptance of new domes will be measured with questionnaires.
Safety Endpoint: The study aims to identify any new risk factors and to ensure the safety of the device with the newly implemented DSP system before releasing it to the market.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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New Device
The new Hearing aid is essentially the same as the current device (i.e., hardware, use) but with an improved digital signal processing (DSP).
Polaris miniRITE BTE
The Polaris device is programmed with computer software to match the Hearing loss of the participant.
Current Device
The current device is the Hearing aid that is currently sold on the market. It is used as a normal Hearing aid that is worn daily to amplify sounds for Hearing-impaired people.
Viron miniRiTE BTE
The Viron Hearing device is programmed with computer software to match the Hearing loss of the participant.
Interventions
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Polaris miniRITE BTE
The Polaris device is programmed with computer software to match the Hearing loss of the participant.
Viron miniRiTE BTE
The Viron Hearing device is programmed with computer software to match the Hearing loss of the participant.
Eligibility Criteria
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Inclusion Criteria
* Severity of Hearing loss ranging from mild to profound
* German speaking
* Current Hearing aid users
* Ability and willingness to sign the consent form
Exclusion Criteria
* New Hearing aid users
* Inability to follow the procedures
* Inability to attend Weekly study Appointments
* Strongly reduced dexterity
* Central Hearing disorders
* Bernafon employees
* Family members of Bernafon employees
18 Years
ALL
Yes
Sponsors
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Bernafon AG
INDUSTRY
Responsible Party
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Principal Investigators
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Barbara Simon, AuD
Role: PRINCIPAL_INVESTIGATOR
Bernafon AG
Locations
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Bernafon AG
Bern, , Switzerland
Countries
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Other Identifiers
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BF005-2000
Identifier Type: -
Identifier Source: org_study_id
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