A Comparative Clinical Investigation of Two Hearing Instrument Digital Signal Processing
1 other identifier
interventional
19
1 country
1
Brief Summary
The purpose of this study is to show that the performance of the new digital signal processing system is better than the system used in the currently CE marked devices. Speech in narrowband noise and acceptable levels of noise should be improved with the new system, and speech understanding overall should not be negatively affected. There should be no artefacts or unwanted noises caused by the new system.
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 Aug 2020
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
April 16, 2020
CompletedFirst Posted
Study publicly available on registry
May 5, 2020
CompletedStudy Start
First participant enrolled
August 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedJanuary 7, 2021
January 1, 2021
4 months
April 16, 2020
January 6, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Speech perception with narrowband noise
Speech perception is tested using a standardized speech test that requires subjects to repeat sentences presented among narrowband background noise. The test is adaptive with the background noise getting louder or softer so that the subject answers 50% correct. The scores are measured in dB SNR (signal-to-noise ratio) and a lower score is better. The lowest possible score is -15 dB SNR and the highest is +20 dB SNR. It is measured in the unaided condition.
Week 1
Speech perception with narrowband noise
Speech perception is tested using a standardized speech test that requires subjects to repeat sentences presented among narrowband background noise. The test is adaptive with the background noise getting louder or softer so that the subject answers 50% correct. The scores are measured in dB SNR (signal-to-noise ratio) and a lower score is better. The lowest possible score is -15 dB SNR and the highest is +20 dB SNR. It is measured in the aided condition with the new device or the current device depending on the randomization.
Week 2
Speech perception with narrowband noise
Speech perception is tested using a standardized speech test that requires subjects to repeat sentences presented among narrowband background noise. The test is adaptive with the background noise getting louder or softer so that the subject answers 50% correct. The scores are measured in dB SNR (signal-to-noise ratio) and a lower score is better. The lowest possible score is -15 dB SNR and the highest is +20 dB SNR. It is measured in the aided condition with the new device or the current device depending on the randomization.
Week 3
Secondary Outcomes (6)
Speech perception with broadband noise
Week 1
Speech perception with broadband noise
Week 2
Speech perception with broadband noise
Week 3
Acceptance of noise
Week 1
Acceptance of noise
Week 2
- +1 more secondary outcomes
Other Outcomes (1)
Preference for Standard or Optimized Fitting
Week 5
Study Arms (2)
New Device
EXPERIMENTALThe new Hearing aid is essentially the same as the current device (i.e., hardware, use) but with an improved digital signal processing (DSP).
Current Device
ACTIVE COMPARATORThe 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.
Interventions
The Polaris device is programmed with computer software to match the Hearing loss of the participant.
The Viron Hearing device is programmed with computer software to match the Hearing loss of the participant.
Eligibility Criteria
You may qualify if:
- Hearing loss (sensorineural, conductive, mixed-must have doctor approval for mixed and conductive Hearing loss)
- Severity of Hearing loss ranging from mild to profound
- German speaking
- Current Hearing aid users
- Ability and willingness to sign the consent form
You may not qualify if:
- Contraindications for amplification
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bernafon AGlead
Study Sites (1)
Bernafon AG
Bern, 3018, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara Simon, AuD
Bernafon AG
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- The subjects will not know which device they are using in each period (new or current) because they look exactly the same. The PI will also not know which device is used as they will be prepared for the PI before the Appointments.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2020
First Posted
May 5, 2020
Study Start
August 3, 2020
Primary Completion
November 30, 2020
Study Completion
November 30, 2020
Last Updated
January 7, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share
There is no plan to share individual data.