A Comparison of a New Acoustic Feedback Canceller in Hearing Aids With the Current System
NCT ID: NCT04146272
Last Updated: 2021-09-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2018-11-01
2019-07-07
Brief Summary
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Detailed Description
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Acoustic feedback is a critical problem to all hearing aids. The acoustic coupling between the hearing aid receiver and the microphone occurs when an endless loop is formed so that the microphone is re-amplifying sound from its own receiver. The higher the amplification of the system, the more unstable it becomes and the more likely an acoustic feedback will occur. When this happens the hearing aid user and those around them hear a loud whistling noise. A common method used to combat this problem is feedback cancellation, more specifically adaptive feedback cancellation. The goal of feedback cancellation is to quickly identify feedback path changes and make adjustments to preserve the stability of the system while maintaining a high sound quality and still providing a high stable gain compared to the gain achieved without an active feedback reduction.
For this study, the Sponsor will carry out testing with participants who have hearing loss to validate the performance of the new feedback cancelling algorithm. Studies have investigated the advantages and disadvantages of different feedback cancellation techniques. However, it is accepted by professionals that having a feedback system is better than not using feedback cancellation. The Sponsor has used an adaptive feedback cancellation algorithm since 2010. For the current study the new adaptive algorithm will be compared to the current algorithm implemented in the hearing aids that are certified by the European Conformity and sold on the market. The aim is to determine if less feedback is experienced using the new system in comparison to the old system.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Moderate Hearing loss current Mermaid first, then new
Participants were randomized to wear the current Mermaid hearing aid that uses the current feedback cancellation first for 10 days. Then they wore the new Mermaid Hearing aid for another 10 days.
Hearing Aid Mermaid Current
The current hearing aid used to treat hearing loss.
Hearing Aid Mermaid New
The new hearing aid used to treat hearing loss with an upgraded feedback cancellation system.
Moderate Hearing loss new Mermaid first, then current
Participants were randomized to wear the new Mermaid hearing aid that uses the new feedback cancellation first for 10 days. Then they wore the current Mermaid Hearing aid for another 10 days.
Hearing Aid Mermaid Current
The current hearing aid used to treat hearing loss.
Hearing Aid Mermaid New
The new hearing aid used to treat hearing loss with an upgraded feedback cancellation system.
Severe hearing loss current Power first, then new
Participants were randomized to wear the current power hearing aid that uses the current feedback cancellation first for 10 days. Then they wore the new power Hearing aid for another 10 days.
Power Hearing Aid Current
The current power hearing aid used to treat strong hearing loss.
Power Hearing Aid New
The new power hearing aid used to treat strong hearing loss with an upgraded feedback cancellation system.
Severe hearing loss new Power first, then current
Participants were randomized to wear the new power hearing aid that uses the new feedback cancellation first for 10 days. Then they wore the current power Hearing aid for another 10 days.
Power Hearing Aid Current
The current power hearing aid used to treat strong hearing loss.
Power Hearing Aid New
The new power hearing aid used to treat strong hearing loss with an upgraded feedback cancellation system.
Interventions
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Hearing Aid Mermaid Current
The current hearing aid used to treat hearing loss.
Hearing Aid Mermaid New
The new hearing aid used to treat hearing loss with an upgraded feedback cancellation system.
Power Hearing Aid Current
The current power hearing aid used to treat strong hearing loss.
Power Hearing Aid New
The new power hearing aid used to treat strong hearing loss with an upgraded feedback cancellation system.
Eligibility Criteria
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Inclusion Criteria
* Conductive and mixed hearing loss must be approved for amplification by a physician
* All shapes of hearing loss (flat, sloping, reverse slope, notch)
* Severity ranging from mild to profound
* German speaking
* Ability and willingness to sign the consent form
Exclusion Criteria
* Active ear disease
* New hearing aid users
* Inability to follow the procedures
* Reduced mobility that makes then unable to attend study Appointments
* Uncooperative so that it's not possible to get a valid audiogram
* A strongly reduced dexterity
* Central hearing disorder
* Sponsor employees
* Family members of Sponsor 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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Babara Simon, AuD
Role: PRINCIPAL_INVESTIGATOR
Sponsor/Bernafon
Locations
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Bernafon
Bern, , Switzerland
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BF004-1901
Identifier Type: -
Identifier Source: org_study_id
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