A Comparison of a New Acoustic Feedback Canceller in Hearing Aids With the Current System
A Comparative, Controlled Clinical Investigation of a New Acoustic Feedback Cancellation Strategy in Comparison With the Currently Marketed System
1 other identifier
interventional
33
1 country
1
Brief Summary
The Purpose of the study is to show that the performance of the new feedback cancellation system is better than the feedback system used in the currently marketed hearing aids. Speech understanding should not be negatively affected by the new system, ad there should be no consequential artifacts 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 P25-P50 for not_applicable
Started Nov 2018
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
Study Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2019
CompletedFirst Submitted
Initial submission to the registry
October 10, 2019
CompletedFirst Posted
Study publicly available on registry
October 31, 2019
CompletedResults Posted
Study results publicly available
September 13, 2021
CompletedSeptember 13, 2021
August 1, 2021
8 months
October 10, 2019
July 31, 2020
August 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Live Feedback Test Scores From Day 10 to Day 20
In the lab, subjects will have the hearing aid placed in their ear. They will rate on a visual analogue scale whether feedback occurs and if so, how much annoyance it causes. The scale has a minimum of 0 and a maximum of 10. A lower score is a better answer. It will be tested in two conditions, aided with the current Hearing aid, and aided with the new Hearing aid at 10 and 20 days. The difference between the scores from day 10 and day 20 was calculated by subtracting day 20 ("new hearing aid") from day 10 ("current hearing aid") after both sessions of testing were completed and reported as the mean difference for the group. Regardless of the arm assignment, participants wore the same hearing aids for the lab test on days 10 and 20.
10 days, 20 days
Secondary Outcomes (3)
Word Recognition - Aided
20 days
Sound Quality Rating
20 days
Word Recognition - Unaided
10 days
Other Outcomes (1)
Number of Participants Reporting an Adverse Event
0, 10, and 20 days
Study Arms (4)
Moderate Hearing loss current Mermaid first, then new
ACTIVE COMPARATORParticipants 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.
Moderate Hearing loss new Mermaid first, then current
ACTIVE COMPARATORParticipants 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.
Severe hearing loss current Power first, then new
ACTIVE COMPARATORParticipants 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.
Severe hearing loss new Power first, then current
ACTIVE COMPARATORParticipants 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.
Interventions
The current hearing aid used to treat hearing loss.
The new hearing aid used to treat hearing loss with an upgraded feedback cancellation system.
The current power hearing aid used to treat strong hearing loss.
The new power hearing aid used to treat strong hearing loss with an upgraded feedback cancellation system.
Eligibility Criteria
You may qualify if:
- All classifications of hearing loss (sensorineural, conductive, mixed)
- 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
You may not qualify if:
- Contraindications for amplification
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bernafon AGlead
Study Sites (1)
Bernafon
Bern, 3018, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
No limitations or caveats
Results Point of Contact
- Title
- Barbara Simon
- Organization
- Bernafon AG
Study Officials
- PRINCIPAL INVESTIGATOR
Babara Simon, AuD
Sponsor/Bernafon
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- The participants are masked during the lab testing. They will not know which device they are testing because the Investigator will place it on their ear without letting them see it.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2019
First Posted
October 31, 2019
Study Start
November 1, 2018
Primary Completion
June 18, 2019
Study Completion
July 7, 2019
Last Updated
September 13, 2021
Results First Posted
September 13, 2021
Record last verified: 2021-08