Trial Outcomes & Findings for A Comparison of a New Acoustic Feedback Canceller in Hearing Aids With the Current System (NCT NCT04146272)
NCT ID: NCT04146272
Last Updated: 2021-09-13
Results Overview
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.
COMPLETED
NA
33 participants
10 days, 20 days
2021-09-13
Participant Flow
33 patients were screened for eligibility from the list of contacts at the Bernafon Hearing clinic.
33 participants were randomized. 22 met the inclusion criteria for moderate Hearing loss and 11 for severe Hearing loss.
Participant milestones
| Measure |
Moderate Hearing Loss Current Mermaid, Then New
Participants first used the current Mermaid hearing aid with the current feedback cancellation system for 10 days. Then they used the new Mermaid Hearing aid with the new feedback system for 10 days.
|
Moderate Hearing Loss New Mermaid, Then Current
Participants first used the new Mermaid hearing aid with the new feedback cancellation system for 10 days. Then they used the current Mermaid Hearing aid with the current feedback system for 10 days.
|
Severe Hearing Loss Current Power, Then New
Participants first used the current power hearing aid with the current feedback cancellation system for 10 days. Then they used the new power Hearing aid with the new feedback system for 10 days.
|
Severe Hearing Loss New Power First/Current Second
The new power hearing aid that is not yet sold and uses the new feedback cancellation system will be worn first by this group. The current power hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn second.
|
|---|---|---|---|---|
|
First Intervention
STARTED
|
11
|
11
|
6
|
5
|
|
First Intervention
COMPLETED
|
11
|
11
|
6
|
5
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Intervention
STARTED
|
11
|
11
|
6
|
5
|
|
Second Intervention
COMPLETED
|
11
|
11
|
6
|
5
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Current Mermaid First, Then New
n=11 Participants
Participants were randomized to wear the current hearing aid that uses the current feedback cancellation first for 10 days. Then they wore the new Hearing aid for another 10 days.
|
New Mermaid First, Then Current
n=11 Participants
Participants were randomized to wear the new Hearing aid that uses the new feedback cancellation first for 10 days. Then they wore the current Hearing aid for another 10 days.
|
Current Power First, Then New
n=6 Participants
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.
|
New Power First, Then Current
n=5 Participants
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.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67 years
n=11 Participants
|
67 years
n=11 Participants
|
67 years
n=6 Participants
|
67 years
n=5 Participants
|
67 years
n=33 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=11 Participants
|
3 Participants
n=11 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=33 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=11 Participants
|
8 Participants
n=11 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=5 Participants
|
25 Participants
n=33 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Switzerland
|
11 participants
n=11 Participants
|
11 participants
n=11 Participants
|
6 participants
n=6 Participants
|
5 participants
n=5 Participants
|
33 participants
n=33 Participants
|
|
Hearing Threshold
|
47 decibels
STANDARD_DEVIATION 11.7 • n=11 Participants
|
50 decibels
STANDARD_DEVIATION 13.1 • n=11 Participants
|
69 decibels
STANDARD_DEVIATION 10.2 • n=6 Participants
|
71 decibels
STANDARD_DEVIATION 10.6 • n=5 Participants
|
59 decibels
STANDARD_DEVIATION 11 • n=33 Participants
|
PRIMARY outcome
Timeframe: 10 days, 20 daysIn 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.
Outcome measures
| Measure |
Moderate Hearing Loss Current Mermaid First/New Second
n=11 Participants
The current Mermaid hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn first for this group. The new Hearing aid with the new feedback system will be used second.
|
Moderate Hearing Loss New Mermaid First/Current Second
n=11 Participants
The new Mermaid Hearing aid with the new feedback system will be worn first for this group.The current hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn second.
|
Severe Hearing Loss Current Power First/New Second
n=6 Participants
The current power hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn first by this group. The new power hearing aid that is not yet sold and uses the new feedback cancellation system will be worn second.
|
Severe Hearing Loss New Power First/Current Second
n=5 Participants
The new power hearing aid that is not yet sold and uses the new feedback cancellation system will be worn first by this group. The current power hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn second.
|
|---|---|---|---|---|
|
Change in Live Feedback Test Scores From Day 10 to Day 20
|
1.7 units on a scale
Standard Deviation 2.0
|
1.7 units on a scale
Standard Deviation 2.0
|
0.1 units on a scale
Standard Deviation 1.1
|
0.1 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 20 daysSubjects will indicate on a touch screen which word that they heard through the loud speaker. The touch screen will give 5 possible answer choices that includes the correct choice and 4 other words that rhyme with the actual word. The test is run in the aided condition with the current Hearing aid and with the new Hearing aid. The test is scored by the percentage of words that they answer correctly. 0 percent is the lowest score possible and 100 percent is the highest. A higher percentage indicates a better score.
Outcome measures
| Measure |
Moderate Hearing Loss Current Mermaid First/New Second
n=11 Participants
The current Mermaid hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn first for this group. The new Hearing aid with the new feedback system will be used second.
|
Moderate Hearing Loss New Mermaid First/Current Second
n=11 Participants
The new Mermaid Hearing aid with the new feedback system will be worn first for this group.The current hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn second.
|
Severe Hearing Loss Current Power First/New Second
n=6 Participants
The current power hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn first by this group. The new power hearing aid that is not yet sold and uses the new feedback cancellation system will be worn second.
|
Severe Hearing Loss New Power First/Current Second
n=5 Participants
The new power hearing aid that is not yet sold and uses the new feedback cancellation system will be worn first by this group. The current power hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn second.
|
|---|---|---|---|---|
|
Word Recognition - Aided
Current hearing
|
0.92 percentage of words correct
Standard Deviation 0.34
|
0.92 percentage of words correct
Standard Deviation 0.34
|
0.77 percentage of words correct
Standard Deviation 0.49
|
0.77 percentage of words correct
Standard Deviation 0.49
|
|
Word Recognition - Aided
New hearing aid
|
0.91 percentage of words correct
Standard Deviation 0.35
|
0.91 percentage of words correct
Standard Deviation 0.35
|
0.78 percentage of words correct
Standard Deviation 0.48
|
0.78 percentage of words correct
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: 20 daysThe subjects will complete a questionnaire that asks them to rate the quality of different aspects of the hearing aid including sound quality, own voice quality, and the sound quality when in a noisy environment. The scale is from 1 to 5 with 1 being the minimum and 5 being the maximum. A higher score indicates better quality. The questionnaire will be answered for two conditions, aided with the current Hearing aid and aided with the new Hearing aid. The difference between the scores for each condition will be calculated and reported as the mean difference across both arms (moderate hearing loss and severe hearing loss). The difference is not calculated over time points but at the end of the field trial and the assignment order of the hearing aid (new first or current first) does not bear an impact.
Outcome measures
| Measure |
Moderate Hearing Loss Current Mermaid First/New Second
n=11 Participants
The current Mermaid hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn first for this group. The new Hearing aid with the new feedback system will be used second.
|
Moderate Hearing Loss New Mermaid First/Current Second
n=11 Participants
The new Mermaid Hearing aid with the new feedback system will be worn first for this group.The current hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn second.
|
Severe Hearing Loss Current Power First/New Second
n=6 Participants
The current power hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn first by this group. The new power hearing aid that is not yet sold and uses the new feedback cancellation system will be worn second.
|
Severe Hearing Loss New Power First/Current Second
n=5 Participants
The new power hearing aid that is not yet sold and uses the new feedback cancellation system will be worn first by this group. The current power hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn second.
|
|---|---|---|---|---|
|
Sound Quality Rating
|
1.6 units on a scale
Interval 1.0 to 2.1
|
1.6 units on a scale
Interval 1.0 to 2.1
|
1.5 units on a scale
Interval 0.1 to 2.9
|
1.5 units on a scale
Interval 0.1 to 2.9
|
SECONDARY outcome
Timeframe: 10 daysThis measurement is made without any hearing aids. Subjects will indicate on a touch screen which word that they heard through the loud speaker. The touch screen will give 5 possible answer choices that includes the correct choice and 4 other words that rhyme with the actual word. The test is run in the unaided condition. The test is scored by the percentage of words that they answer correctly. 0 percent is the lowest score possible and 100 percent is the highest. A higher percentage indicates a better score. The scores are not dependent on the assignment order of the hearing aids (new or current first) as the measurement is made without hearing aids and a score calculated for each group (moderate or severe hearing loss) and not for each arm.-
Outcome measures
| Measure |
Moderate Hearing Loss Current Mermaid First/New Second
n=11 Participants
The current Mermaid hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn first for this group. The new Hearing aid with the new feedback system will be used second.
|
Moderate Hearing Loss New Mermaid First/Current Second
n=11 Participants
The new Mermaid Hearing aid with the new feedback system will be worn first for this group.The current hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn second.
|
Severe Hearing Loss Current Power First/New Second
n=6 Participants
The current power hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn first by this group. The new power hearing aid that is not yet sold and uses the new feedback cancellation system will be worn second.
|
Severe Hearing Loss New Power First/Current Second
n=5 Participants
The new power hearing aid that is not yet sold and uses the new feedback cancellation system will be worn first by this group. The current power hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn second.
|
|---|---|---|---|---|
|
Word Recognition - Unaided
|
0.79 percentage of words correct
Standard Deviation 0.48
|
0.79 percentage of words correct
Standard Deviation 0.48
|
0.40 percentage of words correct
Standard Deviation 0.58
|
0.40 percentage of words correct
Standard Deviation 0.58
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0, 10, and 20 daysThe safety of the hearing aids will be rated by the number of adverse events reported by subjects. The minimum score is Zero and the maximum is not defined but is likely not more than 20. A lower number of adverse Events indicates a better outcome. The Outcome will be reported as the sum of Adverse Events reported across time frames.
Outcome measures
| Measure |
Moderate Hearing Loss Current Mermaid First/New Second
n=5 Participants
The current Mermaid hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn first for this group. The new Hearing aid with the new feedback system will be used second.
|
Moderate Hearing Loss New Mermaid First/Current Second
n=3 Participants
The new Mermaid Hearing aid with the new feedback system will be worn first for this group.The current hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn second.
|
Severe Hearing Loss Current Power First/New Second
n=1 Participants
The current power hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn first by this group. The new power hearing aid that is not yet sold and uses the new feedback cancellation system will be worn second.
|
Severe Hearing Loss New Power First/Current Second
n=3 Participants
The new power hearing aid that is not yet sold and uses the new feedback cancellation system will be worn first by this group. The current power hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn second.
|
|---|---|---|---|---|
|
Number of Participants Reporting an Adverse Event
|
5 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
Adverse Events
Moderate Hearing Loss Current Mermaid Hearing Aid
Moderate Hearing Loss New Mermaid Hearing Aid
Severe Hearing Loss Current Power Hearing Aid
Severe Hearing Loss New Power Hearing Aid
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Moderate Hearing Loss Current Mermaid Hearing Aid
n=22 participants at risk
The number of participants with a moderate hearing loss to report an AE while wearing the Mermaid hearing aid with the current feedback system regardless of the randomization order.
|
Moderate Hearing Loss New Mermaid Hearing Aid
n=22 participants at risk
The number of participants with a moderate hearing loss to report an AE while wearing the Mermaid hearing aid with the new feedback system regardless of the randomization order.
|
Severe Hearing Loss Current Power Hearing Aid
n=11 participants at risk
The number of participants with a severe hearing loss to report an AE while wearing the current Power hearing aid regardless of the randomization order.
|
Severe Hearing Loss New Power Hearing Aid
n=11 participants at risk
The number of participants with a severe hearing loss to report an AE while wearing the new Power hearing aid regardless of the randomization order.
|
|---|---|---|---|---|
|
Infections and infestations
Cold
|
4.5%
1/22 • Number of events 1 • 6 weeks
The Definition is the same. The participants are asked at every Appointment about any Events that may have occurred during the time since the last Appointment.
|
0.00%
0/22 • 6 weeks
The Definition is the same. The participants are asked at every Appointment about any Events that may have occurred during the time since the last Appointment.
|
9.1%
1/11 • Number of events 1 • 6 weeks
The Definition is the same. The participants are asked at every Appointment about any Events that may have occurred during the time since the last Appointment.
|
9.1%
1/11 • Number of events 1 • 6 weeks
The Definition is the same. The participants are asked at every Appointment about any Events that may have occurred during the time since the last Appointment.
|
|
Injury, poisoning and procedural complications
Bodily harm
|
4.5%
1/22 • Number of events 1 • 6 weeks
The Definition is the same. The participants are asked at every Appointment about any Events that may have occurred during the time since the last Appointment.
|
0.00%
0/22 • 6 weeks
The Definition is the same. The participants are asked at every Appointment about any Events that may have occurred during the time since the last Appointment.
|
0.00%
0/11 • 6 weeks
The Definition is the same. The participants are asked at every Appointment about any Events that may have occurred during the time since the last Appointment.
|
0.00%
0/11 • 6 weeks
The Definition is the same. The participants are asked at every Appointment about any Events that may have occurred during the time since the last Appointment.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
9.1%
2/22 • Number of events 2 • 6 weeks
The Definition is the same. The participants are asked at every Appointment about any Events that may have occurred during the time since the last Appointment.
|
9.1%
2/22 • Number of events 2 • 6 weeks
The Definition is the same. The participants are asked at every Appointment about any Events that may have occurred during the time since the last Appointment.
|
0.00%
0/11 • 6 weeks
The Definition is the same. The participants are asked at every Appointment about any Events that may have occurred during the time since the last Appointment.
|
0.00%
0/11 • 6 weeks
The Definition is the same. The participants are asked at every Appointment about any Events that may have occurred during the time since the last Appointment.
|
|
Product Issues
Pain
|
4.5%
1/22 • Number of events 1 • 6 weeks
The Definition is the same. The participants are asked at every Appointment about any Events that may have occurred during the time since the last Appointment.
|
4.5%
1/22 • Number of events 1 • 6 weeks
The Definition is the same. The participants are asked at every Appointment about any Events that may have occurred during the time since the last Appointment.
|
0.00%
0/11 • 6 weeks
The Definition is the same. The participants are asked at every Appointment about any Events that may have occurred during the time since the last Appointment.
|
18.2%
2/11 • Number of events 2 • 6 weeks
The Definition is the same. The participants are asked at every Appointment about any Events that may have occurred during the time since the last Appointment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place