Trial Outcomes & Findings for Evaluation of the Clinical Benefit of the Hearing Aids Tinnitus Feature. (NCT NCT05292534)
NCT ID: NCT05292534
Last Updated: 2024-07-05
Results Overview
Tinnitus Functional Index (TFI) questionnaire results, ranging from 0 to 100, with higher numbers indicating more severe (worse) Tinnitus interference in the person's quality of life.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
TFI collected before intervention to serve as a baseline. TFI change from baseline will be assessed after each study condition, which will last 4 weeks/each.
Results posted on
2024-07-05
Participant Flow
38 participants signed the consent form and met study criteria
38 participants were randomly assigned into one of two groups. Out of the 38 participants, 8 dropped out during the study. There were 2 study groups in this cross-over study, and final numbers were 15 participants in each group.
Participant milestones
| Measure |
Amplification-only, Then Amplification With an Added Sound, Then Intervention Withdrawal
3 study conditions (4 weeks each):
1. Hearing aid amplification-only,
2. Hearing aid amplification with an added sound,
3. intervention withdrawal.
Hearing aid was fit to prescribed participant hearing loss for 4 weeks during the 1st intervention period.
Then the participants wore the same study hearing aids for another 4 weeks with an added sound to the amplification setting.
Then the participants returned the hearing devices to the investigator and were re-assessed 4 weeks after intervention withdrawal.
|
Amplification With Added Sound, Then Amplification-only, Then Intervention Withdrawal
3 study conditions (4 weeks each):
1. Hearing aid amplification with an added sound,
2. Hearing aid amplification-only,
3. intervention withdrawal.
Hearing aid was fit to prescribed participant hearing loss and an added sound activated on the hearing aid and worn for 4 weeks during the 1st intervention period.
Then the participants wore the same study hearing aids for another 4 weeks without the added sound to the amplification setting.
Then the participants returned the hearing devices to the investigator and were re-assessed 4 weeks after intervention withdrawal.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
20
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Amplification-only, Then Amplification With an Added Sound, Then Intervention Withdrawal
3 study conditions (4 weeks each):
1. Hearing aid amplification-only,
2. Hearing aid amplification with an added sound,
3. intervention withdrawal.
Hearing aid was fit to prescribed participant hearing loss for 4 weeks during the 1st intervention period.
Then the participants wore the same study hearing aids for another 4 weeks with an added sound to the amplification setting.
Then the participants returned the hearing devices to the investigator and were re-assessed 4 weeks after intervention withdrawal.
|
Amplification With Added Sound, Then Amplification-only, Then Intervention Withdrawal
3 study conditions (4 weeks each):
1. Hearing aid amplification with an added sound,
2. Hearing aid amplification-only,
3. intervention withdrawal.
Hearing aid was fit to prescribed participant hearing loss and an added sound activated on the hearing aid and worn for 4 weeks during the 1st intervention period.
Then the participants wore the same study hearing aids for another 4 weeks without the added sound to the amplification setting.
Then the participants returned the hearing devices to the investigator and were re-assessed 4 weeks after intervention withdrawal.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Table above present the mean age (and standard deviation) of each separate group of 15 participants.
Baseline characteristics by cohort
| Measure |
Cross Over Design, 2 Groups of Participants
n=30 Participants
First Group: started with amplification-only as a 1st intervention, and switched to amplification+noiser Second Group: started with amplification+noiser as a 1st intervention, and switched to amplification-only
|
|---|---|
|
Age, Continuous
Group 1
|
62.2 years
STANDARD_DEVIATION 9.5 • n=15 Participants • Table above present the mean age (and standard deviation) of each separate group of 15 participants.
|
|
Age, Continuous
Group 2
|
60.6 years
STANDARD_DEVIATION 9.1 • n=15 Participants • Table above present the mean age (and standard deviation) of each separate group of 15 participants.
|
|
Sex: Female, Male
Group 1 · Female
|
8 Participants
n=15 Participants • 30 participants divided into 2 groups of 15 participants/each.
|
|
Sex: Female, Male
Group 1 · Male
|
7 Participants
n=15 Participants • 30 participants divided into 2 groups of 15 participants/each.
|
|
Sex: Female, Male
Group 2 · Female
|
4 Participants
n=15 Participants • 30 participants divided into 2 groups of 15 participants/each.
|
|
Sex: Female, Male
Group 2 · Male
|
11 Participants
n=15 Participants • 30 participants divided into 2 groups of 15 participants/each.
|
|
Region of Enrollment
United States
|
30 Participants
n=30 Participants
|
|
TFI
Group 1
|
50 points
STANDARD_DEVIATION 16.1 • n=15 Participants • 15 participants in each of the 2 groups, totaling 30 participants in the study.
|
|
TFI
Group 2
|
36.2 points
STANDARD_DEVIATION 19.0 • n=15 Participants • 15 participants in each of the 2 groups, totaling 30 participants in the study.
|
PRIMARY outcome
Timeframe: TFI collected before intervention to serve as a baseline. TFI change from baseline will be assessed after each study condition, which will last 4 weeks/each.Population: Repeated measures. Participants served as their own control.
Tinnitus Functional Index (TFI) questionnaire results, ranging from 0 to 100, with higher numbers indicating more severe (worse) Tinnitus interference in the person's quality of life.
Outcome measures
| Measure |
Amplification-only
n=30 Participants
Hearing aid will be fit to prescribed participant hearing loss.
hearing aid amplification: Hearing aid will be fit to prescribed participant hearing loss.
|
Amplification With Added Sound
n=30 Participants
Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated on the hearing aid.
hearing aid amplification with an added sound: Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated.
|
No Intervention
n=30 Participants
Participants will return to their original unaided state.
|
|---|---|---|---|
|
Tinnitus Functional Index Evaluation (TFI)
Group 1
|
35.6 units on a scale
Standard Deviation 20
|
32 units on a scale
Standard Deviation 21.9
|
44.8 units on a scale
Standard Deviation 22.2
|
|
Tinnitus Functional Index Evaluation (TFI)
Group 2
|
36.2 units on a scale
Standard Deviation 19.0
|
34.4 units on a scale
Standard Deviation 19.7
|
40.4 units on a scale
Standard Deviation 16.5
|
Adverse Events
Amplification-only
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Amplification With Added Sound
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
No Intervention
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Amplification-only
n=30 participants at risk
Hearing aid will be fit to prescribed participant hearing loss.
hearing aid amplification: Hearing aid will be fit to prescribed participant hearing loss.
|
Amplification With Added Sound
n=30 participants at risk
Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated on the hearing aid.
hearing aid amplification with an added sound: Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated.
|
No Intervention
n=30 participants at risk
Participants will return to their original unaided state.
|
|---|---|---|---|
|
Immune system disorders
Acquired COVID
|
3.3%
1/30 • Number of events 1 • 10 months (Between Nov 2022 until September 2023).
Safety population included all participants in this study, who experienced at least one intervention mode.
|
0.00%
0/30 • 10 months (Between Nov 2022 until September 2023).
Safety population included all participants in this study, who experienced at least one intervention mode.
|
0.00%
0/30 • 10 months (Between Nov 2022 until September 2023).
Safety population included all participants in this study, who experienced at least one intervention mode.
|
|
Ear and labyrinth disorders
Ear infection after swimming
|
3.3%
1/30 • Number of events 1 • 10 months (Between Nov 2022 until September 2023).
Safety population included all participants in this study, who experienced at least one intervention mode.
|
0.00%
0/30 • 10 months (Between Nov 2022 until September 2023).
Safety population included all participants in this study, who experienced at least one intervention mode.
|
0.00%
0/30 • 10 months (Between Nov 2022 until September 2023).
Safety population included all participants in this study, who experienced at least one intervention mode.
|
|
Musculoskeletal and connective tissue disorders
Body ache after general incidents happening during the trial period
|
0.00%
0/30 • 10 months (Between Nov 2022 until September 2023).
Safety population included all participants in this study, who experienced at least one intervention mode.
|
3.3%
1/30 • Number of events 1 • 10 months (Between Nov 2022 until September 2023).
Safety population included all participants in this study, who experienced at least one intervention mode.
|
6.7%
2/30 • Number of events 2 • 10 months (Between Nov 2022 until September 2023).
Safety population included all participants in this study, who experienced at least one intervention mode.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60