Trial Outcomes & Findings for Hearing Aid Signal Processing Comparative Study (NCT NCT04839289)
NCT ID: NCT04839289
Last Updated: 2023-03-22
Results Overview
Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10).
COMPLETED
NA
27 participants
End of home trial 1 (Day 10 of study)
2023-03-22
Participant Flow
Participant milestones
| Measure |
A-B-A
Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument A Hearing instrument B Hearing instrument A
Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A
Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B
|
B-A-B
Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument B Hearing instrument A Hearing instrument B
Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A
Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
9
|
|
Overall Study
COMPLETED
|
17
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
A-B-A
Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument A Hearing instrument B Hearing instrument A
Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A
Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B
|
B-A-B
Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument B Hearing instrument A Hearing instrument B
Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A
Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
A-B-A
n=17 Participants
Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument A Hearing instrument B Hearing instrument A
Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A
Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B
|
B-A-B
n=9 Participants
Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument B Hearing instrument A Hearing instrument B
Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A
Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.5 years
n=17 Participants
|
67 years
n=9 Participants
|
70.25 years
n=26 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=17 Participants
|
6 Participants
n=9 Participants
|
14 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=17 Participants
|
3 Participants
n=9 Participants
|
12 Participants
n=26 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
17 participants
n=17 Participants
|
0 participants
n=9 Participants
|
17 participants
n=26 Participants
|
|
Region of Enrollment
China
|
0 participants
n=17 Participants
|
9 participants
n=9 Participants
|
9 participants
n=26 Participants
|
|
Mild to moderate severe sensorineural hearing loss, bilaterally
|
17 participants
n=17 Participants
|
9 participants
n=9 Participants
|
26 participants
n=26 Participants
|
PRIMARY outcome
Timeframe: End of home trial 1 (Day 10 of study)Population: Participants who were fit with first set of hearing aids for first home trial. For arm A-B-A, the outcomes will measure hearing aid A, and for arm B-A-B, the outcomes will measure hearing aid B
Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10).
Outcome measures
| Measure |
A-B-A
n=17 Participants
Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument A Hearing instrument B Hearing instrument A
Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A
Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B
|
B-A-B
n=9 Participants
Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument B Hearing instrument A Hearing instrument B
Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A
Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B
|
|---|---|---|
|
Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for First Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B
|
7.16 score on a scale
Standard Deviation 0.46
|
7.12 score on a scale
Standard Deviation 0.85
|
PRIMARY outcome
Timeframe: End of home trial 2 (20 days after study start)Population: Participants who were fit with second set of hearing aids for second home trial. For arm A-B-A, the outcomes will measure hearing aid B, and for arm B-A-B, the outcomes will measure hearing aid A
Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10).
Outcome measures
| Measure |
A-B-A
n=17 Participants
Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument A Hearing instrument B Hearing instrument A
Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A
Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B
|
B-A-B
n=9 Participants
Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument B Hearing instrument A Hearing instrument B
Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A
Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B
|
|---|---|---|
|
Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Second Study Set Worn, i.e. Study Set B for Arm A-B-A and Study Set A for Arm B-A-B
|
7.61 score on a scale
Standard Deviation 0.42
|
6.70 score on a scale
Standard Deviation 0.98
|
PRIMARY outcome
Timeframe: End of home trial 3 (30 days after study start)Population: Participants who were fit with third set of hearing aids for third home trial. For arm A-B-A, the outcomes will measure hearing aid A, and for arm B-A-B, the outcomes will measure hearing aid B
Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10).
Outcome measures
| Measure |
A-B-A
n=17 Participants
Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument A Hearing instrument B Hearing instrument A
Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A
Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B
|
B-A-B
n=9 Participants
Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument B Hearing instrument A Hearing instrument B
Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A
Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B
|
|---|---|---|
|
Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Third Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B
|
7.28 score on a scale
Standard Deviation .51
|
7.52 score on a scale
Standard Deviation 0.95
|
PRIMARY outcome
Timeframe: End of home trial 1 (Day 10 of study)Population: Participants who were fit with first set of hearing aids for first home trial. For arm A-B-A, the outcomes will measure study set A, and for arm B-A-B, the outcomes will measure study set B.
Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral. .
Outcome measures
| Measure |
A-B-A
n=17 Participants
Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument A Hearing instrument B Hearing instrument A
Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A
Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B
|
B-A-B
n=9 Participants
Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument B Hearing instrument A Hearing instrument B
Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A
Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B
|
|---|---|---|
|
Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for First Study Set Worn.
|
3.94 score on a scale
Standard Deviation 0.59
|
3.80 score on a scale
Standard Deviation .30
|
PRIMARY outcome
Timeframe: End of home trial 2 (Day 20 of study)Population: Participants who were fit with second set of hearing aids for second home trial. For arm A-B-A, the outcomes will measure study set B, and for arm B-A-B, the outcomes will measure study set A.
Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral.
Outcome measures
| Measure |
A-B-A
n=17 Participants
Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument A Hearing instrument B Hearing instrument A
Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A
Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B
|
B-A-B
n=9 Participants
Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument B Hearing instrument A Hearing instrument B
Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A
Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B
|
|---|---|---|
|
Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Second Study Set Worn.
|
4.24 score on a scale
Standard Deviation 0.54
|
3.76 score on a scale
Standard Deviation 0.28
|
PRIMARY outcome
Timeframe: End of home trial 3 (Day 30 of study)Population: Participants who were fit with third set of hearing aids for third home trial. For arm A-B-A, the outcomes will measure study set A, and for arm B-A-B, the outcomes will measure study set B.
Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral.
Outcome measures
| Measure |
A-B-A
n=17 Participants
Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument A Hearing instrument B Hearing instrument A
Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A
Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B
|
B-A-B
n=9 Participants
Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument B Hearing instrument A Hearing instrument B
Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A
Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B
|
|---|---|---|
|
Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Third Study Set Worn.
|
4.12 score on a scale
Standard Deviation 0.47
|
3.99 score on a scale
Standard Deviation 0.21
|
Adverse Events
Receiver-in-canal Hearing Instrument Manufacturer A
Receiver-in-canal Hearing Instrument Manufacturer B
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place