Trial Outcomes & Findings for Auditory Training and Hearing Aid Satisfaction (NCT NCT04230876)
NCT ID: NCT04230876
Last Updated: 2022-09-19
Results Overview
The Client Orientated Scale of Improvement (COSI), a subjective measure of improvement on self-defined goals. The scale is relative to a baseline assessed before wearing hearing aids. For each goal participants select from a scale of improvement including Worse (-1), No Difference (0), Slightly Better (+1), Better (+2), and Much Better (+3). Positive values between one and three indicate improvement, negative values indicate that the self-defined goals got worse, and zero is no improvement. COSI scores were assessed before and after participants used the Amptify DTx. The outcome measure reported is the difference between scores before and scores after using the Amptify DTx.
COMPLETED
PHASE1
30 participants
Three weeks after hearing aid fitting and after completing the four week training protocol.
2022-09-19
Participant Flow
Participant milestones
| Measure |
Amptify First
The Amptify First group received the following order:
1. Hearing aid adjustment period (2 weeks)
2. The Amptify DTx curriculum, auditory training, and live coaching (4 weeks)
3. Watch closed caption TV for 20 minutes each day (4 weeks)
|
Amptify Second
The Amptify First group received the following order:
1. Hearing aid adjustment period (2 weeks)
2. Watch closed caption TV for 20 minutes each day (4 weeks)
3. The Amptify DTx curriculum, auditory training, and live coaching (4 weeks)
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Amptify First
The Amptify First group received the following order:
1. Hearing aid adjustment period (2 weeks)
2. The Amptify DTx curriculum, auditory training, and live coaching (4 weeks)
3. Watch closed caption TV for 20 minutes each day (4 weeks)
|
Amptify Second
The Amptify First group received the following order:
1. Hearing aid adjustment period (2 weeks)
2. Watch closed caption TV for 20 minutes each day (4 weeks)
3. The Amptify DTx curriculum, auditory training, and live coaching (4 weeks)
|
|---|---|---|
|
Overall Study
participant did not complete protocol by not training or not wearing aids.
|
1
|
1
|
Baseline Characteristics
Auditory Training and Hearing Aid Satisfaction
Baseline characteristics by cohort
| Measure |
Amptify First
n=14 Participants
The Amptify First group received the following order:
1. Hearing aid adjustment period (2 weeks)
2. The Amptify DTx curriculum, auditory training, and live coaching (4 weeks)
3. Watch closed caption TV for 20 minutes each day (4 weeks)
|
Amptify Second
n=14 Participants
The Amptify First group received the following order:
1. Hearing aid adjustment period (2 weeks)
2. Watch closed caption TV for 20 minutes each day (4 weeks)
3. The Amptify DTx curriculum, auditory training, and live coaching (4 weeks)
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.8 Years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
70.3 Years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
72.6 Years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Pure-Tone-Average
Right Ear
|
30.4 Sound Level in dB(HL)
STANDARD_DEVIATION 12.0 • n=5 Participants
|
31.7 Sound Level in dB(HL)
STANDARD_DEVIATION 11.7 • n=7 Participants
|
31.4 Sound Level in dB(HL)
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Pure-Tone-Average
Left Ear
|
32.5 Sound Level in dB(HL)
STANDARD_DEVIATION 7.3 • n=5 Participants
|
35.2 Sound Level in dB(HL)
STANDARD_DEVIATION 9.1 • n=7 Participants
|
33.5 Sound Level in dB(HL)
STANDARD_DEVIATION 10.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Three weeks after hearing aid fitting and after completing the four week training protocol.The Client Orientated Scale of Improvement (COSI), a subjective measure of improvement on self-defined goals. The scale is relative to a baseline assessed before wearing hearing aids. For each goal participants select from a scale of improvement including Worse (-1), No Difference (0), Slightly Better (+1), Better (+2), and Much Better (+3). Positive values between one and three indicate improvement, negative values indicate that the self-defined goals got worse, and zero is no improvement. COSI scores were assessed before and after participants used the Amptify DTx. The outcome measure reported is the difference between scores before and scores after using the Amptify DTx.
Outcome measures
| Measure |
Amptify First
n=14 Participants
The Amptify First group received the following order:
1. Hearing aid adjustment period (2 weeks)
2. The Amptify DTx curriculum, auditory training, and live coaching (4 weeks)
3. Watch closed caption TV for 20 minutes each day (4 weeks)
|
Amptify Second
n=14 Participants
The Amptify First group received the following order:
1. Hearing aid adjustment period (2 weeks)
2. Watch closed caption TV for 20 minutes each day (4 weeks)
3. The Amptify DTx curriculum, auditory training, and live coaching (4 weeks)
|
|---|---|---|
|
Change in Hearing Aid Satisfaction After Auditory Training
|
1.9 units on a scale
Standard Deviation 0.7
|
1.7 units on a scale
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: Three weeks after hearing aid fitting and after completing the four week training protocol.Population: Two participants in the Amptify First group and one participant in the Amptify second group did not complete the first IOI-HA questionnaire.
The International Outcome Inventory for Hearing Aids (IOI-HA) is a hearing aid satisfaction questionnaire that averages a series of seven questions on a five-point scale (0-5 possible points of improvement). IOI-HA scores were assessed before and after participants used the Amptify DTx. The outcome measure reported is the difference between scores before and scores after using the Amptify DTx. Higher values between 1 and 5 indicate more relative satisfaction.
Outcome measures
| Measure |
Amptify First
n=12 Participants
The Amptify First group received the following order:
1. Hearing aid adjustment period (2 weeks)
2. The Amptify DTx curriculum, auditory training, and live coaching (4 weeks)
3. Watch closed caption TV for 20 minutes each day (4 weeks)
|
Amptify Second
n=13 Participants
The Amptify First group received the following order:
1. Hearing aid adjustment period (2 weeks)
2. Watch closed caption TV for 20 minutes each day (4 weeks)
3. The Amptify DTx curriculum, auditory training, and live coaching (4 weeks)
|
|---|---|---|
|
Change in Hearing Aid Satisfaction After Auditory Training
|
1.1 units on a scale
Standard Deviation 0.4
|
0.1 units on a scale
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: Three weeks after hearing aid fitting and after completing the four week training protocol.Abbreviated Profile of Hearing Aid Benefit (APHAB) is common clinical questionnaire for determining hearing aid benefit using a series of 24 questions on a seven-point scale (A-G; the scale is then converted to "percent of time" from 1% (Never) to 99% (Always) and 50% means half of the time). Hearing aid benefit is calculated as the difference between the performance with a hearing and and performance without a hearing aid. More positive values indicate more benefit.
Outcome measures
| Measure |
Amptify First
n=14 Participants
The Amptify First group received the following order:
1. Hearing aid adjustment period (2 weeks)
2. The Amptify DTx curriculum, auditory training, and live coaching (4 weeks)
3. Watch closed caption TV for 20 minutes each day (4 weeks)
|
Amptify Second
n=13 Participants
The Amptify First group received the following order:
1. Hearing aid adjustment period (2 weeks)
2. Watch closed caption TV for 20 minutes each day (4 weeks)
3. The Amptify DTx curriculum, auditory training, and live coaching (4 weeks)
|
|---|---|---|
|
Change in Hearing Aid Satisfaction After Auditory Training
|
17.4 score on a scale
Standard Deviation 13.4
|
19.4 score on a scale
Standard Deviation 12.3
|
PRIMARY outcome
Timeframe: Three weeks after hearing aid fitting and after completing the four week training protocol.The Speech, Spatial and Qualities of Hearing Scale (SSQ-12) is a subjective tool or assessing the quality of the sound from a hearing aid using a 12-item questionnaire. Questions focus on how well the participant could hear in various situations. The responses range on a scale from "Not At All" (0) to Perfectly (10). Higher values indicate better sound quality.
Outcome measures
| Measure |
Amptify First
n=14 Participants
The Amptify First group received the following order:
1. Hearing aid adjustment period (2 weeks)
2. The Amptify DTx curriculum, auditory training, and live coaching (4 weeks)
3. Watch closed caption TV for 20 minutes each day (4 weeks)
|
Amptify Second
n=14 Participants
The Amptify First group received the following order:
1. Hearing aid adjustment period (2 weeks)
2. Watch closed caption TV for 20 minutes each day (4 weeks)
3. The Amptify DTx curriculum, auditory training, and live coaching (4 weeks)
|
|---|---|---|
|
Change in Hearing Aid Satisfaction After Auditory Training
|
0.7 units on a scale
Standard Deviation 2.7
|
0.5 units on a scale
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Three weeks after hearing aid fitting and after completing the four week training protocol.Daily use (in hours/day) is logged by the participant. Improvement is indicated by an increase in the amount of time the participant uses the hearing aid each day.
Outcome measures
| Measure |
Amptify First
n=14 Participants
The Amptify First group received the following order:
1. Hearing aid adjustment period (2 weeks)
2. The Amptify DTx curriculum, auditory training, and live coaching (4 weeks)
3. Watch closed caption TV for 20 minutes each day (4 weeks)
|
Amptify Second
n=14 Participants
The Amptify First group received the following order:
1. Hearing aid adjustment period (2 weeks)
2. Watch closed caption TV for 20 minutes each day (4 weeks)
3. The Amptify DTx curriculum, auditory training, and live coaching (4 weeks)
|
|---|---|---|
|
Change in Hearing Aid Satisfaction After Auditory Training
|
-.09 hours/day
Standard Deviation 2.3
|
0.8 hours/day
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: At the time of hearing aid fitting (baseline), three weeks after hearing aid fitting, and after completing the four week training protocol.The NU-6 is a standard clinical assessment of word discrimination. Lists consist of 50 words in quiet and were presented through the Amptify DTx while wearing the hearing aid. NU-6 scores are in percent words correctly identified. Scores reported here are the difference between scores measured before and after completing the Amptify DTx.
Outcome measures
| Measure |
Amptify First
n=14 Participants
The Amptify First group received the following order:
1. Hearing aid adjustment period (2 weeks)
2. The Amptify DTx curriculum, auditory training, and live coaching (4 weeks)
3. Watch closed caption TV for 20 minutes each day (4 weeks)
|
Amptify Second
n=14 Participants
The Amptify First group received the following order:
1. Hearing aid adjustment period (2 weeks)
2. Watch closed caption TV for 20 minutes each day (4 weeks)
3. The Amptify DTx curriculum, auditory training, and live coaching (4 weeks)
|
|---|---|---|
|
Change in Percent Words Correct on Speech Perception Measures After Auditory Training
|
4.3 Percent words correct
Standard Deviation 7.8
|
-1.0 Percent words correct
Standard Deviation 11.6
|
Adverse Events
Amptify First
Amptify Second
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