Trial Outcomes & Findings for P-CHAT: Comparison of Direct to Consumer Delivery Models for Hearing Devices (NCT NCT04618315)
NCT ID: NCT04618315
Last Updated: 2025-03-06
Results Overview
66-item self-assessment, disability-based inventory. Participants answer the questionnaire twice, first prior to use of hearing aids and then after hearing aid use. The questionnaire is scored between 0-99% with higher values representing greater difficulty. Benefit is reported as the difference between the two scores with a higher number signifying greater benefit.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
584 participants
Primary outcome timeframe
6 weeks
Results posted on
2025-03-06
Participant Flow
Participant milestones
| Measure |
Audiology-Based Best Practice
Hearing aids will be fit using current best practices used by audiologists to fit hearing aids.
Hearing Aids: Receiver-in-the-ear hearing aids.
|
Consumer Decides
Hearing aids will be self fit by patients using an interactive application on a tablet computer. Patients will choose their preferred hearing aid settings after comparing four settings with varying loudness levels.
Hearing Aids: Receiver-in-the-ear hearing aids.
|
Efficient Fitting
Hearing aids will be self fit by patients using an interactive application on a tablet computer. Patients will choose their preferred hearing aid settings after comparing four settings with varying base and treble settings.
Hearing Aids: Receiver-in-the-ear hearing aids.
|
|---|---|---|---|
|
6-Week Primary Observation Point
STARTED
|
190
|
193
|
201
|
|
6-Week Primary Observation Point
COMPLETED
|
182
|
172
|
178
|
|
6-Week Primary Observation Point
NOT COMPLETED
|
8
|
21
|
23
|
|
6-Month Secondary Observation Point
STARTED
|
182
|
172
|
178
|
|
6-Month Secondary Observation Point
COMPLETED
|
152
|
132
|
140
|
|
6-Month Secondary Observation Point
NOT COMPLETED
|
30
|
40
|
38
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
P-CHAT: Comparison of Direct to Consumer Delivery Models for Hearing Devices
Baseline characteristics by cohort
| Measure |
Audiology-Based Best Practice
n=190 Participants
Hearing aids will be fit using current best practices used by audiologists to fit hearing aids.
Hearing Aids: Receiver-in-the-ear hearing aids.
|
Consumer Decides
n=193 Participants
Hearing aids will be self fit by patients using an interactive application on a tablet computer. Patients will choose their preferred hearing aid settings after comparing four settings with varying loudness levels.
Hearing Aids: Receiver-in-the-ear hearing aids.
|
Efficient Fitting
n=201 Participants
Hearing aids will be self fit by patients using an interactive application on a tablet computer. Patients will choose their preferred hearing aid settings after comparing four settings with varying base and treble settings.
Hearing Aids: Receiver-in-the-ear hearing aids.
|
Total
n=584 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68.42 years
STANDARD_DEVIATION 6.95 • n=99 Participants
|
69.81 years
STANDARD_DEVIATION 6.71 • n=107 Participants
|
69.1 years
STANDARD_DEVIATION 6.71 • n=206 Participants
|
69.11 years
STANDARD_DEVIATION 6.57 • n=7 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=99 Participants
|
104 Participants
n=107 Participants
|
114 Participants
n=206 Participants
|
329 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
255 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
184 Participants
n=99 Participants
|
188 Participants
n=107 Participants
|
197 Participants
n=206 Participants
|
569 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
176 Participants
n=99 Participants
|
187 Participants
n=107 Participants
|
192 Participants
n=206 Participants
|
555 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
190 participants
n=99 Participants
|
193 participants
n=107 Participants
|
201 participants
n=206 Participants
|
584 participants
n=7 Participants
|
|
Better Ear 4-Frequency (0.5, 1, 2, 4 kHz) Pure Tone Average
|
32.1 dB HL
STANDARD_DEVIATION 9.04 • n=99 Participants
|
32.64 dB HL
STANDARD_DEVIATION 9.21 • n=107 Participants
|
31.47 dB HL
STANDARD_DEVIATION 9.06 • n=206 Participants
|
32.06 dB HL
STANDARD_DEVIATION 9.1 • n=7 Participants
|
|
Montreal Cognitive Assessment
|
26.28 units on a scale
STANDARD_DEVIATION 1.93 • n=99 Participants
|
26.18 units on a scale
STANDARD_DEVIATION 1.90 • n=107 Participants
|
26.37 units on a scale
STANDARD_DEVIATION 1.96 • n=206 Participants
|
26.28 units on a scale
STANDARD_DEVIATION 1.93 • n=7 Participants
|
|
Hearing Handicap Inventory - Global
|
39.35 units on a scale
STANDARD_DEVIATION 18.83 • n=99 Participants
|
39.66 units on a scale
STANDARD_DEVIATION 18.26 • n=107 Participants
|
37.51 units on a scale
STANDARD_DEVIATION 19.37 • n=206 Participants
|
38.82 units on a scale
STANDARD_DEVIATION 18.82 • n=7 Participants
|
|
Profile of Hearing Aid Performance/Benefit
|
39.77 units on a scale
STANDARD_DEVIATION 14.21 • n=99 Participants
|
40.05 units on a scale
STANDARD_DEVIATION 14.76 • n=107 Participants
|
38.55 units on a scale
STANDARD_DEVIATION 14.86 • n=206 Participants
|
39.44 units on a scale
STANDARD_DEVIATION 14.6 • n=7 Participants
|
PRIMARY outcome
Timeframe: 6 weeks66-item self-assessment, disability-based inventory. Participants answer the questionnaire twice, first prior to use of hearing aids and then after hearing aid use. The questionnaire is scored between 0-99% with higher values representing greater difficulty. Benefit is reported as the difference between the two scores with a higher number signifying greater benefit.
Outcome measures
| Measure |
Audiology-Based Best Practice
n=182 Participants
Hearing aids will be fit using current best practices used by audiologists to fit hearing aids.
Hearing Aids: Receiver-in-the-ear hearing aids.
|
Consumer Decides
n=172 Participants
Hearing aids will be self fit by patients using an interactive application on a tablet computer. Patients will choose their preferred hearing aid settings after comparing four settings with varying loudness levels.
Hearing Aids: Receiver-in-the-ear hearing aids.
|
Efficient Fitting
n=178 Participants
Hearing aids will be self fit by patients using an interactive application on a tablet computer. Patients will choose their preferred hearing aid settings after comparing four settings with varying base and treble settings.
Hearing Aids: Receiver-in-the-ear hearing aids.
|
|---|---|---|---|
|
Profile of Hearing Aid Benefit
|
23.34 score on a scale
Interval 21.43 to 25.26
|
23.27 score on a scale
Interval 21.54 to 25.0
|
23.33 score on a scale
Interval 21.25 to 25.12
|
SECONDARY outcome
Timeframe: 6 weeksA self-administered scale to identify problems related to hearing loss. The questionnaire has 25 items and can be scored between 0 and 100. The score after hearing aid use is subtracted from the baseline score (prior to hearing aid use) to obtain the benefit score. The higher the difference the greater the benefit.
Outcome measures
| Measure |
Audiology-Based Best Practice
n=182 Participants
Hearing aids will be fit using current best practices used by audiologists to fit hearing aids.
Hearing Aids: Receiver-in-the-ear hearing aids.
|
Consumer Decides
n=172 Participants
Hearing aids will be self fit by patients using an interactive application on a tablet computer. Patients will choose their preferred hearing aid settings after comparing four settings with varying loudness levels.
Hearing Aids: Receiver-in-the-ear hearing aids.
|
Efficient Fitting
n=178 Participants
Hearing aids will be self fit by patients using an interactive application on a tablet computer. Patients will choose their preferred hearing aid settings after comparing four settings with varying base and treble settings.
Hearing Aids: Receiver-in-the-ear hearing aids.
|
|---|---|---|---|
|
Hearing Handicap Inventory for the Elderly
|
20.65 score on a scale
Interval 18.11 to 23.19
|
21.83 score on a scale
Interval 19.42 to 24.23
|
19.15 score on a scale
Interval 16.59 to 21.73
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksAverage hours of hearing aid use per day.
Outcome measures
| Measure |
Audiology-Based Best Practice
n=182 Participants
Hearing aids will be fit using current best practices used by audiologists to fit hearing aids.
Hearing Aids: Receiver-in-the-ear hearing aids.
|
Consumer Decides
n=172 Participants
Hearing aids will be self fit by patients using an interactive application on a tablet computer. Patients will choose their preferred hearing aid settings after comparing four settings with varying loudness levels.
Hearing Aids: Receiver-in-the-ear hearing aids.
|
Efficient Fitting
n=178 Participants
Hearing aids will be self fit by patients using an interactive application on a tablet computer. Patients will choose their preferred hearing aid settings after comparing four settings with varying base and treble settings.
Hearing Aids: Receiver-in-the-ear hearing aids.
|
|---|---|---|---|
|
Duration of Hearing Aid Use
|
8.42 hours/day
Interval 7.91 to 8.92
|
7.18 hours/day
Interval 6.64 to 7.72
|
6.83 hours/day
Interval 6.32 to 7.34
|
Adverse Events
Audiology-Based Best Practice
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Consumer Decides
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Efficient Fitting
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Audiology-Based Best Practice
n=182 participants at risk
Hearing aids will be fit using current best practices used by audiologists to fit hearing aids.
Hearing Aids: Receiver-in-the-ear hearing aids.
|
Consumer Decides
n=172 participants at risk
Hearing aids will be self fit by patients using an interactive application on a tablet computer. Patients will choose their preferred hearing aid settings after comparing four settings with varying loudness levels.
Hearing Aids: Receiver-in-the-ear hearing aids.
|
Efficient Fitting
n=178 participants at risk
Hearing aids will be self fit by patients using an interactive application on a tablet computer. Patients will choose their preferred hearing aid settings after comparing four settings with varying base and treble settings.
Hearing Aids: Receiver-in-the-ear hearing aids.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Receiver Dome in Ear
|
1.1%
2/182 • Number of events 2 • 6 months
|
1.2%
2/172 • Number of events 2 • 6 months
|
2.2%
4/178 • Number of events 4 • 6 months
|
|
Ear and labyrinth disorders
Ear Conditions
|
0.55%
1/182 • Number of events 1 • 6 months
|
0.58%
1/172 • Number of events 1 • 6 months
|
1.1%
2/178 • Number of events 2 • 6 months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/182 • 6 months
|
0.58%
1/172 • Number of events 1 • 6 months
|
0.56%
1/178 • Number of events 1 • 6 months
|
|
Ear and labyrinth disorders
Reduced Hearing
|
0.00%
0/182 • 6 months
|
0.58%
1/172 • Number of events 1 • 6 months
|
0.00%
0/178 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place