Trial Outcomes & Findings for A System and Process to Improve the Satisfaction With Hearing Health Products (NCT NCT04926636)
NCT ID: NCT04926636
Last Updated: 2026-02-20
Results Overview
The Client Oriented Scale of Improvement (COSI) questionnaire tracks the goals and needs of the patient through their hearing aid fitting process. Items allow the patient to qualify their degree of change for each of their needs/goals as 1) Much Worse 2) Worse 3) No Difference 4) Better 5) Much Better. Total scores are an average of item scores and range from 1 to 5 with higher scores indicating more improvement.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
3 months
Results posted on
2026-02-20
Participant Flow
Participant milestones
| Measure |
Standard Mobile App
This group will be supplied with Novidan DTC hearing aids and documentation following standard of care as a control. They will be provided with the mobile application allowing for the monitoring of data for study analysis and personal control of their hearing aids, but not Health and Wellness Coaching features.
|
Enhanced Mobile App With Health Coaching
This group will also be supplied with the Novidan DTC hearings aids and documentation, same as the control group, but will be supplied the enhanced mobile application that allows for participation in health coaching features. They will be assigned to a health coach and will have coaching sessions scheduled.
Health and Wellness Coaching: An enhanced mobile application that allows for participation in health coaching features. Participants will be assigned to a health coach and will have coaching sessions scheduled.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
16
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Standard Mobile App
This group will be supplied with Novidan DTC hearing aids and documentation following standard of care as a control. They will be provided with the mobile application allowing for the monitoring of data for study analysis and personal control of their hearing aids, but not Health and Wellness Coaching features.
|
Enhanced Mobile App With Health Coaching
This group will also be supplied with the Novidan DTC hearings aids and documentation, same as the control group, but will be supplied the enhanced mobile application that allows for participation in health coaching features. They will be assigned to a health coach and will have coaching sessions scheduled.
Health and Wellness Coaching: An enhanced mobile application that allows for participation in health coaching features. Participants will be assigned to a health coach and will have coaching sessions scheduled.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
Baseline Characteristics
A System and Process to Improve the Satisfaction With Hearing Health Products
Baseline characteristics by cohort
| Measure |
Standard Mobile App
n=18 Participants
This group will be supplied with Novidan DTC hearing aids and documentation following standard of care as a control. They will be provided with the mobile application allowing for the monitoring of data for study analysis and personal control of their hearing aids, but not Health and Wellness Coaching features.
|
Enhanced Mobile App With Health Coaching
n=16 Participants
This group will also be supplied with the Novidan DTC hearings aids and documentation, same as the control group, but will be supplied the enhanced mobile application that allows for participation in health coaching features. They will be assigned to a health coach and will have coaching sessions scheduled.
Health and Wellness Coaching: An enhanced mobile application that allows for participation in health coaching features. Participants will be assigned to a health coach and will have coaching sessions scheduled.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=14 Participants
|
2 Participants
n=14 Participants
|
6 Participants
n=29 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=14 Participants
|
14 Participants
n=14 Participants
|
28 Participants
n=29 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=14 Participants
|
14 Participants
n=14 Participants
|
26 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=14 Participants
|
2 Participants
n=14 Participants
|
8 Participants
n=29 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=14 Participants
|
14 Participants
n=14 Participants
|
28 Participants
n=29 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=14 Participants
|
2 Participants
n=14 Participants
|
6 Participants
n=29 Participants
|
PRIMARY outcome
Timeframe: 3 monthsThe Client Oriented Scale of Improvement (COSI) questionnaire tracks the goals and needs of the patient through their hearing aid fitting process. Items allow the patient to qualify their degree of change for each of their needs/goals as 1) Much Worse 2) Worse 3) No Difference 4) Better 5) Much Better. Total scores are an average of item scores and range from 1 to 5 with higher scores indicating more improvement.
Outcome measures
| Measure |
Standard Mobile App
n=14 Participants
This group will be supplied with Novidan DTC hearing aids and documentation following standard of care as a control. They will be provided with the mobile application allowing for the monitoring of data for study analysis and personal control of their hearing aids, but not Health and Wellness Coaching features.
|
Enhanced Mobile App With Health Coaching
n=14 Participants
This group will also be supplied with the Novidan DTC hearings aids and documentation, same as the control group, but will be supplied the enhanced mobile application that allows for participation in health coaching features. They will be assigned to a health coach and will have coaching sessions scheduled.
Health and Wellness Coaching: An enhanced mobile application that allows for participation in health coaching features. Participants will be assigned to a health coach and will have coaching sessions scheduled.
|
|---|---|---|
|
COSI Goal Achievement
|
2.77 score on a scale
Standard Deviation 1.4
|
2.51 score on a scale
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: 3 monthsHearing aid usage information for both groups will be automatically logged on non-volatile memory inside of the hearing aid. It will record the amount of time in hours the user spent wearing their hearing aids. It is accessed and downloaded through the provided companion smartphone application.
Outcome measures
| Measure |
Standard Mobile App
n=14 Participants
This group will be supplied with Novidan DTC hearing aids and documentation following standard of care as a control. They will be provided with the mobile application allowing for the monitoring of data for study analysis and personal control of their hearing aids, but not Health and Wellness Coaching features.
|
Enhanced Mobile App With Health Coaching
n=14 Participants
This group will also be supplied with the Novidan DTC hearings aids and documentation, same as the control group, but will be supplied the enhanced mobile application that allows for participation in health coaching features. They will be assigned to a health coach and will have coaching sessions scheduled.
Health and Wellness Coaching: An enhanced mobile application that allows for participation in health coaching features. Participants will be assigned to a health coach and will have coaching sessions scheduled.
|
|---|---|---|
|
Hours of Hearing Aid Use
|
11.98 hours
Standard Deviation 1.637
|
10.1 hours
Standard Deviation 3.23
|
PRIMARY outcome
Timeframe: 3 monthsOutcome measures
| Measure |
Standard Mobile App
n=14 Participants
This group will be supplied with Novidan DTC hearing aids and documentation following standard of care as a control. They will be provided with the mobile application allowing for the monitoring of data for study analysis and personal control of their hearing aids, but not Health and Wellness Coaching features.
|
Enhanced Mobile App With Health Coaching
n=14 Participants
This group will also be supplied with the Novidan DTC hearings aids and documentation, same as the control group, but will be supplied the enhanced mobile application that allows for participation in health coaching features. They will be assigned to a health coach and will have coaching sessions scheduled.
Health and Wellness Coaching: An enhanced mobile application that allows for participation in health coaching features. Participants will be assigned to a health coach and will have coaching sessions scheduled.
|
|---|---|---|
|
Adherence to Program
|
851 minutes spent in app
Standard Deviation 581
|
885 minutes spent in app
Standard Deviation 787
|
Adverse Events
Standard Mobile App
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Mobile App With Health Coaching
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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