Trial Outcomes & Findings for Comparison of Hearing Aid Fitting Outcomes Between Self-fit and Professional Fit for MDHearing Smart Hearing Aids (NCT NCT05165121)
NCT ID: NCT05165121
Last Updated: 2023-07-06
Results Overview
Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB) and Speech Spatial Qualities 12 (SSQ 12). The lowest possible score on the APHAB is 1% with the highest score being 99%. A higher score indicates improvement. On the SSQ, the scores range from 0 to 10 with a higher score indicating hearing perfectly in that situation. For the SSQ Part B, the scores range from -5 to +5 with a higher score indicating improved hearing for that situation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
91 participants
Primary outcome timeframe
1 month
Results posted on
2023-07-06
Participant Flow
Participant milestones
| Measure |
Human Factors
The purpose of the human factor study was to verify the feasibility of self-fitting MDHearing Smart hearing aid by listeners with a mild to moderate sensorineural hearing loss.
MDHearing smart hearing aid: air conduction hearing aid with app support
|
Clinical Study - Self Fit Group
The clinical study included two groups of subjects (self-fit and professional-fit groups) with the main purpose to compare the fitting outcomes between the two fitting groups. The self fit group intended to show whether the MDHearing Smart hearing aids can be fitted by each user reliably and if each user can use the MDHearing app on their smartphone or tablet to make adjustments to achieve a good aided benefit.
MDHearing smart hearing aid: air conduction hearing aid with app support
|
Clinical Study - Professional Fit Group
The clinical study included two groups of subjects (self-fit and professional-fit groups) with the main purpose to compare the fitting outcomes between the two fitting groups. The professional-fit group aimed to show whether the MDHearing Smart hearing aids can be fitted by audiology professional on each user reliably and if each user can benefit from using the MDHearing smart hearing aids.
MDHearing smart hearing aid: air conduction hearing aid with app support
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
36
|
35
|
|
Overall Study
COMPLETED
|
20
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Clinical Study - Professional Fit Group
n=35 Participants
The clinical study included two groups of subjects (self-fit and professional-fit groups) with the main purpose to compare the fitting outcomes between the two fitting groups. The professional-fit group aimed to show whether the MDHearing Smart hearing aids can be fitted by audiology professional on each user reliably and if each user can benefit from using the MDHearing smart hearing aids.
MDHearing smart hearing aid: air conduction hearing aid with app support
|
Total
n=91 Participants
Total of all reporting groups
|
Human Factors
n=20 Participants
The purpose of the human factor study was to verify the feasibility of self-fitting MDHearing Smart hearing aid by listeners with a mild to moderate sensorineural hearing loss.
MDHearing smart hearing aid: air conduction hearing aid with app support
|
Clinical Study - Self Fit Group
n=36 Participants
The clinical study included two groups of subjects (self-fit and professional-fit groups) with the main purpose to compare the fitting outcomes between the two fitting groups. The self fit group intended to show whether the MDHearing Smart hearing aids can be fitted by each user reliably and if each user can use the MDHearing app on their smartphone or tablet to make adjustments to achieve a good aided benefit.
MDHearing smart hearing aid: air conduction hearing aid with app support
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=35 Participants
|
0 Participants
n=91 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=35 Participants
|
55 Participants
n=91 Participants
|
15 Participants
n=20 Participants
|
20 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=35 Participants
|
36 Participants
n=91 Participants
|
5 Participants
n=20 Participants
|
16 Participants
n=36 Participants
|
|
Age, Continuous
|
58 years
n=35 Participants
|
52 years
n=91 Participants
|
52 years
n=20 Participants
|
62 years
n=36 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=35 Participants
|
49 Participants
n=91 Participants
|
10 Participants
n=20 Participants
|
18 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=35 Participants
|
42 Participants
n=91 Participants
|
10 Participants
n=20 Participants
|
18 Participants
n=36 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
—
|
—
|
|
Region of Enrollment
United States
|
35 Participants
n=35 Participants
|
91 Participants
n=91 Participants
|
20 Participants
n=20 Participants
|
36 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 1 monthComparison of aided benefit between the self-fit group and the professional fit group as measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB) and Speech Spatial Qualities 12 (SSQ 12). The lowest possible score on the APHAB is 1% with the highest score being 99%. A higher score indicates improvement. On the SSQ, the scores range from 0 to 10 with a higher score indicating hearing perfectly in that situation. For the SSQ Part B, the scores range from -5 to +5 with a higher score indicating improved hearing for that situation.
Outcome measures
| Measure |
APHAB - Self Fit Group
n=32 Participants
Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB). The lowest possible score on the APHAB is 1% with the highest score being 99%. A higher score indicates improvement
|
APHAB - Professional Fit Group
n=32 Participants
Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB). The lowest possible score on the APHAB is 1% with the highest score being 99%. A higher score indicates improvement.
|
SSQ 12 - Self Fit Group
n=32 Participants
Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Speech Spatial Qualities 12 (SSQ 12). On the SSQ, the scores range from 0 to 10 with a higher score indicating hearing perfectly in that situation.
|
SSQ 12 - Professional Fit Group
n=32 Participants
Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Speech Spatial Qualities 12 (SSQ 12). On the SSQ, the scores range from 0 to 10 with a higher score indicating hearing perfectly in that situation.
|
SSQ 12 Part B - Self Fit Group
n=32 Participants
Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Speech Spatial Qualities 12 (SSQ 12). For the SSQ Part B, the scores range from -5 to +5 with a higher score indicating improved hearing for that situation.
|
SSQ 12 Part B - Professional Fit Group
n=32 Participants
Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Speech Spatial Qualities 12 (SSQ 12). For the SSQ Part B, the scores range from -5 to +5 with a higher score indicating improved hearing for that situation.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Improvement at 1 Month as Measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB) and Speech Spatial Qualities 12 (SSQ 12) Scale.
|
32 Participants
|
32 Participants
|
32 Participants
|
32 Participants
|
32 Participants
|
32 Participants
|
PRIMARY outcome
Timeframe: 1 hourSubjects are able to use the hearing aids while using the app and manuals as guidance. Ease of use will be self reported by the subjects as to whether the task was able to be completed without guidance, able to be completed with guidance from the manual, or unable to be completed. Participants self-reported their comfort level with hearing aids and with technology in general. Participants sat with a researcher to note if tasks were able to be completed without guidance, with guidance from the manual, or unable to be completed. This group was separate from the Self Fit group and the Professional Group.
Outcome measures
| Measure |
APHAB - Self Fit Group
n=20 Participants
Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB). The lowest possible score on the APHAB is 1% with the highest score being 99%. A higher score indicates improvement
|
APHAB - Professional Fit Group
Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB). The lowest possible score on the APHAB is 1% with the highest score being 99%. A higher score indicates improvement.
|
SSQ 12 - Self Fit Group
Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Speech Spatial Qualities 12 (SSQ 12). On the SSQ, the scores range from 0 to 10 with a higher score indicating hearing perfectly in that situation.
|
SSQ 12 - Professional Fit Group
Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Speech Spatial Qualities 12 (SSQ 12). On the SSQ, the scores range from 0 to 10 with a higher score indicating hearing perfectly in that situation.
|
SSQ 12 Part B - Self Fit Group
Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Speech Spatial Qualities 12 (SSQ 12). For the SSQ Part B, the scores range from -5 to +5 with a higher score indicating improved hearing for that situation.
|
SSQ 12 Part B - Professional Fit Group
Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Speech Spatial Qualities 12 (SSQ 12). For the SSQ Part B, the scores range from -5 to +5 with a higher score indicating improved hearing for that situation.
|
|---|---|---|---|---|---|---|
|
Human Factors Study: Percentage of Participants Able to Use Hearing Aids Both With and Without Guidance.
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Human Factors
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clinical Study - Self-fit Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clinical Study - Professional-fit Group
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