Trial Outcomes & Findings for Validation of Novel BTE and SP Hearing Aid Models (NCT NCT04882787)
NCT ID: NCT04882787
Last Updated: 2024-08-12
Results Overview
Participants with 'good' response of 7 or higher on 'Total Impression' scale; Gabrielsson citation/article includes seven perceptual scales and a scale for 'Total Impression' which is described as 'an overall judgment of how good you think the reproduction is'. Possible scores from 0 to 10 with descriptors provided: 0 (min), 1 (very bad), 3 (rather bad), 5 (midway), 7 (rather good), 9 (very good), 10 (max) A higher score reflects a better outcome.
COMPLETED
NA
14 participants
final appointment (end of 3 weeks home trial for BTE model, end of 7 weeks home trial for SP-BTE model)
2024-08-12
Participant Flow
Participant milestones
| Measure |
BTE Hearing Aid Model
(same arm, different group) hearing aid providing 'less' amplification for less severe hearing losses (mild to moderately-severe) BTE hearing aid: Amplification
|
SP-BTE (Super Power) Hearing Aid Model
(same arm, different group) hearing aid providing more amplification for greater (severe to profound) hearing losses BTE hearing aid: Amplification
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
BTE Hearing Aid Model
n=7 Participants
BTE hearing aid fitting
BTE hearing aid: Amplification
|
SP-BTE Hearing Aid Model
n=7 Participants
Super power BTE hearing aid fitting
BTE hearing aid: Amplification
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=14 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=7 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=14 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=7 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=14 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=7 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=14 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
7 Participants
n=7 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=14 Participants
|
|
Hearing aid candidate
|
7 Participants
n=7 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: final appointment (end of 3 weeks home trial for BTE model, end of 7 weeks home trial for SP-BTE model)Population: Participant (fit with hearing aids binaurally)
Participants with 'good' response of 7 or higher on 'Total Impression' scale; Gabrielsson citation/article includes seven perceptual scales and a scale for 'Total Impression' which is described as 'an overall judgment of how good you think the reproduction is'. Possible scores from 0 to 10 with descriptors provided: 0 (min), 1 (very bad), 3 (rather bad), 5 (midway), 7 (rather good), 9 (very good), 10 (max) A higher score reflects a better outcome.
Outcome measures
| Measure |
BTE Hearing Aid Model
n=7 Participants
BTE hearing aid fitting
BTE hearing aid: Amplification
|
SP-BTE Hearing Aid Model
n=7 Participants
super power hearing aid fitting BTE hearing aid: Amplification
|
|---|---|---|
|
Number of Participants With 'Total Impression' Sound Quality as 'Good'
Count of participants who reported score of 7 or above
|
7 Participants
|
6 Participants
|
|
Number of Participants With 'Total Impression' Sound Quality as 'Good'
Count of participants who reported score of 6 or below
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: at any time during home trial, reported at or by final appointment(end of 3 weeks home trial for BTE model, end of 7 weeks home trial for SP-BTE model)Population: Participant (wearing binaural amplification, using accessories and smartphones with 2.4 GHz connectivity)
Participants to report perceived unwanted reboots of the hearing aids as an indicator of system stability (with use of 2.4 GHz connectivity including accessories and smartphones). Possible responses for perceived reboots (i.e., instances when the amplified sound dropped out and then returned) are: 'No (0) reboots perceived' or 'Reboots perceived (1 or more)'.
Outcome measures
| Measure |
BTE Hearing Aid Model
n=7 Participants
BTE hearing aid fitting
BTE hearing aid: Amplification
|
SP-BTE Hearing Aid Model
n=7 Participants
super power hearing aid fitting BTE hearing aid: Amplification
|
|---|---|---|
|
Number and Percentage of Participants Reporting No Reboots
Count of participants reporting 0 reboots
|
6 Participants
|
6 Participants
|
|
Number and Percentage of Participants Reporting No Reboots
Count of participants reporting 1 or more reboots
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: initial appointment (day of fitting of hearing aids)Population: SP-BTE Participant (wearing binaural amplification, using smartphone app interactive controls); no data were collected for participants in the "BTE hearing aid model" Arm/Group.
Number of SP-BTE participants reporting perceived differences from adjustment of the app's Boost controls. Stimuli were presented in a sound room to check the Clarity \& Comfort Boosts in the app (available in Automatic Program). To comment on the effect of the Boosts, participants listened to simulated acoustic scenarios, initially under default settings (i.e., with no Boost), then with each Boost (Comfort then Clarity) activated separately (by pressing a button on a screen in the app). Yes/No answer to confirm a perceived difference -- 'Did you notice a difference?'
Outcome measures
| Measure |
BTE Hearing Aid Model
n=7 Participants
BTE hearing aid fitting
BTE hearing aid: Amplification
|
SP-BTE Hearing Aid Model
super power hearing aid fitting BTE hearing aid: Amplification
|
|---|---|---|
|
Number of Participants Reporting Perceived Differences With Both of the App Boost Controls
Count of participants reporting a perceived difference, i.e. "yes" with both of the Boost controls
|
7 Participants
|
—
|
|
Number of Participants Reporting Perceived Differences With Both of the App Boost Controls
Count of participants reporting no perceived difference, i.e. "no" with both of the Boost controls
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: initial appointment (day of fitting of hearing aids)Population: SP-BTE Participant (wearing binaural amplification, using smartphone app interactive controls); no data were collected for participants in the "BTE hearing aid model" Arm/Group.
Number of SP-BTE participants reporting perceived differences from adjustment of two of the app's Slider controls. Stimuli were presented in a sound room to check the Enhance Speech and Reduce Noise sliders in the app (available in Manual Program). To comment on the effect of the Sliders, participants were asked to adjust the Enhance Speech and Reduce Noise Sliders (separately) to the Maximum and Minimum settings (by sliding the setting indicator across the available range). Yes/No answer to confirm a perceived difference -- 'Did you notice a difference?'
Outcome measures
| Measure |
BTE Hearing Aid Model
n=7 Participants
BTE hearing aid fitting
BTE hearing aid: Amplification
|
SP-BTE Hearing Aid Model
super power hearing aid fitting BTE hearing aid: Amplification
|
|---|---|---|
|
Number of Participants Reporting Perceived Differences With Both of the App Slider Controls
Count of participants reporting a perceived difference, i.e. "yes" with both of the Slider controls
|
6 Participants
|
—
|
|
Number of Participants Reporting Perceived Differences With Both of the App Slider Controls
Count of participants reporting no perceived difference, i.e. "no" with both of the Slider controls
|
1 Participants
|
—
|
Adverse Events
BTE Hearing Aid Model
SP-BTE Hearing Aid Model
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