Trial Outcomes & Findings for Clinical Study of Released Unitron RIC and BTE Hearing Aid Models (NCT NCT05197803)
NCT ID: NCT05197803
Last Updated: 2025-05-07
Results Overview
Sentences are presented through a speaker in front of the participant's head. Background noise is presented through other seven speakers arranged around the participant. The senteces are presented at varying levels (both louder and softer) than the fixed level of the noise. The SNR50 is the Signal-to-Noise Ratio (SNR) expressed in decibels (dB) at which the participant can repeat 50% of the words correctly. For example, an SNR50 of +3 means that the participant repeated 50% of the words back correctly when the sentences were presented at a level that was 3dB louder than the noise. Lower scores indicate better performance.
COMPLETED
NA
25 participants
2 hours appointment
2025-05-07
Participant Flow
Participants were recruited from the existing participant local database. The first participant was enrolled on January 10, 2022 and the last participant was enrolled on January 28, 2022.
All 25 participants enrolled met the inclusion criteria established for this study.
Participant milestones
| Measure |
Experimental
The same group of participants undergo one similar intervention. Each participant is fit with the BTE and the RIC hearing aids and then complete the speech intelligibility testing aided and unaided.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental
n=25 Participants
All participants are fit with the BTE and the RIC hearing aids and then complete speech intelligibility testing aided and unaided.
|
|---|---|
|
Age, Continuous
|
66.36 years
STANDARD_DEVIATION 11.87 • n=25 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=25 Participants
|
|
Region of Enrollment
Canada
|
25 participants
n=25 Participants
|
|
Speech Intelligibility in Noise
|
1.7 decibels (dB) Signal-to-Noise Ratio
STANDARD_DEVIATION 2.4 • n=25 Participants
|
PRIMARY outcome
Timeframe: 2 hours appointmentPopulation: The data for two participants had to be removed from the final analysis. In both cases, the speech intelligibiliy test could not be completed in one or more study conditions.
Sentences are presented through a speaker in front of the participant's head. Background noise is presented through other seven speakers arranged around the participant. The senteces are presented at varying levels (both louder and softer) than the fixed level of the noise. The SNR50 is the Signal-to-Noise Ratio (SNR) expressed in decibels (dB) at which the participant can repeat 50% of the words correctly. For example, an SNR50 of +3 means that the participant repeated 50% of the words back correctly when the sentences were presented at a level that was 3dB louder than the noise. Lower scores indicate better performance.
Outcome measures
| Measure |
Experimental
n=23 Participants
The same group of participants undergo one similar intervention. Each participant is fit with the BTE and the RIC hearing aids and then complete the speech intelligibility testing aided and unaided.
|
|---|---|
|
Speech Intelligibility Test in Noise
dB SNR unaided condition
|
0.83 decibel (dB) Signal-to-Noise Ratio
Standard Deviation 3.43
|
|
Speech Intelligibility Test in Noise
dB SNR aided condition (BTE)
|
-2.49 decibel (dB) Signal-to-Noise Ratio
Standard Deviation 1.93
|
|
Speech Intelligibility Test in Noise
dB SNR aided condition (RIC)
|
-2.74 decibel (dB) Signal-to-Noise Ratio
Standard Deviation 2.13
|
Adverse Events
Experimental
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