Trial Outcomes & Findings for Investigating Hearing Aid Frequency Response Curves (NCT NCT05521308)
NCT ID: NCT05521308
Last Updated: 2025-03-24
Results Overview
Pre-filtered sound samples (based on frequency response curves) will be presented via a paired comparison task in which participants will determine which sound sample they prefer (i.e. better sound quality). Sound samples will be presented via hearing aids that are programmed to the participant's hearing loss. Participant's will be presented with two samples at a time and will choose which sample they prefer. For example, if Sample A was preferred over Sample B, then Sample A gets a score of 1. If Sample B was preferred over Sample A, then Sample B gets a score of 1. At the end of the task, scores will be tallied to determine which sample was preferred the most overall. There will be 5 different samples. The minimum value for the tallied score would be 0 (the sample was not preferred at all) and the maximum value would be 8 (implying that the sample was preferred in all trials). Higher scores mean that the sample was preferred more and lowers scores mean the sample was not preferred.
COMPLETED
NA
33 participants
60 minutes
2025-03-24
Participant Flow
Recruitment was conducted via an internal database. Participants were recruited from August 2022 - January 2023. Participants were mainly contacted via email or telephone and only seen at the listed study locations.
All participants were exposed to all interventions and as mentioned previously, participants were exposed to multiple interventions at once (i.e., different hearing aid freqeuncy response curves). All 33 participants completed each test (i.e., outcome measure) while exposed to all the interventions. Different periods represent the different outcome measures and in the order in which they occured are listed below. For the final analysis, results from 22 participants was used.
Participant milestones
| Measure |
Participants With Hearing Loss
Individuals with hearing loss that meet the candidacy to wear hearing aids. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.
Hearing Aid - Standard Curve: Our current hearing aids which will be programmed to our standard frequency response curve.
Hearing Aid - Variation #1: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Hearing Aid - Variation #2: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Hearing Aid - Variation #3: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Hearing Aid - Variation #4: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
|
|---|---|
|
US Matrix Test in Quiet - 30 Minutes
STARTED
|
33
|
|
US Matrix Test in Quiet - 30 Minutes
COMPLETED
|
33
|
|
US Matrix Test in Quiet - 30 Minutes
NOT COMPLETED
|
0
|
|
Sound Quality Ratings - Live - 1 Hour
STARTED
|
33
|
|
Sound Quality Ratings - Live - 1 Hour
COMPLETED
|
33
|
|
Sound Quality Ratings - Live - 1 Hour
NOT COMPLETED
|
0
|
|
Break Between Appointments 1 and 2
STARTED
|
33
|
|
Break Between Appointments 1 and 2
COMPLETED
|
33
|
|
Break Between Appointments 1 and 2
NOT COMPLETED
|
0
|
|
Streaming Sound Quality Ratings - 1 Hour
STARTED
|
33
|
|
Streaming Sound Quality Ratings - 1 Hour
COMPLETED
|
33
|
|
Streaming Sound Quality Ratings - 1 Hour
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 |
Participants With Hearing Loss
n=33 Participants
Individuals with hearing loss that meet the candidacy to wear hearing aids. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.
Hearing Aid - Standard Curve: Our current hearing aids which will be programmed to our standard frequency response curve.
Hearing Aid - Variation #1: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Hearing Aid - Variation #2: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Hearing Aid - Variation #3: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Hearing Aid - Variation #4: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=33 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=33 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=33 Participants
|
|
Age, Continuous
|
67.90 years
n=33 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=33 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=33 Participants
|
|
Region of Enrollment
Canada
|
33 Participants
n=33 Participants
|
|
Hearing Thresholds - PTA (500,1000,2000,4000 Hz)
|
38.22 Decibals in Hearing Level (dB HL)
n=33 Participants
|
PRIMARY outcome
Timeframe: 60 minutesPopulation: Out of 33 participants, 4 were pilot participants so their data was not analyzed for the final statistical analysis and 5 participants data was removed due to HL severity. Additionally, 2 participants data was removed for the final analysis as they struggled to understand the tasks within the study. In the end, 22 participants data was used for the final analysis.
Pre-filtered sound samples (based on frequency response curves) will be presented via a paired comparison task in which participants will determine which sound sample they prefer (i.e. better sound quality). Sound samples will be presented via hearing aids that are programmed to the participant's hearing loss. Participant's will be presented with two samples at a time and will choose which sample they prefer. For example, if Sample A was preferred over Sample B, then Sample A gets a score of 1. If Sample B was preferred over Sample A, then Sample B gets a score of 1. At the end of the task, scores will be tallied to determine which sample was preferred the most overall. There will be 5 different samples. The minimum value for the tallied score would be 0 (the sample was not preferred at all) and the maximum value would be 8 (implying that the sample was preferred in all trials). Higher scores mean that the sample was preferred more and lowers scores mean the sample was not preferred.
Outcome measures
| Measure |
Participants With Hearing Loss
n=22 Participants
Individuals with hearing loss that meet the candidacy to wear hearing aids. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.
Hearing Aid - Standard Curve: Our current hearing aids which will be programmed to our standard frequency response curve.
Hearing Aid - Variation #1: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Hearing Aid - Variation #2: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Hearing Aid - Variation #3: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Hearing Aid - Variation #4: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
|
|---|---|
|
Streaming Sound Quality Ratings
Numbe of times Variation 1 was preferred over variation 2 across all genres per participant.
|
10.7 Mean Preference Counts per Participant
Standard Error 0.915
|
|
Streaming Sound Quality Ratings
Numbe of times Variation 1 was preferred over variation 3 across all genres per participant.
|
9.41 Mean Preference Counts per Participant
Standard Error 0.805
|
|
Streaming Sound Quality Ratings
Numbe of times Variation 2 was preferred over variation 1 across all genres per participant.
|
7.46 Mean Preference Counts per Participant
Standard Error 0.939
|
|
Streaming Sound Quality Ratings
Number of times variation 2 was rated higher in sound quality than variation 3 across all samples
|
5.91 Mean Preference Counts per Participant
Standard Error 0.588
|
|
Streaming Sound Quality Ratings
Numbe of times Variation 3 was preferred over variation 1 across all genres per participant.
|
8.32 Mean Preference Counts per Participant
Standard Error 0.815
|
|
Streaming Sound Quality Ratings
Numbe of times Variation 3 was preferred over variation 2 across all genres per participant.
|
8.05 Mean Preference Counts per Participant
Standard Error 0.757
|
|
Streaming Sound Quality Ratings
Numbe of times Variation 1 was rated the same as variation 2 across all genres per participant.
|
3.13 Mean Preference Counts per Participant
Standard Error 0.487
|
|
Streaming Sound Quality Ratings
Numbe of times Variation 1 was rated the same as variation 3 across all genres per participant.
|
3.59 Mean Preference Counts per Participant
Standard Error 0.462
|
|
Streaming Sound Quality Ratings
Numbe of times Variation 2 was rated the same as variation 3 across all genres per participant.
|
6.73 Mean Preference Counts per Participant
Standard Error 1.17
|
SECONDARY outcome
Timeframe: 60 minutesPopulation: Out of 33 participants, 4 were pilot participants so their data was not analyzed for the final statistical analysis and 5 participants data was removed due to HL severity. Additionally, 2 participants data was removed for the final analysis as they struggled to understand the tasks within the study. In the end, 22 participants data was used for the final analysis.
Participants will be asked to wear hearing aids and as they listen to speech in noise. They will be asked to toggle between two hearing aid programs and will be asked to make ratings in the lab and outdoors. Similar to Outcome 1, scores will be tallied at the end to see which program of the two was preferred more in the different listening environments. Scores can range from 0 (the program was not preferred at all) to unlimited (dependent on the numbers of trials run and samples tested). Higher scores will indicate that the program was preferred more than the other program and lowers scores mean the program was not preferred when compared to the other program.
Outcome measures
| Measure |
Participants With Hearing Loss
n=22 Participants
Individuals with hearing loss that meet the candidacy to wear hearing aids. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.
Hearing Aid - Standard Curve: Our current hearing aids which will be programmed to our standard frequency response curve.
Hearing Aid - Variation #1: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Hearing Aid - Variation #2: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Hearing Aid - Variation #3: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Hearing Aid - Variation #4: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
|
|---|---|
|
Sound Quality Rating - Live - Counts
# of times the standard curve was rated higher in preference than variation 4 across samples - Lab
|
79 Count of preferences
|
|
Sound Quality Rating - Live - Counts
# of times the standard curve was rated lower in preference than variation 4 across samples - Lab
|
95 Count of preferences
|
|
Sound Quality Rating - Live - Counts
# of times the standard curve was rated the same as variation 4 in preference across samples - Lab
|
46 Count of preferences
|
|
Sound Quality Rating - Live - Counts
# of times the standard curve was rated higher in preference than variation4 across samples-Outdoors
|
86 Count of preferences
|
|
Sound Quality Rating - Live - Counts
# of times the standard curve was rated lower in preference than variation4 across samples-Outdoors
|
104 Count of preferences
|
|
Sound Quality Rating - Live - Counts
# of times the standard curve was rated the same as variation4 in preference across samples-Outdoors
|
30 Count of preferences
|
SECONDARY outcome
Timeframe: 60 minutesPopulation: Out of 33 participants, 4 were pilot participants so their data was not analyzed for the final statistical analysis and 5 participants data was removed due to HL severity. Additionally, 2 participants data was removed for the final analysis as they struggled to understand the tasks within the study. In the end, 22 participants data was used for the final analysis.
Participants will be asked to wear hearing aids and as they listen to speech in noise. They will be asked to toggle between two hearing aid programs and determine which program they prefer to listen to. Similar to Outcome 1, scores will be tallied at the end to see which program of the two was preferred more in the different listening environments. Scores can range from 0 (the program was not preferred at all) to unlimited (dependent on the numbers of trials run and samples tested). Highers scores will indicate that the program was preferred more than the other program and lowers scores mean the program was not preferred when compared to the other program.
Outcome measures
| Measure |
Participants With Hearing Loss
n=22 Participants
Individuals with hearing loss that meet the candidacy to wear hearing aids. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.
Hearing Aid - Standard Curve: Our current hearing aids which will be programmed to our standard frequency response curve.
Hearing Aid - Variation #1: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Hearing Aid - Variation #2: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Hearing Aid - Variation #3: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Hearing Aid - Variation #4: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
|
|---|---|
|
Sound Quality Rating - Live - Preferences
# of participants that had an overall preference toward variation #4 vs. standard curve - Outdoors
|
15 Count of preferences
|
|
Sound Quality Rating - Live - Preferences
# of participants that had an overall preference toward standard curve vs. Variation #4 - Outdoors
|
6 Count of preferences
|
|
Sound Quality Rating - Live - Preferences
# of participants that had no preference toward standard curve vs. Variation #4 - Outdoors
|
1 Count of preferences
|
SECONDARY outcome
Timeframe: 30 MinutesPopulation: Out of 33 participants, 4 were pilot participants so their data was not analyzed for the final statistical analysis and 5 participants data was removed due to HL severity. Additionally, 2 participants data was removed for the final analysis as they struggled to understand the tasks within the study. In the end, 22 participants data was used for the final analysis.
Oldenburg Sentence Test (OLSA) sentences were presented to participants while they were aided under the standard curve, aided under curve #4, and unaided. Participants are presented with sentences from a loudspeaker placed infront of them and asked to repeat what they heard. Correct repitition results in the next sentence to be presented at a lower sound level. Incorrect repetition results in an increase in presentation level for the next sentence. 20 sentences are presented for each conidition (i.e., unaided, aided with the standard curve, and aided under curve #4). Speech Recognition Threshold at 50% (SRT50) correctness scores were calculated and compared amongst the three conditions. SRT50 is measured in decibel (dB) which is a unit on scale. The scale has no upper or lower limits, however lower scores indicate better performance.
Outcome measures
| Measure |
Participants With Hearing Loss
n=22 Participants
Individuals with hearing loss that meet the candidacy to wear hearing aids. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.
Hearing Aid - Standard Curve: Our current hearing aids which will be programmed to our standard frequency response curve.
Hearing Aid - Variation #1: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Hearing Aid - Variation #2: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Hearing Aid - Variation #3: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Hearing Aid - Variation #4: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
|
|---|---|
|
US Matrix Test in Quiet - SRT
Unaided - Signal to Noise Ratio at 50% correct (SRT50)
|
34.1 decibels (dB)
Standard Deviation 9.9
|
|
US Matrix Test in Quiet - SRT
Standard Curve - Signal to Noise Ratio at 50% correct (SRT50)
|
25.8 decibels (dB)
Standard Deviation 4.3
|
|
US Matrix Test in Quiet - SRT
Variation 4 - Signal to Noise Ratio at 50% correct (SRT50)
|
26.1 decibels (dB)
Standard Deviation 4.21
|
Adverse Events
Participants With Hearing Loss
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