Trial Outcomes & Findings for Evaluation of an Open-source Speech-processing Platform (NCT NCT03686046)
NCT ID: NCT03686046
Last Updated: 2026-07-02
Results Overview
5-point rating scale. 5 = definitely would use. 0 = definitely would not use
Recruitment status
COMPLETED
Target enrollment
22 participants
Primary outcome timeframe
1 hour after use of device in lab and field
Results posted on
2026-07-02
Participant Flow
By invitation from SDSU audiology clinic clientele. Based on inclusion/exclusion criteria
Participant milestones
| Measure |
Exploratory Use
Brief (2 hour) exploratory use of prototype self-adjusted wearable Master Hearing Aid
Exploratory use: Participants will be accompanied by a researcher while wearing the open-source speech processing platform as a hearing aid - adjusted to their needs using a widely accepted Fitting prescription. Using a hand-held controller, they will readjust to their liking as the acoustic conditions change. After returning to the laboratory, they will complete speech perception tests using under their self-selected amplification conditions and respond to a structured interview dealing with perceived performance of the device and its acceptability as a hearing aid during possible field studies.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of an Open-source Speech-processing Platform
Baseline characteristics by cohort
| Measure |
Exploratory Use
n=22 Participants
Brief (2 hour) exploratory use of prototype self-adjusted wearable Master Hearing Aid
Exploratory use: Participants will be accompanied by a researcher while wearing the open-source speech processing platform as a hearing aid - adjusted to their needs using a widely accepted Fitting prescription. Using a hand-held controller, they will readjust to their liking as the acoustic conditions change. After returning to the laboratory, they will complete speech perception tests using under their self-selected amplification conditions and respond to a structured interview dealing with perceived performance of the device and its acceptability as a hearing aid during possible field studies.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=20 Participants
|
|
Hearing aid use
|
22 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 1 hour after use of device in lab and fieldPopulation: Adult hearing-aid users with mild-to-moderate hearing loss.
5-point rating scale. 5 = definitely would use. 0 = definitely would not use
Outcome measures
| Measure |
Exploratory Use
n=20 Participants
Brief (2 hour) exploratory use of prototype self-adjusted wearable Master Hearing Aid
Exploratory use: Participants will be accompanied by a researcher while wearing the open-source speech processing platform as a hearing aid - adjusted to their needs using a widely accepted Fitting prescription. Using a hand-held controller, they will readjust to their liking as the acoustic conditions change. After returning to the laboratory, they will complete speech perception tests using under their self-selected amplification conditions and respond to a structured interview dealing with perceived performance of the device and its acceptability as a hearing aid during possible field studies.
|
|---|---|
|
Willingness to Use During Possible Unsupervised Field Research Study?
Probably, would wear
|
4 Participants
|
|
Willingness to Use During Possible Unsupervised Field Research Study?
Not sure
|
1 Participants
|
|
Willingness to Use During Possible Unsupervised Field Research Study?
Probably would not wear
|
3 Participants
|
|
Willingness to Use During Possible Unsupervised Field Research Study?
Definitely would not wear
|
11 Participants
|
|
Willingness to Use During Possible Unsupervised Field Research Study?
YES,would wear
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 hour after self-fittingPopulation: Adult hearing-aid users with mild-to-moderate hearing loss
Real-ear device output level in dB SPL was measured, as a function of frequency after self-fitting under 2 conditions: 1. After self-adjustment while listening to conversational-level, speech, prerecorded by a female talker. 2. After a second self-adjustment following a brief, accompanied, field experience including conversation in a variety of acoustic experiences. These results were compared with prescriptions based on each participants audiogram. Note: Although dB outputs were measured at several frequencies, only the average of values at 2, 3, and 4 kHz was used, this being the frequency region at which the greatest effects effects of self-adjustment were observed in earlier studies.
Outcome measures
| Measure |
Exploratory Use
n=19 Participants
Brief (2 hour) exploratory use of prototype self-adjusted wearable Master Hearing Aid
Exploratory use: Participants will be accompanied by a researcher while wearing the open-source speech processing platform as a hearing aid - adjusted to their needs using a widely accepted Fitting prescription. Using a hand-held controller, they will readjust to their liking as the acoustic conditions change. After returning to the laboratory, they will complete speech perception tests using under their self-selected amplification conditions and respond to a structured interview dealing with perceived performance of the device and its acceptability as a hearing aid during possible field studies.
|
|---|---|
|
Self-fitted Hearing-aid Output Averaged at 2, 3, and 4 kHz.
|
72.5 dB SPL
Standard Error 7.5
|
SECONDARY outcome
Timeframe: 1 hour after use of Master Hearing AidPopulation: Adults with mild-to-moderate hearing loss
% Recognition of speech sounds in lists of monosyllabic words after self-fitting of the Master Hearing Aid
Outcome measures
| Measure |
Exploratory Use
n=20 Participants
Brief (2 hour) exploratory use of prototype self-adjusted wearable Master Hearing Aid
Exploratory use: Participants will be accompanied by a researcher while wearing the open-source speech processing platform as a hearing aid - adjusted to their needs using a widely accepted Fitting prescription. Using a hand-held controller, they will readjust to their liking as the acoustic conditions change. After returning to the laboratory, they will complete speech perception tests using under their self-selected amplification conditions and respond to a structured interview dealing with perceived performance of the device and its acceptability as a hearing aid during possible field studies.
|
|---|---|
|
Aided Speech Perception
Percent recognition below 80%
|
3 Participants
|
|
Aided Speech Perception
Percent recognition of 80% or more
|
17 Participants
|
SECONDARY outcome
Timeframe: 1 hour after final self-fitting in the labPopulation: Adult hearing-aid users with mild-to-moderate hearing loss
Adjustment time
Outcome measures
| Measure |
Exploratory Use
n=19 Participants
Brief (2 hour) exploratory use of prototype self-adjusted wearable Master Hearing Aid
Exploratory use: Participants will be accompanied by a researcher while wearing the open-source speech processing platform as a hearing aid - adjusted to their needs using a widely accepted Fitting prescription. Using a hand-held controller, they will readjust to their liking as the acoustic conditions change. After returning to the laboratory, they will complete speech perception tests using under their self-selected amplification conditions and respond to a structured interview dealing with perceived performance of the device and its acceptability as a hearing aid during possible field studies.
|
|---|---|
|
Self-fitting Behavior
|
77.6 sec
Standard Deviation 28.2
|
SECONDARY outcome
Timeframe: 1 hour after final self-fitting in the labPopulation: Adult hearing-aid users with mild-to-moderate hearing loss
Number of adjustment steps the participant took during self adjustment in the laboratory. The available changes were in overall output level (a single button labelled "Loudness"), in low-frequency output alone (a single button labeled "Fullness"), and high-frequency output alone (a single button labeled "Crispness"). Each increase or decrease was in 3 dB steps.
Outcome measures
| Measure |
Exploratory Use
n=19 Participants
Brief (2 hour) exploratory use of prototype self-adjusted wearable Master Hearing Aid
Exploratory use: Participants will be accompanied by a researcher while wearing the open-source speech processing platform as a hearing aid - adjusted to their needs using a widely accepted Fitting prescription. Using a hand-held controller, they will readjust to their liking as the acoustic conditions change. After returning to the laboratory, they will complete speech perception tests using under their self-selected amplification conditions and respond to a structured interview dealing with perceived performance of the device and its acceptability as a hearing aid during possible field studies.
|
|---|---|
|
Self-fitting Behavior
|
14.6 Number of adjustment steps
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: 1 hour after final self-fitting in the labPopulation: Adult hearing-aid users with mild-to-moderate hearing loss
Ranges of output
Outcome measures
| Measure |
Exploratory Use
n=19 Participants
Brief (2 hour) exploratory use of prototype self-adjusted wearable Master Hearing Aid
Exploratory use: Participants will be accompanied by a researcher while wearing the open-source speech processing platform as a hearing aid - adjusted to their needs using a widely accepted Fitting prescription. Using a hand-held controller, they will readjust to their liking as the acoustic conditions change. After returning to the laboratory, they will complete speech perception tests using under their self-selected amplification conditions and respond to a structured interview dealing with perceived performance of the device and its acceptability as a hearing aid during possible field studies.
|
|---|---|
|
Self-fitting Behavior
|
2.5 dB
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 1 hour after final self-fitting in the labPopulation: Adult hearing-aid users with mild-to-moderate hearing loss
Spectral tilt explored: The difference between self-adjusted outputs at 750 and 1500 Hz, divided by 2, was defined as "spectral tilt" and recorded in dB per octave. Individual values were averaged and a standard deviation clculated.
Outcome measures
| Measure |
Exploratory Use
n=19 Participants
Brief (2 hour) exploratory use of prototype self-adjusted wearable Master Hearing Aid
Exploratory use: Participants will be accompanied by a researcher while wearing the open-source speech processing platform as a hearing aid - adjusted to their needs using a widely accepted Fitting prescription. Using a hand-held controller, they will readjust to their liking as the acoustic conditions change. After returning to the laboratory, they will complete speech perception tests using under their self-selected amplification conditions and respond to a structured interview dealing with perceived performance of the device and its acceptability as a hearing aid during possible field studies.
|
|---|---|
|
Self-fitting Behavior
|
4.5 dB/octave
Standard Deviation 5.4
|
Adverse Events
Exploratory Use
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