An observational study in Hearing Loss, Sensorineural, sponsored by San Diego State University. Completed at 1 site in United States. Open to participants aged 30 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by San Diego State University · Observational
Determining acceptability and usability of a wearable open-source speech processing platform (Master Hearing Aid) developed for hearing-aid research
Part 1 Speech perception tests. You will hear words and sentences under a variety of listening conditions and be asked either to either repeat them or to select what you heard from a set of options. You will also answer a few questions about the speech and the background noise. The goal is to determine the ability of the most recent version of the device to deliver good quality speech that is comfortable and understandable over a range of conditions that are representative of everyday listening.
Part 2. Suitability and Acceptability. You will be asked to respond to a short structured interview about the device. If the device has reached a wearable stage, you will wear it outside the laboratory while engaging in discussion with one of the researchers before completing the interview. The goal is to obtain the opinions of persons with hearing loss about the device itself, and about their willingness to wear it as a hearing aid in their everyday life, if they were to be involved in a research study.
Part 3 is a focus-group session with about 10 hearing-aid users, some of whom will have participated in Parts 1 and 2. Topics will deal with hearing aids in general and about the current version of the experimental device. Discussion will be recorded for later transcription and analysis. The goal is to gain the perspective of hearing-aid users about hearing aids, hearing-aid research, and the acceptability of this experimental device for field research.
371 studies on the registry are indexed under Hearing Loss, Sensorineural; 112 are open to participants now.
This study's enrollment of 22 is below the median of 78 across 93 observational studies indexed under Hearing Loss, Sensorineural.
Browse Hearing Loss, Sensorineural studies →San Diego State University is the lead sponsor of 145 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults with sensorineural hearing loss Residents of San Diego county and North county, California
- Sensorineural hearing loss
Exclusion Criteria:
Brief (2 hour) exploratory use of prototype self-adjusted wearable Master Hearing Aid
Other: 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?
5-point rating scale. 5 = definitely would use. 0 = definitely would not use
Time frame: 1 hour after use of device in lab and field
Self-fitted Hearing-aid Output Averaged at 2, 3, and 4 kHz.
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.
Time frame: 1 hour after self-fitting
Aided Speech Perception
% Recognition of speech sounds in lists of monosyllabic words after self-fitting of the Master Hearing Aid
Time frame: 1 hour after use of Master Hearing Aid
Self-fitting Behavior
Adjustment time
Time frame: 1 hour after final self-fitting in the lab
Self-fitting Behavior
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.
Time frame: 1 hour after final self-fitting in the lab
Self-fitting Behavior
Ranges of output
Time frame: 1 hour after final self-fitting in the lab
Self-fitting Behavior
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.
Time frame: 1 hour after final self-fitting in the lab
By invitation from SDSU audiology clinic clientele. Based on inclusion/exclusion criteria
| Milestone | Exploratory Use |
|---|---|
| Started | 22 |
| Completed | 22 |
| Not completed | 0 |
5-point rating scale. 5 = definitely would use. 0 = definitely would not use
| Participants | Exploratory Use |
|---|---|
| YES,would wear | 1 |
| Probably, would wear | 4 |
| Not sure | 1 |
| Probably would not wear | 3 |
| Definitely would not wear | 11 |
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.
| dB SPL | Adults With Hearing Loss |
|---|---|
| Self-fitted Hearing-aid Output Averaged at 2, 3, and 4 kHz. | 72.5 ± 7.5 |
% Recognition of speech sounds in lists of monosyllabic words after self-fitting of the Master Hearing Aid
| Participants | Exploratory Users |
|---|---|
| Percent recognition of 80% or more | 17 |
| Percent recognition below 80% | 3 |
Adjustment time
| sec | Exploratory Use |
|---|---|
| Self-fitting Behavior | 77.6 ± 28.2 |
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.
| Number of adjustment steps | Exploratory Use |
|---|---|
| Self-fitting Behavior | 14.6 ± 7.9 |
Ranges of output
| dB | Exploratory Use |
|---|---|
| Self-fitting Behavior | 2.5 ± 2.2 |
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.
| dB/octave | Exploratory Use |
|---|---|
| Self-fitting Behavior | 4.5 ± 5.4 |
Collected over 1 hour after exploratory use of Master Hearing Aid. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Exploratory Use | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
Adults with mild-to-moderate hearing loss
| Age, Categorical(Participants) | Exploratory Use |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 21 |
| Sex: Female, Male(Participants) | Exploratory Use |
|---|---|
| Female | 10 |
| Male | 12 |
| Ethnicity (NIH/OMB)(Participants) | Exploratory Use |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 21 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Exploratory Use |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 21 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Exploratory Use |
|---|---|
| United States | 22 |
| Hearing aid use(Participants) | Exploratory Use |
|---|---|
| Count of participants | 22 |
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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San Diego State University