Hearing Loss, SensorineuralEOSPNCT03686046
Evaluation of an Open-source Speech-processing Platform
An observational study of Hearing Loss, Sensorineural, run by San Diego State University at 1 site in United States.
Trial summary
Determining acceptability and usability of a wearable open-source speech processing platform (Master Hearing Aid) developed for hearing-aid research Read more about this study
- Who is it for?
- Ages 30 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- Exploratory use
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2019to 15 May 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with sensorineural hearing loss Residents of San Diego county and North county, California
Who may be able to join
- Sensorineural hearing loss
Who cannot join
- Cognitively challenged
- Legally blind
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego State University, Audiology Clinic
San Diego, California, 93402
About this study
Determining acceptability and usability of a wearable open-source speech processing platform (Master Hearing Aid) developed for hearing-aid research
Read the detailed description
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.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- Exploratory use
- Keywords
- Hearing aid
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exploratory useOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exploratory use | Brief (2 hour) exploratory use of prototype self-adjusted wearable Master Hearing Aid Receives: Other: Exploratory use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Willingness to Use During Possible Unsupervised Field Research Study?
5-point rating scale. 5 = definitely would use. 0 = definitely would not use
Measured: 1 hour after use of device in lab and field
Secondary outcomes (6)
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:
- After self-adjustment while listening to conversational-level, speech, prerecorded by a female talker.
- 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.
Measured: 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
Measured: 1 hour after use of Master Hearing Aid
Self-fitting Behavior
Adjustment time
Measured: 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.
Measured: 1 hour after final self-fitting in the lab
Self-fitting Behavior
Ranges of output
Measured: 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.
Measured: 1 hour after final self-fitting in the lab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start10 May 2019
- Primary completion15 May 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Arthur Boothroyd, Ph.D, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686046
- Sponsor's protocol ID
- 58786
- Acronym
- EOSP
- Status last verified
- Jun 2026
- First submitted
- 2 Aug 2018
- Last updated
- 2 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Open-source Speech-processing Platform
- ClinicalTrials.gov ID
- NCT03686046
- Acronym / sponsor ID
- EOSP / 58786
- Conditions
- Hearing Loss, Sensorineural
- Keywords
- Hearing aid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- University of California, San Diego
- Study start
- 10 May 2019 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 26 Sep 2018 (actual)
- Results
- Posted 2 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determining acceptability and usability of a wearable open-source speech processing platform (Master Hearing Aid) developed for hearing-aid research
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exploratory use | – | Other: Exploratory useBrief (2 hour) exploratory use of prototype self-adjusted wearable Master Hearing Aid |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with sensorineural hearing loss Residents of San Diego county and North county, California
Key inclusion criteria (1 listed)
- Sensorineural hearing loss
Key exclusion criteria (2 listed)
- Cognitively challenged
- Legally blind
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exploratory useParticipants 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. | Other | Exploratory use |
Primary outcome
Willingness to Use During Possible Unsupervised Field Research Study?
Time frame: 1 hour after use of device in lab and field
5-point rating scale. 5 = definitely would use. 0 = definitely would not use
6 secondary outcomes
Self-fitted Hearing-aid Output Averaged at 2, 3, and 4 kHz.
Time frame: 1 hour after self-fitting
Aided Speech Perception
Time frame: 1 hour after use of Master Hearing Aid
Self-fitting Behavior
Time frame: 1 hour after final self-fitting in the lab
Self-fitting Behavior
Time frame: 1 hour after final self-fitting in the lab
Self-fitting Behavior
Time frame: 1 hour after final self-fitting in the lab
Self-fitting Behavior
Time frame: 1 hour after final self-fitting in the lab
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur Boothroyd, Ph.D principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, Sensorineural, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Willingness to Use During Possible Unsupervised Field Research Study? (time frame: 1 hour after use of device in lab and field). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.