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OpenTrials
Completed

NCT Number: NCT03686046

Evaluation of an Open-source Speech-processing Platform

Determining acceptability and usability of a wearable open-source speech processing platform (Master Hearing Aid) developed for hearing-aid research

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Key information

Conditions

Hearing Loss, Sensorineural Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

San Diego State University, Audiology Clinic

San Diego, California, 93402, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sensorineural hearing loss

Exclusion criteria

  • Cognitively challenged
  • Legally blind

Treatment and study plan

Exploratory use

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Self-fitted Hearing-aid Output Averaged at 2, 3, and 4 kHz.

    Time frame: 1 hour after self-fitting

    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.

  2. Aided Speech Perception

    Time frame: 1 hour after use of Master Hearing Aid

    % Recognition of speech sounds in lists of monosyllabic words after self-fitting of the Master Hearing Aid

  3. Self-fitting Behavior

    Time frame: 1 hour after final self-fitting in the lab

    Adjustment time

  4. Self-fitting Behavior

    Time frame: 1 hour after final self-fitting in the lab

    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.

  5. Self-fitting Behavior

    Time frame: 1 hour after final self-fitting in the lab

    Ranges of output

  6. Self-fitting Behavior

    Time frame: 1 hour after final self-fitting in the lab

    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.

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Collaborators

  • University of California, San Diego

Registry information

Acronym: EOSP

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 26, 2018
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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