Evaluation of an Open-source Speech-processing Platform

• Conditions: Hearing Loss, Sensorineural
• Interventions: Other: Exploratory use

• Registration Number: NCT03686046
• Lead Sponsor: San Diego State University

Brief Summary

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 Timeline

• Study First Submitted: 2018-08-02
• Study First Submitted QC: 2018-09-24
• Study First Posted: 2018-09-26
• Status Verified: 2019-05
• Study Start: 2019-05-10
• Last Update Submitted: 2019-05-15
• Last Update Posted: 2019-05-17
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Sensorineural hearing loss

Exclusion Criteria

• Cognitively challenged
• Legally blind

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exploratory use	Exploratory use	Brief (2 hour) exploratory use of prototype self-adjusted wearable Master Hearing Aid

Primary Outcome Measures

Name	Time	Method
Response to structured interview	Approximately 2 weeks after last participant completes the exploratory use, estimated to be about 6 months.	A wearable speech-processing platform for hearing-aid research; 1. How long might you be prepared to wear this device as a hearing aid for purposes of research?; 2. How do you rate the appearance and wearability of the device?; 3. How do you rate the performance of the device as a hearing aid?; 4. What changes might increase your willingness to wear this device for research purposes?; 5. What changes might increase your rating of appearance?; 6. What changes might increase your rating of performance?

Secondary Outcome Measures

Name	Time	Method
Aided speech perception	Approximately 2 weeks after last participant completes the exploratory use, estimated to be about 6 months.	Participants will repeat prerecorded single syllable words presented at varying levels levels from a loudspeaker. Performance will be assessed as the percentage of speech sounds correctly repeated and will be measured while wearing the speech-processing platform as set before and after self-adjustment. (Boothroyd, 2008)
Pattern of user self-adjustments.	Approximately 2 weeks after last participant completes the exploratory use	Changes of gain and spectral slope initiated by participants in response to changing , estimated to be about 6 months.acoustic conditions will be automatically logged by the self-adjustment software. (Boothroyd and Mackersie (2017)
Electro-acoustic performance of the speech-processing platform	Approximately 2 weeks after last participant completes the exploratory use, estimated to be about 6 months.	Real-ear gain versus frequency curves of the speech-processing platform, before and after self-adjustment during the brief trial, will be obtained with the Verifit 2 hearing-aid test system - using standard audiological clinical procedures. (Mackersie, Boothroyd and Lithgow, 2018).
Participant-specified issues, comments, and opinions	Approximately 2 months after last participant completes the exploratory use, estimated to be about 6 months.	Focus group for all participants

Trial Locations

Locations (1)

San Diego State University, Audiology Clinic; 🇺🇸 San Diego, California, United States