Evaluation of an Open-source Speech-processing Platform (EOSP)

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

Study Overview

• Status: Unknown
• Conditions: Hearing Loss, Sensorineural
• Intervention / Treatment: Other: Exploratory use

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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 93402
      • Recruiting
      • San Diego State University, Audiology Clinic
      • Contact: Christine Kirsch, AuD; Phone Number: 619-594-4176; Email: ckirsch@sdsu.edu
      • Contact: Arthur Boothroyd, PhD; Phone Number: 6195508951; Email: aboothroyd@sdsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with sensorineural hearing loss Residents of San Diego county and North county, California

Description

Inclusion Criteria:

- Sensorineural hearing loss

Exclusion Criteria:

• Cognitively challenged
• Legally blind

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Exploratory use; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electro-acoustic performance of the speech-processing platform	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).	Approximately 2 weeks after last participant completes the exploratory use, estimated to be about 6 months.
Aided speech perception	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)	Approximately 2 weeks after last participant completes the exploratory use, estimated to be about 6 months.
Pattern of user self-adjustments.	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)	Approximately 2 weeks after last participant completes the exploratory use
Participant-specified issues, comments, and opinions	Focus group for all participants	Approximately 2 months after last participant completes the exploratory use, estimated to be about 6 months.

Collaborators and Investigators

• Sponsor: San Diego State University
• Collaborators: University of California, San Diego
• Investigators: Principal Investigator: Arthur Boothroyd, Ph.D, San Diego State University

Publications and helpful links

General Publications

• Boothroyd A, Mackersie C. A "Goldilocks" Approach to Hearing-Aid Self-Fitting: User Interactions. Am J Audiol. 2017 Oct 12;26(3S):430-435. doi: 10.1044/2017_AJA-16-0125.
• Mackersie C, Boothroyd A, Lithgow A. A "Goldilocks" Approach to Hearing Aid Self-Fitting: Ear-Canal Output and Speech Intelligibility Index. Ear Hear. 2019 Jan/Feb;40(1):107-115. doi: 10.1097/AUD.0000000000000617.
• Lee CH, Kates JM, Rao BD, Garudadri H. Speech quality and stable gain trade-offs in adaptive feedback cancellation for hearing aids. J Acoust Soc Am. 2017 Oct;142(4):EL388. doi: 10.1121/1.5007278.
• Boothroyd A. The performance/intensity function: an underused resource. Ear Hear. 2008 Aug;29(4):479-91. doi: 10.1097/AUD.0b013e318174f067.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2019
• Primary Completion (Anticipated): July 31, 2021
• Study Completion (Anticipated): July 31, 2021

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (Actual): September 26, 2018

Study Record Updates

• Last Update Posted (Actual): May 17, 2019
• Last Update Submitted That Met QC Criteria: May 15, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Hearing aid
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, Sensorineural
• Other Study ID Numbers: 58786

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No