NCT03686046

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

May 10, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2020

Completed
6.1 years until next milestone

Results Posted

Study results publicly available

July 2, 2026

Completed
Last Updated

July 2, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

August 2, 2018

Results QC Date

May 26, 2020

Last Update Submit

June 30, 2026

Conditions

Hearing Loss, Sensorineural

Keywords

Hearing aid

Study Arms (1)

Exploratory use

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

Other: Exploratory use

Interventions

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.

Exploratory use

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \- Sensorineural hearing loss

You may not qualify if:

  • Cognitively challenged
  • Legally blind

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Diego State University, Audiology Clinic

San Diego, California, 93402, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Arthur Boothroyd, Ph.D

    San Diego State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2018

First Posted

September 26, 2018

Study Start

May 10, 2019

Primary Completion

May 15, 2020

Study Completion

May 15, 2020

Last Updated

July 2, 2026

Results First Posted

July 2, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)