Actively Recruiting
A Prospective Study to Validate Digital Speech Perception Endpoints Using the Mobile Research App in Adult Cochlear Implant Recipients
Led by Cochlear · Updated on 2025-04-30
46
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, multi-country study to evaluate the use of a Mobile Research App (MRA) in measuring speech perception in adults who use cochlear implants. This investigation aims to validate digital speech perception endpoints by comparing app-based assessments with traditional clinical methods in this population with hearing loss. Participants will use the Mobile Research App to complete speech perception tests either in-clinic or at home. The app streams speech material via Bluetooth to the cochlear implant sound processor, allowing recipients to listen and respond through the app. The study includes two groups: one with cochlear implant recipients only, and another with recipients of both cochlear implants and hearing aids. The app-based testing is compared with standard clinical delivery of speech perception tests conducted in a sound booth. During the study, participants will complete speech perception tests immediately after screening and then repeat testing to assess consistency. Researchers will measure the percent correct performance on these tests. The study does not involve randomization or blinding. Participants' ability to use the app and their speech perception responses are monitored to validate this digital assessment method. The study's duration and follow-up details are not specified.
CONDITIONS
Brief Title
An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Uses a hearing device such as a hearing aid or cochlear implant
- Fluent speaker in the language used to assess clinical performance as judged by the investigator
- Willing and able to provide written informed consent
You will not qualify if you...
- Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
- Investigator site personnel directly affiliated with this study and/or their immediate families
- Cochlear employees or employees of contractors engaged by Cochlear for this investigation
- Currently participating or participated within the last 30 days in another interventional clinical investigation/trial involving an investigational drug or device
- Women who are pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day - immediately post screening
Participants use the Mobile Research App to complete speech perception tests either in-clinic or at home as part of the study assessments.
1 to 2 visits depending on the study arm
Trial Site Locations
Total: 4 locations
1
Denver Research and Technology Labs
Lone Tree, Colorado, United States, 80124
Completed
2
HEARnet Clinical Studies
Melbourne, Victoria, Australia, 3053
Active, Not Recruiting
3
European Institute for Otorhinolaryngology (EIORL) ENT department Sint-Augustinus Antwerp
Antwerp, Antwerp, Belgium, 2610
Actively Recruiting
4
Hoorzorg van Looveren
Wommelgem, Antwerp, Belgium, 2160
Actively Recruiting
Research Team
G
Geert De Ceulaer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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