Status:
RECRUITING
An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App
Lead Sponsor:
Cochlear
Conditions:
Hearing Loss
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study is a feasibility, prospective, repeated-measures, multi-country, multi-centre, study of the Mobile Research App to measure and validate speech perception endpoints in adult cochlear implant ...
Eligibility Criteria
Inclusion
- Adults 18 years of age or older.
- Uses a hearing device or devices (hearing aid/s and/or cochlear implant/s).
- Fluent speaker in the language used to assess clinical performance as judged by the investigator.
- Willing and able to provide written informed consent.
Exclusion
- 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; immediate family is defined as a spouse, parent, child, or sibling.
- Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
- Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).
- Women who are pregnant.
Key Trial Info
Start Date :
February 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 2 2027
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06098482
Start Date
February 5 2024
End Date
May 2 2027
Last Update
April 30 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Denver Research and Technology Labs
Lone Tree, Colorado, United States, 80124
2
HEARnet Clinical Studies
Melbourne, Victoria, Australia, 3053
3
European Institute for Otorhinolaryngology (EIORL) ENT department Sint-Augustinus Antwerp
Antwerp, Antwerp, Belgium, 2610
4
Hoorzorg van Looveren
Wommelgem, Antwerp, Belgium, 2160