NCT06098482NARecruiting
An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App
Cochlear
Start Date
2/5/2024
Completion Date
5/2/2027
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 recipients.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* 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 Criteria:
* 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.
Interventions
DEVICE
Mobile Research App (MRA)
OTHER
SOC/validated delivery of the speech perception test material
Conditions
Hearing Loss
Locations
Denver Research and Technology Labs
Lone Tree, Colorado 80124
United States
HEARnet Clinical Studies
Melbourne, Victoria 3053
Australia
European Institute for Otorhinolaryngology (EIORL) ENT department Sint-Augustinus Antwerp
Antwerp, Antwerp 2610
Belgium
Hoorzorg van Looveren
Wommelgem, Antwerp 2160
Belgium