A Prospective, Repeated-measures Investigation to Validate Digital Speech Perception Endpoints in Adult Cochlear Implant Recipients Using the Mobile Research App: a Master Umbrella Investigation
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Colorado
Denver Research and Technology Labs
COMPLETED
Lone Tree
Other Locations
Australia
HEARnet Clinical Studies
ACTIVE_NOT_RECRUITING
Melbourne
Belgium
European Institute for Otorhinolaryngology (EIORL) ENT department Sint-Augustinus Antwerp
RECRUITING
Antwerp
Hoorzorg van Looveren
RECRUITING
Wommelgem
Contact Information
Primary
Geert De Ceulaer
gdeceulaer@cochlear.com
+32486893006
Time Frame
Start Date: 2024-02-05
Estimated Completion Date: 2027-05-02
Participants
Target number of participants: 46
Treatments
Experimental: Delivery of speech perception materials in-clinic using the Mobile Research App (MRA)
Cochlear implant recipients will participate in this arm (sub-investigation AI5841A).
Experimental: Delivery of speech perception materials in-clinic and at home using the Mobile Research App (MRA)
Cochlear implant and hearing aid recipients will participate in this arm (sub-investigation AI5841B).
Related Therapeutic Areas
Sponsors
Leads: Cochlear