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
Cochlear
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. *…
Interventions
- DeviceMobile Research App (MRA)
The MRA (research tool) is a platform used for the delivery of speech perception material in-clinic outside the sound booth or in the home of the hearing-impaired recipients. The MRA speech testing module delivers speech material via streaming to the single implanted ears of cochlear implant recipients. The recipient listens to the speech material and responds with what was heard via the app. Speech is streamed via Bluetooth from the iOS device to the sound processor of the CI-recipient.
- OtherSOC/validated delivery of the speech perception test material
This involves the delivery of speech perception test material in the sound booth in a clinic.
Locations (4)
- Denver Research and Technology LabsLone Tree, Colorado
- HEARnet Clinical StudiesMelbourne, Victoria
- European Institute for Otorhinolaryngology (EIORL) ENT department Sint-Augustinus AntwerpAntwerp, Antwerp
- Hoorzorg van LooverenWommelgem, Antwerp