An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App

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

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.

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.