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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

Interested in This Trial?

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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