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

RECRUITING

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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.

Conditions:

Hearing Loss

Study Start (Actual) 2024-02-05

Primary Completion (Estimated) 2024-08-31

Study Completion (Estimated) 2024-08-31

Enrollment (Estimated) 46

Study Type INTERVENTIONAL

Phase NA

Locations:

📍 Lone Tree, Colorado, United States

📍 Melbourne, Victoria, Australia

📍 Wommelgem, Antwerp, Belgium

📍 Antwerp, Belgium

Eligibility Criteria

Description

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.

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2023-10-19
First Submitted that Met QC Criteria2023-10-19
First Posted2023-10-24

Study Record Updates

Last Update Submitted that Met QC Criteria2024-06-24
Last Update Posted2024-06-26
Last Verified2024-06