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

Cochlear4 sites in 3 countries46 target enrollmentFebruary 5, 2024

ConditionsHearing Loss

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hearing Loss
Sponsor: Cochlear
Enrollment: 46
Locations: 4
Primary Endpoint: Percent correct performance for the test and retest runs of speech perception ability
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 5, 2024

End Date

May 2, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Cochlear

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Percent correct performance for the test and retest runs of speech perception ability

Time Frame: 1 day - immediately post screening.

To determine if test-retest reliability with a correlation greater than or equal to 0.8 can be achieved for speech perception ability measured on the MRA outside the sound booth, percent correct performance for the test and retest runs of the speech perception ability will be compared. Scoring: Percentage correct Range: 0-100%, higher scores equal better performance