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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HEARnet Clinical Studies, Melbourne, Victoria, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobile Research App (MRA)

Device

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.

SOC/validated delivery of the speech perception test material

Other

This involves the delivery of speech perception test material in the sound booth in a clinic.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Geert De Ceulaer

CONTACT

[email protected]

+32486893006

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Registry information

Official study title

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

Acronym: VALDE-MU

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Oct 24, 2023
Registry last updated: Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting