An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App (VALDE-MU)

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.

Study Overview

• Status: Recruiting
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Mobile Research App (MRA); Other: SOC/validated delivery of the speech perception test material

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Geert De Ceulaer; Phone Number: +32486893006; Email: gdeceulaer@cochlear.com

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3053
      • Active, not recruiting
      • HEARnet Clinical Studies
• Belgium
  • Antwerp, Belgium, 2610
    • Recruiting
    • European Institute for Otorhinolaryngology (EIORL) ENT department Sint-Augustinus Antwerp
    • Contact: Andrzej Zarowski, MD, PhD; Phone Number: +32 34433604; Email: andrzej.zarowski@zas.be
    • Principal Investigator: Andrzej Zarowski, MD, PhD
  • Antwerp
    • Wommelgem, Antwerp, Belgium, 2160
      • Recruiting
      • Hoorzorg van Looveren
      • Contact: Nancy Van Looveren, Aud; Phone Number: +32 33227391; Email: nancy.vanlooveren@outlook.be
      • Principal Investigator: Nancy Van Looveren, Aud
• United States
  • Colorado
    • Lone Tree, Colorado, United States, 80124
      • Completed
      • Denver Research and Technology Labs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Delivery of speech perception materials in-clinic using the Mobile Research App (MRA); Cochlear implant recipients will participate in this arm (sub-investigation AI5841A).	Device: Mobile Research App (MRA); 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.; Other: SOC/validated delivery of the speech perception test material; This involves the delivery of speech perception test material in the sound booth in a clinic.
Experimental: Delivery of speech perception materials in-clinic and at home using the Mobile Research App (MRA); Cochlear implant and hearing aid recipients will participate in this arm (sub-investigation AI5841B).	Device: Mobile Research App (MRA); 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.; Other: SOC/validated delivery of the speech perception test material; This involves the delivery of speech perception test material in the sound booth in a clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent correct performance for the test and retest runs of speech perception ability	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	1 day - immediately post screening.

Collaborators and Investigators

• Sponsor: Cochlear

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2024
• Primary Completion (Estimated): May 2, 2027
• Study Completion (Estimated): May 2, 2027

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 27, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: AI5841

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No