CClinicalTrials.gg
RecruitingNCT06098482VALDE-MUUpdated Apr 30, 2025

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

An interventional study of Mobile Research App (MRA) and SOC/validated delivery of the speech perception test material in Hearing Loss, sponsored by Cochlear. Recruiting at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-30.

Sponsored by Cochlear · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hearing Loss

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03

In context

Hearing Loss

1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.

This study's planned enrollment of 46 is above the median of 40 across 764 interventional studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

Cochlear is the lead sponsor of 91 studies on the registry; 11 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 15 (94%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
46 participants (estimated)

Study arms

  • 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) · Other: SOC/validated delivery of the speech perception test material

  • 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) · Other: SOC/validated delivery of the speech perception test material

Interventions

  • DeviceMobile 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.

  • OtherSOC/validated delivery of the speech perception test material

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 day - immediately post screening.

07

Study locations

2 of 4 sites recruiting
  • Denver Research and Technology Labs
    Lone Tree, Colorado 80124, United States
    Completed
  • HEARnet Clinical Studies
    Melbourne, Victoria 3053, Australia
    Active, not recruiting
  • Hoorzorg van Looveren
    Wommelgem, Antwerp 2160, Belgium
    Recruiting
  • European Institute for Otorhinolaryngology (EIORL) ENT department Sint-Augustinus Antwerp
    Antwerp, 2610, Belgium
    • Andrzej Zarowski, MD, PhD · Contact · andrzej.zarowski@zas.be · 34433604
    • Andrzej Zarowski, MD, PhD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06098482
Lead sponsor
Cochlear
Responsible party
Sponsor
First posted
Oct 24, 2023
Start date
Feb 5, 2024
Primary completion
May 2, 2027 (estimated)
Completion
May 2, 2027 (estimated)
Last update
Apr 30, 2025

Study contacts

Geert De Ceulaer
Contact
gdeceulaer@cochlear.com
+32486893006

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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