Hearing LossVALDE-MUNCT06098482
An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App
A study testing Mobile Research App (MRA) and SOC/validated delivery of the speech perception test material in people with Hearing Loss, run by Cochlear at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Mobile Research App (MRA) and SOC/validated delivery of the speech perception test material
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 5 Feb 2024to 2 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Belgium2 sites
European Institute for Otorhinolaryngology (EIORL) ENT department Sint-Augustinus Antwerp
Antwerp, Antwerp, 2610
Hoorzorg van Looveren
Wommelgem, Antwerp, 2160
United States1 site
Denver Research and Technology Labs
Lone Tree, Colorado, 80124
About this study
Official 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
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
- Being tested
- Mobile Research App (MRA), SOC/validated delivery of the speech perception test material
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 materialOther
This involves the delivery of speech perception test material in the sound booth in a clinic.
| Study group | Role | What they receive |
|---|---|---|
| Delivery of speech perception materials in-clinic using the Mobile Research App (MRA) | Experimental | Cochlear implant recipients will participate in this arm (sub-investigation AI5841A). Receives: Device: Mobile Research App (MRA); Other: SOC/validated delivery of the speech perception test material |
| Delivery of speech perception materials in-clinic and at home using the Mobile Research App (MRA) | Experimental | Cochlear implant and hearing aid recipients will participate in this arm (sub-investigation AI5841B). Receives: Device: Mobile Research App (MRA); Other: SOC/validated delivery of the speech perception test material |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day - immediately post screening.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start5 Feb 2024
- Primary completion2 May 2027 (estimated)
- Study completion2 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by CochlearThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098482
- Sponsor's protocol ID
- AI5841
- Acronym
- VALDE-MU
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06098482
- Acronym / sponsor ID
- VALDE-MU / AI5841
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 2 May 2027 (estimated)
- Study completion
- 2 May 2027 (estimated)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delivery of speech perception materials in-clinic using the Mobile Research App (MRA) | Experimental | Device: Mobile Research App (MRA), Other: SOC/validated delivery of the speech perception test materialCochlear implant recipients will participate in this arm (sub-investigation AI5841A). |
| Delivery of speech perception materials in-clinic and at home using the Mobile Research App (MRA) | Experimental | Device: Mobile Research App (MRA), Other: SOC/validated delivery of the speech perception test materialCochlear implant and hearing aid recipients will participate in this arm (sub-investigation AI5841B). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Delivery of speech perception materials in-clinic and at home using the Mobile Research App (MRA), Delivery of speech perception materials in-clinic using the Mobile Research App (MRA) |
| SOC/validated delivery of the speech perception test materialThis involves the delivery of speech perception test material in the sound booth in a clinic. | Other | Delivery of speech perception materials in-clinic and at home using the Mobile Research App (MRA), Delivery of speech perception materials in-clinic using the Mobile Research App (MRA) |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Research App (MRA) and SOC/validated delivery of the speech perception test material in people with Hearing Loss, run by Cochlear at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent correct performance for the test and retest runs of speech perception ability (time frame: 1 day - immediately post screening.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.