Hearing Loss, SensorineuralELSANCT07077070
Investigating Electrical Categorical Loudness Scaling Using a Mobile Research App in Experienced Adult Cochlear Implant Participants
A study testing Standard Electrical Categorical Loudness Scaling task (Standard-ELS) and Fast Electrical Categorical Loudness Scaling task (Fast-ELS) in people with Hearing Loss, Sensorineural, run by Cochlear at 3 sites in 2 countries.
Trial summary
This clinical study will evaluate a feature of the investigational Nexus Research System used for programming cochlear implants. Programming a cochlear implant-commonly referred to as MAP fitting-involves activating the device, allowing recipients to acclimatize to hearing sounds, and then fine-tuning the program… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- Standard Electrical Categorical Loudness Scaling task (Standard-ELS) and Fast Electrical Categorical Loudness Scaling task (Fast-ELS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 21 Oct 2025to 24 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- At least three months of experience with the cochlear implant.
- Implanted with the CI600 series (CI612, CI622, CI632) or CI500 series (CI512, CI522, CI532) cochlear implant.
- Able to be programmed with ACE (Advanced Combination Encoder), a fixed pulse width (PW) MAP with a maximum PW of 50 us per channel and with ≥ 18 enabled channels on the sound processor MAP.
- Fluent speaker in the language used to conduct the study procedures, as determined by the investigator.
- Willing and able to provide written informed consent and to comply with all requirements of the protocol.
Who cannot join
- Participants programmed with an acoustic component in the tested ear.
- Additional health factors, known to the investigator, that would prevent or restrict participation in the evaluations, including significant visual impairment and/or dexterity issues.
- 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 Organizations or contractors engaged by Cochlear for the purposes of this investigation.
- Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by investigator or Sponsor to not impact this investigation).
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Belgium2 sites
European Institute for Otorhinolaryngology (EIORL), ENT Department, Sint-Augustinus Antwerp
Antwerp, 2610
Cochlear Technology Centre Belgium
Mechelen, Mechelen, B-2800
United States1 site
Cochlear Denver Research Centre
Lone Tree, Colorado, 80124
About this study
Official title: A Feasibility, Prospective, Repeated-measures, Within-subject, Interventional Study Investigating the Electrical Categorical Loudness Scaling Using the Mobile Research App in the Home and In-clinic Situation in Experienced Adult Cochlear Implant Participants
This clinical study will evaluate a feature of the investigational Nexus Research System used for programming cochlear implants.
Programming a cochlear implant-commonly referred to as MAP fitting-involves activating the device, allowing recipients to acclimatize to hearing sounds, and then fine-tuning the program based on the user's perception of loudness across different sounds. This process typically occurs over several visits and requires a clinician to collect data for the fine-tuning phase.
Read more
The Nexus Research System includes an "Electrical Loudness Scaling" task, which participants can complete independently using a mobile application to collect the necessary data. Based on findings from previous studies, this feature has been revised to enable faster data collection. The current study will assess the performance of the updated feature.
The study will involve experienced cochlear implant users. Participants will use the feature, undergo a series of hearing assessments-including evaluations of loudness perception-and provide feedback on the updated feature.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- Standard Electrical Categorical Loudness Scaling task (Standard-ELS), Fast Electrical Categorical Loudness Scaling task (Fast-ELS)
- Keywords
- Cochlear implant, Sensorineural hearing loss, loudness scaling
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Electrical Categorical Loudness Scaling task (Standard-ELS)Device
The Standard-ELS task is conducted using the Mobile Research Application within the Nexus Research system. It is completed in two phases: the first phase identifies the lower and upper bounds of the loudness range based on participant ratings, while the second phase collects data from stimulations delivered within the established range.
Fast Electrical Categorical Loudness Scaling task (Fast-ELS)Device
The Fast-ELS task employs an algorithm to estimate the lower and upper bounds of the loudness range using a limited number of samples. This range is then refined by collecting additional samples across various loudness categories for comprehensive coverage.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Participants receiving both Standard and Fast ELS task | Experimental | Not described Receives: Device: Standard Electrical Categorical Loudness Scaling task (Standard-ELS); Device: Fast Electrical Categorical Loudness Scaling task (Fast-ELS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient reported loudness rating scores for very soft sounds (loudness category 5) between Fast-ELS and Standard-ELS within one on-site session.
To compare the accuracy of Fast-ELS and Standard-ELS obtained on MRA using a visual analogue scale within one session on-site.
Measured: Day 0, Day 14
Change in patient reported loudness rating scores for loud sounds (loudness category 35) between Fast-ELS and Standard-ELS within one on-site session.
To compare the accuracy of Fast-ELS and Standard-ELS obtained on MRA using a visual analogue scale within one session on-site.
Measured: Day 0, Day 14
Change in patient reported loudness rating scores for very soft sounds (loudness category 5) between Fast-ELS and Standard-ELS within one at home session.
To compare the accuracy of Fast-ELS and Standard-ELS obtained on MRA using a visual analogue scale within one session at home.
Measured: Day 0 - Day 14
Change in patient reported loudness rating scores for loud sounds (loudness category 35) between Fast-ELS and Standard-ELS within one at home session.
To compare the accuracy of Fast-ELS and Standard-ELS obtained on MRA using a visual analogue scale within one session at home.
Measured: Day 0 - Day 14
Secondary outcomes (8)
Correlation coefficient of very soft sounds (loudness category 5) obtained with Fast-ELS within one session on-site.
Test-retest reliability of Fast-ELS outcomes to very soft sounds obtained within one session on-site.
Measured: Day 0, Day 14
Correlation coefficient of very soft sounds (loudness category 5) obtained with Fast-ELS within one session at home.
Test-retest reliability of Fast-ELS outcomes to very soft sounds obtained within one session at home.
Measured: Day 0 - Day 14
Correlation coefficient of loud sounds (loudness category 35) obtained with Fast-ELS within one session on-site.
Test-retest reliability of Fast-ELS outcomes to loud sounds obtained within one session on-site.
Measured: Day 0, Day 14
Correlation coefficient of loud sounds (loudness category 35) obtained with Fast-ELS within one session at home.
Test-retest reliability of Fast-ELS outcomes to loud sounds obtained within one session at home.
Measured: Day 0 - Day 14
Correlation coefficient of very soft sounds (loudness category 5) obtained with Fast-ELS obtained during multiple sessions on-site.
Test-retest reliability of Fast-ELS outcomes to very soft sounds obtained during multiple sessions on-site.
Measured: 14 days
Correlation coefficient of very soft sounds (loudness category 5) obtained with Fast-ELS obtained during multiple sessions at home.
Test-retest reliability of Fast-ELS outcomes to very soft sounds obtained during multiple sessions at home.
Measured: 14 days
Correlation coefficient of very soft sounds (loudness category 35) obtained with Fast-ELS obtained during multiple sessions on-site.
Test-retest reliability of Fast-ELS outcomes to loud sounds obtained during multiple sessions on-site.
Measured: 14 days
Correlation coefficient of very soft sounds (loudness category 35) obtained with Fast-ELS obtained during multiple sessions at home.
Test-retest reliability of Fast-ELS outcomes to loud sounds obtained during multiple sessions at home.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start21 Oct 2025
- Primary completion24 Dec 2025
- Study completion24 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SensorineuralStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anke Plasmans, Study director, Cochlear Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077070
- Sponsor's protocol ID
- AI5862
- Acronym
- ELSA
- Status last verified
- Jun 2025
- First submitted
- 20 Jun 2025
- Last updated
- 8 Jan 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 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility, Prospective, Repeated-measures, Within-subject, Interventional Study Investigating the Electrical Categorical Loudness Scaling Using the Mobile Research App in the Home and In-clinic Situation in Experienced Adult Cochlear Implant Participants
- ClinicalTrials.gov ID
- NCT07077070
- Acronym / sponsor ID
- ELSA / AI5862
- Conditions
- Hearing Loss, Sensorineural
- Keywords
- Cochlear implant, Sensorineural hearing loss, loudness scaling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- 24 Dec 2025 (actual)
- Study completion
- 24 Dec 2025 (actual)
- First posted
- 22 Jul 2025 (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.
This clinical study will evaluate a feature of the investigational Nexus Research System used for programming cochlear implants.
Programming a cochlear implant-commonly referred to as MAP fitting-involves activating the device, allowing recipients to acclimatize to hearing sounds, and then fine-tuning the program based on the user's perception of loudness across different sounds. This process typically occurs over several visits and requires a clinician to collect data for the fine-tuning phase.
The Nexus Research System includes an "Electrical Loudness Scaling" task, which participants can complete independently using a mobile application to collect the necessary data. Based on findings from previous studies, this feature has been revised to enable faster data collection. The current study will assess the performance of the updated feature.
The study will involve experienced cochlear implant users. Participants will use the feature, undergo a series of hearing assessments-including evaluations of loudness perception-and provide feedback on the updated feature.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Participants receiving both Standard and Fast ELS task | Experimental | Device: Standard Electrical Categorical Loudness Scaling task (Standard-ELS), Device: Fast Electrical Categorical Loudness Scaling task (Fast-ELS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least three months of experience with the cochlear implant.
- Implanted with the CI600 series (CI612, CI622, CI632) or CI500 series (CI512, CI522, CI532) cochlear implant.
- Able to be programmed with ACE (Advanced Combination Encoder), a fixed pulse width (PW) MAP with a maximum PW of 50 us per channel and with ≥ 18 enabled channels on the sound processor MAP.
- Fluent speaker in the language used to conduct the study procedures, as determined by the investigator.
- Willing and able to provide written informed consent and to comply with all requirements of the protocol.
Key exclusion criteria (6 listed)
- Participants programmed with an acoustic component in the tested ear.
- Additional health factors, known to the investigator, that would prevent or restrict participation in the evaluations, including significant visual impairment and/or dexterity issues.
- 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 Organizations or contractors engaged by Cochlear for the purposes of this investigation.
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 |
|---|---|---|
| Standard Electrical Categorical Loudness Scaling task (Standard-ELS)The Standard-ELS task is conducted using the Mobile Research Application within the Nexus Research system. It is completed in two phases: the first phase identifies the lower and upper bounds of the loudness range based on participant ratings, while the second phase collects data from stimulations delivered within the established range. | Device | Experimental: Participants receiving both Standard and Fast ELS task |
| Fast Electrical Categorical Loudness Scaling task (Fast-ELS)The Fast-ELS task employs an algorithm to estimate the lower and upper bounds of the loudness range using a limited number of samples. This range is then refined by collecting additional samples across various loudness categories for comprehensive coverage. | Device | Experimental: Participants receiving both Standard and Fast ELS task |
Primary outcome
Change in patient reported loudness rating scores for very soft sounds (loudness category 5) between Fast-ELS and Standard-ELS within one on-site session.
Time frame: Day 0, Day 14
To compare the accuracy of Fast-ELS and Standard-ELS obtained on MRA using a visual analogue scale within one session on-site.
Change in patient reported loudness rating scores for loud sounds (loudness category 35) between Fast-ELS and Standard-ELS within one on-site session.
Time frame: Day 0, Day 14
To compare the accuracy of Fast-ELS and Standard-ELS obtained on MRA using a visual analogue scale within one session on-site.
Change in patient reported loudness rating scores for very soft sounds (loudness category 5) between Fast-ELS and Standard-ELS within one at home session.
Time frame: Day 0 - Day 14
To compare the accuracy of Fast-ELS and Standard-ELS obtained on MRA using a visual analogue scale within one session at home.
Change in patient reported loudness rating scores for loud sounds (loudness category 35) between Fast-ELS and Standard-ELS within one at home session.
Time frame: Day 0 - Day 14
To compare the accuracy of Fast-ELS and Standard-ELS obtained on MRA using a visual analogue scale within one session at home.
8 secondary outcomes
Correlation coefficient of very soft sounds (loudness category 5) obtained with Fast-ELS within one session on-site.
Time frame: Day 0, Day 14
Correlation coefficient of very soft sounds (loudness category 5) obtained with Fast-ELS within one session at home.
Time frame: Day 0 - Day 14
Correlation coefficient of loud sounds (loudness category 35) obtained with Fast-ELS within one session on-site.
Time frame: Day 0, Day 14
Correlation coefficient of loud sounds (loudness category 35) obtained with Fast-ELS within one session at home.
Time frame: Day 0 - Day 14
Correlation coefficient of very soft sounds (loudness category 5) obtained with Fast-ELS obtained during multiple sessions on-site.
Time frame: 14 days
Correlation coefficient of very soft sounds (loudness category 5) obtained with Fast-ELS obtained during multiple sessions at home.
Time frame: 14 days
Correlation coefficient of very soft sounds (loudness category 35) obtained with Fast-ELS obtained during multiple sessions on-site.
Time frame: 14 days
Correlation coefficient of very soft sounds (loudness category 35) obtained with Fast-ELS obtained during multiple sessions at home.
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Hearing Loss, Sensorineural
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
RecruitingObservational study
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
Cochlear Implantation, Sensorineural Hearing Loss
Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-hOTOF Gene Therapy
Otoferlin Gene-mediated Hearing Loss
Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
Conductive Hearing Loss, Mixed Hearing Loss
Active, not recruiting
Performance of a Remote Microphone Compared to Hearing Aids Alone
Hearing Loss, Bilateral Sensorineural
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.
Anke Plasmans study director
Cochlear Limited
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Electrical Categorical Loudness Scaling task (Standard-ELS) and Fast Electrical Categorical Loudness Scaling task (Fast-ELS) in people with Hearing Loss, Sensorineural, run by Cochlear at 3 sites in 2 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in patient reported loudness rating scores for very soft sounds (loudness category 5) between Fast-ELS and Standard-ELS within one on-site session. (time frame: Day 0, Day 14). The study lists 4 primary outcomes in all. 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 8 Jan 2026.