Hearing LossCALOS4NCT05709223
Comparing the Performance of a Categorical Loudness Scaling Based Fitting With a Behavioural Fitting in Adults With a Nucleus Cochlear Implant 3 Months Post-activation
A study testing Categorical loudness scaling based fitting using the research fitting system. and Behavioural fitting using Custom Sound Suite (CSS 6.3) Software in people with Hearing Loss, run by Cochlear at 4 sites in 3 countries.
Trial summary
This study aims to collect data in newly implanted cochlear implant-recipients to inform future development of fitting methods to optimally and efficiently program a cochlear implant. 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?
- Categorical loudness scaling based fitting using the research fitting system. and Behavioural fitting using Custom Sound Suite (CSS 6.3) Software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 14 Mar 2023to 26 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Aged 18 years or older (no upper age limit).
- Post-lingually deafened defined as severe or greater sensorineural hearing loss onset after the age of 2 years as reported by the subject
- Unilaterally implanted with the CI600 Series (CI612, CI622, CI632) or CI500 series (CI512, CI522, CI532) cochlear implant.
- Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
- Willingness to participate in and comply with all requirements of the protocol.
- Willing and able to provide written informed consent
Who cannot join
- Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire.
- Subject who will be programmed with an acoustic component in the implanted ear.
- Pure tone average (average of unaided thresholds at 0.5, 1, 2 and 4 kHz) less than or equal to 30 dB HL and aided word score of more than 80% in the contralateral ear.
- Diagnosis of auditory neuropathy.
- 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.
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- 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 the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation). -
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Australia2 sites
HEARnet
Carlton, Victoria, 3053
Cochlear Sydney
Sydney, Sydney, 2113
About this study
Official title: Feasibility, Prospective, Within-subject, Interventional Study Comparing the Performance of a Categorical Loudness Scaling Based Fitting With a Behavioural Fitting in Adults With a Nucleus Cochlear Implant in the First 3 Months Post-activation
This study aims to collect data in newly implanted cochlear implant-recipients to inform future development of fitting methods to optimally and efficiently program a cochlear implant.
Read the detailed description
It aims to collect data to investigate if the new fitting method gives a good fit of MAP for newly implanted CI-recipients in terms of performance outcomes, compared to the standard streamlined behavioural fitting after 3 months of use.
- Conditions
- Hearing Loss
- Being tested
- Categorical loudness scaling based fitting using the research fitting system., Behavioural fitting using Custom Sound Suite (CSS 6.3) Software
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Categorical loudness scaling based fitting using the research fitting system.Device
The research fitting system is used in combination with other devices as part of a hearing implant system. It is intended to create and modify hearing profiles, to monitor the performance of the system and to facilitate firmware updates of the system.
Behavioural fitting using Custom Sound Suite (CSS 6.3) SoftwareDevice
The comparator is the commercially available fitting method (i.e., the behavioural measurement of active channels) using Custom Sound Suite (CSS 6.3) software
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving both Categorical Loudness Scaling Based Fitting and behavioural fitting. | Experimental | Participants will receive a categorical loudness scaling based fitting (Interventional) and behavioural fitting with 4 weeks experience of both MAPS Receives: Device: Categorical loudness scaling based fitting using the research fitting system.; Device: Behavioural fitting using Custom Sound Suite (CSS 6.3) Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percentage of Correct Monosyllabic Word Scores in Quiet (S0) at 50 dB SPL (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting)
To determine whether the loudness target (LT) map provides non-inferior speech understanding in quiet compared to the behavioural map.
Percentage of correct monosyllabic word scores in quiet (S0) at 50 dB SPL averaged across the sessions at visit 4 and visit 5. The higher the score, the better the outcome.
Measured: At visit 4 (week 8) and visit 5 (week 12)
Change in Adaptive Sentence in Noise Scores Measured in Decibels (S0N0 Test Setup) (Categorical Loudness Scaling Based Fitting Minus Behavioural Fitting)
To determine whether the loudness target (LT) map provides non-inferior speech understanding in noise compared to the behavioural map. Adaptive sentence in noise scores (S0N0 test setup) are averaged across the sessions at visit 4 and visit 5. Scores are expressed in decibels (dB).
Measured: At visit 4 (week 8) and visit 5 (week 12)
Secondary outcomes (3)
Speech, Spatial and Qualities of Hearing Scale (SSQ12) Ratings (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting)
To determine whether the loudness target map provides non-inferior speech understanding, sound quality and spatial hearing performance subjective ratings in daily life compared to the behavioural map.
The SSQ12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into 3 sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item. The average SSQ12 scores (on entire questionnaire) for each map type were used. SSQ12 ratings were collected at visit 4 and visit 5. The change between LT to behavioural map is then calculated and the theoretical score could vary between -10 to + 10. The higher the score, the better the benefit. A positive score indicates improved hearing, while a negative value indicates impaired hearing.
Measured: At visit 4 (week 8) and visit 5 (week 12)
Percentage Correct Monosyllabic Word Scores in Quiet (S0) at 60 dB SPL (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting)
To determine whether the LT map provides non-inferior speech understanding in quiet compared to the behavioural map early post activation.
Measured: Visit 3 (week 4)
Adaptive Digit Triplet Test (DTT) in Noise Scores (Categorical Loudnes Scaling Based Fitting Minus Behavioural Fitting)
To determine whether the LT map provides non-inferior speech understanding in noise compared to the behavioural map early post activation. Digit triplets are presented adaptively at different SNRs to estimate a patient's Speech Reception Threshold for 50%-digit triplet identification and expressed as a dB SNR (SNR50). The SRT is determined at the end of the test. A higher SRT means a worse outcome
Measured: Visit 3 (week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start14 Mar 2023
- Primary completion26 Feb 2025
- Study completion26 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- QbD Clinical, Avania
- Responsible party
- Sponsor
- Investigators
- Anke Plasmans, Study director, Cochlear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709223
- Sponsor's protocol ID
- AI5824
- Acronym
- CALOS4
- Status last verified
- Apr 2026
- First submitted
- 1 Dec 2022
- Last updated
- 15 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Prospective, Within-subject, Interventional Study Comparing the Performance of a Categorical Loudness Scaling Based Fitting With a Behavioural Fitting in Adults With a Nucleus Cochlear Implant in the First 3 Months Post-activation
- ClinicalTrials.gov ID
- NCT05709223
- Acronym / sponsor ID
- CALOS4 / AI5824
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Collaborators
- QbD Clinical, Avania
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 26 Feb 2025 (actual)
- First posted
- 2 Feb 2023 (actual)
- Results
- Posted 15 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to collect data in newly implanted cochlear implant-recipients to inform future development of fitting methods to optimally and efficiently program a cochlear implant.
Detailed description
It aims to collect data to investigate if the new fitting method gives a good fit of MAP for newly implanted CI-recipients in terms of performance outcomes, compared to the standard streamlined behavioural fitting after 3 months of use.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receiving both Categorical Loudness Scaling Based Fitting and behavioural fitting. | Experimental | Device: Categorical loudness scaling based fitting using the research fitting system., Device: Behavioural fitting using Custom Sound Suite (CSS 6.3) SoftwareParticipants will receive a categorical loudness scaling based fitting (Interventional) and behavioural fitting with 4 weeks experience of both MAPS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years or older (no upper age limit).
- Post-lingually deafened defined as severe or greater sensorineural hearing loss onset after the age of 2 years as reported by the subject
- Unilaterally implanted with the CI600 Series (CI612, CI622, CI632) or CI500 series (CI512, CI522, CI532) cochlear implant.
- Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
- Willingness to participate in and comply with all requirements of the protocol.
Key exclusion criteria (9 listed)
- Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire.
- Subject who will be programmed with an acoustic component in the implanted ear.
- Pure tone average (average of unaided thresholds at 0.5, 1, 2 and 4 kHz) less than or equal to 30 dB HL and aided word score of more than 80% in the contralateral ear.
- Diagnosis of auditory neuropathy.
- Additional health factors, known to the investigator, that would prevent or restrict participation in the evaluations, including significant visual impairment and/or dexterity issues.
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 |
|---|---|---|
| Categorical loudness scaling based fitting using the research fitting system.The research fitting system is used in combination with other devices as part of a hearing implant system. It is intended to create and modify hearing profiles, to monitor the performance of the system and to facilitate firmware updates of the system. | Device | Participants receiving both Categorical Loudness Scaling Based Fitting and behavioural fitting. |
| Behavioural fitting using Custom Sound Suite (CSS 6.3) SoftwareThe comparator is the commercially available fitting method (i.e., the behavioural measurement of active channels) using Custom Sound Suite (CSS 6.3) software | Device | Participants receiving both Categorical Loudness Scaling Based Fitting and behavioural fitting. |
Primary outcome
Change in Percentage of Correct Monosyllabic Word Scores in Quiet (S0) at 50 dB SPL (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting)
Time frame: At visit 4 (week 8) and visit 5 (week 12)
To determine whether the loudness target (LT) map provides non-inferior speech understanding in quiet compared to the behavioural map. Percentage of correct monosyllabic word scores in quiet (S0) at 50 dB SPL averaged across the sessions at visit 4 and visit 5. The higher the score, the better the outcome.
Change in Adaptive Sentence in Noise Scores Measured in Decibels (S0N0 Test Setup) (Categorical Loudness Scaling Based Fitting Minus Behavioural Fitting)
Time frame: At visit 4 (week 8) and visit 5 (week 12)
To determine whether the loudness target (LT) map provides non-inferior speech understanding in noise compared to the behavioural map. Adaptive sentence in noise scores (S0N0 test setup) are averaged across the sessions at visit 4 and visit 5. Scores are expressed in decibels (dB).
3 secondary outcomes
Speech, Spatial and Qualities of Hearing Scale (SSQ12) Ratings (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting)
Time frame: At visit 4 (week 8) and visit 5 (week 12)
Percentage Correct Monosyllabic Word Scores in Quiet (S0) at 60 dB SPL (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting)
Time frame: Visit 3 (week 4)
Adaptive Digit Triplet Test (DTT) in Noise Scores (Categorical Loudnes Scaling Based Fitting Minus Behavioural Fitting)
Time frame: Visit 3 (week 4)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Anke Plasmans study director
Cochlear
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Categorical loudness scaling based fitting using the research fitting system. and Behavioural fitting using Custom Sound Suite (CSS 6.3) Software 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 6 inclusion and 9 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 15 May 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 Australia, United States, Germany. 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?
Yes. Results are posted in the registry (first posted 15 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Percentage of Correct Monosyllabic Word Scores in Quiet (S0) at 50 dB SPL (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting) (time frame: At visit 4 (week 8) and visit 5 (week 12)). The study lists 2 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 15 May 2026.