Cochlear Hearing LossNCT06894303
Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up
An observational study of Cochlear Hearing Loss, run by Advanced Bionics AG at 1 site in France.
Trial summary
This is a prospective and monocentric clinical investigation, non-interventional and non-randomized. The overall goal of this clinical study is to generate additional clinical data confirming the safety and efficacy of the remote programming functionality of Target CI version 1.5 and the AB Remote Support app. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Hearing Loss
- What is being tested?
- Target CI v1.5 remote programming
- Type of treatment
- Medical device
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2025to Dec 2026
- Phase
- Observational
- 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
Study population: Advanced Bionics adults CI users
Who may be able to join
- Ability to provide informed consent
- Ability to give feedback on hearing impressions
- Aged 18 years of age or older
- Implanted with a HiResolution Bionic Ear System (HiRes 90K or HiRes 90K Advantage or HiRes Ultra or HiRes Ultra 3D) on at least one side
- Group 1 - Unilateral: no hearing device except contralateral routing of signals (CROS) device on the contralateral side
- Group 2 - Bilateral: implanted on both sides
Show all 12Show fewer
- Group 3 - Bimodal: hearing aid on the contralateral side
- Minimum of six months of cochlear implant experience
- Minimum of one month experience with a Naída CI M or Sky CI M sound processor
- Fluent in French language
- Ability to be tested via speech perception test in noise
- Smartphone user
Who cannot join
- Clinical presentation indicative of potential implanted device malfunction
- Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the Investigator
- Unwillingness or inability of subject to comply with all investigational requirements as determined by the Investigator
- Pregnancy and breast-feeding are not exclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Groupement Hospitalier Pitié Salpêtrière
Paris, 75013
Isabelle Mosnier, +33142162606, isabelle.mosnier@aphp.fr
About this study
This is a prospective and monocentric clinical investigation, non-interventional and non-randomized. The overall goal of this clinical study is to generate additional clinical data confirming the safety and efficacy of the remote programming functionality of Target CI version 1.5 and the AB Remote Support app. Hearing outcomes are expected to be similar whether a study subject's sound processor is programmed in the traditional method in the audiologist's office or whether programming is performed via remote fitting. Therefore, the study uses a non-inferiority design to determine whether sentence recognition in noise is no worse with remote fitting than in an in-office setting.
- Conditions
- Cochlear Hearing Loss
- Being tested
- Target CI v1.5 remote programming
- 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.
Target CI v1.5 remote programmingDevice
Use of the remote programming function of Target CI v1.5 and the AB remote support application
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Unilateral users Receives: Device: Target CI v1.5 remote programming | |
| Group 2 | Bilateral users Receives: Device: Target CI v1.5 remote programming | |
| Group 3 | Bimodal users Receives: Device: Target CI v1.5 remote programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
50% SRT measured as signal to noise ratio in DB (French Matrix test in noise)
The primary efficacy objective is to demonstrate that speech recognition in noise after remote fitting is no worse than speech recognition in noise after in-office fitting.
Measured: one-month chronic use of remotely fitted sound processor
Secondary outcomes (1)
Score in the Lafon phoneme test in quiet
The secondary efficacy objective is to demonstrate that speech recognition in quiet after remote fitting is no worse than speech recognition in quiet after in-office fitting.
Measured: one-month chronic use of remotely fitted sound processor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start3 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear Hearing LossStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advanced Bionics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894303
- Sponsor's protocol ID
- ABInt-24-23
- Status last verified
- May 2026
- First submitted
- 19 Mar 2025
- Last updated
- 20 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up
- ClinicalTrials.gov ID
- NCT06894303
- Acronym / sponsor ID
- ABInt-24-23
- Conditions
- Cochlear Hearing Loss
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Advanced Bionics AGIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Mar 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 is a prospective and monocentric clinical investigation, non-interventional and non-randomized. The overall goal of this clinical study is to generate additional clinical data confirming the safety and efficacy of the remote programming functionality of Target CI version 1.5 and the AB Remote Support app. Hearing outcomes are expected to be similar whether a study subject's sound processor is programmed in the traditional method in the audiologist's office or whether programming is performed via remote fitting. Therefore, the study uses a non-inferiority design to determine whether sentence recognition in noise is no worse with remote fitting than in an in-office setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: Target CI v1.5 remote programmingUnilateral users |
| Group 2 | – | Device: Target CI v1.5 remote programmingBilateral users |
| Group 3 | – | Device: Target CI v1.5 remote programmingBimodal users |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced Bionics adults CI users
Key inclusion criteria (12 listed)
- Ability to provide informed consent
- Ability to give feedback on hearing impressions
- Aged 18 years of age or older
- Implanted with a HiResolution Bionic Ear System (HiRes 90K or HiRes 90K Advantage or HiRes Ultra or HiRes Ultra 3D) on at least one side
- Minimum of six months of cochlear implant experience
Key exclusion criteria (4 listed)
- Clinical presentation indicative of potential implanted device malfunction
- Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the Investigator
- Unwillingness or inability of subject to comply with all investigational requirements as determined by the Investigator
- Pregnancy and breast-feeding are not exclusion criteria.
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 |
|---|---|---|
| Target CI v1.5 remote programmingUse of the remote programming function of Target CI v1.5 and the AB remote support application | Device | Group 1, Group 2, Group 3 |
Primary outcome
50% SRT measured as signal to noise ratio in DB (French Matrix test in noise)
Time frame: one-month chronic use of remotely fitted sound processor
The primary efficacy objective is to demonstrate that speech recognition in noise after remote fitting is no worse than speech recognition in noise after in-office fitting.
1 secondary outcome
Score in the Lafon phoneme test in quiet
Time frame: one-month chronic use of remotely fitted sound processor
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 20 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cochlear Hearing Loss, run by Advanced Bionics AG at 1 site in France.
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 12 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 20 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 1 site in France. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
50% SRT measured as signal to noise ratio in DB (French Matrix test in noise) (time frame: one-month chronic use of remotely fitted sound processor). 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 20 May 2026.