Hearing Impairment, SensorineuralSASCNCT05641155
A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation and Sound Coding in Adults.
A study testing Focused Multipolar Stimulation (FMS) strategy in people with Hearing Impairment, Sensorineural, run by Cochlear at 5 sites in 2 countries.
Trial summary
The purpose of this early feasibility study is to explore several facets of hearing performance of Focused Multipolar stimulation in adult cochlear implant users. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Impairment, Sensorineural
- What is being tested?
- Focused Multipolar Stimulation (FMS) strategy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 2 Jun 2023to 8 Dec 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
- 1) Candidate for unilateral cochlear implantation according to bilateral sensorineural hearing loss criteria, who has decided to proceed with implantation through routine processes.
- Bilateral sensorineural hearing loss criteria for clinics in the United States: i) Ear to be implanted:
- Moderate to profound sensorineural hearing loss, defined as a pure-tone average (PTA) (250 - 1000 Hz) ≥ 40 dB HL and a PTA (2000 - 8000 Hz) ≥ 65 dB HL
- Aided word score ≤ 40% ii) Contralateral ear:
- PTA (500, 1000, 2000, and 4000 Hz) > 30 dB HL (2) Aided word score ≤ 80% b) Bilateral sensorineural hearing loss criteria for clinics in Belgium: i) Both ears:
- PTA (500, 1000, 2000, and 4000 Hz) ≥ 70 dB HL for average of 3 out of 4 frequencies
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- Unaided phoneme score ≤ 50% on CVC in quiet at 70 dB SPL in free field
- ABR peak ≥ 75 dB nHL
- 2) 18 years of age or older.
- 3) Fluent in the language used for speech testing.
- 4) Willing to comply with all investigational requirements.
- 5) Willing and able to provide written informed consent
- -
Who cannot join
- Previous or existing cochlear-implant recipient.
- Severe or greater sensorineural hearing loss in the ear to be implanted prior to five years of age.
- Duration of severe to profound hearing loss > 20 years in the ear to be implanted.
- Ossification or other cochlear anomaly that might prevent complete insertion of the electrode array.
- Diagnosis of auditory neuropathy.
- Deafness due to lesions of the acoustic nerve or central auditory pathway.
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- Pregnant at the time of surgery.
- Additional handicaps that would prevent or restrict participation in the audiological evaluations.
- Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and prosthetic device.
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Belgium3 sites
Universitair Ziekenhuis Leuven
Leuven, Leuven, 3000
Cochlear Technology Centre Belgium
Mechelen, Mechelen, B-2800
ENT Department, Sint-Augutinus Antwerp
Wilrijk, Wilrijk, 2610
United States2 sites
Rocky Mountain Ear Center
Englewood, Colorado, 80113
Denver Research and Technology Lab
Lone Tree, Colorado, 80124
About this study
Official title: An Early Feasibility, Prospective, Exploratory Study Evaluating the Performance of Focused Multipolar Stimulation and Sound Coding Enhancements in Adult Cochlear Implant Recipients (SASC).
The purpose of this early feasibility study is to explore several facets of hearing performance of Focused Multipolar stimulation in adult cochlear implant users.
- Conditions
- Hearing Impairment, Sensorineural
- Being tested
- Focused Multipolar Stimulation (FMS) strategy
- 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.
Focused Multipolar Stimulation (FMS) strategyDevice
Cochlear implant programs (A and B) that utilise FMS with sound coding enhancements
| Study group | Role | What they receive |
|---|---|---|
| Cochlear implant user | Experimental | Adult cochlear implant users assessing different Focused Multipolar Stimulation (FMS) programs Receives: Device: Focused Multipolar Stimulation (FMS) strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference Between the Maximum C-Level for MAP A and MAP B
Difference between the maximum comfortable loudness level C-Level for MAP A and MAP B. This is the maximum current level that provides loud but comfortable sound level for the cochlear implant user.
Measured: 10 weeks
Difference in Spectral Resolution (QSMD) Score Between MAP A and MAP B
Mean difference between MAP A and MAP B for Quick Spectral Modulation Detection (QSMD) test. Higher scores indicate better spectral resolution and generally better ability to distinguish acoustic spectral patterns important for speech understanding. It measures the minimum modulation depth that can be perceived to enable discrimination of a spectrally modulated noise from a flat spectrum noise with the same bandwidth and overall intensity level.
Measured: 10 weeks
Difference in Language Independent Test (LIT) Score Between MAP A and MAP B
Mean difference between MAP A and MAP B for the phoneme discrimination test, Language independent test (LIT). The LIT test measures how well a person can hear the difference between speech sounds by asking them to identify which sound is different from the others.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start2 Jun 2023
- Primary completion6 Feb 2025
- Study completion8 Dec 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 Impairment, SensorineuralStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641155
- Sponsor's protocol ID
- AI5781
- Acronym
- SASC
- Status last verified
- Jun 2026
- First submitted
- 9 Nov 2022
- Last updated
- 29 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Feasibility, Prospective, Exploratory Study Evaluating the Performance of Focused Multipolar Stimulation and Sound Coding Enhancements in Adult Cochlear Implant Recipients (SASC).
- ClinicalTrials.gov ID
- NCT05641155
- Acronym / sponsor ID
- SASC / AI5781
- Conditions
- Hearing Impairment, Sensorineural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 6 Feb 2025 (actual)
- Study completion
- 8 Dec 2025 (actual)
- First posted
- 7 Dec 2022 (actual)
- Results
- Posted 29 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this early feasibility study is to explore several facets of hearing performance of Focused Multipolar stimulation in adult cochlear implant users.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cochlear implant user | Experimental | Device: Focused Multipolar Stimulation (FMS) strategyAdult cochlear implant users assessing different Focused Multipolar Stimulation (FMS) programs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1) Candidate for unilateral cochlear implantation according to bilateral sensorineural hearing loss criteria, who has decided to proceed with implantation through routine processes.
- Bilateral sensorineural hearing loss criteria for clinics in the United States: i) Ear to be implanted:
- Moderate to profound sensorineural hearing loss, defined as a pure-tone average (PTA) (250 - 1000 Hz) ≥ 40 dB HL and a PTA (2000 - 8000 Hz) ≥ 65 dB HL
- Aided word score ≤ 40% ii) Contralateral ear:
- PTA (500, 1000, 2000, and 4000 Hz) > 30 dB HL (2) Aided word score ≤ 80% b) Bilateral sensorineural hearing loss criteria for clinics in Belgium: i) Both ears:
Key exclusion criteria (13 listed)
- Previous or existing cochlear-implant recipient.
- Severe or greater sensorineural hearing loss in the ear to be implanted prior to five years of age.
- Duration of severe to profound hearing loss > 20 years in the ear to be implanted.
- Ossification or other cochlear anomaly that might prevent complete insertion of the electrode array.
- Diagnosis of auditory neuropathy.
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 |
|---|---|---|
| Focused Multipolar Stimulation (FMS) strategyCochlear implant programs (A and B) that utilise FMS with sound coding enhancements | Device | Cochlear implant user |
Primary outcome
Difference Between the Maximum C-Level for MAP A and MAP B
Time frame: 10 weeks
Difference between the maximum comfortable loudness level C-Level for MAP A and MAP B. This is the maximum current level that provides loud but comfortable sound level for the cochlear implant user.
Difference in Spectral Resolution (QSMD) Score Between MAP A and MAP B
Time frame: 10 weeks
Mean difference between MAP A and MAP B for Quick Spectral Modulation Detection (QSMD) test. Higher scores indicate better spectral resolution and generally better ability to distinguish acoustic spectral patterns important for speech understanding. It measures the minimum modulation depth that can be perceived to enable discrimination of a spectrally modulated noise from a flat spectrum noise with the same bandwidth and overall intensity level.
Difference in Language Independent Test (LIT) Score Between MAP A and MAP B
Time frame: 10 weeks
Mean difference between MAP A and MAP B for the phoneme discrimination test, Language independent test (LIT). The LIT test measures how well a person can hear the difference between speech sounds by asking them to identify which sound is different from the others.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused Multipolar Stimulation (FMS) strategy in people with Hearing Impairment, Sensorineural, run by Cochlear at 5 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 13 inclusion and 13 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 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Yes. Results are posted in the registry (first posted 29 Jul 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?
Difference Between the Maximum C-Level for MAP A and MAP B (time frame: 10 weeks). The study lists 3 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 29 Jul 2026.