Trial Outcomes & Findings for A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation and Sound Coding in Adults. (NCT NCT05641155)

Last Updated: 2026-07-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

10 weeks

Results posted on

2026-07-29

Participant Flow

All participants evaluated the experimental FMS programs (MAP A and MAP B).

Participant milestones

Participant milestones
Measure	Adult Cochlear Implant Users Adult cochlear implant users who evaluated the test programs (MAP A and MAP B)
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adult Cochlear Implant Users n=18 Participants Adult cochlear implant users who evaluated the test programs (MAP A and MAP B)
Age, Continuous	61.7 years STANDARD_DEVIATION 14.9 • n=18 Participants
Sex: Female, Male Female	9 Participants n=18 Participants
Sex: Female, Male Male	9 Participants n=18 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cochlear Implant Users n=18 Participants Adult cochlear implant users using MAP A and MAP B
Difference Between the Maximum C-Level for MAP A and MAP B MAP A	224.0 Current Units (CU) Standard Deviation 11.1
Difference Between the Maximum C-Level for MAP A and MAP B MAP B	229.3 Current Units (CU) Standard Deviation 11.7
Difference Between the Maximum C-Level for MAP A and MAP B Mean Difference (MAP B-MAP A)	5.3 Current Units (CU) Standard Deviation 6.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cochlear Implant Users n=18 Participants Adult cochlear implant users using MAP A and MAP B
Difference in Spectral Resolution (QSMD) Score Between MAP A and MAP B MAP A	82.8 percentage correct Standard Deviation 16.7
Difference in Spectral Resolution (QSMD) Score Between MAP A and MAP B Map B	83.7 percentage correct Standard Deviation 15.5
Difference in Spectral Resolution (QSMD) Score Between MAP A and MAP B Mean Difference (MAP B-MAP A)	0.88 percentage correct Standard Deviation 5.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cochlear Implant Users n=18 Participants Adult cochlear implant users using MAP A and MAP B
Difference in Language Independent Test (LIT) Score Between MAP A and MAP B MAP B	71.2 percentage correct Standard Deviation 16.0
Difference in Language Independent Test (LIT) Score Between MAP A and MAP B Mean Difference (MAP B-MAP A)	1.3 percentage correct Standard Deviation 4.5
Difference in Language Independent Test (LIT) Score Between MAP A and MAP B MAP A	69.9 percentage correct Standard Deviation 15.6

Adverse Events

Adult Cochlear Implant Users

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Adult Cochlear Implant Users n=18 participants at risk Adult cochlear implant users who evaluated the test programs (MAP A and MAP B)
Ear and labyrinth disorders DIZZINESS	5.6% 1/18 • From enrollment until end of follow-up, up to 14 months Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by for MAP A and MAP B were not prospectively collected, as both MAPs were applied within the same cohort and safety monitoring was conducted at the participant level rather than per MAP used. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.
Cardiac disorders CARDIOMYOPATHY	5.6% 1/18 • From enrollment until end of follow-up, up to 14 months Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by for MAP A and MAP B were not prospectively collected, as both MAPs were applied within the same cohort and safety monitoring was conducted at the participant level rather than per MAP used. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.

Other adverse events

Other adverse events
Measure	Adult Cochlear Implant Users n=18 participants at risk Adult cochlear implant users who evaluated the test programs (MAP A and MAP B)
Respiratory, thoracic and mediastinal disorders Bronchitis	5.6% 1/18 • From enrollment until end of follow-up, up to 14 months Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by for MAP A and MAP B were not prospectively collected, as both MAPs were applied within the same cohort and safety monitoring was conducted at the participant level rather than per MAP used. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.
Infections and infestations Common cold	5.6% 1/18 • From enrollment until end of follow-up, up to 14 months Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by for MAP A and MAP B were not prospectively collected, as both MAPs were applied within the same cohort and safety monitoring was conducted at the participant level rather than per MAP used. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.
Ear and labyrinth disorders Dizziness	16.7% 3/18 • From enrollment until end of follow-up, up to 14 months Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by for MAP A and MAP B were not prospectively collected, as both MAPs were applied within the same cohort and safety monitoring was conducted at the participant level rather than per MAP used. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.
Ear and labyrinth disorders Sore ear	33.3% 6/18 • From enrollment until end of follow-up, up to 14 months Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by for MAP A and MAP B were not prospectively collected, as both MAPs were applied within the same cohort and safety monitoring was conducted at the participant level rather than per MAP used. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.
Ear and labyrinth disorders Falls	5.6% 1/18 • From enrollment until end of follow-up, up to 14 months Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by for MAP A and MAP B were not prospectively collected, as both MAPs were applied within the same cohort and safety monitoring was conducted at the participant level rather than per MAP used. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.
Infections and infestations Head cold	11.1% 2/18 • From enrollment until end of follow-up, up to 14 months Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by for MAP A and MAP B were not prospectively collected, as both MAPs were applied within the same cohort and safety monitoring was conducted at the participant level rather than per MAP used. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.
Nervous system disorders Headache	22.2% 4/18 • From enrollment until end of follow-up, up to 14 months Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by for MAP A and MAP B were not prospectively collected, as both MAPs were applied within the same cohort and safety monitoring was conducted at the participant level rather than per MAP used. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.
Nervous system disorders Imbalance	5.6% 1/18 • From enrollment until end of follow-up, up to 14 months Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by for MAP A and MAP B were not prospectively collected, as both MAPs were applied within the same cohort and safety monitoring was conducted at the participant level rather than per MAP used. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.
Infections and infestations Viral infection	5.6% 1/18 • From enrollment until end of follow-up, up to 14 months Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by for MAP A and MAP B were not prospectively collected, as both MAPs were applied within the same cohort and safety monitoring was conducted at the participant level rather than per MAP used. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.
Nervous system disorders Light headedness	5.6% 1/18 • From enrollment until end of follow-up, up to 14 months Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by for MAP A and MAP B were not prospectively collected, as both MAPs were applied within the same cohort and safety monitoring was conducted at the participant level rather than per MAP used. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.
General disorders Loudness discomfort	5.6% 1/18 • From enrollment until end of follow-up, up to 14 months Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by for MAP A and MAP B were not prospectively collected, as both MAPs were applied within the same cohort and safety monitoring was conducted at the participant level rather than per MAP used. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.
Gastrointestinal disorders Nausea	11.1% 2/18 • From enrollment until end of follow-up, up to 14 months Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by for MAP A and MAP B were not prospectively collected, as both MAPs were applied within the same cohort and safety monitoring was conducted at the participant level rather than per MAP used. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.
General disorders Swelling at surgical site	16.7% 3/18 • From enrollment until end of follow-up, up to 14 months Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by for MAP A and MAP B were not prospectively collected, as both MAPs were applied within the same cohort and safety monitoring was conducted at the participant level rather than per MAP used. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.
Ear and labyrinth disorders Vertigo	5.6% 1/18 • From enrollment until end of follow-up, up to 14 months Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by for MAP A and MAP B were not prospectively collected, as both MAPs were applied within the same cohort and safety monitoring was conducted at the participant level rather than per MAP used. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.
Ear and labyrinth disorders Worsened tinnitus	5.6% 1/18 • From enrollment until end of follow-up, up to 14 months Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by for MAP A and MAP B were not prospectively collected, as both MAPs were applied within the same cohort and safety monitoring was conducted at the participant level rather than per MAP used. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.
Ear and labyrinth disorders Ear pressure/fullness	16.7% 3/18 • From enrollment until end of follow-up, up to 14 months Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by for MAP A and MAP B were not prospectively collected, as both MAPs were applied within the same cohort and safety monitoring was conducted at the participant level rather than per MAP used. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.
Eye disorders Eye injury/visual disturbance	5.6% 1/18 • From enrollment until end of follow-up, up to 14 months Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by for MAP A and MAP B were not prospectively collected, as both MAPs were applied within the same cohort and safety monitoring was conducted at the participant level rather than per MAP used. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.
Ear and labyrinth disorders Non-auditory Stimulation	11.1% 2/18 • From enrollment until end of follow-up, up to 14 months Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by for MAP A and MAP B were not prospectively collected, as both MAPs were applied within the same cohort and safety monitoring was conducted at the participant level rather than per MAP used. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.
Surgical and medical procedures Post-surgical complication (CI surgery)	5.6% 1/18 • From enrollment until end of follow-up, up to 14 months Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by for MAP A and MAP B were not prospectively collected, as both MAPs were applied within the same cohort and safety monitoring was conducted at the participant level rather than per MAP used. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.
General disorders Accidental injury	5.6% 1/18 • From enrollment until end of follow-up, up to 14 months Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by for MAP A and MAP B were not prospectively collected, as both MAPs were applied within the same cohort and safety monitoring was conducted at the participant level rather than per MAP used. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.
Infections and infestations Sexually transmitted infection	5.6% 1/18 • From enrollment until end of follow-up, up to 14 months Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by for MAP A and MAP B were not prospectively collected, as both MAPs were applied within the same cohort and safety monitoring was conducted at the participant level rather than per MAP used. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.
Cardiac disorders Orthostatic hypotension	5.6% 1/18 • From enrollment until end of follow-up, up to 14 months Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by for MAP A and MAP B were not prospectively collected, as both MAPs were applied within the same cohort and safety monitoring was conducted at the participant level rather than per MAP used. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.
Cardiac disorders Cardiomyopathy	5.6% 1/18 • From enrollment until end of follow-up, up to 14 months Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by for MAP A and MAP B were not prospectively collected, as both MAPs were applied within the same cohort and safety monitoring was conducted at the participant level rather than per MAP used. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.
Ear and labyrinth disorders Tinnitus	16.7% 3/18 • From enrollment until end of follow-up, up to 14 months Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by for MAP A and MAP B were not prospectively collected, as both MAPs were applied within the same cohort and safety monitoring was conducted at the participant level rather than per MAP used. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.

Additional Information

[email protected]

Cochlear Limited

Phone: +61 2 9428 6555

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is the sponsor can review results communications before public release and can prohibit communications about trial results for 12 months post study completion (i.e after last subject visit).
Publication restrictions are in place

Restriction type: OTHER