Trial Outcomes & Findings for Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients (NCT NCT06298396)

Results Overview

Speech perception in quiet was measured for each MAP using recorded CNC monosyllabic words. The goal of speech perception assessment in quiet was to compare % words correct for each of the conditions. The minimum score is 0% and maximum sore is 100%. A higher score means a better outcome. An average CNC word score for each MAP was calculated by combining the data from the specified timepoints.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

10 participants completed this test at Week 4, and 10 participants completed this at week 8

Results posted on

2025-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants All participants evaluated each test of the 4 test programs: 1. Default, 900 Hz stimulation rate (rate), 25 µs Pulse Width (PW) using Monopolar (MP) stimulation mode 2. LP1, 900 Hz rate, 50 µs PW, MP mode 3. LP2, 500 Hz rate,100 µs PW, MP mode 4. LP3, 500 Hz rate, 100 µs PW, using an investigational stimulation mode
Default MAP STARTED	20
Default MAP COMPLETED	19
Default MAP NOT COMPLETED	1
Low Power 1 (LP1) MAP STARTED	20
Low Power 1 (LP1) MAP COMPLETED	20
Low Power 1 (LP1) MAP NOT COMPLETED	0
Low Power 2 (LP2) MAP STARTED	20
Low Power 2 (LP2) MAP COMPLETED	20
Low Power 2 (LP2) MAP NOT COMPLETED	0
Low Power 3 (LP3) MAP STARTED	20
Low Power 3 (LP3) MAP COMPLETED	20
Low Power 3 (LP3) MAP NOT COMPLETED	0

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants All participants evaluated each test of the 4 test programs: 1. Default, 900 Hz stimulation rate (rate), 25 µs Pulse Width (PW) using Monopolar (MP) stimulation mode 2. LP1, 900 Hz rate, 50 µs PW, MP mode 3. LP2, 500 Hz rate,100 µs PW, MP mode 4. LP3, 500 Hz rate, 100 µs PW, using an investigational stimulation mode
Default MAP Protocol Violation	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=20 Participants All participants used four different MAPs (Default, LP1, LP2 and LP3) during two take-home periods, completing hearing assessments and questionnaires The study sound processor was Cochlear™ Nucleus® 7, Nucleus® 8 or Kanso® 2 sound processors depending on the participants usual Sound Processor type.
Age, Categorical <=18 years	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=20 Participants
Age, Categorical >=65 years	15 Participants n=20 Participants
Age, Continuous	70.2 years n=20 Participants
Sex: Female, Male Female	7 Participants n=20 Participants
Sex: Female, Male Male	13 Participants n=20 Participants
Region of Enrollment Australia	20 participants n=20 Participants

PRIMARY outcome

Timeframe: 10 participants completed this test at Week 4, and 10 participants completed this at week 8

Population: One participant had the default MAP created using a Pulse Width of 37 µs rather than the required 25 µs, so there were 19 paired data points for analysis. All remaining participants were tested with the Default and LP1 MAPs

Speech perception in quiet was measured for each MAP using recorded CNC monosyllabic words. The goal of speech perception assessment in quiet was to compare % words correct for each of the conditions. The minimum score is 0% and maximum sore is 100%. A higher score means a better outcome. An average CNC word score for each MAP was calculated by combining the data from the specified timepoints.

Outcome measures

Outcome measures
Measure	Sound processor MAP n=19 Participants All participants were tested with each MAP
Paired Mean Difference Score for CNC Words Correct Between Default and LP1 MAPs in Quiet	-0.05 percentage word score Interval -2.92 to 2.81

PRIMARY outcome

Timeframe: 10 participants completed the test at Week 4, 10 participants completed the test at Week 8

Population: One participant had the default MAP created using a Pulse Width of 37 µs rather than the required 25 µs, so there were 19 paired data points for analysis. All remaining participants were tested with the Default and LP1 MAPs

Speech perception in noise was measured using the Australian Speech Test in Noise (AuSTIN), which is a test that uses recorded BKB-like target sentences. The goal of the speech perception test in noise is to provide the Speech Reception Threshold (SRT) in dB for 50% speech intelligibility (dB SRT) There is no minimum score. The maximum score is 15 dB. A lower score means a better outcome. An average SRT score for each MAP was calculated by combining the data from the specified timepoints.

Outcome measures

Outcome measures
Measure	Sound processor MAP n=19 Participants All participants were tested with each MAP
Paired Mean Difference Score in dB SRT (AuSTIN) Between Default and LP1 MAPs in Noise	-0.32 dB SRT Interval -0.87 to 0.24

SECONDARY outcome

Timeframe: 10 participants completed the test at Week 4, 10 participants completed the test at Week 8

Population: All participants were tested with the LP1 and LP2 MAPs

Speech perception in quiet was measured for each MAP using recorded CNC monosyllabic words. The goal of speech perception assessment in quiet was to compare % words correct for each MAP. The minimum score is 0% and maximum sore is 100%. A higher score means a better outcome. An average CNC word score for each MAP was calculated by combining the data from the specified timepoints.

Outcome measures

Outcome measures
Measure	Sound processor MAP n=20 Participants All participants were tested with each MAP
Paired Mean Difference Score for CNC Words Correct Between LP1 and LP2 MAPs in Quiet	0.45 percentage word score Interval -2.72 to 3.62

SECONDARY outcome

Timeframe: 10 participants completed this test at Week 4, and 10 participants completed this at week 8

Population: All participants were tested with the LP1 and LP2 MAPs

Speech perception in noise was measured using the Australian Speech Test in Noise (AuSTIN), which is a test that uses recorded BKB-like target sentences. The goal of the speech perception test in noise is to provide the Speech Reception Threshold (SRT) in dB for 50% speech intelligibility (dB SRT) There is no minimum score. The maximum score is 15 dB. A lower score means a better outcome. An average SRT score for each MAP was calculated by combining the data from the specified timepoints.

Outcome measures

Outcome measures
Measure	Sound processor MAP n=20 Participants All participants were tested with each MAP
Paired Mean Difference Score in dB SRT (AuSTIN) Between LP1 and LP2 MAPs in Noise	-0.23 dB SRT Interval -0.55 to 0.75

SECONDARY outcome

Timeframe: 10 participants completed this test at Week 4, and 10 participants completed this at week 8

Population: All participants were tested with the LP1 and LP3 MAPs

Speech perception in quiet was measured for each MAP using recorded CNC monosyllabic words. The goal of speech perception assessment in quiet was to compare % words correct for each of the conditions. The minimum score is 0% and maximum sore is 100%. A higher score means a better outcome. An average CNC word score for each MAP was calculated by combining the data from the specified timepoints.

Outcome measures

Outcome measures
Measure	Sound processor MAP n=20 Participants All participants were tested with each MAP
Paired Mean Difference Score in Percentage CNC Words Correct Between LP1 and LP3 MAPs in Quiet	-1.6 percentage word score Interval -5.15 to 1.95

SECONDARY outcome

Timeframe: 10 participants completed this test with at Week 4 and 10 participants completed this at week 8

Population: All participants were tested with the LP1 and LP3 MAPs.

Speech perception in noise was measured using the Australian Speech Test in Noise (AuSTIN), which is a test that uses recorded BKB-like target sentences. The goal of the speech perception test in noise is to provide the Speech Reception Threshold (SRT) in dB for 50% speech intelligibility (dB SRT) There is no minimum score. The maximum score is 15 dB. A lower score means a better outcome. An average SRT score for each MAP was calculated by combining the data from the specified timepoints.

Outcome measures

Outcome measures
Measure	Sound processor MAP n=20 Participants All participants were tested with each MAP
Paired Mean Difference Score in dB SRT (AuSTIN) Between LP1 and LP3 MAPs in Noise	-0.39 dB SRT Interval -1.1 to 0.32

SECONDARY outcome

Timeframe: 10 participants were evaluated at week 4 and 10 participants were evaluated at week 8

Population: All participants evaluated switching between the LP2 and LP3 MAPs.

Participants rated the sound quality when switching between the LP2 and LP3 MAPs with the investigator asking the question: How does the sound quality of the new program compare with the previous program in terms of sound quality? The possible responses being "very different, somewhat different, similar, or the same". The number of participants in each category will be reported.

Outcome measures

Outcome measures
Measure	Sound processor MAP n=20 Participants All participants were tested with each MAP
Switching Acceptability Rating Between LP2 and LP3 MAPs Somewhat different sound quality	7 Participants
Switching Acceptability Rating Between LP2 and LP3 MAPs Very different sound quality	0 Participants
Switching Acceptability Rating Between LP2 and LP3 MAPs Same sound quality	5 Participants
Switching Acceptability Rating Between LP2 and LP3 MAPs Similar sound quality	8 Participants

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Participants n=20 participants at risk All participants who were tested with each MAP and completed the study.
Infections and infestations Viral infection	5.0% 1/20 • Number of events 1 • Each participant was assessed from enrollment to final study visit, approximately 8 weeks

Additional Information

PRS Specialist

Cochlear Limited

Phone: +61 2 9428 6555

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place