Trial Outcomes & Findings for Acceptance and Performance of the CP1170 Sound Processor in Experienced Adult Cochlear Implant Recipients (NCT NCT05619575)

Results Overview

Speech perception in noise was measured using the Australian Speech Test In Noise (AUSTIN), which is a test that uses Bamford-Kowal-Bench (BKB)-like target sentences presented in adaptive noise. The goal of the speech perception test in noise was to provide the speech-to-noise ratio for 50% speech intelligibility.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

During a Single Ad-Hoc Visit (between Day 141 - Day 218)

Results posted on

2025-08-22

Participant Flow

Participant milestones

Participant milestones
Measure	Adults With a Cochlear Implant All study participants (post-lingually deafened adults with at least 6 months experience with a cochlear implant and 3 months experience with SCAN program).
Overall Study STARTED	20
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	3

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	Adults With a Cochlear Implant n=20 Participants All study participants (post-lingually deafened adults with at least 6 months experience with a cochlear implant and 3 months experience with SCAN program).
Age, Continuous	63.4 years n=20 Participants
Sex: Female, Male Female	16 Participants n=20 Participants
Sex: Female, Male Male	4 Participants n=20 Participants
Region of Enrollment Australia	20 participants n=20 Participants

PRIMARY outcome

Timeframe: During a Single Ad-Hoc Visit (between Day 141 - Day 218)

Speech perception in noise was measured using the Australian Speech Test In Noise (AUSTIN), which is a test that uses Bamford-Kowal-Bench (BKB)-like target sentences presented in adaptive noise. The goal of the speech perception test in noise was to provide the speech-to-noise ratio for 50% speech intelligibility.

Outcome measures

Outcome measures
Measure	All Participants n=17 Participants Participants completed a hearing test using CP1170 with automated ForwardFocus switched on (SCAN 2 FF) or ForwardFocus switched off (SCAN 2).
Paired Difference in dB SRT Between the CP1170 SCAN 2 FF (Automated ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF) in 65 dB SPL (Sound Pressure Level) S0Nrearhalf 4Talker Babble (Speech Perception in Noise) CP1170 SCAN 2 FF	-6.58 dB SRT Interval -8.38 to -4.77
Paired Difference in dB SRT Between the CP1170 SCAN 2 FF (Automated ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF) in 65 dB SPL (Sound Pressure Level) S0Nrearhalf 4Talker Babble (Speech Perception in Noise) CP1170 SCAN 2	-4.58 dB SRT Interval -6.3 to -2.86
Paired Difference in dB SRT Between the CP1170 SCAN 2 FF (Automated ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF) in 65 dB SPL (Sound Pressure Level) S0Nrearhalf 4Talker Babble (Speech Perception in Noise) Difference between CP1170 SCAN 2 FF and SCAN 2	-2.00 dB SRT Interval -2.82 to -1.18

SECONDARY outcome

Timeframe: During a single Ad-Hoc Visit (anytime between Day 141 - Day 218)

Speech perception in noise was measured using the Australian Speech Test In Noise (AUSTIN), which is a test that uses Bamford-Kowal-Bench (BKB)-like target sentences presented in adaptive noise. The goal of the speech perception test in noise was to provide the speech-to-noise ratio for 50% speech intelligibility.

Outcome measures

Outcome measures
Measure	All Participants n=17 Participants Participants completed a hearing test using CP1170 with automated ForwardFocus switched on (SCAN 2 FF) or ForwardFocus switched off (SCAN 2).
Paired Difference in dB SRT Between the CP1170 SCAN 2 FF (Automated ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF) in 65 dB SPL S0N3 Babble (Speech Perception in Noise) CP1170 SCAN 2 FF	-4.66 dB SRT Interval -6.65 to -2.67
Paired Difference in dB SRT Between the CP1170 SCAN 2 FF (Automated ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF) in 65 dB SPL S0N3 Babble (Speech Perception in Noise) CP1170 SCAN 2	-3.24 dB SRT Interval -5.29 to -1.18
Paired Difference in dB SRT Between the CP1170 SCAN 2 FF (Automated ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF) in 65 dB SPL S0N3 Babble (Speech Perception in Noise) Difference between SCAN 2 FF and SCAN 2	-1.43 dB SRT Interval -2.2 to -0.65

SECONDARY outcome

Timeframe: During Ad-Hoc Visit (anytime between Day 127 - Day 190)

Speech perception in quiet was measured using the CNC monosyllabic words at 50 dB SPL from S0 position. The goal of speech perception assessment in quiet was to compare % words correct for each of the conditions.

Outcome measures

Outcome measures
Measure	All Participants n=17 Participants Participants completed a hearing test using CP1170 with automated ForwardFocus switched on (SCAN 2 FF) or ForwardFocus switched off (SCAN 2).
Paired Difference in Percentage CNC (Consonant-nucleus-consonant) Words Correct in Quiet (50 dB) Between the CP1170 Sound Processor and CP1150 Sound Processor (Commercial Version) CP1170 SCAN 2	59.06 Percentage of correct words Interval 51.91 to 66.21
Paired Difference in Percentage CNC (Consonant-nucleus-consonant) Words Correct in Quiet (50 dB) Between the CP1170 Sound Processor and CP1150 Sound Processor (Commercial Version) CP1150 SCAN	56.53 Percentage of correct words Interval 49.09 to 63.97
Paired Difference in Percentage CNC (Consonant-nucleus-consonant) Words Correct in Quiet (50 dB) Between the CP1170 Sound Processor and CP1150 Sound Processor (Commercial Version) Difference between CP1170 and CP1150	2.53 Percentage of correct words Interval -0.41 to 5.47

SECONDARY outcome

Timeframe: 2 weeks

Population: At baseline, 20 participants completed the Baseline Questionnaire. As three participants did not complete the study, the CP1170 Questionnaire was completed by 17 participants rather than 20.

Number of participants who were somewhat or very satisfied with the overall sound quality of their SCAN program (SCAN in own sound processor, SCAN 2 FF in CP1170) as indicated through two questionnaires. The CP1170 Questionnaire and Baseline Questionnaire have a 5-point Likert scale for each rating (with the values ranging from: 1 = least favourable option to 3 = Neutral to 5 = most favourable option).

Outcome measures

Outcome measures
Measure	All Participants n=20 Participants Participants completed a hearing test using CP1170 with automated ForwardFocus switched on (SCAN 2 FF) or ForwardFocus switched off (SCAN 2).
Subjective Acceptance and Satisfaction Between the CP1170 Sound Processor and the Subject's Own Processor CP1170 Sound Processor	16 Participants
Subjective Acceptance and Satisfaction Between the CP1170 Sound Processor and the Subject's Own Processor Own Sound Processor	18 Participants

SECONDARY outcome

Timeframe: During a Single Ad-Hoc Visit (anytime between Day 23 - Day 70)

Population: Twenty participants completed the SSQ12 at Baseline for their own sound processor, however, due to subject attrition, only 18 participants completed the questionnaire on the CP1170 Sound Processor.

The SSQ12, which measures subjective hearing performance, is comprised of 12 items using the response format on a scale from 0 to 10, where 0 equals no ability and 10 equals perfect ability. These are divided into three 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 change from baseline is then calculated and the theoretical score could vary between -10 to +10. The higher the score, the higher the benefit. A positive score indicates improved hearing, and a negative value indicates impaired hearing.

Outcome measures

Outcome measures
Measure	All Participants n=20 Participants Participants completed a hearing test using CP1170 with automated ForwardFocus switched on (SCAN 2 FF) or ForwardFocus switched off (SCAN 2).
Paired Difference in Global SSQ12 Scores After Experience With the CP1170 Sound Processor and Own Processor CP1170 Sound Processor	6.07 SSQ12 Global score Interval 5.31 to 6.83
Paired Difference in Global SSQ12 Scores After Experience With the CP1170 Sound Processor and Own Processor Own Sound Processor	6.06 SSQ12 Global score Interval 5.29 to 6.83
Paired Difference in Global SSQ12 Scores After Experience With the CP1170 Sound Processor and Own Processor Difference between CP1170 and own sound processor	0.10 SSQ12 Global score Interval -0.52 to 0.72

Adverse Events

Adults With a Cochlear Implant

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Adults With a Cochlear Implant n=20 participants at risk All study participants (post-lingually deafened adults with at least 6 months experience with a cochlear implant and 3 months experience with SCAN program).
Ear and labyrinth disorders Ear-related adverse event	30.0% 6/20 • Number of events 6 • 12 months
Gastrointestinal disorders Non ear-related	5.0% 1/20 • Number of events 1 • 12 months

Additional Information

PRS Specialist, Clinical Affairs

Cochlear

Phone: +61 2 9428 6555

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place