Trial Outcomes & Findings for Acceptance and Performance of CP1110 Sound Processor With Experienced Adult Cochlear Implant Recipients. (NCT NCT05080283)
NCT ID: NCT05080283
Last Updated: 2025-03-25
Results Overview
Paired difference in dB SRT (AuSTIN) between the CP1110 Sound Processor with automated ForwardFocus ON (SCAN 2 FF) and ForwardFocus OFF (SCAN 2) in 65 dB SPL S0Nrearhalf 4TB.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
6 months
Results posted on
2025-03-25
Participant Flow
Participant milestones
| Measure |
All Participants
All participants were assigned to CP1110 Sound Processor System with automated ForwardFocus On (SCAN 2 FF), CP1110 Sound Processor System with ForwardFocus Off (SCAN 2) compared to the previously marketed Nucleus 7 Sound Processor (Model: CP1000).
|
|---|---|
|
CP1110 With ForwardFocus On (SCAN 2 FF)
STARTED
|
20
|
|
CP1110 With ForwardFocus On (SCAN 2 FF)
COMPLETED
|
20
|
|
CP1110 With ForwardFocus On (SCAN 2 FF)
NOT COMPLETED
|
0
|
|
CP1110 With ForwardFocus Off (SCAN 2)
STARTED
|
20
|
|
CP1110 With ForwardFocus Off (SCAN 2)
COMPLETED
|
20
|
|
CP1110 With ForwardFocus Off (SCAN 2)
NOT COMPLETED
|
0
|
|
CP1000
STARTED
|
20
|
|
CP1000
COMPLETED
|
20
|
|
CP1000
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
| Measure |
All Participants
n=20 Participants
All participants were assigned to CP1110 Sound Processor System with ForwardFocus On (SCAN), CP1110 Sound Processor System with ForwardFocus Off (SCAN) compared to the previously marketed Nucleus 7 Sound Processor (Model: CP1000) in a random order.
|
|---|---|
|
Age, Continuous
|
61 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=20 Participants
|
|
Region of Enrollment
Australia
|
20 participants
n=20 Participants
|
|
Age of onset of hearing loss
|
21.4 years
STANDARD_DEVIATION 19.84 • n=20 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPaired difference in dB SRT (AuSTIN) between the CP1110 Sound Processor with automated ForwardFocus ON (SCAN 2 FF) and ForwardFocus OFF (SCAN 2) in 65 dB SPL S0Nrearhalf 4TB.
Outcome measures
| Measure |
Within-subject Comparison of CP1110 ForwardFocus On Versus ForwardFocus Off in S0Nrearhalf
n=20 Participants
All participants were assigned to CP1110 Sound Processor System with automated ForwardFocus On (SCAN 2 FF), CP1110 Sound Processor System with ForwardFocus Off (SCAN 2) compared to the previously marketed Nucleus 7 Sound Processor (Model: CP1000). Participants' speech performance (sentences in noise score) in 65 dB SPL S0Nrearhalf 4 Talker Babble was assessed between two programs in CP1110 Sound Processor: automated ForwardFocus On (SCAN 2 FF) versus ForwardFocus Off (SCAN 2).
|
|---|---|
|
Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0Nrearhalf)
CP1110 ForwardFocus On
|
-10.34 dB SRT
Interval -11.1 to -9.57
|
|
Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0Nrearhalf)
CP1110 ForwardFocus Off
|
-6.04 dB SRT
Interval -7.32 to -4.76
|
|
Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0Nrearhalf)
Difference between CP1110 ForwardFocus On and ForwardFocus off
|
-4.30 dB SRT
Interval -5.19 to -3.41
|
SECONDARY outcome
Timeframe: 6 monthsPaired difference in dB SRT (AuSTIN) between the CP1110 Sound Processor with automated ForwardFocus On (SCAN 2 FF) and ForwardFocus OFF (SCAN 2) in 65 dB SPL S0N3 Babble.
Outcome measures
| Measure |
Within-subject Comparison of CP1110 ForwardFocus On Versus ForwardFocus Off in S0Nrearhalf
n=20 Participants
All participants were assigned to CP1110 Sound Processor System with automated ForwardFocus On (SCAN 2 FF), CP1110 Sound Processor System with ForwardFocus Off (SCAN 2) compared to the previously marketed Nucleus 7 Sound Processor (Model: CP1000). Participants' speech performance (sentences in noise score) in 65 dB SPL S0Nrearhalf 4 Talker Babble was assessed between two programs in CP1110 Sound Processor: automated ForwardFocus On (SCAN 2 FF) versus ForwardFocus Off (SCAN 2).
|
|---|---|
|
Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0N3)
CP1110 ForwardFocus On
|
-8.35 dB SRT
Interval -9.68 to -7.01
|
|
Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0N3)
CP1110 ForwardFocus Off
|
-4.16 dB SRT
Interval -5.49 to -2.83
|
|
Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0N3)
Difference between CP1110 ForwardFocus On and ForwardFocus Off
|
-4.18 dB SRT
Interval -4.9 to -3.47
|
SECONDARY outcome
Timeframe: 6 monthsPaired difference in percentage CNC Words correct in quiet (50 dB) with the CP1110 Sound Processor and Nucleus 7 Sound Processor.
Outcome measures
| Measure |
Within-subject Comparison of CP1110 ForwardFocus On Versus ForwardFocus Off in S0Nrearhalf
n=20 Participants
All participants were assigned to CP1110 Sound Processor System with automated ForwardFocus On (SCAN 2 FF), CP1110 Sound Processor System with ForwardFocus Off (SCAN 2) compared to the previously marketed Nucleus 7 Sound Processor (Model: CP1000). Participants' speech performance (sentences in noise score) in 65 dB SPL S0Nrearhalf 4 Talker Babble was assessed between two programs in CP1110 Sound Processor: automated ForwardFocus On (SCAN 2 FF) versus ForwardFocus Off (SCAN 2).
|
|---|---|
|
Adult Cochlear Implant Recipient Speech Perception in Quiet With the CP1110 Sound Processor and the Nucleus 7 Sound Processor
CP1110 Sound Processor
|
60.40 percentage of correct words
Interval 54.81 to 65.99
|
|
Adult Cochlear Implant Recipient Speech Perception in Quiet With the CP1110 Sound Processor and the Nucleus 7 Sound Processor
Nucleus 7 Sound Processor
|
56.80 percentage of correct words
Interval 50.37 to 63.23
|
|
Adult Cochlear Implant Recipient Speech Perception in Quiet With the CP1110 Sound Processor and the Nucleus 7 Sound Processor
Difference between CP1110 and Nucleus 7 Sound Processor
|
3.60 percentage of correct words
Interval 0.77 to 6.43
|
SECONDARY outcome
Timeframe: Baseline (Nucleus 7) and Visit 2 (6 months, CP1110)Paired difference in Global Speech, Spatial and Qualities of Hearing Scale (SSQ12) scores after experience with the CP1110 Sound Processor and Nucleus 7 Sound Responses. SSQ12 have a minimum value of 0 and a maximum of 10, wherein a higher score means a better outcome.
Outcome measures
| Measure |
Within-subject Comparison of CP1110 ForwardFocus On Versus ForwardFocus Off in S0Nrearhalf
n=20 Participants
All participants were assigned to CP1110 Sound Processor System with automated ForwardFocus On (SCAN 2 FF), CP1110 Sound Processor System with ForwardFocus Off (SCAN 2) compared to the previously marketed Nucleus 7 Sound Processor (Model: CP1000). Participants' speech performance (sentences in noise score) in 65 dB SPL S0Nrearhalf 4 Talker Babble was assessed between two programs in CP1110 Sound Processor: automated ForwardFocus On (SCAN 2 FF) versus ForwardFocus Off (SCAN 2).
|
|---|---|
|
Adult Cochlear Implant Subjective Hearing Performance and Sound Quality With the CP1110 Sound Processor and Nucleus 7 Sound Processor
CP1110 Sound Processor
|
5.96 units on a scale
Interval 5.27 to 6.65
|
|
Adult Cochlear Implant Subjective Hearing Performance and Sound Quality With the CP1110 Sound Processor and Nucleus 7 Sound Processor
Nucleus 7 Sound Processor
|
5.95 units on a scale
Interval 5.19 to 6.71
|
|
Adult Cochlear Implant Subjective Hearing Performance and Sound Quality With the CP1110 Sound Processor and Nucleus 7 Sound Processor
Difference between CP1100 and Nucleus 7 Sound Processor
|
0.01 units on a scale
Interval -0.58 to 0.61
|
Adverse Events
All Participants
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Participants
n=20 participants at risk
All 20 participants were assigned to investigate the acceptance and performance of a new behind-the-ear sound processor (Model: CP1110) with the ForwardFocus feature turned on and off, as compared to the previously marketed Nucleus 7 Sound Processor (Model: CP1000).
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|---|---|
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Investigations
Headache
|
10.0%
2/20 • Number of events 2 • 6 months
|
|
General disorders
Bodyache
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
General disorders
Common cold
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
General disorders
Cough
|
10.0%
2/20 • Number of events 2 • 6 months
|
|
General disorders
High fever
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
General disorders
One sided headache and neck pain
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
10.0%
2/20 • Number of events 2 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin lump
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Urine retention
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Infections and infestations
Viral infection
|
15.0%
3/20 • Number of events 3 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place