Adult Cochlear Implant Recipients
Conditions
Brief summary
The clinical study aims to investigate acceptance, actual-use usability and speech performance with a new behind-the-ear sound processor (model number: CP1110) system, compared with the commercially available Nucleus 7 Sound Processor (model: CP1000) system, with particular focus on the acceptance of and satisfaction with a noise reduction feature in the Automatic Scene Classifier 'SCAN 2'.
Detailed description
The clinical study aims to investigate acceptance, actual-use usability and speech performance with a new behind-the-ear sound processor (model number: CP1110) system, compared with the commercially available Nucleus 7 Sound Processor (model: CP1000) system, with particular focus on the acceptance of and satisfaction with a noise reduction feature in the Automatic Scene Classifier 'SCAN 2'. This study will build on the evidence collected in previous Nucleus 7 Sound Processor take home studies and will also aim to confirm the in-booth performance of CP1110 and Nucleus 7 Sound Processors.
Interventions
DEVICECP1110 Sound Processor System with automated ForwardFocus On (SCAN 2 FF)
Sound Processor
DEVICENucleus 7 Sound Processor (model: CP1000) system
Sound Processor
DEVICECP1110 Sound Processor System with ForwardFocus Off (SCAN 2)
Sound Processor
Sponsors
Avania
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, pre-market, single-site, non-randomized.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Aged 18 years or older. 2. Post lingually deafened. 3. Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI532, CI522) or Freedom Series (CI24RE(CA), CI24RE(ST), CI422). 4. At least 6 months experience with a cochlear implant. 5. At least 3 months experience with a Nucleus 7 (CP1000) Sound Processor 6. Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test 7. Willingness to participate in and to comply with all requirements of the protocol. 8. Fluent speaker in English as determined by the investigator 9. Willing and able to provide written informed consent
Exclusion criteria
1. Additional disabilities that would prevent participation in evaluations. 2. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedures. 3. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator. 4. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. 5. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation. 6. Currently participating, or participated in another interventional clinical study/trial in the past 30 days or if less than 30 days, the prior investigation was Cochlear sponsored and determined by the investigator to not impact clinical findings of this investigation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0Nrearhalf) | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0N3) | 6 months | 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 S0N3 Babble. |
| Adult Cochlear Implant Recipient Speech Perception in Quiet With the CP1110 Sound Processor and the Nucleus 7 Sound Processor | 6 months | Paired difference in percentage CNC Words correct in quiet (50 dB) with the CP1110 Sound Processor and Nucleus 7 Sound Processor. |
| Adult Cochlear Implant Subjective Hearing Performance and Sound Quality With the CP1110 Sound Processor and Nucleus 7 Sound Processor | 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. |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All 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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Continuous | 61 years | — |
| Age of onset of hearing loss | 21.4 years STANDARD_DEVIATION 19.84 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Australia | 20 participants | — |
| Sex: Female, Male Female | 11 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 13 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0Nrearhalf)
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.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Within-subject Comparison of CP1110 ForwardFocus On Versus ForwardFocus Off in S0Nrearhalf | Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0Nrearhalf) | CP1110 ForwardFocus On | -10.34 dB SRT |
| Within-subject Comparison of CP1110 ForwardFocus On Versus ForwardFocus Off in S0Nrearhalf | Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0Nrearhalf) | CP1110 ForwardFocus Off | -6.04 dB SRT |
| Within-subject Comparison of CP1110 ForwardFocus On Versus ForwardFocus Off in S0Nrearhalf | Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0Nrearhalf) | Difference between CP1110 ForwardFocus On and ForwardFocus off | -4.30 dB SRT |
Secondary
Adult Cochlear Implant Recipient Speech Perception in Quiet With the CP1110 Sound Processor and the Nucleus 7 Sound Processor
Paired difference in percentage CNC Words correct in quiet (50 dB) with the CP1110 Sound Processor and Nucleus 7 Sound Processor.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Within-subject Comparison of CP1110 ForwardFocus On Versus ForwardFocus Off in S0Nrearhalf | 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 |
| Within-subject Comparison of CP1110 ForwardFocus On Versus ForwardFocus Off in S0Nrearhalf | 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 |
| Within-subject Comparison of CP1110 ForwardFocus On Versus ForwardFocus Off in S0Nrearhalf | 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 |
Secondary
Adult Cochlear Implant Subjective Hearing Performance and Sound Quality With the CP1110 Sound Processor and Nucleus 7 Sound Processor
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.
Time frame: Baseline (Nucleus 7) and Visit 2 (6 months, CP1110)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Within-subject Comparison of CP1110 ForwardFocus On Versus ForwardFocus Off in S0Nrearhalf | 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 |
| Within-subject Comparison of CP1110 ForwardFocus On Versus ForwardFocus Off in S0Nrearhalf | 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 |
| Within-subject Comparison of CP1110 ForwardFocus On Versus ForwardFocus Off in S0Nrearhalf | 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 |
Secondary
Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0N3)
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 S0N3 Babble.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Within-subject Comparison of CP1110 ForwardFocus On Versus ForwardFocus Off in S0Nrearhalf | Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0N3) | CP1110 ForwardFocus On | -8.35 dB SRT |
| Within-subject Comparison of CP1110 ForwardFocus On Versus ForwardFocus Off in S0Nrearhalf | Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0N3) | CP1110 ForwardFocus Off | -4.16 dB SRT |
| Within-subject Comparison of CP1110 ForwardFocus On Versus ForwardFocus Off in S0Nrearhalf | Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0N3) | Difference between CP1110 ForwardFocus On and ForwardFocus Off | -4.18 dB SRT |