Hearing Impairment
Conditions
Brief summary
Acceptance and performance of the CP1170 sound processor in experienced adult cochlear implant recipients compared with the CP1150 sound processor and their current sound processor.
Detailed description
This investigation is planned to investigate the performance and clinical benefits of features that are new to the CP1170 Sound Processor. This study will build on the evidence previously collected on off-the-ear (OTE) sound processors and ForwardFocus, with particular focus on the acceptance and satisfaction of the automation of ForwardFocus in the CP1170 Sound Processor and associated components in general.
Interventions
DEVICECP1170 Sound Processor
The CP1170 Sound Processor will be used to determine the hearing performance with the new implementation of ForwardFocus in SCAN 2 (SCAN 2 FF), as assessed by speech perception in noise.
DEVICECP1150 Sound Processor
Active comparator off-the-ear sound processor.
Sponsors
Avania
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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); Freedom Series (CI24RE(CA), CI24RE(ST), CI422) or N24 Series (CIC3). 4. At least 6 months experience with a cochlear hearing implant 5. At least 3 months experience with any Nucleus sound processor and SCAN program 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, as determined by the Investigator. 6. Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| 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) | 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. |
| Subjective Acceptance and Satisfaction Between the CP1170 Sound Processor and the Subject's Own Processor | 2 weeks | 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). |
| Paired Difference in Global SSQ12 Scores After Experience With the CP1170 Sound Processor and Own Processor | During a Single Ad-Hoc Visit (anytime between Day 23 - Day 70) | 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. |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Adults With a Cochlear Implant | — |
|---|---|---|
| Age, Continuous | 63.4 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Australia | 20 participants | — |
| Sex: Female, Male Female | 16 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 7 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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)
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.
Time frame: During a Single Ad-Hoc Visit (between Day 141 - Day 218)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Participants | 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 |
| All Participants | 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 |
| All Participants | 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 |
Secondary
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)
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.
Time frame: During a single Ad-Hoc Visit (anytime between Day 141 - Day 218)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Participants | 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 |
| All Participants | 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 |
| All Participants | 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 |
Secondary
Paired Difference in Global SSQ12 Scores After Experience With the CP1170 Sound Processor and Own 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Participants | Paired Difference in Global SSQ12 Scores After Experience With the CP1170 Sound Processor and Own Processor | CP1170 Sound Processor | 6.07 SSQ12 Global score |
| All Participants | Paired Difference in Global SSQ12 Scores After Experience With the CP1170 Sound Processor and Own Processor | Own Sound Processor | 6.06 SSQ12 Global score |
| All Participants | 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 |
Secondary
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)
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.
Time frame: During Ad-Hoc Visit (anytime between Day 127 - Day 190)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Participants | 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 |
| All Participants | 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 |
| All Participants | 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 |
Secondary
Subjective Acceptance and Satisfaction Between the CP1170 Sound Processor and the Subject's Own Processor
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).
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Subjective Acceptance and Satisfaction Between the CP1170 Sound Processor and the Subject's Own Processor | CP1170 Sound Processor | 16 Participants |
| All Participants | Subjective Acceptance and Satisfaction Between the CP1170 Sound Processor and the Subject's Own Processor | Own Sound Processor | 18 Participants |