Hearing Loss, Sensorineural
Conditions
Keywords
Cochlear implant, Sensorineural hearing loss, Programming, Speech perception
Brief summary
This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients.
Detailed description
Performance of four programs (MAPs), each with a different rate, PW and stimulation mode were evaluated, all using 8 maxima: (i) 900 Hz rate, 25 µs PW Default (ii) 900 Hz rate, 50 µs PW LP1, (iii) 500 Hz rate, 100 µs PW LP2 all using Monopolar stimulation mode, and (iv) 500 Hz rate, 100 µs PW using an investigational stimulation mode LP3
Interventions
DEVICEProgram using default MAP
Each MAP uses a specific combination of stimulation parameters and electrode mode.
DEVICEProgram using low-power 1 (LP1) MAP
Each MAP uses a specific combination of stimulation parameters and electrode mode.
DEVICEProgram using low-power 2 (LP2) MAP
Each MAP uses a specific combination of stimulation parameters and electrode mode.
DEVICEProgram using low-power 3 (LP3) MAP
Each MAP uses a specific combination of stimulation parameters and electrode mode.
Sponsors
Avania
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
There is no masking in this study as all participants receive all MAPs (single group study model). The term single-blinded in the official title refers to the fact that participants are blinded to the order in which they receive the MAPs.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI513, CI532, CI522) or Freedom Series (CI24RE(CA), CI24RE(ST), CI24RE(CS), CI422) * At least three months after activation of the cochlear implant. * Eighteen years or older at the time of consent. * User of 900Hz ACE (Advanced Combination Encoder) strategy MAP. * Score of 20% or more for CNC words presented at 60dBSPL with CI alone in the test ear. * Fluent speaker in English. * Willing and able to provide written informed consent.
Exclusion criteria
* One or more electrodes turned off in the MAP used regularly. * Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator. * Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. * Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation. * 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 Mean Difference Score for CNC Words Correct Between Default and LP1 MAPs in Quiet | 10 participants completed this test at Week 4, and 10 participants completed this at week 8 | 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. |
| Paired Mean Difference Score in dB SRT (AuSTIN) Between Default and LP1 MAPs in Noise | 10 participants completed the test at Week 4, 10 participants completed the test at Week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Paired Mean Difference Score in Percentage CNC Words Correct Between LP1 and LP3 MAPs in Quiet | 10 participants completed this test at Week 4, and 10 participants completed this at week 8 | 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. |
| Paired Mean Difference Score for CNC Words Correct Between LP1 and LP2 MAPs in Quiet | 10 participants completed the test at Week 4, 10 participants completed the test at Week 8 | 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. |
| Switching Acceptability Rating Between LP2 and LP3 MAPs | 10 participants were evaluated at week 4 and 10 participants were evaluated at week 8 | 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. |
| Paired Mean Difference Score in dB SRT (AuSTIN) Between LP1 and LP3 MAPs in Noise | 10 participants completed this test with at Week 4 and 10 participants completed this at week 8 | 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. |
| Paired Mean Difference Score in dB SRT (AuSTIN) Between LP1 and LP2 MAPs in Noise | 10 participants completed this test at Week 4, and 10 participants completed this at week 8 | 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. |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All 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. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Default MAP | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 15 Participants | — |
| Age, Categorical Between 18 and 65 years | 5 Participants | — |
| Age, Continuous | 70.2 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Australia | 20 participants | — |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 13 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Paired Mean Difference Score for CNC Words Correct Between Default and LP1 MAPs in Quiet
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.
Time frame: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sound processor MAP | Paired Mean Difference Score for CNC Words Correct Between Default and LP1 MAPs in Quiet | -0.05 percentage word score |
95% CI: [-2.92, 2.81]
Primary
Paired Mean Difference Score in dB SRT (AuSTIN) Between Default and LP1 MAPs in Noise
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.
Time frame: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sound processor MAP | Paired Mean Difference Score in dB SRT (AuSTIN) Between Default and LP1 MAPs in Noise | -0.32 dB SRT |
95% CI: [-0.87, 0.24]
Secondary
Paired Mean Difference Score for CNC Words Correct Between LP1 and LP2 MAPs in Quiet
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.
Time frame: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sound processor MAP | Paired Mean Difference Score for CNC Words Correct Between LP1 and LP2 MAPs in Quiet | 0.45 percentage word score |
95% CI: [-0.55, 0.75]
Secondary
Paired Mean Difference Score in dB SRT (AuSTIN) Between LP1 and LP2 MAPs in Noise
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.
Time frame: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sound processor MAP | Paired Mean Difference Score in dB SRT (AuSTIN) Between LP1 and LP2 MAPs in Noise | -0.23 dB SRT |
95% CI: [-0.55, 0.75]
Secondary
Paired Mean Difference Score in dB SRT (AuSTIN) Between LP1 and LP3 MAPs in Noise
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sound processor MAP | Paired Mean Difference Score in dB SRT (AuSTIN) Between LP1 and LP3 MAPs in Noise | -0.39 dB SRT |
95% CI: [-1.1, 0.32]
Secondary
Paired Mean Difference Score in Percentage CNC Words Correct Between LP1 and LP3 MAPs in Quiet
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.
Time frame: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sound processor MAP | Paired Mean Difference Score in Percentage CNC Words Correct Between LP1 and LP3 MAPs in Quiet | -1.6 percentage word score |
95% CI: [-5.15, 1.95]
Secondary
Switching Acceptability Rating Between 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.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sound processor MAP | Switching Acceptability Rating Between LP2 and LP3 MAPs | Same sound quality | 5 Participants |
| Sound processor MAP | Switching Acceptability Rating Between LP2 and LP3 MAPs | Very different sound quality | 0 Participants |
| Sound processor MAP | Switching Acceptability Rating Between LP2 and LP3 MAPs | Similar sound quality | 8 Participants |
| Sound processor MAP | Switching Acceptability Rating Between LP2 and LP3 MAPs | Somewhat different sound quality | 7 Participants |