This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Acceptance and Performance of the CP1170 Sound Processor in Experienced Adult Cochlear Implant Recipients (NCT05619575), a na na study. The primary outcome is 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).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05619575 |
| Phase | NA |
| Condition | Hearing Impairment |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 20 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Cochlear |
| Results posted | Yes |
2. Clinical Question
Population
Adults with a cochlear implant who were experienced users of a sound processor. The registry record lists hearing impairment as the condition and an enrollment of 20. It does not provide further eligibility details or a fuller description of the participant population.
Intervention
The investigational CP1170 sound processor. The record describes take-home use for 2 weeks followed by in-booth testing. For the primary question, the two CP1170 programs are SCAN 2 FF, with automated ForwardFocus on, and SCAN 2, with ForwardFocus off.
Comparator
The primary comparison is within the CP1170: each participant's speech-reception-threshold result with SCAN 2 FF is compared with that participant's result with SCAN 2. Other stated comparisons involve the CP1150 commercial version and each participant's own processor. This is not a randomized, parallel-group comparison.
Primary question
What is the mean paired difference in dB SRT between the two CP1170 programs during speech-in-noise testing at 65 dB SPL, using S0Nrearhalf 4Talker Babble? The registry specifies an Australian Speech Test In Noise measure aimed at the speech-to-noise ratio for 50% speech intelligibility. The numerical difference and its confidence interval are not reported in the registry record.
3. Trial Design
This was a completed, pre-market, open-label, within-subject study of the CP1170 sound processor in experienced adult cochlear implant recipients. The registry lists an enrollment of 20, a single-group model, no masking, and allocation recorded as NA. The study started on 2022-12-20 and had a primary completion date of 2023-09-07. Its status is COMPLETED.
A within-subject design compares measurements from the same participant under different conditions. For the primary outcome, the two conditions are CP1170 SCAN 2 FF, with automated ForwardFocus on, and CP1170 SCAN 2, with ForwardFocus off. This makes the primary contrast paired rather than a comparison of two independently assigned groups. The record also describes take-home use of the CP1170 for 2 weeks followed by in-booth testing.
The registry lists the CP1150 sound processor as another device and names outcomes comparing CP1170 with CP1150, as well as the participant's own processor. The description of the CP1170 arm is truncated in the registry record, so the full sequence and details of all device comparisons are not reported there. The study is open-label, and masking is listed as NONE; no blinded assessment is described in the record.
The primary outcome is a continuous measure, reported as a mean paired difference with a 95% confidence interval. The registry lists 5 outcome measures and 0 analyses. No outcome estimates, analysis populations, or detailed statistical analysis plan are reported in the registry record. The sample-size justification is also not reported in the registry record. The registry's design information therefore supports describing the planned comparisons, but not reconstructing the full conduct or analysis of the study.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Adults With a Cochlear Implant |
|---|---|
| STARTED | 20 |
| COMPLETED | 17 |
| NOT COMPLETED | 3 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Adults With a Cochlear Implant |
|---|---|---|
| Participants analysed | 20 | |
| Age, Continuous | years | 63.4 (35 to 84) |
| Sex: Female, Male: Female | Participants | 16 |
| Sex: Female, Male: Male | Participants | 4 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: Australia | participants | 20 |
6. Primary Endpoint
The registry lists the primary outcome as 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), measured over During a Single Ad-Hoc Visit (between Day 141 - Day 218).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | dB SRT |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the paired difference in speech reception threshold, measured in dB SRT, between two CP1170 programs: SCAN 2 FF, with automated ForwardFocus on, and SCAN 2, with ForwardFocus off. Testing is described at 65 dB SPL in S0Nrearhalf 4Talker Babble. The record says speech perception in noise was assessed with the Australian Speech Test In Noise, using BKB-like target sentences in adaptive noise. The test aims to estimate the speech-to-noise ratio at which 50% speech intelligibility is reached.
An SRT expresses the speech-to-noise conditions associated with a specified level of speech recognition. Measuring speech in noise can characterize performance under a listening condition that differs from speech in quiet. The paired comparison is useful because each participant serves as their own reference across the two programs. In general, this can account for stable differences between participants, although it does not remove possible effects of test order, learning, fatigue, or other time-varying factors.
The endpoint is summarized as a mean paired difference and a 95% confidence interval. The registry record does not report the numerical mean difference or confidence interval, so the direction, size, and precision of the observed comparison cannot be described. It also does not report further details about endpoint scoring or handling of incomplete tests.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical issue is that the registry record describes the primary question but does not report its numerical result. It identifies a mean paired difference in dB SRT between two CP1170 programs and specifies a 95% confidence interval. Without the estimate and interval, it is not possible to describe which program had the lower or higher mean SRT, how large the observed difference was, or how precisely it was estimated. No p-value for the primary comparison is reported in the registry record.
The paired design means that the relevant information is the within-participant contrast, not simply the separate average scores under each program. A paired estimate reflects the direction and magnitude of the differences within participants. The registry does not report those individual differences, the number with usable paired measurements, or the analysis population. The enrollment of 20 should not be treated as proof that all enrolled participants contributed to every outcome.
A 95% confidence interval describes uncertainty around an estimated effect under the assumptions of the analysis. In general, it is not a range containing 95% of individual participant results, and it does not establish that the true effect has a 95% probability of lying within the particular interval. Here, there are no reported interval limits to assess. It is therefore not possible to judge whether the estimate is precise or whether the data are compatible with a range of effects that could matter for interpretation.
Other outcomes listed in the record include speech perception in noise comparing CP1170 programs, percentage CNC words correct in quiet comparing CP1170 with CP1150, subjective acceptance and satisfaction comparing CP1170 with the participant's own processor, and global SSQ12 scores after experience with CP1170 and the participant's own processor. Their numerical findings are not reported in the registry record. The record therefore supports an account of the outcomes the study set out to assess, not a conclusion about their observed values.
The study is not a randomized comparison between independent arms. Its within-subject structure can make each participant a useful control for stable individual characteristics, but the open-label design leaves subjective outcomes open to expectation and awareness effects. The record does not describe random ordering of device conditions or adjustment for order effects. These design considerations should be kept separate from the missing results: neither the design label nor the completion status reveals the size or direction of an outcome.
The record reports no serious adverse events among the 20 adults with a cochlear implant at risk, and 7 other adverse events among those at risk. These are descriptive safety counts. They do not give event-level detail, establish whether an event was related to a device, or by themselves characterize comparative safety. More detail on their interpretation appears in the safety discussion.
9. Statistical Methods Explained
Statistical interpretation begins with identifying the kind of outcome and comparison. The primary outcome is continuous, measured in dB SRT, and summarized by a mean. The comparison is paired because the same participant is assessed under both CP1170 program conditions. This differs from an independent-group comparison, where each group contains different participants. For paired data, the analysis is based on each participant's within-person contrast and then summarizes those contrasts across participants.
What does the paired mean represent?
For each participant with measurements under both programs, a paired difference can be formed by subtracting one condition's result from the other according to a prespecified direction. The mean paired difference summarizes the average of those participant-level contrasts. Its interpretation depends on the subtraction order and on the scale: a positive estimate and a negative estimate would point in opposite directions under the chosen convention. The registry names the conditions but does not report the convention used to define the subtraction, the estimated mean, or a numerical result. Accordingly, no direction can be assigned from the registry record.
Pairing can be helpful because characteristics that remain stable within a participant are shared by both measurements. This may reduce variability in the contrast compared with treating the measurements as though they came from unrelated people. Pairing does not automatically control for changes between assessments. Test order, familiarity with a task, fatigue, or other time-dependent influences can still affect a within-person comparison. The record does not report whether the order of program testing was randomized or counterbalanced.
How should the confidence interval be read?
A confidence interval communicates the uncertainty associated with an estimated mean difference under the statistical model and sampling assumptions used. In general, a narrower interval indicates greater precision than a wider interval on the same measurement scale. The interval is not a display of the spread of individual observations, nor does it show how many participants had a positive or negative difference. A mean and interval can also conceal variation in individual responses. The registry specifies a 95% confidence interval but reports neither its limits nor the estimation method used to construct it.
To assess an interval substantively, a reader would need the numerical estimate, interval limits, and a relevant interpretation of differences on the dB SRT scale. No threshold for a meaningful difference is reported in the registry record. Without the actual estimate and limits, it is not possible to discuss the range of effects compatible with the data, or to distinguish a precise estimate from an uncertain one.
Why does outcome type matter?
The primary measure is continuous, while other listed measures include percentage CNC words correct and questionnaire-based scores or ratings. Different outcome types can call for different summaries and analysis models. A mean is a familiar summary for continuous outcomes, but its usefulness depends on the distribution and the study question. The registry identifies the primary summary as a mean and the dispersion measure as a 95% confidence interval. It does not report diagnostic checks, transformations, covariate adjustments, or the detailed model specification.
Speech-in-noise measurement is described as an adaptive test using BKB-like target sentences, with a goal of estimating the speech-to-noise ratio for 50% speech intelligibility. Adaptive procedures adjust testing conditions in response to performance. The registry does not report further scoring details or how the test's measurement properties were handled statistically. General considerations such as test reliability and possible floor or ceiling effects may matter for speech measures, but the record does not report whether these were assessed.
What can planning calculations say?
Planning calculations are distinct from observed trial results. The record's stated planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with an effect defined as a stated fraction of the observed effect. It also distinguishes calculations expressed as participants per arm from event-based calculations expressed as total events. These assumptions do not describe the study's listed single-group, within-subject design, and they should not be read as the trial's own sample-size justification. The justification is not reported in the registry record.
Such calculations are planning illustrations, not observed power. They address hypothetical design choices under specified assumptions; they cannot establish whether an observed result is reliable, whether the study was adequately designed, or how likely a particular conclusion is. No numerical planning outputs are described in the registry record. The stated assumptions also do not replace the need to understand the paired analysis used for the primary endpoint.
What is missing from the statistical record?
The registry lists 0 analyses and reports no primary or secondary effect estimates, confidence-interval limits, or p-values. It does not report the analysis population, the number of participants contributing data to each outcome, or how incomplete observations were handled. A full analysis description would ordinarily clarify the paired-difference convention, the model or calculation used, any prespecified adjustments, and the treatment of missing data. Those details are not reported in the registry record. Statistical interpretation should therefore remain descriptive: the design and endpoint are identifiable, while the numerical findings and key analytic details are not available.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 5 outcome measures: a primary speech-in-noise endpoint and secondary measures covering speech-in-noise performance, CNC words correct in quiet, subjective acceptance and satisfaction, and global SSQ12 scores. When a study examines multiple outcomes or makes multiple comparisons, the chance of at least one apparently unusual result can increase if each is interpreted separately without considering multiplicity. General approaches can include prespecifying a primary outcome, adjusting statistical thresholds, or treating secondary findings as exploratory. The registry record does not report a multiplicity strategy, a hierarchy among secondary outcomes, or a statistical analysis plan that explains how results would be interpreted across outcomes.
The record also does not report missing-data methods or the number of participants with data for each measure. Enrollment is listed as 20, but that does not establish that all 20 contributed complete paired observations for every outcome. Details about exclusions, incomplete tests, or reasons for missing measurements are not reported in the registry record.
Analysis populations are likewise not described. The record does not state whether analyses included all enrolled participants, only participants who completed specified procedures, or another defined group. It reports 0 analyses, so no outcome-specific analytical population can be identified from the registry record. These omissions limit assessment of how the planned outcomes were connected to the analyses and whether missingness or multiple testing could influence interpretation.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Adults With a Cochlear Implant | 0 | 20 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Adults With a Cochlear Implant | 0 of 20 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Adults With a Cochlear Implant | 7 of 20 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Adults With a Cochlear Implant |
|---|---|---|
| Ear-related adverse event | Ear and labyrinth disorders | 6 of 20 |
| Non ear-related | Gastrointestinal disorders | 1 of 20 |
For the registry's group of adults with a cochlear implant, 20 participants were listed as at risk for serious adverse events and 0 as affected. The same group had 20 participants at risk for other adverse events and 7 affected. The record lists 0 deaths. These are counts of participants, not a detailed account of the number, duration, or severity of individual events.
No serious adverse-event terms are listed. That should be read alongside the reported count of 0 affected for serious events in this group; it does not provide event descriptions beyond that count. For other adverse events, the record does not identify the event types or report whether they were judged related to a device, how they were managed, or when they occurred. The figures also do not distinguish events by processor or study condition.
These data are descriptive and do not establish comparative safety. The registry record does not report a randomized safety comparison, exposure-adjusted event rates, or detailed follow-up by device. Counts from a study with an enrollment of 20 should be interpreted within that study's recorded scope. No causal attribution should be inferred from the event counts alone.
12. What the Result Does, and Does Not, Mean
The registry record identifies a focused within-subject question: the mean paired difference in dB SRT between two CP1170 programs during speech-in-noise testing. It also describes other comparisons involving the CP1150 and participants' own processors. However, numerical primary and secondary outcome results are not reported in the registry record. This means the observed direction, magnitude, and precision of the comparisons cannot be described from the available record.
The design can support a paired comparison because each participant is assessed under multiple conditions. In general, this approach accounts for stable participant characteristics shared across those conditions. It does not, by itself, resolve possible order effects or other changes across assessments. The study was open-label and unmasked, and the record does not state whether condition order was randomized. Subjective acceptance and satisfaction outcomes may be especially sensitive to participants' awareness of the processor they are using, but the record does not report a method to address that issue.
The record's completed status indicates that the study is marked completed, but completion does not substitute for numerical outcome reporting. Likewise, enrollment of 20 does not show how many participants completed each test or contributed to each analysis. No analysis population, missing-data approach, or full statistical plan is reported in the registry record.
The safety counts describe no serious adverse events and 7 participants with other adverse events among 20 at risk in the listed group. Without event descriptions or device-specific attribution, these counts do not establish why events occurred or compare safety between devices. They are a limited descriptive account.
Overall, the record supports understanding the study's design and intended measurements, but it does not support claims about the observed performance differences, acceptance findings, or the precision of any estimated effect. Those conclusions would require numerical outcome results and fuller analysis details, which are not reported in the registry record.
13. Why This Trial Matters Statistically
This study is statistically interesting because it uses a within-subject structure to compare sound-processor conditions in experienced adult cochlear implant recipients. For its primary question, the comparison is between two programs on the same CP1170 device. In general, paired designs can make efficient use of participant-level information by comparing each person with their own measurement under another condition, rather than treating the conditions as unrelated groups.
The design also highlights the importance of keeping the estimand clear. The primary outcome is not simply an average score under one program; it is the mean paired difference in dB SRT between two specified programs in a specified speech-in-noise setting. Other outcomes ask different questions, including comparisons with the CP1150, the participant's own processor, and questionnaire measures. Distinguishing these contrasts helps prevent unlike outcomes from being treated as interchangeable evidence.
The statistical record is limited, however, because it identifies the outcomes but reports no numerical findings or analysis details. Without estimates and confidence intervals, the magnitude and precision of any paired differences cannot be evaluated. Without information about missing data, analysis populations, multiplicity, or test order, important features of interpretation remain unresolved. These are not merely technical details: they determine what the reported estimates would represent and how uncertainty should be understood.
The example also illustrates why a completed study record and a design description do not answer the outcome question on their own. Statistical interpretation depends on the observed estimates, their uncertainty, and an account of how the data were analyzed. Here, those elements are not reported in the registry record, so the appropriate statistical account is bounded by the study's stated questions and available descriptive safety counts.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The central limitation of the available record is that it contains no numerical primary or secondary outcome results. The mean paired difference and 95% confidence interval specified for the primary endpoint are not reported in the registry record. As a result, the observed direction, size, and precision of the primary comparison cannot be assessed. The record also does not report p-values or numerical findings for the secondary outcomes.
The registry identifies an enrollment of 20 but does not report outcome-specific denominators, the analysis population, or the handling of missing measurements. The number enrolled therefore cannot be assumed to equal the number analyzed for every endpoint. The full arm description is truncated, and the complete sequence of device exposure and testing is not available in the registry record.
The study is open-label and masking is listed as NONE. The record does not report whether the order of testing conditions was randomized or counterbalanced, leaving possible order and familiarity effects unaddressed in the available description. This is relevant to performance testing and to subjective acceptance measures. The registry also does not report details of multiplicity control, the statistical analysis plan, or the sample-size justification.
Finally, adverse-event information is limited to participant counts. Event types, timing, device attribution, and comparative exposure details are not reported. These limitations constrain interpretation to the stated design and descriptive counts; they do not establish the direction or clinical importance of any processor comparison.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Acceptance and Performance of the CP1170 Sound Processor in Experienced Adult Cochlear Implant Recipients — NCT05619575.
- Registry record last updated 2025-08-22; status last verified 2025-08.
- Results first posted 2025-07-31.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT05619575 is a completed, pre-market, open-label, within-subject study of the CP1170 sound processor in experienced adult cochlear implant recipients. The registry lists an enrollment of 20, no masking, and a single-group model. Its primary endpoint is the mean paired difference in dB SRT between CP1170 SCAN 2 FF and SCAN 2 in speech-in-noise testing, with a 95% confidence interval specified. Other listed outcomes include comparisons involving CP1150, participants' own processors, CNC words correct, acceptance and satisfaction, and SSQ12 scores.
The registry record does not report numerical outcome results, analysis populations, missing-data methods, or a detailed statistical analysis plan. It lists 0 analyses. For safety, 0 of 20 participants at risk were affected by serious adverse events, 7 of 20 were affected by other adverse events, and 0 deaths were listed. These counts do not provide event-level or device-attribution details.