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 Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults (NCT03007472), a na na study. The primary outcome is Change From Pre- to 6 Months Post-implantation Speech Recognition in Quiet in the Implanted Ear Alone.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03007472 |
| Phase | NA |
| Condition | Hearing Loss, Sensorineural |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 96 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Cochlear |
| Results posted | Yes |
2. Clinical Question
Population
Adults with sensorineural hearing loss were enrolled. The registry record lists an enrollment of 96. It does not report further eligibility details or describe the characteristics of the analyzed population.
Intervention
Participants received a CI532 cochlear implant and were fit with the CP1000 (Nucleus 7) sound processor. The record describes this as the CI532/N7 study group.
Comparator
There is no separate control group in this single-group study. The primary outcome compares speech-recognition scores before implantation with scores after activation of the sound processor, using the preoperative best unilateral condition as the reference.
Primary question
How did mean CNC word recognition in quiet in the implanted ear change from the preoperative assessment to 6 months after sound processor activation? The registry describes the endpoint but does not report the observed scores, change estimate, uncertainty, or statistical test result.
This is a within-group, before-and-after question, not a randomized treatment comparison. The record does not describe an untreated or alternative-device group, so the primary outcome cannot by itself separate changes associated with implantation from changes over time or other influences. The preoperative score is a baseline reference, not a concurrent control.
The registry also lists evaluation of speech recognition in noise and change in the Health Utility Index-3. These are secondary outcomes; their numerical results and analysis details are not reported in the registry record. The clinical question is therefore clear at the level of the planned measure, but the posted record does not contain the results needed to quantify the observed change or its precision.
3. Trial Design
The registry describes a completed, prospective device study with one study group. Its title concerns clinical evaluation of the Cochlear Nucleus CI532 cochlear implant in adults, and the brief summary states that the purpose was to gather long-term data on the FDA-approved CI532 implant and CP1000 (Nucleus 7) sound processor. The recorded condition is sensorineural hearing loss.
All subjects in the study group were to receive the CI532 implant and be fit with the CP1000 sound processor. The model is listed as single group; allocation is listed as NA, and masking is listed as none. Phase is also listed as NA. These registry fields do not describe a randomized, masked comparison against another intervention.
The recorded enrollment is 96. The study start date is 2017-02-15, the primary completion date is 2018-12-03, and status is completed. These design and status details describe the registry entry; they do not establish how many participants contributed data to each endpoint. The analyzed population and endpoint-specific denominators are not reported in the registry record.
The primary outcome is change in mean CNC word recognition in quiet in the implanted ear alone, assessed preoperatively and 6 months after sound processor activation. The record also lists secondary outcomes for speech recognition in noise and the Health Utility Index-3. It lists five outcome measures overall, but does not give analysis results. The number of analyses is recorded as zero.
Because the study has no separate comparison arm, its design can describe changes observed within the study group but cannot provide a randomized estimate of the difference between the device and an alternative. Details such as eligibility criteria, follow-up completeness, and the statistical analysis plan are not reported in the registry record.
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 | CI532/N7 Study Group |
|---|---|
| STARTED | 96 |
| COMPLETED | 91 |
| NOT COMPLETED | 5 |
Reasons for not completing this period:
| Reason | CI532/N7 Study Group |
|---|---|
| Did not have aidable contralateral thresholds at the time | 2 |
| Death | 2 |
| Loss to Follow Up | 1 |
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 | CI532/N7 Study Group |
|---|---|---|
| Participants analysed | 96 | |
| Age, Continuous | years | 67.39 (23 to 91) |
| Sex: Female, Male: Female | Participants | 34 |
| Sex: Female, Male: Male | Participants | 62 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: United States | participants | 96 |
| Ipsilateral Ear Mean - Duration of Hearing Loss | years | 21.7 (SD 14) |
| Contralateral Ear Mean - Duration of Hearing Loss | years | 26.7 (SD 14) |
6. Primary Endpoint
The registry lists the primary outcome as Change From Pre- to 6 Months Post-implantation Speech Recognition in Quiet in the Implanted Ear Alone, measured over Preoperatively and 6 months post sound processor activation.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | percentage of correct words |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from preoperative assessment to 6 months after sound processor activation in mean Consonant Nucleus Consonant word recognition in quiet, measured in the implanted ear alone. The registry describes the score as a percentage of correct words and states that the CNC test ranges from 0-100%, with higher scores indicating better scores. The preoperative reference is the group mean score in the best unilateral condition.
Word recognition in quiet is a direct performance measure: it records how many test words are recognized correctly under the stated listening condition. Comparing a post-implantation score with a preoperative reference can describe the direction and size of within-group change. The mean summarizes the group’s average score, while the standard deviation describes variability in individual scores around that average.
For interpretation, the time points and listening condition matter. The comparison is specifically between preoperative testing and testing 6 months after activation, and it concerns the implanted ear alone. It is not a comparison of two randomized groups. The registry does not report the mean scores at either time point, the mean change, a confidence interval, or a test result. Therefore, the endpoint definition is available, but the observed result and its precision cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a meaningful statistical question: whether mean CNC word recognition in quiet changed between the preoperative assessment and 6 months after sound processor activation in the implanted ear. It does not report the numerical outcome needed to answer that question. There are no posted group means, mean change, standard deviation values, confidence interval, p-value, or analysis result for the primary endpoint. The number of analyses is recorded as zero.
Without an effect estimate, the direction and magnitude of any observed change are unknown from this record. Without a confidence interval or other uncertainty measure, its precision is also unknown. The endpoint description alone is not evidence that scores increased, decreased, or stayed similar. No conclusion about the result should be drawn from the study title, device description, study status, or outcome definition.
The single-group before-and-after design also shapes what a result could mean. A change from baseline would describe the study group over time, but there is no concurrent comparison group to show what would have happened over the same period without the implant and processor. A before-and-after difference is therefore not equivalent to a randomized estimate of treatment effect. The registry does not report an adjustment strategy or other methods intended to address this limitation.
The study lists two secondary outcomes by name: speech recognition in noise and change in the Health Utility Index-3. Their results are not reported in the registry record. Although five outcome measures are listed overall, the record does not specify the numerical findings for them or provide analyses. Consequently, it is not possible to compare the primary outcome with secondary outcomes or judge whether findings were consistent across measures.
The enrollment entry of 96 is a registry-level study figure, not a reported endpoint denominator. It should not be treated as the number analyzed for the primary outcome. The registry does not report how many participants completed each assessment, whether observations were missing, or how missing observations were handled. The result’s representativeness and precision cannot be judged without those details.
Safety information is also descriptive in the record. Serious adverse events affected 16 of 96 at risk, other adverse events affected 26 of 96 at risk, and 2 deaths are recorded. These counts do not establish whether events were caused by the device or procedure, nor do they supply a comparison with another group. The record does not report event-level timing, attribution, or the relationship between event counts and participants across categories.
Overall, the registry supports a description of the intended study question and design, but not a quantitative interpretation of the primary efficacy outcome. Any statistical conclusion about change, precision, or causal effect would require results and analysis details that are not reported in the registry record.
9. Statistical Methods Explained
What does a mean describe?
The primary outcome is a continuous score expressed as a percentage of correct words. A group mean is the arithmetic average of the scores contributing to an analysis. It provides a concise description of the group’s typical score, but it does not show how individual scores are distributed or whether all participants changed in the same direction. The registry identifies the mean as the summary parameter and standard deviation as its dispersion measure, but supplies no observed values.
Standard deviation describes how spread out observations are around the mean. A larger spread means individual scores vary more; a smaller spread means scores are more concentrated around the average. It is not the same as the standard error, which describes the uncertainty in an estimated mean, and it is not a confidence interval. Since no standard deviation or endpoint sample size is reported, these quantities cannot be assessed for the primary outcome.
How should a before-and-after change be understood?
In general, repeated measurements on the same participant are related: a person’s earlier score may help explain their later score. An analysis that accounts for that pairing can estimate average within-person change and may use information more efficiently than treating measurements as independent. This is a general statistical point, not a description of the analysis used in this study. The registry does not report whether the primary outcome was analyzed as paired observations, how change was calculated, or which statistical test or model was used.
The endpoint compares a preoperative group mean with a group mean 6 months after sound processor activation, using the preoperative best unilateral condition as reference. The exact participant-level data structure and handling of incomplete pairs are not reported. If different participants contributed to each time point, a simple difference between group means would not necessarily equal the average of individual changes. The posted record does not clarify this issue or report the analysis population.
What would uncertainty measures add?
In general, a confidence interval gives a range of values compatible with the observed data under the analysis assumptions. Its width conveys precision: narrower intervals indicate more precise estimates, while wider intervals indicate greater uncertainty. A confidence interval for mean change would help readers judge the plausible size and direction of the change, rather than relying only on a point estimate. No such interval is reported for the primary outcome.
A p-value, when reported, describes how compatible the data are with a specified null hypothesis under the statistical model. It does not measure the size or importance of an effect, and it does not establish causation. The registry record provides no primary-outcome p-value or test result. The absence of a reported result should not be interpreted as evidence of no change or as evidence of a statistically significant change.
What can a single-group design estimate?
General interpretation of a single-group before-and-after study requires care. A within-group change can reflect the intervention and other factors that vary over time, including changes in measurement conditions or participant characteristics. Without a concurrent control group, those influences cannot be separated by a randomized comparison. Baseline measurements are useful references, but they are not a substitute for a control group observed over the same period.
The record explicitly describes a single-group model, with allocation listed as NA and masking as none. It does not report a planned adjustment for potential confounding or a detailed analysis plan. Thus, even if a numerical pre-to-post change were available, its interpretation would remain that of an observed within-group change rather than a randomized treatment contrast.
What do the planning assumptions mean?
The record describes a sample-size planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect. These are planning assumptions for an illustration, not a description of the enrolled single-group design, and the resulting planning figures are not reported in the registry record.
Such planning calculations generally ask how many participants would be needed under specified assumptions to detect an effect with a target probability, often called power. They are not observed power and do not demonstrate that the study had a particular probability of detecting an effect. The record states that time-to-event planning outputs use total event counts, while other outputs use participants per arm. The primary endpoint is continuous, but the record does not report a numerical effect estimate or a corresponding planning value.
Equal allocation between two arms is a hypothetical planning assumption; the clinical study itself is recorded as single group. The sample-size illustration therefore should not be mistaken for evidence that the trial randomized participants or included two arms. The stated assumptions alone are insufficient to evaluate a particular sample-size result, especially because no endpoint result or numerical planning output is reported.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists five outcome measures and identifies one as primary, while naming secondary outcomes for speech recognition in noise and the Health Utility Index-3. The number of analyses is recorded as zero. Numerical results and analysis details are not reported in the registry record. It therefore does not establish which outcomes were analyzed, whether additional endpoints or time points were tested, or how results were selected for reporting.
Multiplicity arises when several statistical hypotheses are examined. In general, testing many outcomes can increase the chance that at least one result appears noteworthy by chance. Common approaches include designating a primary endpoint in advance, controlling an overall error rate, or presenting secondary analyses as exploratory. The registry’s identification of a primary endpoint helps describe the intended focus, but no multiplicity adjustment or hierarchy for secondary outcomes is reported.
Missing data are also important for a pre-to-post endpoint. A participant may lack one or both assessments, and the analysis can differ depending on how such observations are handled. The enrollment entry is not an endpoint-specific denominator. The number completing each assessment, reasons for missingness, and method of handling missing values are not reported in the registry record. No conclusion about follow-up completeness can be made from the listed enrollment alone.
The record does not describe analysis populations, such as whether all enrolled participants or only those with paired assessments were included. It also does not report sensitivity analyses for missing data. These omissions limit assessment of the robustness and generalizability of any outcome estimate; in this record, no numerical outcome estimate is available to assess.
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 |
|---|---|---|---|
| CI532/N7 Study Group | 16 | 96 | 16.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| CI532/N7 Study Group | 2 of 96 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| CI532/N7 Study Group | 26 of 96 |
Most frequent serious adverse event terms
| Event term | Organ system | CI532/N7 Study Group |
|---|---|---|
| Acid Reflux | Gastrointestinal disorders | 1 of 96 |
| Active Meniere's Disease/Vertigo | Ear and labyrinth disorders | 1 of 96 |
| Anemia | Blood and lymphatic system disorders | 1 of 96 |
| Atrial Fibrillation requiring Ablation Procedure | Cardiac disorders | 1 of 96 |
| CI Explanted Due to Non-Auditory Stimulation | Product Issues | 1 of 96 |
| Coxsackievirus, subsequent labyrinthitis/vestibular neuritis | Ear and labyrinth disorders | 1 of 96 |
| CVA (cerebrovascular accident) | Vascular disorders | 1 of 96 |
| Cardio-respiratory failure | Cardiac disorders | 1 of 96 |
| Alcoholic cirrhosis of the liver | Hepatobiliary disorders | 1 of 96 |
| Decreased Hearing in Non-Implanted Ear | Ear and labyrinth disorders | 1 of 96 |
Most frequent non-serious adverse event terms
| Event term | Organ system | CI532/N7 Study Group |
|---|---|---|
| Dizziness | General disorders | 14 of 96 |
| Vertigo | Ear and labyrinth disorders | 13 of 96 |
Serious events with the highest arm-level rate: acid reflux (1.0%), active meniere's disease/vertigo (1.0%), anemia (1.0%), atrial fibrillation requiring ablation procedure (1.0%), ci explanted due to non-auditory stimulation (1.0%).
The registry lists 16 of 96 at risk as affected by serious adverse events, 26 of 96 at risk as affected by other adverse events, and 2 deaths. These are safety counts for the CI532/N7 study group. The top serious-event terms each have a listed value of 1.0%: Acid Reflux; Active Meniere's Disease/Vertigo; Anemia; Atrial Fibrillation requiring Ablation Procedure; CI Explanted Due to Non-Auditory Stimulation; and Coxsackievirus, subsequent labyrinthitis/vestibular neuritis.
These figures are descriptive. The record does not report whether an event was judged related to the implant, procedure, or sound processor, nor does it give event timing or duration. It also does not explain whether individuals could contribute to more than one event category, so the category counts should not be added together or interpreted as a count of unique people. The denominator shown as at risk is the group-level registry figure; exposure time and endpoint-specific follow-up are not described.
With no comparison group, the counts do not estimate how safety outcomes would differ under another intervention or without implantation. The registry record does not report further detail on the deaths or provide a causal assessment. These limitations mean the listed counts should be read as recorded safety information, not as proof of causation or as a comparative safety estimate.
12. What the Result Does, and Does Not, Mean
The registry record establishes the intended clinical question: measurement of mean CNC word recognition in quiet before implantation and 6 months after sound processor activation in the implanted ear alone. It also specifies the score’s range and direction, names secondary outcomes, and describes a single study group receiving the CI532 implant with the Nucleus 7 sound processor. These details clarify what the study was designed to examine.
The record does not report the primary outcome values or statistical analysis. It cannot show whether the mean changed, how large any change was, how variable the participant scores were, or how precisely the change was estimated. The absence of posted results is not evidence that the score did not change, and it is not evidence that a change occurred.
Even with numerical pre-to-post results, the single-group design would support a description of change over time rather than a randomized comparison against an alternative. A baseline assessment is a reference within the same study, not a concurrent control. Other changes occurring over time could contribute to a before-and-after difference, and the registry does not report methods to separate these influences.
The record also does not report endpoint-specific denominators, missing-data methods, or analysis populations. This prevents assessment of how complete the outcome data were and which participants contributed to an estimate. The sample-size planning assumptions describe an illustration rather than the actual single-group design; they do not establish observed power or provide a substitute for outcome results.
Safety counts are recorded, but event attribution and comparative safety are not. Taken together, the available information describes the study’s design, outcome definitions, and some safety counts. It does not support a quantitative conclusion about the primary endpoint or a causal claim about the device.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of how the design determines the kind of question a study can answer. A single-group before-and-after evaluation can track outcome scores over time in people receiving the device and processor. It does not provide the same evidence as a randomized comparison, because no concurrent control group is described.
The primary endpoint is clearly specified as a continuous score, with a defined assessment context, time points, and direction of scoring. That clarity helps distinguish the measured outcome from broader claims about hearing or daily function. The listed secondary measures also signal that the study considered outcomes beyond speech recognition in quiet, although their results are not reported in the registry record.
The record also illustrates why outcome definitions alone are not enough for statistical interpretation. Readers need estimates, measures of uncertainty, endpoint-specific denominators, and analysis details to assess magnitude, precision, and robustness. Those details are not reported for the primary outcome. Without them, neither the clinical size of a change nor its statistical uncertainty can be evaluated.
Finally, the described planning assumptions should be distinguished from the actual study design and from observed results. A hypothetical two-arm planning illustration does not turn a single-group study into a controlled trial, and planning calculations are not observed power. Keeping design, endpoint, analysis, and safety information separate helps prevent stronger conclusions than the registry record can support.
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.
Several limitations specific to this registry entry affect interpretation. First, the study is recorded as single group, with allocation listed as NA and masking as none. There is no concurrent comparison group described, so the design cannot isolate a randomized contrast between the device and another intervention.
Second, the record defines the primary endpoint but does not report its results. It gives no mean scores, mean change, standard deviation, confidence interval, or p-value. The number of analyses is recorded as zero. The clinical effect and its precision therefore cannot be evaluated from the registry record.
Third, the enrollment figure does not establish how many participants contributed to each outcome. Endpoint-specific denominators, completion rates, analysis populations, and missing-data methods are not reported. The record also does not provide the detailed statistical analysis plan or explain whether a paired analysis was used for repeated assessments.
Fourth, although five outcome measures are listed, results and multiplicity procedures are not reported. The listed safety counts lack reported attribution, timing, and comparative context. These limitations are distinct from the stated planning assumptions, which are an illustration and not the actual single-group trial design.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults — NCT03007472.
- Registry record last updated 2020-12-30; status last verified 2020-12.
- Results first posted 2020-12-03.
- 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
NCT03007472 is a completed, single-group study of the CI532 cochlear implant with the CP1000 (Nucleus 7) sound processor in adults with sensorineural hearing loss. Enrollment is listed as 96. The study started on 2017-02-15, with primary completion on 2018-12-03. Allocation and phase are listed as NA, and masking as none.
The primary outcome is change in mean CNC word recognition in quiet from the preoperative best unilateral condition to 6 months after sound processor activation, in the implanted ear alone. Secondary outcomes include speech recognition in noise and the Health Utility Index-3. The registry lists five outcome measures and zero analyses. Numerical primary and secondary outcome results are not reported in the registry record.
Safety entries list serious adverse events affecting 16 of 96 at risk, other adverse events affecting 26 of 96 at risk, and 2 deaths. The record does not report event attribution or a comparison group.