Safety and Performance of HiRes Ultra/Ultra 3D Cl Mid-Scala Electrodes in Adults With Severe-to-profound Hearing Loss: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Safety and Performance of HiRes Ultra/Ultra 3D Cl Mid-Scala Electrodes in Adults With Severe-to-profound Hearing Loss (NCT04610112), a registered phase not stated study. The primary outcome is Freiburger Monosyllables Score in Quiet.

2. Clinical Question

Consequently, the registry entry defines a device-focused safety and performance investigation rather than a randomized comparative-effectiveness question. The posted information identifies what outcome was intended to be measured and the follow-up timeframe, but it does not establish what the participants’ scores were or how those scores changed. No conclusion about comparative performance can be drawn from the listed safety group or from the study description alone.

3. Trial Design

This is a prospective study of cochlear implantation with HiRes Ultra Cl HiFocus MS and HiRes Ultra 3D Cl HiFocus MS electrodes in adults with severe-to-profound hearing loss. The registry record lists an enrollment of 30 and identifies Advanced Bionics AG as the sponsor. The record states that the study is completed. Its listed start date is 2020-09-16, and its primary completion date is 2025-05-21.

The stated aim is to evaluate the safety and performance of the devices under normal conditions of use as approved for the device. The listed intervention is cochlear implantation, classified as a procedure. The record identifies the primary endpoint as the Freiburger Monosyllables Score in Quiet at 6 months, with Speech Reception Theshold (SRT) in Noise listed as a secondary outcome. Two outcome measures are listed in total.

The record does not describe a randomized allocation process. It explicitly indicates that the study is not a randomized comparison, that allocation is not stated, and that arms are not a like-for-like control comparison. The registry record does not report the number of participants assigned to each device, the method used to choose a device, or whether all enrolled participants received the same device. It also does not report a comparator that would support a direct between-group estimate.

Although the record is marked completed, it lists 0 analyses and does not report results for the primary endpoint or the secondary outcome. It does not report details such as the analysis population, follow-up completeness, or protocol deviations. Therefore, the design description identifies the clinical setting, intended outcomes, and broad study purpose, but leaves important operational and analysis details 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

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.

6. Primary Endpoint

The registry lists the primary outcome as Freiburger Monosyllables Score in Quiet, measured over 6 months.

The primary endpoint is the Freiburger Monosyllables Score in Quiet at 6 months. It is measured as percent correct, on a scale from 0 to 100% of correct answers. In general, a speech-recognition score of this kind records how many presented speech items are identified correctly under the stated listening condition. The quiet condition distinguishes this endpoint from speech testing conducted with competing noise.

The registry record specifies that the endpoint is summarized using a mean and a standard deviation. In general, the mean describes the central value of a set of scores, while the standard deviation describes how dispersed individual scores are around that mean. Reporting both can help readers understand not only the average score but also the degree of variation among participants. The registry record does not report the observed mean or standard deviation, so the score level and variability cannot be characterized from this entry.

Speech-recognition measures are relevant to a device performance investigation because they describe an aspect of hearing-related function under a defined test condition. That general rationale does not mean that this endpoint alone captures every aspect of hearing, communication, or device performance. The record does not report other details needed to interpret test administration, such as the specific scoring procedures, testing environment beyond “in Quiet,” or how missing measurements were handled. Nor does it report a comparison against a baseline value or a control group. The endpoint definition therefore clarifies what was intended to be measured, but not the result or its clinical importance.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the endpoint summary describe?

The primary measure is continuous: the Freiburger Monosyllables Score in Quiet is recorded as percent correct on a scale from 0 to 100% of correct answers. The registry specifies a mean as the summary parameter and a standard deviation as the dispersion measure. In general, a mean condenses a set of observations to a central value, while a standard deviation describes how much observations vary around that value. These summaries are useful for describing a continuous outcome, but their interpretation depends on the observed values and the number of participants contributing data. Neither the endpoint mean nor its standard deviation is reported in the registry record.

In general, a summary of the mean does not show the full distribution. It may not reveal whether scores cluster tightly, include unusually high or low values, or have a shape that makes a mean less representative of a typical participant. A standard deviation adds information about spread but does not by itself show the distribution’s shape. No distributional description is reported for this outcome, so those features cannot be assessed from the entry.

What would an uncertainty estimate add?

General explanation: an estimate describes the observed data, while a confidence interval communicates uncertainty about the quantity being estimated. A narrow interval generally indicates greater precision than a wide interval, conditional on the statistical method and assumptions. A p-value, when reported, addresses compatibility between data and a specified null hypothesis under a model; it does not measure the size or clinical importance of an effect. The registry record lists 0 analyses and does not report a confidence interval, p-value, or primary endpoint estimate. There is therefore no posted inferential result to interpret, and no recalculated result is available to discuss.

What do the planning illustrations mean?

The planning illustrations are not the trial’s own design justification and are not observed power. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect expressed as a stated fraction of the observed effect. The record describes sample counts for continuous outcomes as participants per arm. These are hypothetical planning quantities tied to the stated assumptions, not observed enrollment outcomes or a report of the study’s prespecified sample-size rationale.

In general, a sample-size calculation depends on the target effect, variability, significance level, power target, allocation, and analysis method. If an assumed effect or variability differs from the values relevant to a future study, the resulting planning quantity may also differ. A calculation based on an observed effect is particularly dependent on that observed estimate and should not be interpreted as proof that a completed study had adequate power. No sample-size justification from the study protocol is reported in the registry record. The illustration cannot substitute for that missing design information.

Why does over-dispersion matter in general?

General explanation: a statistical model may assume a particular amount of variability. Over-dispersion occurs when the observed variation is greater than the model expects. If a model does not account for that extra variability, uncertainty estimates can be too small and tests can appear more decisive than warranted. This concept is most relevant when the outcome and model involve a variance structure for which over-dispersion is possible. The registry record does not report a fitted model or an over-dispersion assessment for the continuous primary measure, so it is not possible to say whether this issue arose in the analysis.

What can be inferred from the registry’s analysis listing?

The record lists 0 analyses. This means that the registry entry does not contain a posted analysis result for the listed outcomes; it does not establish what analyses may or may not have been conducted outside the record. The statistical plan, model specification, covariate adjustments, handling of repeated measurements, and any sensitivity analyses are not reported in the registry record. No unadjusted recalculation is possible without summary statistics for the endpoint, and there is no sponsor analysis in the entry to compare against such a recalculation. Consequently, interpretation should remain descriptive: the record defines the endpoint and gives limited safety counts, but it does not provide the statistical results needed to quantify performance or precision.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Group1")
n   <- c(30)
m   <- c(54.58)
sp  <- c(26.84)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Group1  30  54.580  26.840  44.558  64.602

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 2 outcome measures: the primary Freiburger Monosyllables Score in Quiet and the secondary Speech Reception Theshold (SRT) in Noise. It does not report a multiplicity strategy, such as whether testing across outcomes was adjusted or whether one outcome was designated for a particular inferential role beyond its primary or secondary label. With 0 analyses listed, there are no posted outcome-specific estimates or tests to interpret in relation to multiplicity.

In general, multiplicity arises when multiple outcomes, time points, groups, or hypotheses are examined. Without an appropriate plan, the chance of obtaining at least one apparently notable result can increase as the number of tests grows. This general issue does not establish that a problem occurred in this study; the registry record does not report enough about the analysis plan or results to assess it.

Missing-data methods are not reported in the registry record. The entry does not state how many participants contributed a 6-month score, whether any measurements were missing, why data might be missing, or how missing measurements were handled. The analysis population is also not reported. It is therefore not possible to determine whether the primary endpoint was analyzed among all enrolled participants, among participants with available measurements, or within another defined population.

The record’s enrollment of 30 is not a count of participants with observed primary endpoint data. Completion status does not establish complete follow-up or complete outcome data. Without denominators for the endpoint, missingness details, and a stated analysis population, readers cannot assess how representative the analyzed participants may have been of those enrolled. These gaps also limit assessment of potential bias from incomplete follow-up.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

For Group1, the registry record lists 30 participants at risk for serious adverse events and 0 affected. It lists 30 participants at risk for other adverse events and 21 affected. The number of deaths listed is 0. The record does not list individual serious adverse event terms.

These figures are counts for the group as recorded, not a comparison between treatment groups. They do not show the timing, duration, recurrence, or clinical details of events. The registry record does not report event definitions beyond the serious and other categories, nor does it provide narratives or a separate analysis of severity. The fact that the listed number affected differs between the serious and other categories should be read only as the posted category-specific counts, not as a basis for calculating a rate or comparing risks. No new percentage or rate is calculated.

In general, safety counts are most interpretable when the group definition, period of observation, event definitions, and number with complete safety follow-up are clear. The entry provides a group label and at-risk counts, but other details are not reported in the registry record. The counts therefore describe the registry’s safety entries without establishing a comparative safety profile.

13. What the Result Does, and Does Not, Mean

The record establishes that a prospective study was designed to evaluate safety and performance of the named electrodes in adults with severe-to-profound hearing loss. It identifies cochlear implantation as the procedure, specifies a 6-month primary speech-recognition outcome, and lists SRT in Noise as a secondary outcome. It also reports limited adverse-event counts for Group1. These details describe the study’s stated scope and the information entered in the registry.

The record does not report the primary endpoint result, its standard deviation, a confidence interval, or a statistical test. It therefore does not show the average score achieved, the variability in scores, or the precision of an estimated performance quantity. The secondary outcome result is also not reported. The listed outcome definitions should not be mistaken for evidence that scores improved, worsened, or remained unchanged.

Nor does the entry provide a randomized comparison. Allocation is not stated, and the record cautions that arms are not a like-for-like control comparison. The information cannot establish whether one electrode type performed differently from another or whether any observed outcome would be attributable to a particular device. No comparator estimate is reported.

The safety counts have a similarly limited interpretation. They record 0 serious adverse events among 30 at risk, 21 affected for other adverse events among 30 at risk, and 0 deaths. Without event details, follow-up information, or a comparison group, these counts do not characterize the full nature or comparative frequency of safety events.

In general, a study’s meaning depends on its design, completeness of follow-up, outcome definitions, analysis methods, and uncertainty around results. Several of these elements are not reported in the registry record. The completed status indicates that the study is marked completed, but it does not supply missing estimates. Accordingly, the registry entry supports a description of study intent and selected safety counts, not a conclusion about the size, precision, or comparative meaning of the primary outcome.

14. Why This Trial Matters Statistically

This trial is statistically notable because its registry entry separates a clearly defined outcome from the results needed to interpret it. The primary measure is identified by name, scale, summary type, and timeframe: the Freiburger Monosyllables Score in Quiet, expressed as percent correct, summarized by a mean and standard deviation at 6 months. That specification helps clarify what outcome was intended, while the absence of posted estimates leaves its observed level and precision unknown.

The design description also matters for interpretation. The entry states that the study is not randomized, that allocation is not stated, and that arms are not a like-for-like control comparison. Those features constrain the kinds of comparisons that can be supported by the registry information. A reader cannot treat the study as a randomized head-to-head evaluation or infer that a group difference, if reported elsewhere, would necessarily reflect a device effect.

The entry lists 2 outcome measures but 0 analyses. This makes the distinction between outcome registration and statistical reporting especially important. A listed endpoint tells readers what was to be measured; it does not show the result, account for multiplicity, describe missing data, or communicate uncertainty. These analysis details are not reported in the registry record.

The posted safety counts illustrate another statistical distinction: event counts describe a recorded group, while comparative safety questions require clearly defined comparison groups and appropriate context. Group1 has listed counts for serious events, other events, and deaths, but no comparative analysis or event detail is reported. Thus, the record is useful for identifying the intended assessment and the limited results entered, while also making clear which statistical questions remain unanswered by the registry data.

15. 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 principal limitation for interpreting performance is that the registry record does not report the primary outcome result. Although the endpoint, scale, summary type, and 6-month timeframe are specified, no mean or standard deviation is posted. The secondary outcome result is also not reported. There is consequently no basis in this entry for describing observed speech-recognition performance or its variability.

Design and analysis details are limited. The record states that the study is not randomized, allocation is not stated, and arms are not a like-for-like control comparison. It does not report how device selection occurred, whether there were device-specific groups, or how any group-level results would be adjusted for differences between participants. The analysis population, endpoint denominators, missing-data handling, and statistical plan are not reported in the registry record.

The safety information is also restricted. Counts are listed for Group1, but the record does not report event timing, detailed event descriptions, duration, or comparative safety results. No serious adverse event terms are listed. The registry entry does not establish how long participants were observed for safety or whether the listed at-risk counts represent complete follow-up.

Finally, the completed status and enrollment figure do not resolve these limitations. The entry lists 30 enrolled and 0 analyses, but does not show how many participants contributed to each endpoint. The study’s sample-size justification and any interim analyses are not reported in the registry record. The planning illustrations are not the study’s own design rationale and are not observed power. These limitations mean the registry entry can be read as a description of intended assessment and selected counts, but not as a complete statistical report of the investigation.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Safety and Performance of HiRes Ultra/Ultra 3D Cl Mid-Scala Electrodes in Adults With Severe-to-profound Hearing Loss — NCT04610112.
• Registry record last updated 2026-03-25; status last verified 2026-02.
• Results first posted 2026-03-25.
• 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.

19. Record Summary

NCT04610112 is a completed prospective study sponsored by Advanced Bionics AG. It lists an enrollment of 30 and concerns cochlear implantation with HiRes Ultra Cl HiFocus MS and HiRes Ultra 3D Cl HiFocus MS electrodes in adults with severe-to-profound hearing loss. The stated purpose is to evaluate safety and performance under normal conditions of use as approved for the device.

The primary endpoint is the Freiburger Monosyllables Score in Quiet at 6 months, measured as percent correct and described using a mean and standard deviation. Speech Reception Theshold (SRT) in Noise is listed as a secondary outcome. The registry record reports safety counts for Group1: 0 serious adverse events among 30 at risk, 21 affected for other adverse events among 30 at risk, and 0 deaths.

The entry lists 0 analyses and does not report primary or secondary outcome results, a statistical plan, missing-data methods, or an analysis population. It also states that the study is not randomized, allocation is not stated, and arms are not a like-for-like control comparison. The posted information therefore defines the study’s question and limited safety counts, but does not provide outcome estimates or their precision.