Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System (NCT05034731), a non-randomized phase not stated study. The primary outcome is Speech Performance in Quiet - Chronic Use (Includes Overall - Both Groups).

2. Clinical Question

This is a question about measured speech performance under two fitting approaches, not a question answered by the design label alone. The brief summary calls the study a within-subjects repeated-measures study, which implies that assessments are made on the same users under both fitting conditions. The registry also lists a parallel model. How that model designation relates to the described repeated-measures comparison is not reported in the registry record.

The trial is marked completed, and its listed conditions include hearing loss, ear diseases, hearing disorders, and otolaryngological disease. Those registry entries provide context, but they do not establish that every participant had every listed condition. Likewise, the title refers to adult and pediatric users, while the brief summary specifies users aged 13 years or older; the enrolled participants’ age distribution is not reported in the registry record.

3. Trial Design

The registry lists a completed, prospective study sponsored by Advanced Bionics. It records a start date of 2021-08-18, a primary completion date of 2022-05-23, and enrollment of 19. The brief summary describes enrollment of 17 users aged 13 years or older, implanted with a HiResolution Bionic Ear System. The difference between the brief-summary target and the listed enrollment is not explained in the registry record.

The two named interventions are Remote Fitting and In-Office Fitting. Allocation is listed as non-randomized and masking as none. Accordingly, the registry does not describe randomized assignment or masking of participants or assessors. The record’s primary endpoint description compares chronic AzBio sentence recognition after remote fitting with chronic recognition after control in-office fitting.

There is a design-description tension worth keeping in view: the brief summary calls the study a within-subjects repeated-measures study, while the registry lists a parallel model. A within-subjects comparison generally means that each participant contributes measurements under both conditions; a parallel design generally means that different groups receive different conditions. These are general design meanings. The registry does not explain how the model label, arm structure, and within-subjects description fit together, so a more specific account of the actual sequence or allocation cannot be established from this record.

The arm descriptions are named Electric Only and Aidable Residual Hearing, but no descriptions are posted for those arms. The record lists 12 participants at risk in Electric Only and 5 in Aidable Residual Hearing for the adverse-event data. Those safety denominators should not be assumed to describe the primary endpoint analysis population, because the endpoint population and analysis counts are not reported in the registry record. Details such as fitting order, washout or stabilization procedures, eligibility criteria beyond the summary, and protocol deviations are also 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.

Before assignment: Per protocol, a subject is considered enrolled upon giving written informed consent. After undergoing the ICF process, subjects completed a hearing test. Depending on the outcome of that test, eligible subjects were enrolled for aidable residual hearing (ARH) fitting with an acoustic earhook. Unilaterally implanted subjects not meeting ARH fitting criteria were enrolled for electric only (EO) fitting. Bilaterally implanted subjects meeting ARH criteria only in one ear were screen failed.

Overall Study

Reasons for not completing this period:

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 Speech Performance in Quiet - Chronic Use (Includes Overall - Both Groups), measured over Test performed 2-3 weeks after fitting.

The primary endpoint is chronic AzBio sentence recognition in quiet, measured as a percentage of recognized words. Scores are described on a scale from 0% to 100% words correct, with higher scores indicating better performance on this speech-recognition measure. The registry specifies that testing occurs two-to-three weeks after fitting: after investigational remote fitting at visit 3 and after control in-office fitting at visit 2.

Speech recognition in quiet is used as a performance measure: it records how many words in the test sentences are recognized correctly under the stated test condition. A percentage makes the score interpretable as the share of words recognized, while the quiet listening condition defines the setting in which performance is assessed. The chronic-use timing is intended to assess performance after use following a fitting rather than immediately at the fitting visit, as described by the registry.

The registry labels the endpoint parameter as a mean and its dispersion measure as a standard deviation. In general, the mean describes the central value of a set of scores, while the standard deviation describes how spread out individual scores are around that mean. Those summaries do not by themselves show the difference between fitting conditions or the uncertainty in that difference. The observed means, standard deviations, sample sizes for this endpoint, and a between-condition estimate are not reported in the registry record. Nor does the record state how the endpoint was analyzed statistically.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary outcome as a continuous measure summarized by a mean and standard deviation. It does not report the inferential method used for the primary comparison, the estimates, or their uncertainty. The explanations below describe general statistical ideas relevant to this type of endpoint; they are not a description of an analysis confirmed in the registry record.

What does a mean describe?

A mean is a measure of the central level of a set of observations. For this endpoint, each observation is a speech-recognition score expressed as a percentage of recognized words. A mean can summarize the average score in a fitting condition, but it does not show whether individual participants had similar or widely varying scores. The standard deviation provides a summary of that variability around the mean. Neither statistic alone establishes whether the two fitting conditions differ.

How would a within-subjects comparison work?

In general, when the same participant is measured under two conditions, the analysis can focus on the participant-level difference between those measurements. This retains the pairing of observations. The standard error for a paired contrast depends not only on the spread of scores in each condition, but also on how strongly a participant’s scores under the conditions move together. If the measurements are not paired, an analysis of separate groups instead estimates uncertainty from the group-level variation and group sizes.

The registry’s brief summary describes repeated measures within subjects, while its model field says parallel. Because the record does not reconcile those descriptions, the intended statistical structure cannot be determined with confidence. It also does not report whether the analysis used paired differences, a model for repeated observations, or another approach. It would therefore be inappropriate to attribute a particular test or model to the study.

What does a confidence interval convey?

In general, a confidence interval gives a range of values compatible with the observed data and the assumptions of the analysis, and communicates uncertainty around an estimate. A narrow interval indicates greater precision than a wide interval, although precision alone does not establish practical importance. For a comparison, an interval around the estimated difference can show which directions and magnitudes remain compatible with the data. No confidence interval for the primary endpoint is reported in the registry record.

What does a significance test convey?

In general, a significance test assesses how compatible the observed data are with a stated null hypothesis under an analysis model. A p-value is not the probability that the null hypothesis is true, nor does it measure the size or importance of an effect. A small p-value does not replace an effect estimate and interval, while a larger p-value does not establish equivalence. The registry record does not report a p-value or the testing procedure for the primary endpoint.

Why can dispersion and distribution matter?

Continuous scores can vary across participants, and the way that variation is distributed can affect the appropriateness and precision of a statistical model. A standard deviation is useful for describing spread, but it does not show the shape of the score distribution or whether there are unusual values. Scores are bounded by 0% and 100%, as stated in the endpoint description; general statistical models may need to account for bounded outcomes when that feature affects the data. The record does not provide the observed score distribution or state how distributional assumptions were assessed.

Over-dispersion is a general concern for some models when observed variability is greater than the model expects. If present, it can make model-based uncertainty too small unless handled appropriately. The registry does not report an over-dispersion assessment, and the endpoint’s analysis method is not specified, so there is no basis to say whether this issue arose or applied to the chosen analysis.

How should planning calculations be read?

General sample-size planning asks how many participants might be needed to detect an effect under stated assumptions. Such calculations depend on factors including the target effect, variability, significance level, power, allocation, and the statistical model. The registry describes planning illustrations based on fractions of an observed effect and states assumptions involving a two-sided significance level of 0.05, equal allocation, and a normal approximation. The numerical illustration results are not reported in the registry record. These assumptions do not establish the trial’s original design rationale, and calculated planning sizes are not observed power. The trial-specific sample-size justification is not reported in the registry record.

The registry also does not describe interim analyses, adjustment for repeated measures, handling of missing outcomes, covariate adjustment, or sensitivity analyses. These are distinct analytic decisions; none can be inferred from a continuous endpoint label or from the fact that the study is completed.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures and two analyses, but does not give the analysis details or explain whether multiple primary or secondary hypotheses were tested. The multiplicity strategy, including whether any adjustment was planned or used, is not reported in the registry record. In general, testing several outcomes or contrasts can increase the chance of at least one apparently notable result by chance. Whether that concern applies to the reported analyses depends on the hypotheses and decision rules, which are not available in the record.

Missing-data procedures are also not reported in the registry record. For a repeated-measures comparison, participants may have one or both assessments available; how incomplete pairs were handled can affect both the analysis population and the estimated contrast. The record does not report how many participants contributed endpoint data, the amount or reasons for missingness, or whether an imputation or other missing-data method was used.

The analysis population is not specified. The listed enrollment is 19, while the brief summary describes a planned group of 17 users. Neither figure establishes the number included in the primary endpoint analysis. The registry does not state whether analysis followed an intention-to-treat principle, included only participants with complete observations, or used another population definition. It also does not report exclusions, withdrawals, or protocol deviations relevant to analysis.

These omissions limit assessment of possible bias and reproducibility. Without a defined analysis population, missingness account, and multiplicity plan, readers cannot determine how the posted endpoint analysis should be interpreted. These details are not reported in the registry record.

11. 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

The registry reports serious adverse events for the Electric Only group and the Aidable Residual Hearing group. In Electric Only, 12 participants were listed at risk and 0 were reported with a serious adverse event. In Aidable Residual Hearing, 5 were listed at risk and 0 were reported with a serious adverse event. The deaths field is 0 for both groups.

For other adverse events, 12 participants were listed at risk in Electric Only, with 2 affected; 5 were listed at risk in Aidable Residual Hearing, with 0 affected. These are counts of participants affected as recorded, not a description of event severity, duration, or causal relationship. The record does not list serious-event terms.

In general, zero reported events in a group does not establish that the risk is absent. Safety counts are interpreted in light of the number observed, the observation period, how events were collected, and the definitions used. The adverse-event observation period and detailed collection methods are not reported in the registry record. The listed safety denominators are not necessarily the primary endpoint analysis sample sizes, which are also not reported.

The study is non-randomized, and the two groups are named by hearing status. Those group labels do not establish that they are comparable safety populations. The reported counts describe what the registry records; they do not establish that an intervention caused or prevented an event.

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

The registry establishes that the study was completed and identifies a comparison of remote and in-office fitting using chronic AzBio sentence recognition in quiet. It also reports adverse-event counts for two named groups. However, the primary endpoint results are not reported in the registry record, so the posted information does not show the observed mean scores or the estimated difference between fitting conditions.

Without an estimate and a measure of uncertainty, readers cannot assess the magnitude or precision of any difference in speech-recognition performance. The endpoint scale indicates that higher scores represent more words recognized correctly, but that direction alone does not reveal what happened in the study. The absence of a result in the registry should not be interpreted as a finding of no difference, equivalence, or benefit.

The design information also constrains interpretation. The study is listed as non-randomized and unmasked. Its summary describes repeated measurements within participants, while its model designation is parallel; the registry does not explain the apparent inconsistency. These design features and reporting gaps mean the comparison cannot be characterized fully from the registry information alone. The specific allocation process, analysis method, and analysis population are not reported in the registry record.

The safety entries report no serious adverse events and no deaths in either listed group, alongside two participants with other adverse events in Electric Only and none in Aidable Residual Hearing. These counts are descriptive and do not, by themselves, establish comparative safety or causation. More detailed event descriptions and follow-up information are not reported in the registry record.

Overall, the registry supplies the endpoint definition and some study characteristics, but not the primary efficacy results needed to characterize the speech-performance comparison. The statistically appropriate conclusion is therefore about reporting: the size, direction, and precision of the primary contrast remain unknown from the registry record.

13. Why This Trial Matters Statistically

This study raises several statistical issues that are common in clinical research using repeated measurements. The endpoint is assessed after remote and in-office fitting, and the brief summary describes a within-subjects design. When measurements are paired within participants, their dependence is part of the analysis rather than a nuisance to ignore. The record’s separate parallel-model designation makes it especially important to clarify the actual design before interpreting an estimate or its uncertainty.

The non-randomized allocation is also relevant. In general, randomization helps balance measured and unmeasured participant characteristics across assigned conditions on average. Without random allocation, the process determining which condition is received, and when, can influence a comparison. Repeated measures may reduce the influence of stable differences between people, but they do not necessarily address time-related changes or sequence effects. The registry does not report how these design issues were addressed.

The endpoint is a bounded percentage score, and the record describes it using a mean and standard deviation. Statistical summaries need to be read in relation to the score’s scale and observed distribution. The posted registry does not give the distributions or inferential results, so readers cannot assess whether the chosen summary and model matched the observed data.

Finally, a completed study with an identified primary endpoint does not automatically provide a statistically interpretable result. An estimate, uncertainty interval, analysis population, and account of missing data are needed to understand how much the data support a comparison. Those primary outcome details are not reported in the registry record. The design and endpoint information still identify the central statistical question, but the absence of results prevents assessment of its answer.

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 trial-specific limitations follow from the information recorded. The primary AzBio outcome values and the comparison estimate are not reported in the registry record. There is consequently no basis to describe the direction, magnitude, or precision of the primary result. The record also does not state the statistical test or model used, or provide a confidence interval or p-value.

The description of the design is not internally clear: the brief summary calls the study a prospective within-subjects repeated-measures study, whereas the model is listed as parallel. The registry does not explain this distinction. Allocation is non-randomized and masking is listed as none, but details of allocation, fitting sequence, or safeguards against order and period effects are not reported.

The brief summary states that 17 users aged 13 years or older would be enrolled, while the registry lists enrollment of 19. The explanation for this difference, participants’ age distribution, and the number included in endpoint analyses are not reported in the registry record. Although arm labels are present, their descriptions are blank. The endpoint population and whether both fitting assessments were available for each participant are not reported.

Missing-data handling, multiplicity procedures, analysis populations, interim analyses, and the trial’s sample-size justification are not reported in the registry record. The planning assumptions described in the record do not establish the original design rationale. Safety results are limited to counts by group; event terms and observation-period details are not reported. Together, these gaps limit independent evaluation of the primary comparison and its safety context.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System — NCT05034731.
• Registry record last updated 2023-09-21; status last verified 2023-08.
• Results first posted 2023-09-21.
• 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.

18. Record Summary

The registry record describes a completed, non-randomized study of Remote Fitting and In-Office Fitting in users of the HiResolution Bionic Ear System. It lists enrollment of 19, while the brief summary describes a planned enrollment of 17 users aged 13 years or older. The summary calls the study prospective and within-subjects with repeated measures; the model is listed as parallel, and the relationship between these descriptions is not explained.

The primary endpoint is chronic AzBio sentence recognition in quiet, measured as percentage of recognized words two-to-three weeks after fitting. Higher scores represent better recognition. The observed endpoint results and analysis details are not reported in the registry record. Safety entries list no serious adverse events and no deaths in either named group; other adverse events affected 2 participants in Electric Only and 0 in Aidable Residual Hearing.

Details of the primary analysis population, missing data, multiplicity, and statistical method are not reported in the registry record.