Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor (NCT03848910), a na na study. The primary outcome is Abbreviated Profile of Hearing Aid Benefit (APHAB).

2. Clinical Question

This is a question about reported hearing-related experiences across device assessments, not a randomized comparison of independent treatment groups. Because the record describes a single-group design and no masking, the contrast cannot by itself distinguish a device-related difference from changes associated with assessment order, expectations, or other factors. Those are general considerations for interpreting an unmasked within-participant comparison, not findings about what occurred in this investigation.

3. Trial Design

The registry describes a completed, single-group device investigation sponsored by Cochlear. Its title is “Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor.” The phase and allocation are recorded as NA, and masking is recorded as NONE. Enrollment is 11. The status is COMPLETED.

The stated investigation aim is to examine overall preference, hearing performance, and self-reported assessments using the investigational device and its precursor Sound Processor after 6 weeks. For the primary APHAB endpoint, the precursor processor assessment is at Day 0 (Visit 1), and the investigational device assessment is after 6 weeks (Visit 3). This timing describes a before-and-after device assessment in the same investigation; a randomized parallel-group comparison is not described.

The listed intervention is the investigational Sound Processor, categorized as a device. The arm description is blank. The record lists conditions of deafness; sensoneural single sided, conductive hearing loss, and mixed hearing loss. It does not report participant-level characteristics, the number in each condition, or details of eligibility and device use.

The registry records a start date of 2019-02-19 and a primary completion date of 2019-04-23. It lists 14 outcome measures and 0 analyses. These entries describe the registry record, not the completeness of all study activity or whether analyses may exist outside it. The record does not report a protocol, a sample-size justification, interim analyses, or the planned statistical analysis methods. The sample-size assumptions associated with the posted planning illustrations are not a description of the investigation’s own design.

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 Abbreviated Profile of Hearing Aid Benefit (APHAB), measured over Day 0 (Visit 1) and after 6 weeks (Visit 3).

The primary endpoint is the Abbreviated Profile of Hearing Aid Benefit (APHAB), a questionnaire measure reported in units on a scale. The registry describes the Ease of communication, Reverberation, Background noise, and Aversiveness subscales, along with a Global score. Each subscale ranges from 0-100%, and the total score is the average of all subscales on a 0-100% scale. In the registry’s description, 0% indicates no problems and 100% indicates always problem.

The endpoint is used to capture participants’ self-reported hearing-related difficulties across the situations represented by the subscales. As a patient-reported measure, it addresses perceived experience rather than a direct instrument-based measurement of hearing performance. The record states that a decrease in APHAB values indicates improvement. For the reported change from the precursor sound processor at Day 0 (Visit 1) to the investigational device after 6 weeks (Visit 3), the record defines a positive value as improvement with the investigational device and a negative value as impairment.

The endpoint is specified as a mean with Standard Deviation. The registry describes assessment timing and the direction of interpretation, but does not report the numerical means, the change estimate, the Standard Deviation values, or a confidence interval. Consequently, the magnitude and precision of any observed change cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is a continuous measure reported as a mean with Standard Deviation. A mean conveys the average score or average change in a group of measurements. A Standard Deviation describes how dispersed individual measurements are around that mean. These are different kinds of information: the mean describes the central value, while the Standard Deviation describes variability among the measurements. Neither is reported numerically for APHAB in the registry record.

What does the APHAB change represent?

The registry describes APHAB scores at Day 0 (Visit 1) with the precursor sound processor and after 6 weeks (Visit 3) with the investigational device. Its change measure is intended to express the difference between those assessments. The registry states that decreases in APHAB values indicate improvement and defines a positive change as improvement with the investigational device. This is the endpoint’s stated sign convention; it does not indicate that an improvement was observed. The change estimate itself is not reported in the registry record.

General statistical interpretation distinguishes the direction of an estimate from its magnitude and precision. Direction indicates which way the estimate points according to the defined scale. Magnitude indicates how large the estimated change is, in the endpoint’s units. Precision indicates how uncertain that estimate is. A confidence interval is a common way to express precision: under its statistical assumptions, it gives a range of values compatible with the data and method. No confidence interval is reported for the APHAB endpoint, so its precision cannot be evaluated from this record.

Why does the single-group design matter?

The registry identifies the study model as SINGLE GROUP, allocation as NA, and masking as NONE. The primary assessment compares a precursor-processor measurement at Day 0 with an investigational-device measurement after 6 weeks. In general, a before-and-after contrast can describe how measurements differ across these occasions. Without a separate randomized comparison, however, the contrast does not by itself separate the device change from all other differences between occasions. Expectation, assessment order, and change over time are general interpretive considerations for an unmasked assessment; the registry does not report whether these affected this study.

A within-participant comparison can account for the fact that repeated measurements come from the same person, if the analysis is designed accordingly. That does not remove the need to specify how paired measurements were analyzed or how incomplete pairs were handled. The statistical analysis method is not reported in the registry record. It is therefore not possible to determine from the record whether the analysis used paired changes, a model for repeated measurements, or another method.

What do the planning illustrations mean?

The record describes sample-size planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. These are planning assumptions, not evidence that the investigation was planned or conducted as a two-arm trial. The record identifies this investigation as single-group. It also does not report the numerical planning outputs in the information available for this analysis, so no sample-size values can be interpreted.

Planning calculations that use an observed effect are illustrative: they show how a hypothetical future design might be sized under stated assumptions. They do not measure the probability that the current investigation detected an effect, and they are not observed power. A planning estimate based on an observed effect can also depend heavily on the stability of that effect estimate. Since the APHAB effect is not reported in the registry record, the planning illustration’s numerical implications cannot be assessed from this information.

General sample-size calculations depend on assumptions about the outcome, variability, target effect, significance level, allocation, and analysis method. If these assumptions do not match the actual design, the resulting planning figure may not apply to it. Here, the posted assumptions describe equal allocation between two arms, while the registry’s recorded study model is single-group. The registry does not provide a study-specific sample-size justification or explain how the illustrations relate to the enrolled study.

How should variability and scale be read?

APHAB is described on a 0-100% scale, with 0% indicating no problems and 100% indicating always problem. The Global score is described as the average of all subscales. An average can help condense multiple questionnaire dimensions into a single score, while the subscales retain information about particular reported situations. The record does not report the numerical results for the Global score or any subscale, so it is not possible to tell whether the dimensions moved in the same direction or differed.

General statistical methods may need to account for features such as skewed measurements, repeated observations, or over-dispersion, depending on the outcome and data structure. Over-dispersion means that observed variability is greater than a model assumes; if ignored, uncertainty estimates can be too small. This is a general concept, not a description of the APHAB data in this investigation. The registry reports the endpoint as a mean with Standard Deviation and does not report a distributional assessment or a model choice.

Interpretation also depends on the analysis population and missing data rules. For example, an analysis may use all participants with relevant measurements or may apply a specified method for incomplete observations. The registry does not report which participants contributed to the APHAB analysis, whether responses were missing, or how any missing data were handled. The enrollment figure alone does not establish the denominator for the endpoint.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 14 outcome measures and 0 analyses. It does not report a multiplicity strategy or explain whether the outcomes were arranged in a hierarchy, whether one was designated as primary in a statistical plan, or whether any adjustment for multiple testing was planned. The registry does identify APHAB as the primary endpoint. That designation helps identify the main stated outcome, but without a reported analysis plan or numerical result, the role of the other outcome measures in interpretation cannot be assessed.

In general, when several outcomes or comparisons are tested, the chance of at least one apparently notable result can increase if each is assessed independently. Statistical methods can address that issue through prespecified outcome hierarchies or adjustments, but the registry record does not say whether such methods were used. No multiplicity-adjusted or unadjusted APHAB result is reported.

Missing-data handling is not reported in the registry record. The record does not say whether all enrolled participants completed both APHAB assessments, whether any questionnaire items or visits were incomplete, or how missing observations were treated. It also does not identify the analysis population for APHAB. Thus, the endpoint denominator, the number of complete assessment pairs, and any assumptions used for missing data are not reported.

These omissions limit interpretation of both the estimate and its uncertainty. A result based on complete paired assessments may represent a different analysis population from one using other methods for incomplete data. This is a general consideration; the registry does not report which approach applies. The listed count of 0 analyses describes the registry entry and should not be taken as evidence that no analysis exists outside 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 lists the investigational Sound Processor group with 11 participants at risk for serious adverse events and 0 affected. For other adverse events, it lists 11 at risk and 4 affected. Deaths are listed as 0. These are counts recorded for the listed group, not comparative estimates against a control group. The record does not provide event-level descriptions, severity details for the other adverse events, or information about their timing.

The serious adverse event entry indicates that the registry reports no affected participants in that category for the listed group. It does not establish that no adverse experiences of any kind occurred: the record separately lists other adverse events. Nor does a count of 0 establish the absence of risk. General interpretation of safety counts depends on the observation period, how events were defined and collected, and the completeness of reporting. Those details are not reported in the registry record.

The record also does not report a statistical comparison, an assessment of relatedness to the device, or a narrative explaining the other adverse events. Because there is no separate control group described, these figures cannot show whether event frequency differed between devices or groups. They should be read as registry-reported counts, with the available event detail and comparative context limited.

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

The record establishes that a completed, single-group investigation assessed a new Sound Processor in relation to hearing performance, functionality, preference, and self-reported assessments. It identifies APHAB as the primary endpoint and specifies assessment with the precursor sound processor at Day 0 (Visit 1) and with the investigational device after 6 weeks (Visit 3). It also gives the scale’s direction: lower APHAB values indicate improvement, and a positive change is defined as improvement with the investigational device.

Those design and measurement details explain what the investigation set out to examine. They do not establish the direction, size, or precision of the observed APHAB change. Numerical endpoint results are not reported in the registry record. As a result, no conclusion about the observed difference in self-reported problems, or about whether that difference was large or small, can be drawn from this information.

The absence of a reported confidence interval or Standard Deviation also means the uncertainty and variability around the endpoint cannot be characterized. Enrollment is 11, but that number does not indicate how many participants contributed to the APHAB estimate or how precisely the estimate was measured. The analysis population and missing-data handling are not reported.

Because the registry describes a single-group, unmasked comparison across assessments at different times, any numerical change would be a descriptive contrast unless supported by further design or analysis details. In general, such a contrast does not by itself attribute the difference to the device. The registry record does not report a separate randomized control group or methods that would address other possible influences.

The safety entries report 0 serious adverse events, 4 participants affected by other adverse events, and 0 deaths in the listed investigational-device group. These entries do not provide event descriptions or comparative evidence. Overall, the record documents the question, endpoint, and some safety counts, but does not provide the primary numerical findings needed to judge what change was observed.

13. Why This Trial Matters Statistically

This investigation is statistically notable for the contrast between the clinical question and the design information in the registry. The stated aim includes preference, hearing performance, and self-reported assessments with a new processor and its precursor. The recorded study model is single-group, with no masking and allocation recorded as NA. The APHAB assessment compares the precursor at Day 0 with the investigational device after 6 weeks. Recognizing that structure is essential: the endpoint is a change across assessments, not a randomized comparison between independent groups.

The record also makes the scale direction explicit. A decrease in APHAB values indicates improvement, while the described change is coded so that a positive value indicates improvement with the investigational device. Stating this convention is useful because the meaning of a positive or negative estimate depends on how change is defined. However, the numerical estimate is not reported, so direction cannot be inferred from the convention alone.

The study illustrates why a complete statistical account needs more than an endpoint name and enrollment figure. Interpretation also depends on the estimated change, variability, precision, analysis population, handling of incomplete assessments, and analysis method. Those details are not reported in the registry record. Without them, readers cannot evaluate the magnitude or reliability of the endpoint finding.

The record’s planning assumptions also merit separation from the actual design. The illustrations use equal allocation between two arms and a normal approximation, while the study model is recorded as single-group. Planning calculations are not observed study outcomes or evidence of achieved power. Keeping design details distinct from planning assumptions prevents a hypothetical calculation from being mistaken for a feature of the completed investigation.

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 main limitation for interpreting this specific investigation is that the registry record does not report the numerical primary endpoint results. Although it identifies APHAB, its subscales, timing, scale range, and direction, it does not give means, change estimates, Standard Deviation values, or confidence intervals. The magnitude and precision of the primary finding therefore cannot be evaluated.

The registry records a single-group design with no masking and no randomized allocation. The primary endpoint compares different processors at different assessment times. Without a separate randomized comparison described in the record, any reported change would require cautious interpretation as a time-separated contrast. The record does not describe methods to address expectations, order, or other influences that may affect self-reported assessments.

Participant detail is limited. Enrollment is 11, and the registry lists conductive hearing loss, mixed hearing loss, and deafness; sensoneural single sided. It does not report the distribution of participants among conditions, baseline characteristics, or further eligibility details. The analysis population and endpoint denominator are also not reported.

Other important statistical details are absent: the analysis method, missing-data approach, multiplicity strategy, and study-specific sample-size justification are not reported in the registry record. The registry lists 14 outcome measures and 0 analyses, but this does not establish what analyses may exist outside the record. Safety information is also limited to counts; descriptions and comparative context for the other adverse events are not reported.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor — NCT03848910.
• Registry record last updated 2021-10-14; status last verified 2020-01.
• Results first posted 2020-02-05.
• 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, single-group device investigation sponsored by Cochlear, with enrollment of 11. The study status is COMPLETED; the recorded start date is 2019-02-19 and the primary completion date is 2019-04-23. Allocation is NA, masking is NONE, and the phase is NA.

The stated aim is to assess overall preference, hearing performance, and self-reported assessments with the investigational Sound Processor and its precursor after 6 weeks. The primary endpoint is APHAB, assessed with the precursor at Day 0 (Visit 1) and with the investigational device after 6 weeks (Visit 3). The registry describes its subscales, Global score, scale range, and direction of interpretation.

The record lists 14 outcome measures and 0 analyses. It does not report numerical APHAB results, the analysis method, missing-data handling, or an analysis population. Safety entries list 0 serious adverse events, 4 affected by other adverse events, and 0 deaths in the investigational-device group. The event descriptions are not reported in the registry record.