Lab Evaluation of Novel Hearing Aid Coupling Method: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Lab Evaluation of Novel Hearing Aid Coupling Method (NCT05377359), a na na study. The primary outcome is Sound Quality Ratings While Streaming.

2. Clinical Question

The registry describes a laboratory evaluation rather than a clinical effectiveness comparison. Participants were presented with recordings and asked to rate and compare sound-quality attributes. The primary outcome timeframe is 60 minutes. Situational preference ratings are listed as a secondary outcome, but their numerical results are not reported in the registry record.

The main interpretive question is therefore about the intended measurement and comparison, not about an established direction or size of a difference. The record explains how higher ratings should be interpreted for each attribute, but it does not report the observed ratings, uncertainty around them, or an analysis comparing coupling methods.

3. Trial Design

This is a completed, single-group study listed for Hearing Loss. It is described as a laboratory evaluation of different hearing-aid coupling methods. The record lists enrollment of 20 and identifies Sonova AG as the sponsor. The study start date is 2023-02-07, and the primary completion date is 2023-11-20. The phase is listed as NA.

The design is within-participant in the sense that all participants were assessed under all interventions. The four recording conditions were open domes, closed domes, Novel State 1, and Novel State 2. The description says participants were fitted with binaural hearing aids using various coupling methods, while the primary outcome describes recordings presented to participants for rating. The record does not provide further procedural detail about how recordings were made or presented beyond the MUSHRA paradigm.

Allocation is listed as NA, and masking is listed as NONE. The record therefore does not describe a randomized allocation to separate treatment groups or masking. The intervention conditions should not be read as independent parallel arms: the same participants were assessed across all interventions. This structure allows ratings to be considered across methods within participants, but the registry record does not report how the order of conditions was handled or what statistical model was used to account for repeated assessments.

The study status is COMPLETED. However, a completed status does not itself establish that outcome data or statistical results have been posted. The registry record lists two outcome measures and zero analyses. It describes the primary sound-quality rating and lists situational preference ratings as secondary, but numerical results for either outcome are not reported in the registry record. Details of the protocol, prespecified analysis plan, and sample-size justification 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.

Intake and Consent Form Completion

Breaks Between Appointment 1 and 2

Streaming Sound Quality Task

Situational Preference Task

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 Sound Quality Ratings While Streaming, measured over 60 minutes.

The primary endpoint is sound-quality ratings while streaming, measured in units on a rating scale. Participants compare recordings from different coupling options using a Multiple Stimuli with Reference and Anchor (MUSHRA) paradigm. Ratings are made on a scale from 0, the minimum value, to 100, the maximum value. The primary outcome timeframe is 60 minutes.

The endpoint includes fullness, sharpness, and overall impression. Higher fullness ratings mean that a recording was perceived as fuller, with a thicker or richer sound; the registry describes higher scores as better for this attribute. Higher sharpness ratings mean that a recording was perceived as sharper, thinner, or more shrill; lower scores are described as better for sharpness. Higher overall-impression ratings indicate greater preference for a recording relative to the other recordings and are described as better for this attribute.

These attributes capture distinct aspects of a listening judgment. A single overall score would not necessarily convey whether participants perceived a recording as fuller or sharper, or whether they preferred it overall. The MUSHRA approach is intended to elicit comparative ratings among presented recordings. General statistical interpretation: a rating scale records participants’ judgments in the units defined by the study, but the scale alone does not establish how precise an estimated difference is or whether any difference is important outside the study context.

The registry describes the measurement but does not report observed ratings, summaries by coupling method, comparative estimates, or uncertainty intervals. Therefore, the endpoint’s definition can be interpreted, but the direction, magnitude, and precision of any observed contrast cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry lists a single-group study in which all participants were assessed under all interventions. This makes the intended structure different from a parallel-group trial, where participants are assigned to one condition and compared with participants assigned to another. Here, the four conditions are recordings associated with open domes, closed domes, Novel State 1, and Novel State 2. The design description supports understanding the comparison as repeated ratings across methods within participants. It does not specify the statistical procedure used to analyze those repeated observations.

What does a within-participant comparison mean?

General statistical explanation: repeated measurements from one person are often related. Someone who tends to use the rating scale generously may give relatively high ratings across several conditions. A within-participant analysis can focus on how that person's ratings vary across conditions, rather than treating every rating as if it came from an unrelated person. This can be useful, but it requires an analysis that recognizes the dependence among measurements. Treating correlated observations as independent can misstate uncertainty.

The registry record does not report whether the primary analysis used participant-level contrasts, a repeated-measures model, or another method. It also does not report how the presentation order was determined or whether order was included in an analysis. Those details matter because ratings can potentially depend on the sequence or context of listening; whether such effects occurred in this study is not reported in the registry record.

How should the rating scale be understood?

The primary measure is a rating in units on a scale whose endpoints are 0 and 100. The record names three sound-quality attributes and states the direction associated with a better outcome for each. Fullness and overall impression are interpreted in the higher direction, while sharpness is interpreted in the lower direction. General statistical explanation: scale values summarize judgments according to the measurement task. A difference in ratings can be described in scale units, but its interpretation depends on the measurement context and on the size and uncertainty of the estimated contrast.

The registry says participants compare recordings using a MUSHRA paradigm. It does not report the observed distribution of ratings, summary statistics, or contrasts. It is therefore not possible to describe typical ratings, variation between participants, or the comparative pattern among conditions. The scale endpoints do not substitute for those results.

What would uncertainty describe?

General statistical explanation: a confidence interval communicates uncertainty in an estimated quantity, such as a difference in average ratings. A narrower interval indicates greater precision under the model and assumptions used; a wider interval indicates less precision. An interval can also show whether data are compatible with a range of effect sizes, which is often more informative than a binary significance label. No confidence interval or other uncertainty estimate for the primary outcome is reported in the registry record.

A p-value, if reported, would need to be interpreted in relation to a defined hypothesis and analysis. It would not measure the magnitude or practical importance of a difference. The registry record lists zero analyses and does not report a p-value for the primary outcome. It also does not report the statistical model, hypothesis test, or handling of multiple outcome attributes.

What does the sample-size information allow?

The record lists enrollment of 20, but the sample-size justification and statistical plan are not reported in the registry record. An enrollment figure describes the study record; it does not by itself show the precision of an estimate or the ability to detect a particular difference. No observed effect estimate is reported, so a planning illustration based on a fraction of an observed effect cannot be interpreted from this record. Such illustrations, when available, are planning aids and not evidence of observed power.

General statistical explanation: planning calculations depend on assumptions about the effect to detect, variability, allocation, and the analysis. A calculation based on an observed estimate is especially dependent on that estimate and is not a substitute for a prespecified design justification. The registry does not report the assumptions used to plan this study or an intended minimum meaningful difference.

Finally, the registry lists a secondary outcome of situational preference ratings but does not provide results or an analysis plan for it. Any interpretation across multiple attributes or outcomes would need to consider how the questions were specified and how multiplicity was handled. Those analysis details are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome includes fullness, sharpness, and overall impression. The record also lists situational preference ratings as a secondary outcome. This creates more than one outcome dimension for interpretation, but the registry record does not report a prespecified hierarchy, a multiplicity adjustment, or an analysis plan describing how results across outcomes or coupling conditions would be evaluated.

General statistical explanation: when several outcomes or contrasts are examined, the chance of obtaining at least one apparently unusual result can increase if each is assessed separately. Multiplicity procedures can address that issue, while a prespecified outcome hierarchy can clarify which comparisons are primary. Without an analysis plan, readers cannot determine whether any adjustment was intended or how to interpret a set of possible findings. No outcome analyses are listed in this record.

Missing-data handling is also not reported in the registry record. The enrollment figure does not establish how many participants contributed ratings to each endpoint, whether every participant completed every condition, or whether any ratings were excluded. The record does not describe an analysis population or the assumptions used to handle missing observations. Consequently, the extent and possible influence of missing data cannot be assessed.

The registry describes all participants as assessed under all interventions, but this design description is not a report of complete outcome data. The status is COMPLETED, yet completion status does not establish that every planned assessment was available or analyzed. Readers need reported participant flow, outcome-specific denominators, and analysis methods to judge these issues; those 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.

The registry lists adverse-event information for the intake and consent form, streaming sound-quality task, and situational preference task groups. Each group lists 20 participants at risk, 0 with serious adverse events, 0 with other adverse events, and 0 deaths. These figures describe the entries recorded for those groups; they should not be added across groups, because the record describes the same study population in task-specific groupings.

General statistical interpretation: an observed count of 0 means no events of that category were recorded in the listed group during the registry’s reporting context. It does not prove that the risk is absent, and it does not establish what might occur in a larger or different population. The record does not provide further detail about event definitions, surveillance procedures, duration of safety follow-up, or whether adverse-event collection was designed to capture all possible events.

The absence of reported events should also be kept separate from the primary sound-quality outcome. Safety counts do not supply evidence about comparative ratings, and the rating outcome does not determine the safety profile. The registry reports zero serious events and zero other events in the listed groups, but the available information is not enough to make broader safety claims.

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

This record describes how a laboratory study set out to compare sound-quality ratings for recordings associated with four hearing-aid coupling methods. Participants with hearing loss were assessed under all interventions. The primary endpoint concerns fullness, sharpness, and overall impression during a MUSHRA listening task, and the record states how higher or lower ratings should be interpreted for each attribute. A secondary outcome of situational preference ratings is also listed.

The record does not report the numerical primary or secondary outcome results, comparative estimates, or statistical analyses. It therefore does not show whether ratings favored any coupling method, how large any contrast was, or how precise an estimated contrast might be. It does not support a claim of equivalence or a claim that one method was superior. No such conclusion can be drawn from the study description or enrollment count alone.

General statistical explanation: an observed difference and its uncertainty are both needed for a careful comparison. A point estimate indicates the direction and size of an estimated contrast, while an uncertainty interval helps readers understand how much the estimate could vary under the analysis. Even a statistically detectable difference would need to be interpreted in relation to the outcome scale and the relevance of the contrast. Those results and a threshold for a meaningful difference are not reported in the registry record.

The study’s single-group, within-participant structure is relevant to how comparisons should be analyzed. It is not a randomized comparison of separate groups, and the record does not describe the statistical model or the presentation order. Findings from a laboratory rating task would also address the listening judgments measured in that task; the registry does not report outcomes beyond the specified rating measures that would support broader conclusions.

The completed status and safety entries provide additional context about the record but do not fill the outcome-results gap. The registry lists 0 serious adverse events and 0 other adverse events in each task-specific group. These observations should be read as registry entries, not as proof of no risk. Overall, the available information defines the question and design but does not provide a comparative result.

13. Why This Trial Matters Statistically

This study is statistically notable for its repeated-assessment structure. All participants were assessed under all interventions, so the relevant comparison is across conditions within participants rather than between separate randomized groups. That distinction affects the analysis: repeated ratings from the same person may be correlated, and uncertainty estimates should reflect that dependence. The registry record does not report the method used to do so.

The outcome is also multidimensional. Fullness, sharpness, and overall impression describe different judgments, and the registry assigns different favorable directions to sharpness than to the other named attributes. Reporting those attributes separately can preserve distinctions that a single overall summary might obscure. At the same time, multiple outcomes and condition contrasts raise questions about prespecification and multiplicity, which the record does not answer.

The case illustrates why a completed study record and a result are not the same thing. The record provides a clear description of the listening task, rating scale, interventions, and outcome timeframe, but lists zero analyses and does not report outcome values. Without estimates and uncertainty, readers cannot judge the size, direction, or precision of a comparison. Enrollment and design details cannot replace those results.

General statistical lesson: design, measurement, analysis, and reporting need to align. A within-participant design can be informative when the analysis respects the repeated measurements, but the registry must report enough detail to let readers understand that analysis. For this study, key elements such as the statistical model, missing-data handling, and multiplicity approach are not reported in the registry record. The description therefore supports careful questions about analysis and reporting, not a claim about which coupling method received the best ratings.

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 comparative outcomes is that numerical ratings and analyses are not reported in the registry record. There are no reported estimates for fullness, sharpness, or overall impression, and no reported contrasts between open domes, closed domes, Novel State 1, and Novel State 2. Precision and statistical evidence therefore cannot be assessed.

The registry identifies a single-group design with all participants assessed under all interventions, but does not report how repeated ratings were modeled. It also does not report the order of presentations, whether order was controlled, or whether order was considered in analysis. These omissions limit assessment of possible dependence among ratings and of the conditions under which comparisons were made.

The record does not report the analysis population, outcome-specific denominators, participant flow through each task, or missing-data methods. Enrollment of 20 should not be treated as proof that every participant contributed complete ratings to every condition. Details of the MUSHRA implementation beyond the stated paradigm, rating scale, and timeframe are also not reported in the registry record.

Although a secondary outcome is listed, its results are not reported. The record does not describe a hierarchy across outcomes, multiplicity procedures, or a statistical analysis plan. A sample-size justification and a minimum meaningful difference are not reported in the registry record. These gaps prevent evaluation of planned precision, the handling of multiple comparisons, and practical importance.

Finally, the outcome is a laboratory rating of recordings. The registry record does not report measures that would support conclusions beyond the stated listening judgments. This does not invalidate the design; it defines the scope of what the recorded outcome could address.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Lab Evaluation of Novel Hearing Aid Coupling Method — NCT05377359.
• Registry record last updated 2025-03-28; status last verified 2024-02.
• Results first posted 2025-03-28.
• 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

NCT05377359 is a completed, single-group laboratory evaluation of hearing-aid coupling methods in participants with hearing loss. The record lists enrollment of 20, sponsor Sonova AG, a start date of 2023-02-07, and a primary completion date of 2023-11-20. All participants were assessed under recordings associated with open domes, closed domes, Novel State 1, and Novel State 2.

The primary outcome is sound-quality ratings for fullness, sharpness, and overall impression using a MUSHRA paradigm, on a scale from 0 to 100, with a timeframe of 60 minutes. Situational preference ratings are listed as a secondary outcome. The record lists zero analyses and does not report numerical outcome results, comparative estimates, or analysis methods. Safety entries list 0 serious adverse events, 0 other adverse events, and 0 deaths in each task-specific group.