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 Benefit of Assistive Listening Device for Lateralization (NCT05072457), a na na study. The primary outcome is Lateralization Hearing Ability.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05072457 |
| Phase | NA |
| Condition | Hearing Loss, Sensorineural |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 10 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sonova AG |
| Results posted | Yes |
2. Clinical Question
Population
Adults with moderate to moderate-severe sensorineural hearing loss. The registry lists hearing loss, sensorineural, as the condition and records enrollment of 10. Further eligibility details and demographic characteristics are not reported in the registry record.
Intervention
Participants were fitted with Phonak Audeo P hearing aids and compatible Phonak Roger receivers. Lateralization was assessed using the Roger On microphone and the Roger Select microphone. The registry describes speech presented from multiple directions with competing noise.
Comparator
The registry identifies a single-group study and does not describe a separate control group or a randomized comparison. Both microphone systems are named in the outcome description, but the order of testing and the precise comparison procedure are not reported in the registry record.
Primary question
How accurately did participants identify whether target speech was coming from the left, center, or right while competing noise was present, when assessed with the Roger On and Roger Select microphone systems? The primary outcome is the mean percentage of correct responses; its numerical result is not reported in the registry record.
The question concerns a listening task under competing-noise conditions. Participants hear target speech sentences while background noise is presented through four corner speakers, then indicate the direction of the target speech. The study description also refers to speech intelligibility in noise, assessed by having participants repeat words and calculating percent correct. The registry lists lateralization hearing ability as the primary outcome, so that direction-identification task is the focus of the primary endpoint.
This is a descriptive question about performance under the study’s test conditions, not a randomized treatment-effect question. The registry does not describe a separate untreated or alternative-device control arm. Although both microphone systems are named, the record does not provide enough detail to establish the testing sequence, whether every participant completed both conditions, or how any within-participant contrast was analyzed. Those details are not reported in the registry record.
3. Trial Design
The registry identifies the study as completed, with a single-group model and enrollment of 10. Allocation is listed as NA, and masking is listed as none. The record names Sonova AG as sponsor. The study began on 2021-10-18, and primary completion is recorded as 2021-12-13. Its phase is listed as NA.
All participants in the experimental group were fitted with Phonak Audeo P hearing aids and compatible Phonak Roger receivers. The listed devices are the Roger On microphone and Roger Select microphone. There is no separate control group described in the registry, and the record explicitly indicates that the arms do not constitute a like-for-like control comparison. Accordingly, the study should not be interpreted as a randomized comparison of an intervention against a control condition.
The registry describes assessment on Day 1 of a 1 day study. For the primary outcome, target speech sentences come from different directions while competing noise is played through four corner speakers. Participants indicate the perceived direction. The broader study description also mentions speech-intelligibility testing in noise, in which participants repeat words and percent correct is calculated.
The record lists two outcome measures and two analyses, but details of the additional outcome and the analysis procedures are not reported in the registry record. The order in which the microphone systems were used, any acclimatization procedures, and whether condition order was controlled are also not reported. Enrollment is not necessarily the same as the number contributing data to each analysis; the analysis population and outcome-specific denominators are not reported in the registry record.
The registry does not report a protocol rationale for the enrollment target, a sample-size justification, or detailed statistical methods. Planning illustrations based on an observed effect, where included in statistical summaries, should be understood as hypothetical planning calculations rather than as the study’s design or as observed power. They do not replace the missing design rationale or establish a causal comparison.
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 | Experimental |
|---|---|
| STARTED | 10 |
| COMPLETED | 10 |
| NOT COMPLETED | 0 |
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.
Population: Adults with moderate-severe bilateral sensorineural hearing loss
| Characteristic | Unit | Experimental |
|---|---|---|
| Participants analysed | 10 | |
| Age, Continuous | years | 74 (48 to 87) |
| Sex: Female, Male: Female | Participants | 7 |
| Sex: Female, Male: Male | Participants | 3 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: United States | Participants | 10 |
6. Primary Endpoint
The registry lists the primary outcome as Lateralization Hearing Ability, measured over Day 1 of 1 day study.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | percent correct responses |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is lateralization hearing ability, measured as percent correct responses. Participants indicate whether target speech sentences are coming from the left, center, or right while competing noise is presented through four corner speakers. The registry states that a higher number of correct responses indicates better lateralization performance. Testing is described with the Roger On and Roger Select microphone systems, and the timeframe is Day 1 of a 1 day study.
Percent correct is a direct measure of how often responses match the intended speech direction. It translates task performance into a proportion of correct answers, which can be readily interpreted as accuracy on the listening task. The endpoint is therefore aligned with the study’s stated question about locating speech in noise. It measures performance under the specified test setup; it does not, by itself, describe performance in every listening environment or establish why a response was correct or incorrect.
The registry identifies the summary parameter as a mean and the dispersion as the full range. A mean describes the average response level across the analyzed observations. A full range describes the lowest and highest observed values, but does not indicate how responses are distributed between those extremes or how precisely the mean is estimated. The numerical mean and range are not reported in the registry record, nor are the number of observations contributing to them.
The registry’s study summary also mentions speech intelligibility in noise, measured by repeating words and calculating percent correct. That description is related to listening performance but is not the listed primary endpoint. The exact relationship between the speech-intelligibility task and the two registered outcome measures is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the primary outcome and how it was intended to be measured, but it does not report a numerical result for lateralization hearing ability. It therefore does not establish the observed mean percentage of correct responses, the full range, or the number of participants contributing to the primary analysis. Without those results, the magnitude and precision of observed performance cannot be assessed from the registry record.
The outcome is a task-specific measure: participants identify the direction of target speech in the presence of competing noise. A mean percent correct would describe average accuracy in the tested conditions. It would not, without a comparison and suitable analysis, show that one microphone system caused better performance than another. The registry identifies a single-group model and does not describe a separate control arm. Although the outcome description names both microphone systems, the comparison procedure and analysis of any difference are not reported.
The registry lists the full range as the dispersion measure. A range can show the span from the lowest to the highest observed response, but it does not reveal how responses cluster around the mean. It is also not a measure of uncertainty in the estimated mean. A confidence interval, if reported, would address sampling uncertainty by describing a range of values compatible with the data under the method’s assumptions. Such an interval for the primary outcome is not reported in the registry record.
No p-value or other inferential result for the primary endpoint is reported in the registry record. Statistical significance, if available in another analysis, would not alone indicate the size or practical importance of a difference. In this case, the record also does not identify a registered control comparison that could support a causal interpretation. The posted registry information is therefore insufficient to judge either a between-condition effect or the uncertainty around such an effect.
Enrollment is recorded as 10, and the adverse-event group also lists 10 participants at risk. Those figures do not establish that all enrolled participants contributed primary-outcome data. The number analyzed, any exclusions, and the handling of incomplete responses are not reported in the registry record. These details matter because the interpretation of an average depends on which observations were included and whether missing responses could be related to performance.
In short, the registry supports a description of the question, devices, task, endpoint, and broad design. It does not provide the numerical primary outcome or sufficient analysis detail to quantify performance or compare the systems. Any interpretation should remain within that boundary and should not turn a task description into evidence of a treatment effect.
9. Statistical Methods Explained
The registry lists the primary summary as a mean and the measure of dispersion as the full range. These choices describe different features of the observed data. The mean gives an average across the observations included in the analysis. The full range gives the span between the lowest and highest values. Neither statistic is reported numerically for the primary endpoint in the registry record.
What does the mean describe?
For a percent-correct outcome, the mean summarizes average accuracy across the analyzed observations. Its interpretation depends on what counts as an observation in the analysis: an individual response, a participant-level score, or another unit. The registry does not state that unit, the aggregation procedure, or the number of observations contributing to the mean. These distinctions matter because repeated responses from one participant are not necessarily independent observations. An analysis that treats repeated responses as independent when they are clustered within participants can understate uncertainty. The registry’s analysis description does not say whether responses were aggregated or modeled with their participant-level structure taken into account.
What does the full range add?
The full range communicates the extremes among observed values. It can show whether the data span a narrow or broad interval, but it is highly influenced by the most extreme observations. It does not show whether most participants had similar results or whether observations were concentrated near one end. It also does not quantify uncertainty around the mean. General statistical practice often considers a confidence interval or another uncertainty measure alongside a point estimate; no confidence interval for the primary endpoint is reported in the registry record.
Why does the study structure matter?
A single-group study can describe outcomes among participants in that group. It cannot, by itself, separate an intervention effect from other explanations for observed performance. The registry does not describe a randomized control group. The primary outcome names both the Roger On and Roger Select systems, but the record does not state the order of testing, the details of the comparison, or whether results were analyzed as paired observations. A paired analysis can account for the fact that measurements from the same participant are related; an independent-groups analysis makes a different assumption. The analysis method is not reported, so it is not possible to determine which approach was used.
Masking is listed as none. General statistical context: masking can reduce the risk that expectations influence assessment or participant responses, but its relevance depends on the task and procedures. The registry does not describe assessor roles or safeguards for scoring responses. Allocation is listed as NA, consistent with the record’s single-group model, rather than a documented randomized allocation between control and intervention arms.
How should uncertainty and significance be understood?
A point estimate is a summary of observed data; it is not a guarantee that the same value would be observed in another sample. A confidence interval is a statistical method for conveying the uncertainty of an estimate under specified assumptions. A p-value, when used, assesses how compatible the observed data are with a null hypothesis under a statistical model; it does not measure effect size or the probability that a hypothesis is true. The registry record does not report a primary-outcome confidence interval, p-value, or detailed inferential model. Consequently, those quantities cannot be used to characterize this result from the registry record.
Statistical precision is also affected by the amount and structure of available data. Enrollment is 10, but the primary analysis denominator is not reported. If responses are repeated within participants, their dependence affects how much independent information the analysis contains. Missing or unusable responses can also affect the analyzed sample and the interpretation of an average. The registry does not report whether responses were missing, how missing data were handled, or whether the analysis used all enrolled participants.
What do planning calculations mean?
General statistical context: a sample-size calculation uses assumptions about the target effect, variability, significance level, power, and analysis design to illustrate how much data might be needed for a future study. It is a planning exercise, not evidence that a completed study had a particular probability of detecting an effect. The planning assumptions associated with this record describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the detectable effect expressed as a fraction of an observed effect. These assumptions do not describe the single-group registry design, and the record does not report that they were the study’s own design rationale. Any sample-size illustrations should not be described as observed power.
The registry does not report the study’s sample-size justification, statistical analysis plan, interim analyses, or a detailed model for the primary endpoint. It lists two outcome measures and two analyses, but does not provide enough detail to establish how the analyses were specified or how they relate to the primary outcome. Those omissions limit assessment of the analysis choices and the uncertainty of any estimated performance.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures and two analyses. It identifies lateralization hearing ability as the primary outcome, but the other outcome and the corresponding analysis details are not reported in the registry record. The record does not state whether the analyses were prespecified as confirmatory or exploratory, or whether any adjustment was planned for considering more than one outcome or analysis.
Multiplicity is the general statistical issue that arises when several outcomes, comparisons, or analyses are examined. If many inferential tests are conducted, the chance of finding at least one apparently notable result can increase. Methods for addressing multiplicity depend on the questions and analysis plan. Because the registry does not report the relevant plan or inferential results, it is not possible to determine whether multiplicity adjustments were needed or used.
The registry does not report missing-data counts for the primary outcome, reasons for missing responses, or a method for handling incomplete data. It also does not report the number of participants included in each analysis. Enrollment of 10 should not be assumed to equal the primary analysis population. General statistical context: missingness can affect an estimate if the people or responses missing differ systematically from those observed; the direction and size of any such effect cannot be determined without information about the missing data and analysis.
The analysis population is not defined in the registry record. There is no reported description of whether all enrolled participants were analyzed, whether analyses were limited to participants with complete measurements, or how participant-level and response-level data were handled. The order of device testing and any rules for valid responses are also not reported. These gaps prevent a full assessment of analysis eligibility, missingness, multiplicity, and reproducibility.
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 |
|---|---|---|---|
| Experimental | 0 | 10 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Experimental | 0 of 10 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Experimental | 0 of 10 |
The registry’s adverse-event information lists 10 participants at risk in the experimental group. It reports 0 participants with serious adverse events, 0 with other adverse events, and 0 deaths. These figures describe the events recorded for that group in the registry; they are not a comparison with a separate control group.
A count of zero means no event was recorded in the relevant category for the listed group. It does not establish that the risk is absent, and it does not show that an event could not occur in a larger or differently observed population. Interpretation also depends on the period and completeness of safety monitoring. The primary outcome timeframe is Day 1 of a 1 day study, but the registry does not report a separate safety follow-up duration or detailed adverse-event collection procedures.
The number at risk is the denominator for reading these reported counts, but the record does not provide event narratives, severity details beyond the serious/other categories, or a description of how events were solicited and coded. The appropriate reading is therefore limited: the registry reports zero serious adverse events, zero other adverse events, and zero deaths among 10 participants at risk in the listed group. This information alone does not establish comparative safety or rule out uncommon events.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this completed study examined lateralization and spatial hearing in adults with sensorineural hearing loss using Phonak hearing aids and compatible Roger receivers. It describes testing with the Roger On and Roger Select microphone systems and identifies percent correct responses as the primary endpoint. The task involved identifying the direction of target speech while competing noise was presented. These details define what performance was intended to measure and the conditions in which it was assessed.
The record does not report the numerical primary outcome. It therefore does not show how many responses were correct on average, how wide the observed range was, or how precise an estimate might be. It also does not report an inferential result that would support a statistical comparison. No claim about the magnitude or direction of performance differences can be established from the registry information.
The study is listed as single-group, with allocation NA and no masking. The registry does not describe a separate control group. While both microphones are named in the endpoint description, the record does not explain the comparison procedure or the analysis of measurements across systems. A difference in observed task scores, if reported elsewhere, would need interpretation in light of those design and analysis details before it could be attributed to a device.
The endpoint is specific to a listening task conducted with competing noise and directional speech. It does not, by itself, represent all forms of hearing performance or everyday listening. Nor does a registry description of an outcome establish that the intended measurement was completed for every enrolled participant. The analysis population and missing-data handling are not reported.
Thus, the record provides useful information about the study question, test setup, devices, primary endpoint, and broad design, but leaves the primary numerical result and important analysis details unreported. It can be read as a description of the study’s intended assessment, not as sufficient evidence for a causal or comparative conclusion about the microphone systems.
13. Why This Trial Matters Statistically
This study illustrates how a clinical measurement question and a treatment-effect question are not always the same. The primary endpoint captures accuracy at identifying the direction of speech in competing noise. That is a concrete, task-based outcome. The registry design, however, is single-group and does not describe a separate control arm, so the recorded structure does not support the same kind of causal contrast that a randomized comparison could address.
It also highlights why an endpoint definition is only part of statistical interpretation. A mean and full range describe the intended summary and spread, but numerical estimates, analysis denominators, and uncertainty measures are needed to understand the observed data. The registry does not report the primary numerical result, the number analyzed, or an uncertainty interval. Readers therefore cannot assess the magnitude or precision of average performance from this record.
The study description names two microphone systems, but does not provide details of the order or comparison analysis. If participants are assessed under multiple conditions, the statistical analysis needs to account for whether observations are related within the same person. That issue cannot be resolved from the registry’s brief methods information. This is a useful reminder that the labels for devices and endpoints do not, on their own, specify the statistical contrast.
Finally, the record lists two outcomes and two analyses without describing a multiplicity plan, analysis populations, or missing-data procedures. Those details affect how results should be interpreted and how reproducible an analysis is. The study is therefore statistically informative as an example of the limits of registry-level information: the design and intended measurement are identifiable, while the numerical outcome and key analytic decisions are not reported in the registry record.
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 most direct limitation for interpreting this study is that the registry record does not report the numerical result for the primary endpoint. Although it specifies the mean and full range as the summary and dispersion, their values are not reported. The record therefore cannot establish average accuracy, the spread of observed results, or the precision of an estimate.
The study is described as single-group, with allocation NA and no masking. No separate control group is reported, and the record cautions that the arms are not a like-for-like control comparison. The outcome description names both microphone systems, but the registry does not describe the testing order, the exact comparison, or the statistical handling of the resulting measurements. These omissions limit any comparison between systems and rule out treating the design description as a randomized treatment-effect estimate.
Enrollment is recorded as 10, but the number contributing to the primary analysis is not reported. The record does not define the analysis population, describe missing responses, or state how incomplete or invalid responses were handled. The unit of analysis and any accounting for repeated responses within participants are also not reported. These issues matter for both the estimate and its uncertainty.
Further limitations include the absence of a reported sample-size justification, detailed statistical analysis plan, multiplicity approach, and primary-outcome inferential results. The registry also does not provide detailed participant characteristics or the order and conduct of device testing. The task uses a defined speech-and-noise setup, so its outcome should not be generalized beyond that setting without supporting evidence. The registry’s adverse-event counts are limited by the absence of detailed monitoring and follow-up information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Benefit of Assistive Listening Device for Lateralization — NCT05072457.
- Registry record last updated 2023-06-15; status last verified 2023-05.
- Results first posted 2023-05-18.
- 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
NCT05072457 is a completed, single-group study titled “Benefit of Assistive Listening Device for Lateralization.” The registry lists Sonova AG as sponsor, enrollment of 10, phase NA, allocation NA, and masking none. The recorded start date is 2021-10-18, and primary completion is 2021-12-13.
The study concerns adults with sensorineural hearing loss. Participants were fitted with Phonak Audeo P hearing aids and compatible Phonak Roger receivers. The named devices are the Roger On and Roger Select microphones. The primary endpoint is mean percent correct responses on a task identifying the direction of target speech while competing noise is present; its timeframe is Day 1 of a 1 day study.
The registry lists two outcome measures and two analyses, but the numerical primary result, analysis population, missing-data procedures, and detailed statistical plan are not reported in the registry record. The adverse-event record lists 10 participants at risk and reports 0 serious adverse events, 0 other adverse events, and 0 deaths.