Open-source Hearing Aid Platform Comparisons: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Open-source Hearing Aid Platform Comparisons (NCT05693610), a randomized na study. The primary outcome is Word-identification Ability.

2. Clinical Question

The study compares two versions of an open-source speech platform: a portable version and a cloud-based version. Its primary question concerns word-identification ability after intervention, measured as the percentage of words identified correctly on the Modified Rhyme Test. The registry describes the outcome as assessed post-intervention, at 1 day.

The record states that the study included individuals with normal hearing and individuals with hearing loss. It does not report a more detailed eligibility description or the number of participants in each hearing-status subgroup. The comparison is between platform versions, not between an open-source platform and no platform or a commercial hearing aid.

The posted results give a mean word-identification score and a 95% confidence interval for each arm. They do not report an estimated difference between the arms, a confidence interval for that difference, or a statistical test of the comparison. Consequently, the posted results describe each arm separately but do not quantify the uncertainty around a direct contrast.

3. Trial Design

The record describes a randomized, unmasked, factorial study of the portable and cloud-based versions of an open-source speech platform. Northwestern University is listed as the sponsor, and the study summary describes a single-site study at Northwestern University. The listed enrollment is 11. The study status is terminated.

The record lists the portable OSP and cloud-based OSP as device interventions. The arm descriptions say that outcomes were assessed with the corresponding platform version. It does not describe the allocation procedure beyond identifying the study as randomized. Allocation concealment, the details of the factorial structure, and any additional factors or combinations are not reported in the registry record. The masking designation is none, so the record does not describe masking.

The study start date is 2023-01-06, and the primary completion date is 2023-04-25. The record does not state why the study was terminated, whether recruitment ended as planned, or whether the listed enrollment reflects the number analyzed for the primary outcome. It reports 11 in the enrollment field and lists 11 for each arm in the primary outcome results; the relationship between these entries is not explained in the registry record.

The primary outcome is word-identification ability, expressed as a percentage of words correct, at post-intervention (1 day). Secondary outcomes listed are phoneme confusions and response time. The record does not describe the statistical analysis plan, the intended comparisons among factorial conditions, or how the secondary outcomes were to be analyzed. The results available for the primary outcome are arm-level means with confidence intervals rather than a direct comparison estimate.

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: This was a single arm, within-subjects study design and each participant completed both study interventions. First the portable OSP was tested followed by the cloud-based OSP for all participants.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Includes individuals with normal hearing and hearing loss

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 Word-identification Ability, measured over Post-intervention (1 day).

The primary endpoint is word-identification ability, measured as the percentage of words identified correctly on the Modified Rhyme Test. Participants select a word from a choice of six rhyming words. The words may be presented in quiet or mixed with background noise. The record describes presentation through headphones for the cloud-based OSP and through loudspeakers for the portable OSP. Response recording may be on paper or through a button or mouse click on a computer or tablet screen.

The endpoint turns performance on the listening task into a continuous score, with a stated range from 0 to 100%. A higher score indicates better word-identification ability. The registry reports the mean and a 95% confidence interval for each arm at post-intervention (1 day). The task is expected to take 30 minutes for each test condition.

As a measure of speech recognition, this endpoint addresses whether participants can identify presented words under the test conditions. It is relevant to a comparison of platform versions because the study aims to evaluate portable and cloud-based applications of the open-source platform. The registry does not report a separate outcome measuring user preference, usability, or performance outside the described word task. Nor does it report whether results were analyzed separately by listening condition, presentation device, hearing status, or response method.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry labels the outcome parameter as a mean of a continuous measure. Word-identification ability is recorded as a percentage score, so reporting an arm mean describes the average score in that arm. A mean is useful for summarizing a continuous endpoint, but by itself it does not show how individual scores are distributed. The record does not report standard deviations or other measures of within-arm variability.

What does the confidence interval express?

In general, a confidence interval is a range calculated from data using a specified method to express uncertainty around an estimate. The registry reports 95% confidence intervals around the two arm means. Under the usual repeated-sampling interpretation, a confidence-interval procedure is designed to cover the target quantity at its stated rate when its assumptions hold. A 95% interval does not mean that 95% of individual participant scores fall inside the interval, and it does not give the probability that a fixed mean lies within this particular interval.

The intervals in this record describe uncertainty in each mean, not uncertainty in the difference between means. For a randomized comparison, the contrast is generally the quantity needed to evaluate how the arms differ. Its uncertainty depends on the information and analysis used for both arms, and should be reported directly. The registry does not post that contrast, its confidence interval, or a test result. No method for constructing the reported intervals is specified, so details such as distributional assumptions or whether repeated conditions were accounted for are not reported in the registry record.

Why does the factorial label matter?

In general, a factorial design evaluates more than one study factor within a design. Depending on the intended question, analysis may estimate effects for each factor and may consider whether factors interact. The record calls this study factorial, but does not identify the factors, their levels, or the intended factorial contrasts. The two named arms identify portable and cloud-based platform versions, but they do not, on their own, explain the full structure represented by the factorial designation. The statistical plan for handling that structure is not reported in the registry record.

That missing design detail matters for interpretation because a simple comparison of two arm means might not capture all planned questions in a factorial study. Whether an overall contrast, a factor-specific effect, or an interaction was the intended target cannot be determined from the registry description. No adjusted or factorial analysis estimate is posted in the outcome information.

What can be learned from the posted arm summaries?

The reported means and intervals allow a descriptive account of the primary endpoint by arm. They do not reveal the individual scores, the distribution of scores, or the within-person relationship among measurements if participants completed multiple conditions. General statistical practice distinguishes descriptive summaries from an inferential comparison: the former characterize the reported arms, whereas the latter estimates a contrast and quantifies its uncertainty under a defined analysis.

The registry identifies a primary outcome and also lists phoneme confusions and response time as secondary outcomes. A statistical analysis plan would ordinarily clarify how those outcomes are measured and analyzed, how comparisons are organized, and how uncertainty is reported. Those details are not reported in the registry record. No analysis results for the secondary outcomes are included in the available outcome information.

What is over-dispersion, and is it relevant?

In general, over-dispersion occurs when the observed variability in data is greater than expected under a chosen statistical model. It can make standard errors too small if a model assumes less variability than the data contain. Whether over-dispersion is relevant depends on the outcome and analysis model. The primary endpoint is a bounded percentage score, but the registry does not report the model used or the distribution of individual scores. It is therefore not possible to assess over-dispersion or determine whether a particular adjustment was needed.

How should planning illustrations be read?

In general, sample-size planning asks how much information a future study would need to detect a specified effect under assumptions about the analysis. Planning calculations are not observed outcomes, and they are not a measure of the actual study's power after results are known. The registry's planning assumptions describe a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. Such calculations are planning illustrations based on the observed effect, not evidence that the original study was designed with those assumptions. The registry record does not report the original sample-size justification or the design assumptions used when the study was planned.

Because no between-arm effect estimate or analysis variance is posted, a reader should distinguish any planning illustration from the primary outcome evidence. A planning calculation cannot replace a direct treatment-effect estimate, a confidence interval for that effect, or a description of the analysis actually conducted. The record does not report an analysis plan or any recalculated comparison that could clarify these points.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary outcome and two secondary outcomes: phoneme confusions and response time. It does not report how many comparisons were planned for these outcomes, whether outcomes were tested across multiple conditions, or whether any method was planned to address multiplicity. In general, testing multiple hypotheses can increase the chance of at least one false-positive finding if no adjustment or hierarchy is specified. No multiplicity strategy is reported in the registry record, so the handling of that issue cannot be assessed.

Missing-data methods and analysis populations are also not reported in the registry record. The outcome entries list 11 for each arm, while the enrollment field lists 11; the record does not explain how these entries relate to the participants assessed or analyzed. It does not state whether there were missing endpoint observations, how missing observations were handled, or whether the analysis followed an intention-to-treat or another population definition.

The record does not describe exclusions after randomization, adherence criteria, or rules for selecting observations from test conditions. These details are especially relevant when an endpoint could involve different listening conditions or response methods, as described for the Modified Rhyme Test. It is not reported whether each condition was analyzed separately or combined in a prespecified way. Without this information, the posted arm summaries cannot establish the completeness of outcome data or the robustness of an analysis to missingness.

These omissions do not demonstrate that missing data or multiplicity affected the results. They mean that the registry record does not document how these matters were handled, limiting assessment of the analysis and the scope of any conclusions from the posted summaries.

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

The results provide descriptive information about mean word-identification scores for the portable and cloud-based versions of the open-source platform at the stated post-intervention assessment. The registry reports each mean with a 95% confidence interval. These summaries help characterize the endpoint as recorded, but they do not supply a direct estimate of the difference between versions.

The result does not establish that one platform version is better than the other. A judgment about the comparison requires a direct contrast and its uncertainty, neither of which is reported. It also does not establish whether any difference would be meaningful for participants, since the registry does not state a threshold for a meaningful change. The score is one specified measure of word identification, not a complete evaluation of all possible outcomes or uses of the platform.

The registry describes participants as including individuals with normal hearing and hearing loss. It does not report subgroup-specific results, so the arm means cannot be interpreted as separate findings for those groups. The record also does not report a comparison with commercial hearing aids, an untreated group, or another platform. The results therefore address only the two named OSP versions as represented in the posted arm summaries.

The listed secondary outcomes are phoneme confusions and response time, but their results are not included in the available outcome information. The absence of those results in the registry record does not show what those outcomes would have indicated. Similarly, the record's adverse-event entries do not support broader conclusions about safety or tolerability beyond the categories and entries recorded.

Finally, the study status is terminated, and the reason is not reported in the registry record. The posted means should be interpreted as the results recorded for this study, not as proof of a general effect across settings or participants. The registry does not report sufficient design and analysis detail to determine the extent to which the findings generalize beyond the described study.

12. Why This Trial Matters Statistically

This study raises statistical questions that are common when evaluating technology platforms: what the target comparison is, how a continuous performance measure is summarized, and how the uncertainty around the contrast is reported. The registry provides arm-specific means and confidence intervals for word-identification ability. A direct between-arm estimate would address the comparison more directly than separate summaries of each arm.

The factorial designation also makes clarity about the design and analysis important. In general, factorial studies can address more than one factor or combination of factors, and the intended effects depend on the design and analysis plan. The registry does not describe those factors or specify the planned contrasts. The label alone is not enough to determine which statistical question the analysis was meant to answer.

The record also illustrates why enrollment and analysis details matter. It reports an enrollment of 11 and lists 11 for each outcome arm, without explaining the relationship between those entries. Transparent reporting of the analysis population, missing observations, and the method used to calculate intervals would help readers assess how the results were obtained. These details are not reported in the registry record.

The trial is a comparison between two versions of an open-source platform, not a comparison of open-source and commercial devices. Its statistical contribution in the registry is therefore defined by the question and endpoint it records: word-identification scores after intervention. The available information supports a careful descriptive reading while leaving important inferential and design details unresolved.

13. 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 important limitation for statistical interpretation is the absence of a posted between-arm estimate for the primary outcome. Although the registry gives a mean and 95% confidence interval for each arm, it does not report a contrast, a confidence interval for the contrast, or a p-value. The method used to calculate the arm-level intervals is also not reported in the registry record.

The factorial structure is not described beyond the design label. The factors, their levels, and the planned comparisons are not reported, so it is unclear how the two named arms relate to the full design or which contrast was primary for analysis. The registry also does not report the statistical model or analysis plan.

The enrollment field lists 11, while each arm's outcome entry lists 11. The record does not explain this relationship, identify the analysis population, or state whether any outcomes were missing. It does not report how observations across the described listening conditions were handled. These gaps constrain assessment of the endpoint summaries and their precision.

The registry lists the study as terminated but does not report the reason. It does not describe a sample-size justification, recruitment progress, or any interim analyses. These details should not be inferred from the status or dates. The planning assumptions on the registry describe an illustration based on the observed effect; they do not document the original design rationale.

The listed secondary outcomes have no results in the outcome information, and no multiplicity plan is reported. Generalization is also limited by the absence of detailed participant characteristics and subgroup results. The study summary identifies a single site and a population including normal hearing and hearing loss, but does not give further detail needed to assess which groups or settings are represented.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: Open-source Hearing Aid Platform Comparisons — NCT05693610.
• Registry record last updated 2025-01-10; status last verified 2024-11.
• Results first posted 2025-01-10.
• 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.

17. Record Summary

The registry record describes a randomized, unmasked, factorial study comparing portable and cloud-based versions of an open-source speech platform. Northwestern University is listed as sponsor, and the study summary identifies Northwestern University as the single study site. The listed enrollment is 11, and the study status is terminated.

The primary outcome is word-identification ability, measured as the percentage of words correct on the Modified Rhyme Test at post-intervention (1 day). The portable arm mean is 78.12, with a 95% confidence interval from 71.54 to 84.71. The cloud-based arm mean is 85.07, with a 95% confidence interval from 80.77 to 89.36. No direct comparison estimate is reported.

Phoneme confusions and response time are listed as secondary outcomes. The record does not report the analysis plan, missing-data approach, factorial contrasts, or reason for termination. The study start date is 2023-01-06, and the primary completion date is 2023-04-25.