Evaluation of the Clinical Benefit of the Hearing Aids Tinnitus Feature.: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluation of the Clinical Benefit of the Hearing Aids Tinnitus Feature. (NCT05292534), a randomized na study. The primary outcome is Tinnitus Functional Index Evaluation (TFI).

2. Clinical Question

The clinical question concerns whether tinnitus scores change differently across hearing-aid conditions: amplification alone, and amplification with an added sound. The study also included a no-intervention condition, described as participants returning to their original unaided state. The registry record says participants with hearing loss and tinnitus would wear the hearing aids and have their tinnitus level evaluated before and after intervention.

The outcome description focuses on change from baseline after each condition. It does not state a single numerical contrast or provide results for the conditions. Therefore, the registry record identifies the question being studied but does not establish the size, direction, or precision of any difference between conditions.

3. Trial Design

This is a randomized crossover study with no masking reported. Enrollment was 38, and the registry lists the study status as completed. The recorded start date is 2022-06-01 and the primary completion date is 2023-09-20. The trial is listed with phase NA and was sponsored by Sonova AG.

In a crossover design, participants receive or experience more than one study condition, so each participant can contribute observations under different conditions. The primary outcome description explicitly says that participants served as their own control and that measurements were repeated. This structure can help account for stable differences between participants when comparing their outcomes across conditions. It does not, by itself, remove the possibility that order, time, or carryover effects could influence the observations.

The conditions described are amplification-only, amplification with an added sound, and no intervention. The two hearing-aid conditions are devices fitted to prescribed hearing loss, with the added-sound condition activating an additional sound on the hearing aid. The no-intervention condition is described as a return to the original unaided state. The timeframe says the Tinnitus Functional Index was collected before intervention as baseline and that change from baseline would be assessed after each study condition, which would last 4 weeks/each.

The registry record does not report the order in which conditions were assigned or experienced, whether a washout period was used, or how the no-intervention condition fitted into the sequence. It also does not report masking beyond listing none. These omissions matter when interpreting a crossover study because they leave the sequence and protections against carryover unclear. The record identifies randomization and repeated measurement, but detailed operational and statistical procedures 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.

Before assignment: 38 participants were randomly assigned into one of two groups. Out of the 38 participants, 8 dropped out during the study. There were 2 study groups in this cross-over study, and final numbers were 15 participants in each group.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Repeated measures. Participants served as their own control.

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: Group 1 and Group 2 had 15 participants/each.

6. Primary Endpoint

The registry lists the primary outcome as Tinnitus Functional Index Evaluation (TFI), measured over TFI collected before intervention to serve as a baseline. TFI change from baseline will be assessed after each study condition, which will last 4 weeks/each..

The primary endpoint is the Tinnitus Functional Index (TFI), described as a questionnaire measuring tinnitus interference in a person’s quality of life. Its score ranges from 0 to 100 units on a scale, with higher numbers indicating more severe, or worse, tinnitus interference. The registry describes the outcome as a mean with standard deviation and says the baseline TFI would be collected before intervention.

The planned endpoint is change from baseline assessed after each study condition. Using a baseline measure gives a point of reference for describing how a participant’s score differs after a condition. In a repeated-measures design, outcomes from the same participant across conditions are related rather than independent; the record accordingly describes participants as their own control.

In general, a patient-reported measure can capture an aspect of experience that may not be represented by a device setting or a clinical observation alone. The TFI is relevant to the stated study question because the trial concerns tinnitus interference, and the scale’s direction makes higher scores correspond to worse interference. However, the registry record does not report the observed baseline or follow-up means, the changes from baseline, their variability, or a between-condition estimate. It therefore does not show how the endpoint changed in this completed trial.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies a continuous outcome summarized as a mean and standard deviation. It describes repeated measures, with participants serving as their own control, and specifies change from baseline after each study condition. These details describe the measurement structure, but the record lists no analyses and does not report a statistical model or a numerical primary outcome result.

What does a mean and standard deviation describe?

In general, a mean is a measure of the center of a set of scores. A standard deviation describes how dispersed those scores are around the mean. Reporting both can help readers understand the typical score and the variability among participants, but neither alone gives the precision of a comparison between conditions. The registry record states that the primary measure is a mean with standard deviation, but does not give the observed summaries.

Why does the crossover structure matter?

In general, repeated observations from the same person are statistically related. An analysis that accounts for this relationship can distinguish within-person variation from differences between people. Since participants are described as their own control, the intended comparison uses repeated measurements rather than treating all condition-specific observations as unrelated. The registry record does not name the model or method used to account for repeated measures, nor does it report the estimated within-person contrasts.

Crossover trials can also be sensitive to condition order and carryover. If experience in one condition affects observations in a later condition, a comparison may reflect more than the condition currently being assessed. This is a general design consideration, not a reported problem in this trial. The sequence, washout procedures, and any analysis of order or carryover are not reported in the registry record.

What would an estimate and confidence interval contribute?

In general, a contrast between conditions estimates how far apart their outcomes are on the chosen scale. A confidence interval communicates the uncertainty around that estimate, subject to the analysis assumptions and design. For a change-from-baseline endpoint, the contrast would need to reflect the trial’s repeated-measures structure. The registry record contains no comparative estimate or confidence interval, so neither the size nor precision of a condition difference can be evaluated.

A p-value, if reported, would address compatibility between the observed data and a specified null hypothesis under the chosen statistical procedure. It would not by itself describe the magnitude or practical importance of a difference. No p-value or testing procedure is reported in the registry record. It is therefore not possible to characterize the primary result as statistically significant or not significant.

How should the planning assumptions be read?

The registry record describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the target effect as a stated fraction of the observed effect. Such figures, in general, are planning illustrations rather than observed trial outcomes and are not observed power. The calculated planning values are not reported in the registry record. The assumptions also do not establish that these were the trial’s original design assumptions; a sample-size justification is not reported in the registry record.

There is no reported primary analysis with which to assess whether the assumptions were appropriate for the crossover design, the repeated-measures outcome, or the available data. The registry record does not identify adjustment variables, model structure, handling of missing measurements, or a procedure for comparing the study conditions. Those methods should not be inferred from the design label or from the outcome description.

What does the absence of an analysis mean?

The record lists one outcome measure and zero analyses. The stated outcome includes baseline measurement and change after each study condition, but the registry record does not provide a selected single comparison or its results. This absence limits statistical interpretation: the design and planned measure can be described, but the observed effect and its precision cannot. It does not establish that no analysis was conducted outside the registry record; it means that an analysis is not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists one outcome measure, the Tinnitus Functional Index, but describes measurements at baseline and after each study condition. The registry record notes that the primary outcome has several categories or time points and was not reduced to one comparison. It lists zero analyses. Thus, it does not identify a single primary contrast or report a result for one.

Multiplicity arises in general when several outcomes, time points, or comparisons are examined. Testing many contrasts can increase the chance of obtaining an apparently unusual result by chance unless the analysis plan accounts for the comparisons. The registry record does not report a multiplicity adjustment, a hierarchy among comparisons, or a prespecified primary contrast. It is not possible to determine whether any such procedures were used outside the registry record.

Missing-data methods are not reported in the registry record. The record does not state how incomplete TFI measurements were handled, whether participants with partial condition data were included, or whether sensitivity analyses were planned or performed. In general, these choices can affect both the estimated change and the uncertainty, particularly when repeated measurements are incomplete.

The primary analysis population is also not described beyond the statement that participants served as their own control. The enrollment is 38, while the safety entries list 30 at risk for each condition; the relationship between those counts and the primary outcome analysis population is not explained. No randomized, treated, or analyzed participant counts for the TFI outcome are reported in the registry record. Without these details, the completeness of the outcome data and the exact population represented by any analysis cannot be assessed.

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 serious adverse events for each of the three conditions. For amplification-only, 30 participants are listed as at risk and zero as affected by a serious adverse event. For amplification with added sound, 30 are listed at risk and zero affected. For no intervention, 30 are listed at risk and zero affected. The registry also records zero deaths in each group.

Other adverse events are listed separately: two for amplification-only, one for amplification with added sound, and two for no intervention. These are counts in the registry record, not comparative estimates. The record does not provide event descriptions, seriousness criteria, timing, or details about whether events were judged related to a study condition.

Because this is described as a crossover study, the same participant may contribute observations under more than one condition. The registry does not explain whether the at-risk counts represent distinct people, condition exposures, or another accounting approach. Enrollment was 38, and the relationship between enrollment and the listed safety denominators is not reported in the registry record. The counts therefore should be read as recorded for each condition, without inferring a unique participant total or a rate comparison. The entries describe what the registry reports; they do not establish that no unlisted or unreported events occurred.

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

The registry record establishes that a randomized, unmasked crossover trial was completed to evaluate hearing-aid amplification alone and amplification with an added sound in participants with hearing loss and tinnitus. It also describes a no-intervention condition and identifies change in the Tinnitus Functional Index as the primary outcome. These registry entries explain the study’s purpose and measurement approach.

The record does not report the primary outcome data or any analysis. Consequently, it cannot show whether TFI scores changed after any condition, whether the changes differed across conditions, or how precise a comparison might be. The scale’s interpretation is stated: higher scores indicate worse tinnitus interference. But no observed scores or changes are available to apply that interpretation to the trial findings.

This absence does not mean that the conditions had identical outcomes, nor does it show that one condition had a larger or smaller effect. It means that the registry record does not contain the result needed to answer those questions. Similarly, the completed status does not establish that the planned outcome was analyzed or that a particular conclusion was reached.

In general, trial findings need to be interpreted alongside the estimate, its uncertainty, the population analyzed, and the analysis methods. Those details are not reported for the primary endpoint. The design has features that can support within-participant comparisons, but interpretation also depends on condition order, missing observations, and how repeated measurements are modeled. The registry record does not describe these elements in sufficient detail to assess them.

The safety entries list no serious adverse events and no deaths for the recorded groups, alongside counts of other adverse events. These entries should be understood as registry counts, not as a complete account of event types or a basis for comparing risks. Overall, the posted record is informative about the research question and basic structure, but it does not provide enough primary outcome evidence to quantify the clinical result.

13. Why This Trial Matters Statistically

This trial is statistically notable for its crossover structure and repeated measurement of a patient-reported outcome. In a crossover study, the same participant can contribute data under more than one condition. In general, this allows comparisons to use within-person information and can reduce the influence of stable differences between participants. It also means that methods should account for the dependence among observations from the same person.

The stated question compares amplification-only with amplification that includes an added sound, with a no-intervention condition also described. The Tinnitus Functional Index provides a defined outcome scale, and the registry explains its direction: higher scores indicate worse tinnitus interference. The outcome description calls for baseline collection and subsequent changes after each condition. These features make clear what the study aimed to measure, even though the result is not reported.

The record also illustrates why design labels and outcome definitions are not substitutes for analysis reporting. Randomization is listed, but the randomized sequence, order handling, and any washout procedures are not reported. The record identifies a mean and standard deviation but supplies no observed summaries, estimates, or uncertainty intervals. Without a reported comparison, readers cannot assess the size or precision of the observed effect.

Finally, the registry’s note that the primary outcome was not reduced to a single comparison highlights a key interpretive issue. Multiple condition-specific changes can pose a choice about which contrast answers the main question, and that choice should be transparent. The record does not report a selected contrast or multiplicity approach. The trial is therefore a useful example of how a clear design and endpoint description can coexist with substantial uncertainty about the statistical findings when the analysis and results are absent from 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 principal limitation for interpreting this trial is that the registry record contains no primary outcome analysis. It gives no baseline or follow-up TFI summaries, changes from baseline, comparative estimates, confidence intervals, or p-values. Consequently, the magnitude, direction, and precision of the outcome cannot be assessed.

The record describes repeated measurements and participants serving as their own control but does not report the condition sequence, the randomization procedure, or whether a washout period was used. It does not explain how possible order effects or carryover were addressed. These are relevant design considerations for a crossover study, but the registry record does not establish whether they affected the results.

The outcome is described as change from baseline after each condition, and the registry notes that it was not reduced to a single comparison. The record does not identify which contrast was considered primary, whether multiple comparisons were adjusted, or how repeated measurements were modeled. Details of missing-data handling and the primary analysis population are also not reported.

Enrollment is listed as 38, whereas the safety entries list 30 at risk in each condition. The registry record does not explain how these counts relate to one another or to the number of participants with complete TFI data. The safety information also lacks event descriptions and timing. These omissions limit assessment of participant flow and the scope of the recorded safety results.

Finally, the status is completed, but completion alone does not resolve these reporting gaps. A sample-size justification and the calculated values for the described planning illustration are not reported in the registry record. The available information supports a description of the trial’s objective and broad design, but not a quantitative assessment of its primary findings.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Evaluation of the Clinical Benefit of the Hearing Aids Tinnitus Feature. — NCT05292534.
• Registry record last updated 2024-07-05; status last verified 2024-04.
• Results first posted 2024-07-05.
• 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 randomized crossover trial sponsored by Sonova AG, with enrollment of 38 and no masking reported. It evaluated hearing-aid amplification alone and amplification with an added sound in participants with sensorineural hearing loss and tinnitus; a no-intervention condition was also described.

The primary outcome was the Tinnitus Functional Index, a 0-to-100 scale on which higher scores indicate worse tinnitus interference. The record describes baseline measurement and change after each study condition, with participants serving as their own control. Each condition was described as lasting 4 weeks/each.

No primary outcome analysis or comparative result is reported in the registry record. It also does not report the selected comparison, analysis methods, missing-data procedures, or primary analysis population. Safety entries list zero serious adverse events and zero deaths for each condition, with other adverse event counts of two, one, and two, respectively.