Self-efficacy-based Auditory Rehabilitation With Over-the-Counter Hearing Aids: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Self-efficacy-based Auditory Rehabilitation With Over-the-Counter Hearing Aids (NCT06560918), a na na study. The primary outcome is Percentage of Total Confidence.

2. Clinical Question

The study also aimed to assess readiness to adopt hearing aids, satisfaction, emotional state, and hearing-related quality of life. The stated goal was to learn whether SEBAR could improve confidence and success with over-the-counter hearing aids. In a single-group design, however, a change between assessments is not a direct estimate of how outcomes would differ with SEBAR versus a separate untreated or alternative-treatment group. Changes may reflect the intervention, the hearing aids, participants’ experience over time, or other influences.

The registry describes one appointment to complete questionnaires without hearing aids, a week wearing the devices while receiving SEBAR, and a second appointment to complete the questionnaires with hearing aids. It does not report comparative results for the primary or secondary outcomes. The clinical question can therefore be described from the planned assessments, but the size and direction of any outcome change are not reported in the registry record.

3. Trial Design

This is a completed, single-group pilot study of SEBAR with over-the-counter hearing aids. The registry reports enrollment of 5 participants with sensorineural hearing loss. It describes a pre–post design: participants received the same intervention, and outcomes were assessed in conditions with and without hearing aids. There was no control group, and the allocation field is recorded as NA. The study is not a randomized comparison.

Participants were to attend an appointment without hearing aids, wear in-the-canal hearing aids for a week while receiving SEBAR, and complete questionnaires again at a second appointment with the hearing aids. They also used an app to answer questions about their experiences. The registry lists hearing aids as the intervention. It does not provide further detail about how SEBAR was delivered or whether every participant completed each assessment.

The primary outcome is percentage of total confidence measured with MARS-HA, a 24-item self-report questionnaire. Secondary outcomes are readiness to adopt hearing aids, hearing-aid satisfaction, emotional state, and hearing-related quality of life. The registry lists a timeframe of 1 week for the primary outcome. The study is marked completed, with start and primary-completion dates of 2024-10-30 and 2026-01-31. The phase is recorded as NA, and masking is listed as none.

Because there is no independent control group, pre–post change cannot separate the effect of SEBAR from the effect of wearing hearing aids or other changes over time. The registry record does not report a statistical analysis plan, a sample-size justification, or details of any interim analyses.

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

Analysis population for the primary outcome, as defined in the registry: As there was no control group, this was a single-arm study with pre- and post-conditions. There was only one group of participants and everyone went through the same intervention. But as per the comment, we separated the results for pre and post and presented the results

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: There was no difference in these numbers

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Total Confidence, measured over 1 week.

The primary endpoint is percentage of total confidence, based on the Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA), also referred to as MARSHA. The registry describes this as a validated self-report questionnaire with 24 items. Participants rate their confidence in using and managing hearing aids for each item on a 0 - 100% scale; the average across items is reported as percentage of total confidence.

This measure is relevant to the study’s stated focus on confidence and self-efficacy in managing hearing aids. A questionnaire score can capture a participant’s own assessment of this ability, rather than an externally observed measure of device use. The registry says pre- and post-condition scores were compared and identifies the outcome as a mean difference score on a scale, with standard deviation as the dispersion measure.

The registry record does not report the pre-condition mean, post-condition mean, mean difference, standard deviation, confidence interval, or p-value. It therefore does not show how much confidence changed, in which direction, or how precisely that change was estimated. The listed timeframe is 1 week. The record does not report further details about the timing of the questionnaire relative to the appointments or how missing questionnaire items were handled.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the single-group design estimate?

In general, a pre–post design compares measurements taken from participants in different conditions or at different times. It can describe whether the measured outcome changed within the study group. Without a separate control group, it cannot establish what would have happened over the same period in the absence of the intervention. That distinction matters because the intervention and hearing-aid use occurred together in this study.

The registry describes outcomes assessed without and with hearing aids, before and after the study experience. These conditions differ in more than the presence of SEBAR: participants also wore the devices and gained experience using them. A change in questionnaire responses would therefore be an observed pre–post change, not a clean contrast between SEBAR and no SEBAR. This is a design limitation, not a statistical adjustment that can be resolved from the registry information.

What does a mean difference represent?

For a continuous outcome, a mean summarizes the average score in a group or condition. A mean difference expresses the contrast between two means on the outcome’s scale. Here, the registry identifies the primary measure as a mean difference score and identifies standard deviation as the dispersion measure. The record does not state the observed means, difference, or standard deviation.

In general, standard deviation describes how dispersed individual scores are around their mean. It is not the same as the uncertainty in an estimated mean difference. A confidence interval is commonly used to express uncertainty in an estimate; it incorporates both the variability of the data and the amount of information available. The registry record does not report a confidence interval for the primary outcome, so precision cannot be evaluated from the posted results.

Why can a small pilot be imprecise?

In general, estimates based on a small study group can be sensitive to the scores of individual participants. This can make an estimated change uncertain, even when the average change appears notable. The registry reports enrollment of 5 participants, but does not report the number included in each outcome analysis. Enrollment should not be assumed to equal the analysis population. Without outcome values and an analysis count, the stability of any estimated effect cannot be assessed.

Sample-size planning asks how many participants might be needed for a future study under specified assumptions about the effect to detect, variability, significance level, power, and design. The stated planning illustration uses a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. These are planning assumptions, not evidence that this pilot had two randomized arms. A calculated sample size is not the same as observed power, and it does not establish that the observed result is reliable.

What are the limits of a p-value?

In general, a p-value describes how compatible the observed data are with a specified null model, under the assumptions of the analysis. It does not give the probability that a treatment works, nor does it measure the size or practical importance of an effect. Interpretation also depends on the design, analysis choices, data quality, and whether outcomes were selected or adjusted for appropriately. No p-value for the primary outcome is reported in the registry record.

Why do distributional assumptions matter?

Statistical methods for continuous outcomes often rely on assumptions about the distribution of measurements or model errors. When data are sparse, unusual observations or departures from assumptions can have an outsized influence. In general, analysts may inspect the data and consider methods suited to their characteristics. The registry record does not report the method used to analyze the primary outcome or any diagnostic checks, so those choices cannot be evaluated.

The registry also does not report an inferential method for paired observations, an adjustment strategy, or how missing data were handled. No method should be inferred from the outcome label alone. The posted result is not sufficiently detailed to reconstruct an analysis or independently assess its assumptions.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Pre (Unaided)", "Post (Aided)")
n   <- c(5, 5)
m   <- c(81.75, 91.99)
sp  <- c(8.31, 11.6)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Pre (Unaided)  5  81.750  8.310  71.432  92.068
CARM  Post (Aided)  5  91.990  11.600  77.587  106.393

11. Multiplicity, Missing Data and Analysis Populations

The registry lists five outcome measures: the primary confidence measure and secondary measures of readiness to adopt hearing aids, satisfaction, emotional state, and hearing-related quality of life. It lists one analysis. The registry record does not report whether all outcomes were tested, how they were prioritized in analysis, or whether any adjustment for multiple comparisons was planned or used.

In general, when several outcomes are examined, the chance of obtaining at least one apparently unusual result can increase if each is assessed separately without accounting for the number of analyses. Methods for addressing multiplicity can alter how evidence is interpreted. The record does not provide enough information to determine whether such methods were relevant to, or applied in, this study. The primary endpoint is identified, but the analysis details and numerical results are not reported.

The registry describes appointments and questionnaire assessments but does not report outcome completion counts, missingness, exclusions, or methods for handling missing responses. It also does not report an analysis population definition. The enrollment figure cannot establish how many participants contributed data to each outcome. Missing-data handling can affect estimates when information is incomplete, so the absence of these details limits interpretation of any reported analysis.

The record does not report a prespecified statistical plan, interim analyses, or a sample-size justification. These details are not available for assessing whether outcome selection, analysis choices, or missing-data decisions followed a plan set before results were examined.

12. 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 the pre–post single-arm group with 5 participants at risk for serious adverse events and 0 affected. For other adverse events, it likewise lists 5 at risk and 0 affected. Deaths are listed as 0, and no serious adverse-event terms are listed.

These figures describe what is recorded in the registry; they should not be interpreted as proof that no adverse events of any kind occurred. The record does not provide event definitions, reporting procedures, follow-up details beyond the study description, or a narrative explaining the zero counts. It also does not provide information about event severity apart from the serious-event category, or about whether events were judged related to the hearing aids or SEBAR.

In general, safety counts depend on how events are defined, collected, and reported. A small study group offers limited information about uncommon events, and a zero count in a registry entry does not establish that a risk is absent. The registry figures are descriptive and do not support a comparative safety assessment because the study has no separate control group.

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

The study addresses a practical research question: whether a self-efficacy-based rehabilitation process used alongside over-the-counter hearing aids is associated with changes in confidence and other participant-reported outcomes. It focuses on confidence in managing hearing aids, with additional measures of readiness, satisfaction, emotional state, and hearing-related quality of life. The registry describes a week of hearing-aid use and assessment with and without the devices.

The record does not report numerical results for the primary endpoint or the listed secondary outcomes. It therefore does not show whether confidence changed, how large any change was, or how uncertain an estimate might be. It also does not provide a basis for judging whether changes in other outcomes occurred. The study’s completed status is not itself evidence of a particular result.

Even if a pre–post change were reported, the single-group design would not isolate the contribution of SEBAR from hearing-aid use, experience over time, or other influences. It could describe a change among participants in this study, but it would not provide the same causal evidence as a controlled comparison. The registry record also does not report enough analysis detail to assess missing data, the precision of estimates, or the handling of multiple outcomes.

The study can be understood as a pilot investigation of an approach and a set of participant-reported measures. Its design and enrollment give context for the evidence, but the absence of posted outcome estimates prevents a statistical assessment of the primary question. No treatment recommendation follows from the registry information.

14. Why This Trial Matters Statistically

This trial is statistically notable because it studies a participant-reported outcome closely aligned with its intervention: confidence in using and managing hearing aids. The MARS-HA questionnaire translates that concept into a scored measure, while the additional outcomes address readiness, satisfaction, emotional state, and hearing-related quality of life. Such measures can broaden an evaluation beyond device use alone.

The single-group pre–post structure also makes the interpretation challenge clear. A change over the study period would be informative as a description of participants’ experience, but it could not distinguish SEBAR from the experience of wearing hearing aids or from other time-related influences. The design can support exploratory learning, while a controlled comparison would be needed to estimate a contrast against a separate group.

The registry reports enrollment of 5 participants, which places the study in a pilot context and signals that estimates may have limited precision. Yet the record does not report the primary or secondary numerical results, confidence intervals, or p-values. This illustrates why a completed status and a defined endpoint are not enough to evaluate evidence: interpretation depends on the observed estimates, their uncertainty, and the analysis details.

The record also highlights the distinction between planning calculations and trial findings. A sample-size illustration based on an observed effect is a planning aid under stated assumptions, not an observed measure of power or proof of an effect. Clear reporting of outcome estimates, missingness, analysis populations, and multiplicity methods would be needed for a fuller statistical reading.

15. 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 consequential limitation for interpreting the registry record is that it does not report numerical results for the primary endpoint or secondary outcomes. There are no reported means, mean differences, standard deviations, confidence intervals, or p-values for the primary confidence measure. Direction, magnitude, and precision of change are therefore unavailable.

The single-group pre–post design has no control group. Because participants received SEBAR while wearing hearing aids, the design does not separate the contribution of rehabilitation from the contribution of device use, practice, or other changes during the study. The registry itself notes that there was no control group; the pre- and post-conditions should not be read as a randomized treatment comparison.

Enrollment was 5 participants, but the registry record does not report how many contributed data to each outcome, whether any responses were missing, or how missing information was handled. The analysis population is not reported. The record also does not provide the statistical method, adjustment details, multiplicity approach, or a sample-size justification. These omissions prevent assessment of key analytic choices and the precision of the estimates.

The registry describes the assessment schedule and app use but does not give further detail about adherence, the intervention’s delivery, or the completeness of follow-up. It lists no serious or other adverse events, but does not describe event ascertainment or reporting procedures. These limitations should be considered alongside the pilot nature of the study and the absence of posted outcome estimates.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Self-efficacy-based Auditory Rehabilitation With Over-the-Counter Hearing Aids — NCT06560918.
• Registry record last updated 2026-08-05; status last verified 2026-07.
• Results first posted 2026-08-05.
• 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.

19. Record Summary

The registry record describes NCT06560918, a completed pilot study of self-efficacy-based auditory rehabilitation with over-the-counter hearing aids in people with sensorineural hearing loss. It reports enrollment of 5 participants and a single-group pre–post design without a control group. Participants wore in-the-canal hearing aids for a week while receiving SEBAR and completed questionnaires in conditions without and with hearing aids.

The primary outcome is percentage of total confidence measured by MARS-HA. Secondary outcomes concern readiness to adopt hearing aids, satisfaction, emotional state, and hearing-related quality of life. The registry lists 0 serious adverse events, 0 other adverse events, and 0 deaths in the group.

Numerical outcome results, analysis-population details, missing-data handling, and a statistical analysis plan are not reported in the registry record. Consequently, the size, direction, and precision of outcome changes cannot be assessed from the posted results.