Evaluation of Extended Wear Technology: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluation of Extended Wear Technology (NCT04882800), a na na study. The primary outcome is Subjective Questionnaire of Comfort.

2. Clinical Question

In practical terms, the study was set up to collect comfort ratings while participants experienced the two device-and-ear configurations in sequence. The registry describes an assessment after 14 days with device A in the right ear and device B in the left, and another after 14 days with the positions reversed, at the Day 28 final appointment. Because the same fitting sequence changes both which device is in each ear and the period of assessment, the record does not establish a randomized, parallel-group comparison that isolates a device effect from ear or period effects.

The registry’s brief summary says the study evaluated an advancement in fitting characteristics against the commercially available device. However, the primary endpoint description states that no statistical analysis was planned for the comfort measure. Numerical comfort results, a comparison estimate, and its uncertainty are not reported in the registry record. The clinical question can therefore be described from the planned measure and fitting sequence, but the record does not support a conclusion about which configuration received more comfortable ratings.

3. Trial Design

NCT04882800 is titled Evaluation of Extended Wear Technology, with an official title referring to evaluation of a fitting modification. The record lists Sonova AG as sponsor, Hearing Loss as the condition, and the study status as COMPLETED. The start date is 2021-04-08, and primary completion is listed as 2021-05-31. Phase is listed as NA.

The study is classified as SINGLE GROUP, with allocation listed as NA and masking as NONE. The available description starts with participants wearing device A in the right ear and fitting-modified device B in the left ear for 14 days. It then describes switching the devices between ears, with device B in the right ear and commercially available device A in the left ear. The full arm description is not reported in the registry record. The sequence is therefore described as a fitting comparison within a single group, not as a randomized allocation to separate treatment and control groups.

The comfort endpoint was scheduled for assessment after the initial fitting period and again after the reversed fitting period, at Day 28, the final appointment. This sequence means the record’s conditions differ by both device placement and assessment period. It does not describe random order, counterbalancing, a washout period, or other steps to separate those influences; those details are not reported in the registry record. The record also does not explain whether every participant completed both periods.

Enrollment is listed as 15. That is the registry’s enrollment figure, not a reported count of participants with complete comfort data. The record lists 2 outcome measures and 0 analyses. It does not provide a statistical analysis plan, a sample-size justification for the study design, or a detailed account of how participants were included in the primary analysis. Those omissions limit what can be inferred about how the planned fitting sequence was carried out and how its results were intended to be interpreted.

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.

Device A Right Ear/Device B Left Ear

Device B Right Ear/Device A Left Ear

Analysis population for the primary outcome, as defined in the registry: All participants who were fit with commercially available Lyric extended wear hearing aid device A in right ear and Lyric extended wear hearing aid device B in left ear Day 1- Day 14, and who were fit with extended wear hearing aid device B in right ear and commercially available hearing aid device A in left ear Day 15 to Day 28 of study.

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: Experienced hearing aid users

6. Primary Endpoint

The registry lists the primary outcome as Subjective Questionnaire of Comfort, measured over Two weeks after fitting device A in right ear/device B in left ear (Day 14 of study), and two weeks after fitting device A in left ear/device B in right ear (Day 28 of study-final appointment).

The primary endpoint is Subjective Questionnaire of Comfort. It records participants’ subjective ratings of comfort for each device in the ear. The scale runs from 0, very comfortable, to 10, very uncomfortable or painful. The registry describes ratings after the first fitting period, when device A was in the right ear and device B in the left, and after the devices were switched, at the Day 28 final appointment.

Comfort is relevant to an extended-wear hearing aid because it captures the wearer’s experience of the device in the ear, rather than a technical property alone. A questionnaire can give a structured way to record that experience across the fitting configurations. The scale’s direction matters when reading any results: lower ratings correspond to greater comfort, while higher ratings correspond to greater discomfort or pain.

The registry specifies the summary parameter as the median and the dispersion as the full range. In general, a median describes the middle of the observed ratings, while the full range conveys the lowest and highest recorded values; neither alone shows how ratings are distributed between those extremes. The registry states that no statistical analysis was planned for this measure. Actual medians, ranges, participant-level ratings, and comparisons are not reported in the registry record, so the endpoint’s observed pattern and precision cannot be assessed from this record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The methods information in the registry is limited. It identifies a single-group study, describes device placement and switching, and names a subjective comfort measure. It does not report an inferential analysis for that endpoint. The concepts below explain how such information is generally interpreted; they do not imply that these methods were used in this study.

What does the single-group fitting sequence imply?

In a parallel-group trial, separate groups are assigned to different conditions. In a within-participant sequence, the same participant experiences more than one condition, so each participant can serve as a reference for their own ratings. This can reduce the impact of stable differences between participants, such as a generally high or low tendency to report discomfort. It does not, by itself, remove effects that change across periods or between ears.

Here the registry describes device A in the right ear and device B in the left, followed by a switch in which device B is in the right ear and device A is in the left. A rating contrast could therefore reflect the device, the ear, the order of exposure, or changes over time. A design or analysis can address such factors, but the registry record does not report randomization of order or a statistical method for separating them. The sequence should not be read as a randomized comparison between independent groups.

What do median and full range communicate?

The registry names the median and full range as summaries for the comfort ratings. In general, the median identifies the central ordered observation and is less affected by extreme values than the arithmetic mean. The full range gives the minimum and maximum observed values, but it does not show whether most responses cluster near the median or are spread across the scale. These summaries can describe the observed ratings, but without the actual values they cannot establish a pattern or a difference.

For paired or repeated observations, an analysis may focus on the within-participant differences in ratings. Such an analysis would need to account for how observations are paired and for the fitting sequence. The record does not report a calculated paired contrast, its uncertainty, or any model used to account for period or ear. No new contrast can be reconstructed from the information reported.

What would a confidence interval add?

In general, a confidence interval describes the uncertainty around an estimated quantity under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval, while an interval compatible with a range of effects may leave substantial uncertainty. It is not a guarantee that the true value lies within its limits. The registry record reports no confidence interval for comfort, so precision cannot be described for a treatment contrast.

A p-value, when reported, addresses how compatible the data are with a specified null model and its assumptions. It does not measure the size or practical importance of an effect. Here, the registry states that no statistical analysis was planned for the comfort measure and lists 0 analyses. There is no reported p-value to interpret, and it would be inappropriate to infer one from descriptive information that is not reported.

How should the sample-size assumptions be read?

The record describes a sample-size planning illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the target effect is a stated fraction of the observed effect. Such calculations are planning illustrations, not observed power and not evidence that the study had a particular probability of detecting an effect. They do not replace the study’s actual design rationale. The registry does not report the trial’s own sample-size justification or the numerical result of a planning calculation in the registry record for this analysis.

The stated assumptions also describe a two-arm framework, whereas the trial is classified as SINGLE GROUP and its fitting description involves switching devices between ears. A planning calculation under equal allocation between two arms should not be mistaken for proof that participants were randomized to separate arms or that the resulting calculation matches the design and analysis of this study.

What can be concluded from the reported methods?

The record supports a descriptive account of the endpoint scale, timing, summary types, and fitting sequence. It does not report participant-level observations, endpoint summaries, a contrast, a model, or uncertainty estimates. Without those elements, neither an effect size nor its precision can be evaluated. General statistical principles can clarify what results would mean, but they cannot supply missing study results or establish which analysis was actually performed.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 2 outcome measures and 0 analyses. It identifies Subjective Questionnaire of Comfort as the primary measure and explicitly states that no statistical analysis was planned for it. The other outcome measure and its results are not described in the registry information available for this analysis. No multiplicity strategy, such as an adjustment for testing several outcomes or comparisons, is reported in the registry record.

Multiplicity matters when several outcomes, contrasts, time points, or subgroup questions are tested. In general, conducting many tests can increase the chance of finding an apparently unusual result even when there is no underlying effect. A prespecified testing strategy can help readers distinguish the main planned question from exploratory analyses. Because the record does not report an inferential analysis or a multiplicity plan, there is no basis to assess how multiple testing was handled.

The registry names a primary-measure population, but the wording is incomplete and does not fully define the analysis population. Enrollment is listed as 15; the number with observed ratings at each assessment is not reported in the registry record. The record also does not report whether participants who missed an assessment were excluded, whether any values were imputed, or how incomplete questionnaires were treated.

Missing-data methods can affect results when observations are unavailable, particularly if missingness is related to discomfort or a participant’s experience of the device. Without counts and reasons for missing observations or a stated approach to incomplete data, the potential effect of missingness cannot be assessed. These are reporting gaps, not evidence that data were missing or that a particular method was used.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry lists 0 serious adverse events among 15 at risk in the first intervention listing and 0 in the second. It also lists 0 other adverse events among 15 at risk in each listing, and 0 deaths in each. No serious adverse event terms are listed.

These figures indicate that no events in those categories were reported for the listed intervention periods. They do not establish that the risk of an event is absent. With no events recorded, the data provide limited information about the frequency of uncommon harms; a zero count is not the same as evidence that an event is impossible.

The study is classified as SINGLE GROUP and describes switching the devices between ears. The intervention listings therefore should not be treated automatically as independent treatment and control groups, nor should their at-risk counts or event counts be added to create a combined figure. The record does not give further details about how adverse events were monitored, attributed, or collected. The safety counts should be read as descriptive registry reports within the study’s fitting sequence, not as a comparative estimate of risk.

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

The registry record describes a study of comfort ratings for commercially available Lyric extended-wear hearing aid device A and a version of device B with a fitting modification. Participants were described as receiving the devices in opposite ears and then switching their positions. The primary measure was subjective comfort, assessed on a scale from 0 (very comfortable) to 10 (very uncomfortable or painful), with ratings scheduled after each fitting period.

Those details establish the question and measurement approach, but they do not establish the answer. Numerical comfort ratings, medians, full ranges, and a comparison between configurations are not reported in the registry record. The record also says no statistical analysis was planned for the primary measure. It therefore does not support a claim about which configuration had better comfort ratings, whether ratings differed, or how precise a difference might be.

The design imposes further limits on interpretation. The study is labeled SINGLE GROUP, allocation is listed as NA, and the description involves switching device placement between ears. Any comparison would need to be considered in the context of ear and period effects, as well as the possibility of incomplete assessments. The registry does not report an analysis addressing these issues.

The safety listings show no reported serious or other adverse events and no deaths in the listed intervention periods. These descriptive counts should not be taken as proof that adverse events cannot occur or as a comparative estimate of safety.

In short, the registry helps identify what was studied and how comfort was intended to be recorded. It does not report enough outcome or analysis information to establish an observed comfort effect, its precision, or a comparative safety conclusion. Absence of a reported result should not be confused with a finding of no difference.

13. Why This Trial Matters Statistically

This trial raises a useful statistical distinction between a study question and the evidence needed to answer it. The registry defines a subjective comfort outcome and a fitting sequence in which devices are switched between ears. That is enough to identify the kind of comparison of interest, but not enough to quantify what participants reported. Without endpoint summaries or an analysis, readers cannot assess the size, direction, or precision of a difference.

The sequence also illustrates why study structure matters. A within-participant experience can make observations from the same person informative about one another, but changes in ear placement and assessment period can complicate interpretation. Random order or an analysis that accounts for the sequence may help address such concerns in general. Whether such steps were used is not reported in the registry record.

The record’s sample-size assumptions are another reason to distinguish planning from evidence. A planning illustration based on an observed effect and specified assumptions is not a measure of the study’s observed power, nor does it establish that the trial was designed around a particular effect. The trial’s own sample-size justification is not reported in the registry record.

Finally, the safety listings demonstrate the limits of zero-event observations. They report no events in the listed categories, but do not establish absence of risk. Careful interpretation separates descriptive reporting from inferential conclusions. In this case, the registry documents a completed fitting study and its intended comfort measure, while leaving the primary numerical findings and statistical analysis unreported.

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 is that the registry record does not report numerical results for the primary comfort endpoint. Although it identifies the scale and intended summaries, it gives no observed medians, full ranges, participant-level ratings, contrast, or uncertainty estimate. The record says no statistical analysis was planned for this measure, so the endpoint cannot support an inferential comparison as documented.

The fitting sequence also limits interpretation. The study is classified as SINGLE GROUP, allocation is NA, and the described sequence changes device placement between ears over successive periods. The record does not report random order, counterbalancing, a washout, or an analysis that separates device, ear, and period effects. These details should not be assumed absent from study conduct, but they are not reported in the registry record.

The registry lists enrollment as 15, but does not report the number of participants with complete ratings at each time point or explain how incomplete observations were handled. The primary-measure population description is incomplete, and the full arm description is not reported in the registry record. This prevents a clear assessment of which participants contributed to the intended endpoint summaries.

Other limitations include the absence of a reported statistical analysis plan, sample-size justification, multiplicity approach, and detailed adverse-event collection methods. The safety listings contain zero reported events, but provide no comparative risk estimate. These reporting limitations do not show that the study was conducted improperly; they define what can and cannot be concluded from the registry information.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Evaluation of Extended Wear Technology — NCT04882800.
• Registry record last updated 2022-12-14; status last verified 2022-07.
• Results first posted 2022-12-14.
• 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

NCT04882800, Evaluation of Extended Wear Technology, is listed as COMPLETED and sponsored by Sonova AG. The study is classified as SINGLE GROUP, with allocation listed as NA and masking as NONE. Enrollment is listed as 15, and the condition is Hearing Loss.

The registry describes a sequence using commercially available device A and fitting-modified device B, with the devices switched between ears. The primary endpoint is a subjective comfort questionnaire rated from 0 (very comfortable) to 10 (very uncomfortable or painful), with median and full range specified as summaries. The record states that no statistical analysis was planned for this measure.

Numerical comfort results, an analysis, and a complete description of the endpoint population are not reported in the registry record. The listed safety counts are 0 serious adverse events, 0 other adverse events, and 0 deaths in each intervention listing.