Post-market Study to Capture Information Regarding Performance of Lyric2: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Post-market Study to Capture Information Regarding Performance of Lyric2 (NCT01861704), a randomized na study. The primary outcome is Immediate Refit Upon Device Removal.

2. Clinical Question

This is a post-market comparison of device performance rather than a question about a broad clinical outcome. The endpoint focuses on the condition of the ear at device removal and whether an audiologist considered it suitable for immediate refitting. The registry explains that slight irritation can occur when people first experience this type of device, and that sizing can increase stress on the ear. The endpoint therefore captures an immediate practical aspect of device use. It does not, by itself, describe longer-term comfort, hearing performance, or whether a person continued using a device.

3. Trial Design

The registry describes a randomized, single-masked, parallel-group study comparing the Lyric and Lyric2 devices. It is identified as a post-market study, and its brief summary says it was intended to capture comparative performance and safety information. The listed condition is hearing loss. The registry records enrollment of 177 and a completed status.

The study start is recorded as 2011-04, and primary completion as 2012-01. The sponsor is Phonak AG, Switzerland. The registry lists the interventions as devices: Lyric and Lyric2. It identifies the Lyric arm as the Silver Lyric device and the Lyric2 arm as the Lyric2 (Barracuda) device.

Randomized allocation means the record identifies assignment to the study arms as randomized. The record does not describe the randomization sequence, allocation concealment, or the details of how assignment was implemented. It labels masking as single but does not say which people involved in the study were masked or how masking was maintained. The parallel model indicates that the arms were compared as separate groups; the record does not describe a crossover design.

The primary endpoint is reported as a percentage of ears, and its population is restricted to ears from experienced users who had previously worn an extended wear device. The arm counts for this endpoint are 35 for Lyric and 41 for Lyric2. Those endpoint counts are not the same quantity as the overall enrollment figure, and the registry notes that some patients were fitted with only one instrument. The record does not provide a full accounting that reconciles the enrollment with the endpoint counts or explains all exclusions from the endpoint population.

The record lists Device Comfort and Gain, Speech Understanding and Sound Quality as secondary outcomes. Although it records three outcome measures, the registry record does not report secondary outcome results in the registry record for this comparison. The study phase is listed as NA.

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: Only ears from experienced users were taken into account, i.e. only users that have previously worn an extended wear device. Some patients previously worn only one hearing instrument, therefor a significant number of patients were only fitted with one instrument

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 Immediate Refit Upon Device Removal, measured over Following device removal at the same appointment (Up to 24 hours after removal).

The primary endpoint is the percentage of ears judged available for immediate refitting after device removal. A qualified audiologist examined the ears at the removal visit and assessed whether another hearing aid device could be fitted immediately. The timeframe is stated as following removal at the same appointment, with the registry also specifying up to 24 hours after removal.

The registry explains the rationale in relation to the initial experience of wearing an extended wear device. It notes that slight irritation is not uncommon and that the sizing process for Lyric or Lyric2.0 can increase stress on the ear. This endpoint captures an immediate assessment relevant to refitting, rather than a measure of hearing benefit, long-term device use, or comfort over time.

The endpoint is expressed as a percentage of ears, not as a percentage of people. The population is limited to ears from experienced users who had previously worn an extended wear device. The record also notes that some patients had previously worn only one hearing instrument and were fitted with only one instrument. These details matter when interpreting the listed arm counts: the endpoint population and unit are not interchangeable with the overall enrollment of 177 participants.

For Lyric, the posted percentage is 78.0% with a 90% confidence interval from 68.0% to 86.0%. For Lyric2, it is 93.0% with a 90% confidence interval from 86.0% to 98.0%. The registry does not provide an estimable two-arm comparison for this count-type endpoint, so these arm-level estimates should not be treated as a reported test of a difference.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a count-type measure expressed as a percentage of ears. Each ear was assessed for availability for immediate refitting after device removal. The posted arm estimates are 78.0% for Lyric and 93.0% for Lyric2. Their reported 90% confidence intervals are 68.0% to 86.0% and 86.0% to 98.0%, respectively. The registry does not describe the formula or statistical method used to calculate those intervals.

What does a confidence interval communicate?

In general, a confidence interval represents uncertainty in an estimate under a specified statistical procedure. The estimate is the central summary, while the interval gives a range of values compatible with the observed data under that procedure. It does not describe the spread of outcomes among individual ears, and it is not a guarantee about the value in any particular sample or person. The confidence level describes the long-run behavior of the method when used repeatedly under its assumptions; it is not the probability that a fixed parameter changes from sample to sample.

The confidence level reported for these results is 90%. The registry record does not identify whether the interval calculation accounted for any clustering of ears within people, nor does it describe other assumptions used in constructing the intervals. This is relevant because the endpoint unit is ears, while some patients contributed only one instrument. Without fuller information about the analytic unit and the relationship between ears and participants, the precision estimates cannot be independently evaluated from the record alone.

Why is there no reported two-arm test?

The registry marks a two-arm comparison as not estimable for this count-other endpoint and lists zero analyses. Consequently, the record supplies arm-level percentages and intervals but no direct statistical estimate of the Lyric2-versus-Lyric contrast. A direct comparison would ordinarily be the analysis that addresses whether the groups differ on the endpoint, with an estimate and uncertainty for that contrast. Those results are not reported in the registry record.

General statistical methods for comparing proportions can differ in their assumptions, including how they treat small counts, dependence among observations, or variation beyond a simple model. The registry record does not say which approach was planned or attempted, why the comparison could not be estimated, or whether any alternative analysis was performed. It would therefore be inappropriate to infer a method or reconstruct an unreported test from the arm summaries.

The arm-specific confidence intervals do not answer the same question as a confidence interval for a between-arm contrast. Nor does the fact that the displayed intervals meet at 86.0% provide a formal significance test. In general, interval overlap is not a substitute for testing or estimating the contrast directly. Since the record does not report a contrast, no conclusion about statistical significance can be drawn from the posted values alone.

What does randomization contribute?

As a general principle, random allocation can help balance both measured and unmeasured characteristics between groups on average, subject to how assignment was implemented and how participants were analyzed. Here, the registry identifies the allocation as randomized, but does not report the sequence-generation method, concealment procedures, or analysis population. The label alone does not show whether all randomized participants contributed to the endpoint analysis or how missing observations were handled.

The record identifies a single-masked design, but does not say who was masked. It also does not explain whether the audiologist’s assessment was masked to device assignment. Because the outcome involves a clinical assessment of ear availability, knowledge of assignment could be relevant to the possibility of assessment bias; whether that concern applies cannot be determined from the registry description.

What can be inferred from the available summaries?

The reported arm counts are 35 for Lyric and 41 for Lyric2, and the endpoint is a percentage of ears. The overall enrollment is 177. These figures refer to different populations or units as described in the record, and they should not be combined or treated as equivalent. No further reconciliation of the counts is reported. General statistical interpretation requires keeping the denominator and the unit of analysis clear, particularly when ears rather than people are counted.

The posted summary statistics do not include an adjusted estimate, a model specification, or a test statistic. The registry does not report whether covariates were included, whether any interim analyses were conducted, or the statistical analysis plan. Those details are not reported in the registry record. The observed arm results are not a basis for claiming that a particular analysis was prespecified.

Planning calculations based on an observed effect are not the same as observed trial evidence or observed power. The record describes planning assumptions in general terms, including a two-sided significance level of 0.05, equal allocation, a normal approximation, and effects defined as fractions of the observed effect. However, no planning values are included in the registry record for this result, so no numerical planning requirement can be interpreted. Such illustrations would not change the fact that the registry does not report an estimable two-arm analysis for the endpoint.

In short, the statistical record supports reporting the two arm-level estimates and their stated intervals, while keeping their descriptive status clear. The comparison method, interval construction, missing-data approach, and analysis population are not reported in enough detail to assess or reproduce the primary endpoint analysis.

10. Multiplicity, Missing Data and Analysis Populations

The registry names Device Comfort and Gain, Speech Understanding and Sound Quality as secondary outcomes. It records three outcome measures, but results for those secondary measures are not included in the registry record for this comparison. Their definitions, analysis populations, estimates, and uncertainty are not reported in the registry record.

The record does not describe how many statistical hypotheses were planned across the primary and secondary outcomes, whether any multiplicity adjustment was used, or how the primary endpoint was prioritized relative to other analyses. No statistical analysis plan or interim analysis information is reported. Because the endpoint comparison itself is marked not estimable, the posted summaries also do not establish a formal primary-outcome test to place within a multiplicity strategy.

Missing-data handling is not reported in the registry record. The registry entries do not state how many endpoint assessments were unavailable, why any observations might be missing, or whether any imputation or sensitivity analysis was performed. The registry also does not describe an intention-to-treat, per-protocol, or other analysis population for this endpoint.

The primary endpoint population is described as ears from experienced users with prior extended wear device use. The registry notes that some patients had previously worn only one instrument and were fitted with only one instrument. It does not provide a participant flow or a complete explanation of how that population was selected from the overall enrollment. Those gaps limit assessment of selection, missingness, and the relationship between the endpoint analysis and randomized assignment.

11. Safety Results

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

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 reports zero serious adverse events among the listed at-risk groups for Lyric and Lyric2. The listed numbers at risk are 70 for Lyric and 107 for Lyric2. For other adverse events, the record reports 4 affected in the Lyric group and 6 in the Lyric2 group, with the same listed at-risk counts of 70 and 107, respectively. Death counts are not reported in the registry record.

These are safety counts as recorded, not a comparison adjusted for differences in group size, follow-up, or exposure. No such adjusted comparison is reported. The serious-event terms list is empty, and the registry records zero serious events in each group; this does not establish that the devices have no serious-event risk or that no events could occur outside the recorded follow-up. The record does not provide definitions of the event categories, a detailed follow-up period for adverse events, or a formal statistical comparison of safety outcomes.

The safety figures should therefore be read as descriptive registry counts. They do not establish equivalence between the devices or settle a broader safety question.

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

The primary endpoint describes an immediate clinical assessment after removal: whether an ear was judged available for refitting at the same appointment, with the timeframe stated as up to 24 hours after removal. The posted estimate is 78.0% for Lyric, with a 90% confidence interval from 68.0% to 86.0%, and 93.0% for Lyric2, with a 90% confidence interval from 86.0% to 98.0%. These results summarize the endpoint population of ears from experienced users.

The result does show that the two posted arm-level percentages are not identical. It does not, by itself, establish the size or statistical certainty of a difference between the devices. The registry does not report an estimable two-arm analysis, an interval for the contrast, or a p-value for this outcome. The separate arm intervals represent uncertainty in their respective estimates, not uncertainty in the difference between them.

The endpoint also has a narrow scope. It is not a direct measure of long-term comfort, hearing gain, speech understanding, sound quality, continued device use, or overall benefit. Although the registry lists Device Comfort and Gain, Speech Understanding and Sound Quality as secondary outcomes, their results are not reported in the registry record for this comparison. The immediate refitting assessment should not be used as a substitute for those outcomes.

The findings should not automatically be extended beyond the experienced-user population described in the record. The results are stated for ears, and some patients contributed only one instrument. The registry does not fully explain how the endpoint population relates to the overall enrollment of 177 or how ears within a person were handled analytically. Nor does it provide enough methodological detail to assess the construction of the confidence intervals or the impact of missing data.

For safety, the registry records zero serious adverse events in the listed groups and reports other adverse-event counts of 4 for Lyric and 6 for Lyric2. These counts alone do not show that one device is safer, nor do they prove the absence of risk. A broader interpretation would require event definitions, follow-up detail, and a comparative analysis, none of which is reported.

Overall, the record offers descriptive arm-level information on an immediate refitting endpoint and safety counts. It does not establish a statistically tested difference, a comprehensive performance comparison, or a general conclusion about clinical benefit or safety.

13. Why This Trial Matters Statistically

This trial illustrates why the unit of analysis and endpoint population matter in clinical statistics. The overall enrollment is 177, but the primary outcome is expressed as a percentage of ears from experienced users, with arm counts of 35 for Lyric and 41 for Lyric2. The registry also notes that some patients were fitted with only one instrument. Participant totals, ear counts, and endpoint denominators should not be treated as interchangeable. Clear reporting of these relationships is important for interpreting both estimates and their uncertainty.

It also shows the distinction between descriptive results and a comparative analysis. The registry reports arm-specific percentages and confidence intervals, yet marks a two-arm comparison as not estimable and lists zero analyses. A reader can describe the posted values, but cannot replace the missing direct comparison by treating separate intervals as a test. In general, randomized allocation is intended to support a between-group comparison, but the comparison still needs an analyzable endpoint definition, suitable denominators, and a reported statistical method.

The endpoint is clinically specific: an audiologist’s assessment of immediate refitting availability after device removal. That specificity can be useful when the practical question concerns the ear at the time of removal. At the same time, the endpoint does not stand in for longer-term experience or other dimensions of device performance. The listed secondary outcomes indicate that comfort and hearing-related measures were relevant, but their results are not reported in the available record.

Finally, the record demonstrates the value of reporting analysis details alongside results. The method for constructing intervals, handling ears contributed by the same person, defining analysis populations, and addressing missing data is not reported. Without those details, readers can retain the descriptive estimates while recognizing that precision and comparability cannot be fully assessed. The distinction between what the registry reports and what remains unreported is central to responsible interpretation.

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 primary result is restricted to ears from experienced users who had previously worn an extended wear device. It may not describe first-time users or all participants enrolled in the trial. The registry notes that some patients had worn only one hearing instrument and were fitted with only one instrument, but it does not provide a full account of how the endpoint population was selected or how the arm counts relate to overall enrollment.

The endpoint is a judgment by a qualified audiologist about immediate availability for refitting. The record does not report whether the audiologist was masked to device assignment, despite identifying the study as single-masked. It also does not provide an operational definition of “available” beyond the described examination and refitting assessment. Assessment reliability or consistency across evaluators is not reported.

The two arm estimates are presented with 90% confidence intervals, but the method used to calculate the intervals is not reported. The registry does not describe whether the statistical analysis accounted for possible dependence between ears belonging to the same person. It also does not report an estimable two-arm comparison, an adjusted estimate, or a formal test for this endpoint.

Missing-data methods, analysis populations, and a participant flow are not reported in the registry record. Details of randomization implementation and allocation concealment are also not reported. The record does not describe interim analyses or provide the statistical analysis plan. These limitations prevent a full assessment of how the observed endpoint summaries were generated and how representative they are of all randomized participants.

The endpoint captures an immediate post-removal assessment and cannot establish longer-term comfort or hearing-related outcomes. Although secondary outcomes are named, their results are not included in the registry record for this comparison. Safety reporting is likewise limited to the listed event counts; event definitions and a formal comparative safety analysis are not reported.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Post-market Study to Capture Information Regarding Performance of Lyric2 — NCT01861704.
• Registry record last updated 2014-05-19; status last verified 2014-04.
• Results first posted 2014-05-19.
• 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 describes a completed randomized, single-masked, parallel-group post-market study of Lyric and Lyric2 for hearing loss. Enrollment is recorded as 177, with study start in 2011-04 and primary completion in 2012-01. The sponsor is Phonak AG, Switzerland.

The primary endpoint is the percentage of ears from experienced users judged available for immediate refitting after device removal. Lyric is reported at 78.0% with a 90% confidence interval from 68.0% to 86.0%; Lyric2 is reported at 93.0% with a 90% confidence interval from 86.0% to 98.0%. The registry marks a two-arm comparison for this endpoint as not estimable and lists zero analyses.

Secondary outcomes listed are Device Comfort and Gain, Speech Understanding and Sound Quality, but their results are not reported in the registry record for this comparison. The registry records zero serious adverse events in each listed group and reports other adverse-event counts of 4 for Lyric and 6 for Lyric2. Death counts are not reported in the registry record.