Home Test of New Sound Processor: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Home Test of New Sound Processor (NCT04559282), a randomized na study. The primary outcome is Hearing Performance of Speech in Noise for Unaided Hearing and the Baha 6 Max Assessed Via Adaptive Speech Test in Noise.

2. Clinical Question

3. Trial Design

The registry describes a pivotal, prospective, single-centre, randomized test-order crossover study. Its official title also describes it as open label, while the masking field says single. Arm descriptions clarify that subjects were blinded for hearing testing in a laboratory environment; the record does not give a fuller account of masking beyond that description. The study is listed as completed, with enrollment of 16.

Participants followed one of two test sequences. One sequence began with the new Sound Processor, followed by Baha 5, unaided hearing, and then laboratory testing with both devices. The other began with Baha 5, then the new Sound Processor, unaided hearing, and laboratory testing with both devices. This randomized order is relevant because performance may be measured under more than one hearing condition within a crossover study. The registry record does not report whether the analysis adjusted for sequence, period, or within-participant correlation.

The primary outcome compared Baha 6 Max on Day 0 and day 7 with unaided hearing on day 14. The registry states that data for each of these conditions were collected for all 16 participants. The primary outcome timeframe is described as Day 0, day 7 and day 14. The registry record does not report the original sample-size justification, detailed analysis plan, or whether any planned interim analyses were conducted.

Secondary outcomes covered adaptive speech-in-noise testing, speech-in-quiet testing, audiometric thresholds, participant ratings, listening effort, internal noise, and diary-based performance in a home or normal-hearing environment. The registry lists nine posted secondary outcomes and 11 outcome measures overall. Numerical results are available for some, but not all, of the secondary outcomes. The record lists Cochlear as sponsor and gives the study start as 2020-09-23 and primary completion as 2020-11-27.

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.

Intervention 1 (Day 0)

Intervention 2 (Day 7)

Intervention 3 (Day 14)

Analysis population for the primary outcome, as defined in the registry: Data for Baha 6 Max was collected on Day 0 and day 7 for all 16 participants. Data for unaided hearing was collected on day 14 for all 16 participants.

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 Hearing Performance of Speech in Noise for Unaided Hearing and the Baha 6 Max Assessed Via Adaptive Speech Test in Noise, measured over Day 0, day 7 and day 14.

The primary endpoint measures speech understanding in background noise using validated lists of phonetically balanced sentences. Noise is held constant at 65 dB Sound Pressure Level, while speech level is adapted stepwise. The endpoint is the speech-to-noise ratio associated with a 50% level of understanding, expressed in dB SNR. In general, this type of adaptive test estimates the signal-to-noise conditions at which a specified performance threshold is reached, rather than simply counting correct responses at one fixed speech level.

The endpoint is useful for comparing performance under aided and unaided listening conditions because it translates speech recognition in noise into a continuous measure. A mean and standard deviation describe the group’s average outcome and its spread. The primary means were -3.7 for Baha 6 Max and 4.8 for unaided hearing. The comparison is expressed as unaided minus Baha 6 Max, so the reported positive mean difference of 8.5 reflects the direction of the two posted means. The registry record does not report a clinically meaningful difference threshold for interpreting the size of this contrast.

Although the primary outcome timeframe includes Day 0, day 7 and day 14, the registry describes Baha 6 Max measurements on Day 0 and day 7 and unaided measurements on day 14. The record does not explain how repeated measurements or their timing were incorporated into the reported group summaries. That distinction matters when interpreting a crossover study, because measurements taken from the same participant can be statistically related.

7. Results Posted in the Registry

• Unaided: mean 4.80 versus -3.70 on control; difference 8.50 (95% CI 5.02 to 11.98), standardized effect d = 1.69; z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Adaptive Speech Test in Noise

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Baha 5: mean -2.80 versus -3.70 on control; difference 0.90 (95% CI -0.90 to 2.70), standardized effect d = 0.35; z-test p = 0.327.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Baha 5 and the control. The interval gives the range of effects that remain compatible with the data.

Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Speech Test in Quiet

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Baha 5: mean 77.90 versus 88.40 on control; difference -10.50 (95% CI -24.68 to 3.68), standardized effect d = -0.51; z-test p = 0.147.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Baha 5 and the control. The interval gives the range of effects that remain compatible with the data.

Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Listening Effort.

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Baha 5: mean 3.02 versus 1.97 on control; difference 1.05 (95% CI -0.53 to 2.63), standardized effect d = 0.46; z-test p = 0.192.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Baha 5 and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes broaden the assessment beyond the primary adaptive speech-in-noise comparison. They include speech testing in quiet, audiometric thresholds, diary-based performance in a home or normal-hearing environment, participant ratings, internal noise and listening effort. These measures address related aspects of hearing performance, but they are not identical outcomes. Differences in setting, measurement scale and construct mean that agreement across them would be informative without making them direct substitutes for the primary endpoint.

Numerical results and unadjusted comparisons are available for secondary speech-in-noise performance, speech-in-quiet performance and listening effort. Their confidence intervals include zero. The registry record lists additional secondary outcomes but does not report numerical results for all of them. The available secondary findings therefore offer limited corroboration of the primary result; they do not reproduce its clear unadjusted separation, and they cannot establish that all aspects of performance follow the same pattern.

Secondary outcomes are usually interpreted with less weight than a prespecified primary outcome, particularly when many outcomes are examined. Testing multiple outcomes increases the chance that at least one result will appear unusual by chance if no adjustment is made. The posted secondary p-values are unadjusted, and the registry record does not report a multiplicity strategy. They should be treated as exploratory evidence rather than as independent confirmation of a primary finding.

The range of secondary measures can still be useful for understanding what was assessed and where further study may be needed. But outcome-specific differences, uncertainty and missing reporting matter. The record does not report whether all secondary analyses were prespecified, how participant ratings were summarized beyond the listed means and standard deviations, or how diary data were analyzed. Those gaps limit synthesis across the secondary outcomes.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary
• Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Adaptive Speech Test in Noise
• Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry
• Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Speech Test in Quiet
• Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating
• Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise
• Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Listening Effort.
• Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry

9. Statistical Interpretation

10. Statistical Methods Explained

The numerical comparisons are mean differences for continuous outcomes. A mean is the arithmetic average of the observed values, while a standard deviation describes how dispersed observations are around that average. The standard deviation is not a confidence interval: it describes variability among observations, whereas a confidence interval describes uncertainty around an estimated quantity such as a mean difference.

What does the mean difference represent?

For the primary comparison, the contrast is written as unaided minus Baha 6 Max. The posted mean for unaided hearing is 4.8, and the posted mean for Baha 6 Max is -3.7; the recalculated mean difference is 8.5. The sign depends on the subtraction order. Reversing the order would reverse the sign, without changing the underlying separation between the two means. The unit remains dB SNR. The number is an unadjusted comparison of the posted summaries, not an estimate adjusted for crossover sequence or repeated measurements.

What does a confidence interval add?

A confidence interval gives a range of values compatible with the estimate under the calculation’s assumptions. It communicates precision as well as direction: a narrower interval indicates greater precision, while a wider interval leaves more uncertainty about the size of the difference. A 95% confidence interval is a procedure with 95% long-run coverage under its assumptions; it is not a statement that there is a 95% probability that this particular fixed interval contains the true value. For the primary mean difference, the interval is 5.019 to 11.98. It does not include zero, the value corresponding to no mean difference under this contrast.

How should the p-value be read?

The primary unadjusted p-value is <0.001. In general, a p-value measures how incompatible the observed data, or more extreme data, are with a specified null hypothesis under the statistical model. It is not the probability that the null hypothesis is true, nor does it measure clinical importance. A small p-value does not correct for an analysis that fails to reflect the design. The reported value is unadjusted; the registry record does not report a multiplicity adjustment or a full analysis plan.

Why does the crossover design matter?

In a crossover study, participants experience more than one condition, and observations from the same participant can be correlated. A paired analysis can use that relationship, while an independent-groups calculation treats the compared sets as if they were independent. The recalculations from posted summary statistics are simple unadjusted calculations and do not incorporate participant-level pairing, because such participant-level data are not included in the posted summaries. The registry describes randomized test order and a crossover design, but does not report a model accounting for sequence, period, carryover, or within-participant correlation. This is a limitation of the recalculated comparisons, not evidence that any particular design effect occurred.

Over-dispersion is a general concern when observed variation is larger than a model expects. If a model assumes less variability than is present, standard errors can be too small and confidence intervals too narrow. Here, the primary standard deviations differ between the aided and unaided conditions, but the record does not report a model-based assessment of over-dispersion. The posted summaries alone do not establish whether it affected the trial’s own analysis.

What can the reported summaries establish?

Means, standard deviations, confidence intervals and unadjusted p-values describe the posted aggregate results. They do not reveal individual participant trajectories, missing observations between visits, or whether all planned measurements were included in an analysis. The primary outcome description says data were collected for all 16 participants under each named condition. However, the analysis population definition and missing-data procedures are not reported in the registry record. The record also does not report whether repeated Baha 6 Max observations were combined, modeled separately, or handled through another method in the sponsor’s analysis.

Because the registry’s own analysis details are not reported, the recalculated contrasts should be treated as descriptive, unadjusted checks of the posted summaries. They should not be mistaken for a reconstruction of a full crossover analysis. The sponsor’s original analysis is not reported in the registry record, and the posted results do not specify adjustment for design features or for multiple secondary outcomes.

11. Confidence Intervals and Precision

Precision is conveyed chiefly by the confidence interval around a mean difference. For the primary contrast, the unadjusted estimate is 8.5 dB SNR, and its 95% confidence interval extends from 5.019 to 11.98. The interval excludes zero, so the primary summary comparison is not compatible with no mean difference at the stated interval level under the calculation assumptions. Its width also shows that the exact size of the mean contrast is not known with the same precision as its direction in this unadjusted analysis.

The primary standard deviations are 2.75 for Baha 6 Max and 6.55 for unaided hearing. These describe the variability of observed scores within each condition, not uncertainty around the difference. The larger spread for unaided hearing indicates more dispersion in those posted observations. The registry record does not provide confidence intervals for the individual group means.

Confidence intervals for the secondary comparisons are less conclusive about differences from zero: the posted intervals include zero for the adaptive speech-in-noise, speech-in-quiet and listening-effort comparisons. This does not prove that the conditions are identical. It indicates that the estimates are uncertain enough, under the simple calculations, to include both no difference and values on either side. These intervals are unadjusted and should be interpreted cautiously alongside the number and variety of secondary outcomes.

Precision is also limited by the information available for analysis. The registry record reports aggregate means and standard deviations, not participant-level data or a design-adjusted analysis. It does not report an interval accounting for repeated measures, randomized sequence, or within-participant correlation. Thus, the intervals convey precision for the recalculated unadjusted comparisons, not necessarily for the study’s intended crossover estimand.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm, not total events. They are illustrations based on the observed effect and are not the trial’s original sample-size justification. The planning assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is the stated fraction of the observed effect. The registry record does not report the assumptions used for the original trial design.

The 80% power column gives the estimated participants per arm for a future study to have an 80% chance of detecting the specified effect under the listed assumptions, if that effect is present and the calculation model applies. The 90% power column describes the corresponding planning target with a higher chance of detection. These are design targets, not guarantees about the outcome of a future study.

Rows planning for 100% of the observed effect use the full observed effect as the target. Rows planning for 75% or 50% use smaller target effects. Smaller effects are harder to distinguish from random variation under the same assumptions, so they require more participants per arm to reach the same power target. This relationship is a general feature of statistical planning, not a finding about the trial’s observed participants.

The figures are not observed power. They are prospective planning illustrations generated from the observed effect, rather than a measure of how likely the completed study was to detect an effect after seeing its results. Since the study used a crossover design, while the planning assumptions specify equal allocation between two arms, these figures should not be mistaken for a design-specific sample-size calculation for this trial. The registry record does not report whether the original design used a different approach.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 8.500; pooled standard deviation σ = 5.023.
2. n = 2 × (1.96 + 0.842)² × 5.023² / 8.500² = 5.5, rounded up to 6 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 8.5                      # observed difference in means
sigma <- 5.02319619365997                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(4559282)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 6 (80% power), 8 (90% power)
 75% of observed effect: n per arm = 10 (80% power), 14 (90% power)
 50% of observed effect: n per arm = 22 (80% power), 30 (90% power)
power.t.test: 6.6 
Simulated power at n = 6 per arm: 0.752 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The study lists a primary outcome alongside multiple secondary outcomes. When several outcomes are tested, the chance of at least one apparently unusual result can increase. Statistical methods can control this multiplicity, for example by adjusting significance thresholds or using a prespecified hierarchy of tests. The registry record does not report whether such a strategy was planned or used. The secondary p-values are unadjusted, so they should not be read as though they account for the full family of outcomes.

The registry lists nine posted secondary outcomes and 11 outcome measures overall. Numerical results are not reported for every listed secondary outcome. The absence of a posted estimate does not establish that the outcome was not measured; it means the result is not reported in the registry record. The record does not explain whether unreported outcomes were unavailable, omitted, or analyzed without posting numerical results.

For the primary outcome, the registry states that data were collected for all 16 participants in each of the named hearing conditions. That statement describes collection, but it does not define the analysis population or establish how every observation entered the reported estimate. The registry record does not report missing-data handling, exclusions from analyses, imputation methods, or sensitivity analyses. It also does not report whether participants were analyzed according to randomized test sequence.

These details are important in a crossover study, where the analysis may depend on complete observations across conditions and on how within-participant measurements are handled. The posted aggregate summaries cannot establish whether missingness, sequence, period or carryover affected the estimates. Nor can they show whether the trial used an intention-to-treat, per-protocol, or other analysis population. These matters are not reported in the registry record, so no particular procedure should be assumed.

15. 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 reports serious adverse events, other adverse events and deaths separately for Baha 6 Max, Baha 5 and unaided hearing. For each of these groups, 16 participants were listed at risk for serious adverse events and 0 were affected; 16 were listed at risk for other adverse events and 0 were affected; and 0 deaths were reported. No serious adverse event terms are listed.

These figures mean that the registry record reports no events in the listed categories during the relevant reporting period. They do not establish that the risk of an event is absent, nor do they provide a precise estimate of uncommon harms. The study enrollment and exposure are limited, and the record does not give further detail about event definitions, collection procedures, follow-up completeness, or exposure duration for each condition.

Because this is a crossover study, the same participants may contribute experience under more than one condition. The group-specific figures should not be added together to infer a total number of different participants. The registry record presents the categories by condition, and the counts should be read as reported rather than as independent groups of people.

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

The primary posted summaries show a mean difference between Baha 6 Max and unaided hearing on the adaptive speech-in-noise measure. The unadjusted recalculation is 8.5 dB SNR for unaided minus Baha 6 Max, with a 95% confidence interval from 5.019 to 11.98 and an unadjusted p-value of <0.001. These statistics describe the observed contrast in the registry summaries and the uncertainty under the simple calculation used.

They do not, by themselves, establish how large a difference is important to participants or clinicians. The registry record does not report a threshold for clinical importance, and statistical evidence against a zero difference is not the same as evidence of meaningful improvement. The outcome is a laboratory speech-in-noise measure; it does not represent every listening situation or all outcomes that matter to participants.

The findings also do not show that one device is better across every measured outcome. Secondary outcomes cover different tasks and ratings, and the available unadjusted estimates have confidence intervals that include zero. Preference was part of the study purpose, but preference results are not reported in the registry record. Results for several listed secondary outcomes are also not reported.

The crossover design and timing deserve attention. Baha 6 Max performance was collected on Day 0 and day 7, whereas unaided performance was collected on day 14. The registry record does not describe how the sponsor’s analysis handled repeated measurements, sequence or period effects. The aggregate recalculation cannot resolve these questions. Consequently, the primary contrast is best read as an unadjusted comparison of posted summaries, not as a full design-adjusted causal estimate.

Finally, the results apply to the participants and procedures recorded for this study. The registry lists enrollment of 16 in a single-centre investigation. It does not report a detailed analysis population, missing-data method, clinical importance criterion, or full statistical plan. The results are informative about the posted measurements, but they do not settle broader questions about performance, preference, safety or effects in other settings and populations.

17. Why This Trial Matters Statistically

This study is statistically interesting because it combines a randomized test order with a crossover design and repeated hearing assessments. Crossover designs can make within-participant comparisons informative: each participant may contribute measurements under more than one condition, and accounting for that relationship can affect uncertainty. The registry record describes the design but does not report whether its analysis used the paired structure, adjusted for test sequence, or modeled period effects.

The primary endpoint is continuous and has a clear measurement definition: an adaptive speech-in-noise test estimates the speech-to-noise ratio associated with a 50% understanding level. The posted difference is accompanied by a confidence interval, making it possible to consider both the estimated contrast and its precision rather than relying on a p-value alone. The primary interval is separated from zero in the unadjusted recalculation, while the secondary intervals are less conclusive.

The study also illustrates why statistical and clinical interpretations should be kept distinct. A comparatively small p-value does not specify whether a measured difference matters in everyday listening. Secondary measures and participant ratings can contribute context, but multiple unadjusted comparisons require caution. The record does not report a multiplicity plan or a clinical-importance threshold.

Finally, registry reporting determines how much can be independently assessed. Aggregate means and standard deviations support simple recalculations, but they do not permit reconstruction of a full crossover analysis or investigation of participant-level patterns. More detail on the analysis model, missing data, outcome hierarchy and interpretation thresholds would make the statistical evidence easier to evaluate.

18. 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 available numerical comparisons are based on aggregate means and standard deviations. They cannot account for the crossover structure at the participant level, including within-person correlation, test order or period effects. The registry record does not report whether the sponsor’s analysis adjusted for these features, so the unadjusted recalculations should not be assumed to reproduce the original analysis.

The timing of the primary measurements also complicates interpretation: Baha 6 Max data were collected on Day 0 and day 7, while unaided data were collected on day 14. The record does not state how the repeated Baha 6 Max measurements were handled in the posted mean, or whether time-related changes were modeled. No carryover effect is established, but its assessment is not reported in the registry record.

The study was single-centre and enrolled 16 participants. The record does not report a detailed description of the analysis population, missing-data procedures, participant exclusions, or sensitivity analyses. It also does not report the original sample-size justification or full analysis plan. The planning illustrations based on observed effects are not a substitute for the original design calculation.

Secondary reporting is incomplete: the registry lists multiple outcomes, but numerical results are available for only some. The available secondary comparisons are unadjusted, and no multiplicity approach is reported. Preference was part of the stated purpose, but preference results are not reported in the registry record. The record also does not provide a clinical-importance threshold for the primary outcome or detailed safety follow-up information.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Home Test of New Sound Processor — NCT04559282.
• Registry record last updated 2021-11-22; status last verified 2020-12.
• Results first posted 2021-11-22.
• 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.

22. Record Summary

The registry record describes a completed, prospective, single-centre randomized test-order crossover study of a new Sound Processor, identified in the posted results as Baha 6 Max, compared with Baha 5 and unaided hearing. Enrollment was 16. The primary outcome was adaptive speech-in-noise performance, measured as mean dB SNR at the 50% understanding level.

The posted primary means were -3.7 for Baha 6 Max and 4.8 for unaided hearing. The unadjusted recalculated mean difference was 8.5, with a 95% confidence interval from 5.019 to 11.98 and p <0.001. Secondary results cover several performance and rating measures, but numerical results are not reported for every listed outcome. No adverse events or deaths were reported in the listed groups.

The registry record does not report the detailed analysis plan, missing-data procedures, multiplicity approach, clinical-importance threshold, or the sponsor’s full crossover analysis.