Osia CPT Code Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Osia CPT Code Study (NCT04320407), a na na study. The primary outcome is Change From Baseline in Adaptive Speech in Noise Test Score for Osia 2 System at 3 Months Post-surgery.

2. Clinical Question

The question is therefore about a before-and-after score in participants using the Osia 2 System, rather than an estimate of how the system compares with an untreated or alternative-treatment group. The study is identified as interventional and post-market, and its stated aim is to evaluate clinical efficacy in a US cohort. The registry also names device- or procedure-related adverse events as a secondary outcome. The posted safety figures describe serious and other adverse events, but do not specify which, if any, were device- or procedure-related. This distinction limits what can be concluded from the record about the primary question and safety attribution.

3. Trial Design

The registry identifies NCT04320407, titled “Osia CPT Code Study,” as a completed post-market interventional cohort study. Its official title describes an evaluation of the clinical efficacy of the Osia 2 System in the US market. The study began on 2020-09-30, had a primary completion date of 2021-10-05, and lists enrollment of 20. The phase is recorded as NA.

The design is single-group, with no separate control arm. Allocation is recorded as NA, and masking as NONE. The arm is named Osia 2 System and is described as the Osia 2 Active Osseointegrated Implant System for Bone Conduction. The listed conditions are conductive hearing loss and mixed hearing loss. These design details identify the population and intervention, but they do not establish what would have happened to the same participants over the same period without the intervention.

The primary outcome is a mean continuous score: change from baseline in adaptive speech-in-noise test score at 3 months post-surgery. The assessment uses the Quick SIN test preoperatively and at 3 months after surgery, with the preoperative unaided score subtracted from the aided score at 3 months. A secondary outcome is the number of device- or procedure-related adverse events. The registry lists two outcome measures, but does not provide numerical primary outcome results or a detailed analysis plan.

These features make the study descriptive of change over time within the enrolled cohort. A before-and-after comparison can characterize observed scores in participants who were assessed at both time points, but without a concurrent comparison group it cannot isolate the intervention’s contribution from other explanations for change. The registry record does not report further details about participant selection, follow-up completion, or the conduct of outcome assessments.

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

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 Change From Baseline in Adaptive Speech in Noise Test Score for Osia 2 System at 3 Months Post-surgery, measured over Preoperative, 3 months post-surgery.

The primary endpoint is change from baseline in the adaptive speech-in-noise test score for the Osia 2 System at 3 months post-surgery. It is a continuous measure reported as a mean with standard deviation. The registry describes assessment using the Quick SIN test before surgery and at 3 months afterward. It defines the change as the mean unaided preoperative score subtracted from the aided score at 3 months. The record states that a lower score indicates better performance.

The Quick SIN test assesses speech recognition in background noise. In the registry description, its score ranges from +25.5 dB SNR to -5 dB SNR. Participants are tested on four lists, each containing six sentences with five key words per sentence. The sentences are presented at signal-to-noise ratios that decrease manually in 5-dB steps from 25 to 0. Key words are scored as correct or incorrect, and the best possible score is -5 dB SNR, when all key words are repeated correctly as a function of the SNR.

General: a continuous score can capture the amount and direction of change rather than sorting participants into a small set of outcome categories. A mean describes the average score, while a standard deviation describes how dispersed individual scores are around that average. Here, however, the registry record supplies the measurement definition but not the observed mean change, its standard deviation, or an uncertainty interval. The endpoint’s intended clinical interpretation is therefore clear, but the magnitude and precision of the observed change cannot be assessed from the reported result information.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes the primary outcome as a mean of a continuous measure with standard deviation. It identifies the outcome as change from baseline in an adaptive speech-in-noise score, measured preoperatively and at 3 months post-surgery. The endpoint description specifies how the preoperative unaided and postoperative aided scores are contrasted. It does not specify the statistical procedure used to estimate the mean change, handle incomplete measurements, or calculate uncertainty. Those details are not reported in the registry record.

What does a mean change represent?

General: for a continuous outcome, a mean change summarizes the average within-participant difference between measurements. It can describe the cohort’s overall pattern while concealing variation between participants. A standard deviation describes the spread of individual observations around the mean; it is not the same as the uncertainty in the mean. The registry identifies standard deviation as the dispersion measure, but does not report its value or the observed mean change. Thus, the endpoint’s statistical summary format is stated, while its numerical result is not.

The direction of change needs to be read in light of the score definition. The registry states that lower Quick SIN scores indicate better performance and defines the change by subtracting the preoperative unaided score from the aided score at 3 months. A numerical estimate would need to be interpreted using both details. Since the estimate is not reported, it is not possible to say whether the observed change was toward better or worse performance, or to quantify its size.

How should uncertainty be understood?

General: an uncertainty interval communicates the range of values that remain reasonably compatible with the observed data under a specified statistical model. It helps distinguish a relatively precise estimate from one with substantial uncertainty. A p-value, when used, addresses how compatible the observed data are with a specified null hypothesis under the analysis assumptions; it does not measure the size or clinical importance of an effect. The registry record does not report a confidence interval or p-value for the primary endpoint. It also does not report an inferential analysis for that endpoint, so no statistical significance statement can be assessed.

The study’s single-group structure matters to interpretation regardless of the analytic method. A within-participant comparison uses measurements from the same enrolled cohort at different times. It can describe temporal change, but without a concurrent control group it cannot establish how much of that change is attributable to the intervention rather than to other time-related influences. Statistical adjustment cannot by itself create the missing randomized comparison. No adjusted analysis is reported in the registry record.

What do the planning assumptions say?

The registry’s planning-assumption description refers to an illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. The accompanying description distinguishes total events for time-to-event calculations from participants per arm for other calculations. These are planning conventions, not results from a randomized comparison in this single-group study. Numerical planning estimates and a sample-size justification for the trial are not reported in the registry record. Such illustrations should not be read as observed power or as evidence that a particular effect was detected.

General: normal-approximation planning methods rely on assumptions about the sampling distribution of the estimate. The adequacy of an approximation depends on the outcome, design, and data. For event counts, over-dispersion means that observed variability exceeds what a simple count model assumes; accounting for it can affect uncertainty and planning. The record does not describe an over-dispersion adjustment or a count model for adverse events. This general point does not imply that over-dispersion was present in this study.

What analysis details remain unclear?

The registry reports no listed analyses. It does not state a statistical model, analysis population, approach to missing outcome measurements, covariate adjustment, or handling of multiple outcomes. It also does not provide the primary endpoint’s numerical estimate or its dispersion. These omissions mean that readers cannot reproduce an analysis or assess whether a particular modeling choice was appropriate. The endpoint and design can still be described, but inferential claims require reported estimates and sufficient methods detail. No additional statistical procedure should be assumed from the outcome format or from the planning 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("Osia 2 System")
n   <- c(20)
m   <- c(6.1)
sp  <- c(6.9)
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  Osia 2 System  20  6.100  6.900  2.871  9.329

11. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures: the primary change in adaptive speech-in-noise score and a secondary outcome concerning device- or procedure-related adverse events. It does not report a multiplicity strategy, such as a testing hierarchy or adjustment across outcomes. The record also lists no analyses. Therefore, it is not possible to determine whether any formal hypothesis tests were planned or how multiple comparisons would have been addressed. This absence should not be interpreted as proof that no such plan existed outside the registry record.

The primary outcome is a continuous mean score, while the secondary outcome concerns adverse events. These outcomes have different measurement forms and purposes. General: when multiple outcomes or comparisons are tested, the chance of finding an apparently notable result by chance can increase if the analysis does not account for multiplicity. A prespecified testing strategy can clarify which result is primary and how secondary findings should be interpreted. The registry does not provide that strategy or numerical efficacy results, so multiplicity-adjusted interpretation is unavailable.

The record does not report whether all enrolled participants completed both speech-in-noise assessments, how missing measurements were handled, or which participants were included in any primary analysis. The enrollment count alone does not establish that all participants contributed paired outcome data. The analysis population and missing-data methods are not reported in the registry record. General: missingness can affect an estimate when the participants with observed outcomes differ in relevant ways from those without observed outcomes; the direction and extent of any such effect depend on the data and missingness process.

These gaps limit assessment of selection into the analysis, the impact of incomplete follow-up, and the robustness of any result. They do not establish that data were missing or that an analysis was biased. Without an analysis population, completion information, and methods for handling missing values, readers cannot determine how the endpoint estimate would relate to all enrolled participants.

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 5% reporting threshold.

Most frequent non-serious adverse event terms

The posted safety figures list 20 participants at risk for serious adverse events and zero participants affected. The record lists no serious-event terms. For other adverse events, it lists 20 participants at risk and seven affected. Deaths are listed as zero. These are the recorded counts; the registry does not give additional event descriptions in the serious-event terms list.

The secondary outcome is described as the number of device- or procedure-related adverse events, but the figures do not identify whether the seven participants with other adverse events had events considered related to the device or procedure. They should therefore be read as the reported other-adverse-event count, not as a count of confirmed device- or procedure-related events. The record also does not report event timing, severity details for the other events, or participant-level information.

General: an observed count of zero serious events in a cohort does not establish that the underlying risk is zero. Counts are descriptive and need to be interpreted in relation to the number and duration of participants observed, the event definitions, and completeness of follow-up. The registry does not provide enough detail about those elements to characterize the precision of the safety estimates. These figures describe what is posted and do not establish a comparative safety profile.

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

The registry record establishes that a completed, single-group post-market study enrolled 20 participants with conductive or mixed hearing loss and evaluated the Osia 2 System. It defines a primary outcome based on preoperative unaided and 3-month aided Quick SIN scores, and it states that lower scores indicate better performance. These elements tell readers what was intended to be measured and the time point used.

The primary outcome result itself is not reported in the registry record. There is no numerical mean change, standard deviation, confidence interval, or p-value in the listed information. As a result, the direction, magnitude, and statistical precision of the observed score change cannot be described. The endpoint definition is not evidence of an improvement, and the study’s stated objective is not a result.

The single-group design also defines what the study can establish. A before-and-after score contrast can describe change within participants who were assessed at both times, but it does not provide a concurrent estimate of change without the intervention. Other influences on scores over time cannot be ruled out by the design alone. This does not mean that any specific alternative explanation occurred; it means that the registry does not report a control comparison that could help distinguish among explanations.

The safety record reports zero participants affected by serious adverse events, seven affected by other adverse events, and zero deaths, among the stated at-risk groups of 20. The record does not establish that the other adverse events were related to the device or procedure. These counts are descriptive and do not by themselves quantify comparative risk or its precision.

In sum, the posted information supports understanding the study structure, the endpoint definition, and the recorded safety counts. It does not support a quantitative claim about efficacy, a causal estimate, or a conclusion that the system does or does not work. Such claims would require outcome estimates and sufficient analysis and follow-up information, which are not reported in the registry record.

14. Why This Trial Matters Statistically

Statistically, the study is useful to examine because it pairs a clearly described continuous endpoint with a design that has important interpretive limits. The Quick SIN outcome is defined in enough detail to understand the test, assessment timing, score direction, and contrast between the unaided preoperative and aided 3-month measurements. That clarity helps define what an eventual estimate would mean.

The study is single-group and has no separate control arm. This distinction matters because a within-cohort change is not the same estimand as a difference between intervention and control groups. The registry’s design can describe the observed course among enrolled participants, but cannot by itself separate intervention-related change from other changes over time. Recognizing that boundary is essential when reading any before-and-after study.

The record also highlights the difference between an outcome being specified and a result being reported. Although the primary endpoint, its dispersion measure, and its timeframe are named, no numerical primary outcome analysis is listed. The absence of an estimate and uncertainty measure prevents assessment of size and precision. Similarly, the listed adverse-event counts are informative as descriptive safety data, but lack attribution details and a comparative group.

Finally, the registry’s planning assumptions are not a substitute for results or a documented trial design justification. The planning description refers to a two-arm illustration, while the trial itself is listed as single-group. Keeping planning illustrations separate from observed analyses prevents sample-size calculations from being mistaken for evidence of effect or observed power. The statistical value of this record lies in making those distinctions visible and in identifying what additional outcome and methods information would be needed for a fuller assessment.

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.

Several limitations specific to this record affect interpretation. The study is listed as single-group, with no concurrent control arm. Its primary endpoint compares a preoperative unaided measurement with an aided measurement at 3 months post-surgery, so changes over time cannot be attributed uniquely to the intervention on the basis of this design. Allocation is recorded as NA and masking as NONE; the record does not provide further details about outcome assessment procedures.

The enrollment is 20, and the record does not report the number of participants with completed measurements at both time points. It does not describe the analysis population or the handling of missing values. Consequently, it is unclear from the registry whether the primary endpoint would represent all enrolled participants or a subset with available measurements.

The primary outcome description is detailed, but its numerical result is absent. No mean change, standard deviation, confidence interval, or p-value is reported, and no analysis is listed. This prevents evaluation of the observed effect’s magnitude, direction, and precision. The record also does not report a statistical analysis plan, model, sample-size justification, or multiplicity approach.

The secondary outcome is named as device- or procedure-related adverse events, but the posted counts do not specify relatedness for the seven participants with other adverse events. There are no serious-event terms listed. Further details about event definitions, timing, duration of safety observation, and follow-up completeness are not reported in the registry record. The listed figures therefore provide a limited descriptive account rather than a complete basis for estimating or comparing risk.

These limitations reflect information and design features recorded for this study. They do not establish that unreported procedures were not conducted or that unreported events occurred. They do mean that stronger conclusions would require details beyond those included in the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Osia CPT Code Study — NCT04320407.
• Registry record last updated 2022-11-25; status last verified 2022-09.
• Results first posted 2022-11-25.
• 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

NCT04320407 is a completed, single-group post-market interventional cohort study of the Osia 2 System in a US cohort. The record lists 20 enrolled participants with conductive or mixed hearing loss. The study began on 2020-09-30 and reached primary completion on 2021-10-05.

The primary endpoint is change in adaptive speech-in-noise Quick SIN score from preoperative unaided assessment to aided assessment at 3 months post-surgery. Lower scores indicate better performance. The record does not report the numerical primary outcome result or an analysis.

The secondary outcome concerns device- or procedure-related adverse events. Posted safety counts list zero participants affected by serious adverse events, seven affected by other adverse events, and zero deaths, with 20 at risk in each listed adverse-event group. The record does not specify whether the other adverse events were related to the device or procedure.