This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Investigating Hearing With Ponto 3 SuperPower, a Bone Anchored Hearing Aid - Investigating Hear (NCT04803279), a registered phase not stated study. The primary outcome is Change in Functional Gain Thresholds: Unaided Air Conduction (AC) Thresholds Compared to Aided Bone Conduction (BC) Thresholds, in Ponto 3 SuperPower Users With Conductive Hearing Loss (CHL) and/or Mixed Hearing Loss (MHL)..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04803279 |
| Phase | Phase not stated |
| Condition | Hearing Loss, Conductive, Hearing Loss Mixed, Hearing Disability |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 57 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Oticon Medical |
| Results posted | Yes |
2. Clinical Question
Population
People fitted with Ponto 3 SuperPower who had conductive hearing loss (CHL) and/or mixed hearing loss (MHL) were the population for the primary endpoint. The registry also describes users fitted unilaterally or bilaterally on an abutment. The primary measurement is not applicable to the target population with single-sided deafness (SSD).
Intervention
The device of interest is the CE-marked Ponto 3 SuperPower bone anchored hearing aid. Participants were already fitted with the device as part of clinical routine. The study collected audiologic and other information from routine records rather than assigning a new treatment.
Comparator
The primary endpoint contrasts unaided air-conduction thresholds with aided bone-conduction thresholds. This is a within-participant comparison of measurements under different hearing conditions, not a randomized comparison between treatment groups. A separate control group is not described in the registry record.
Primary question
At Visit 2, described as 3 months, what functional gain was observed by comparing average unaided thresholds with average aided thresholds among Ponto 3 SuperPower users with CHL and/or MHL? The registry record defines the measurement but does not report the observed functional gain, its variability, or an analysis of the comparison.
3. Trial Design
This completed study was a retrospective post-market clinical follow-up activity sponsored by Oticon Medical. It enrolled 57 participants and used information from clinical routine visits; the study description says there were no study visits for treatment or follow-up. Participants had already been fitted with the Ponto 3 SuperPower, a device described as CE-marked and available on the market since December 2016.
The registry describes collecting data from the routine visit at or just before fitting and from the following clinical routine visit, when audiologic fitting follow-up procedures were performed. The latter is described as approximately 3 months after fitting, and the primary endpoint timeframe is Visit 2, 3 months. Enrollment was intended to include users fitted across the 4 years since the device became available. The study start is listed as 2021-03-16, primary completion as 2021-06-08, and status as completed.
This is not described as a randomized controlled trial. The registry record does not state an allocation method, and it does not describe a separate control arm. The primary comparison uses unaided and aided threshold measurements, rather than comparing assigned groups. As the observations came from routine care and the device was already in use, the design is descriptive and retrospective; it does not by itself isolate the device's effect from other influences on measured hearing.
The listed data collection includes pure-tone thresholds, bone-conduction in-situ thresholds, aided sound-field thresholds, speech intelligibility, skin reaction, Glasgow Benefit Inventory, and power-on usage time. The registry lists several additional hearing, speech, quality-of-life, and skin-related outcomes. It does not report a detailed statistical analysis plan, a sample-size justification, or the rules used to select records for each analysis.
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.
Before assignment: Target population 1 - Conductive/Mixed Hearing Loss (CHL/MHL) within indication Target population 1 - Bilaterally fitted CHL/MHL within indication Target population 2 - Single Sided Deafness (SSD) within indication Participants were assigned into groups based on type of hearing loss (not by ears or any other unit).
Overall Study
| Stage | Target Population 1 - CHL/MHL | Target Population 2 - CHL/MHL Bilateral | Target Population 3 - SSD |
|---|---|---|---|
| STARTED | 46 | 8 | 3 |
| COMPLETED | 46 | 8 | 3 |
| NOT COMPLETED | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Measurement not applicable for Target Population 3 - SSD
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.
| Characteristic | Unit | Target Population 1 - CHL/MHL | Target Population 2 - Bilateral | Target Population 3 - SSD | Total |
|---|---|---|---|---|---|
| Participants analysed | 46 | 8 | 3 | 57 | |
| Age, Continuous | years | 59.5 (SD 16.4) | 63.5 (SD 15.6) | 57.7 (SD 4.7) | 60.6 (SD 15.6) |
| Sex: Female, Male: Female | Participants | 30 | 7 | 1 | 38 |
| Sex: Female, Male: Male | Participants | 16 | 1 | 2 | 19 |
| Race and Ethnicity Not Collected | Participants | — | — | — | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Functional Gain Thresholds: Unaided Air Conduction (AC) Thresholds Compared to Aided Bone Conduction (BC) Thresholds, in Ponto 3 SuperPower Users With Conductive Hearing Loss (CHL) and/or Mixed Hearing Loss (MHL)., measured over Visit 2, 3 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | dB |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is titled as a change in functional gain thresholds. Functional gain is defined as the difference between the average unaided air-conduction threshold and the average aided bone-conduction threshold, with each average taken across 500, 1000, 2000 and 4000 Hz. The measurement is expressed in dB and is reported as a mean with standard deviation. For bilaterally fitted participants, the best ear is selected.
This endpoint is used to describe the contrast between hearing thresholds without the device and thresholds with the Ponto 3 SuperPower. A paired contrast can characterize the measured difference within participants rather than relying on a comparison of unrelated groups. The registry identifies the relevant follow-up as Visit 2, 3 months. It also states that the measurement does not apply to Target Population 3, SSD.
The definition explains what is measured, but the registry record does not give the observed mean functional gain, its standard deviation, the number of participants with endpoint data, or an interval estimate. It therefore supports an explanation of the endpoint but not a conclusion about the size or precision of the observed contrast.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a clinically routine, retrospective comparison of unaided and aided hearing thresholds in users with CHL and/or MHL. The primary outcome is a continuous measurement of functional gain in dB, defined using threshold averages at 500, 1000, 2000 and 4000 Hz. The primary time point is Visit 2, 3 months. These details identify the question and measurement, but they do not reveal the numerical answer.
No primary endpoint result is reported in the registry record. The record does not provide the mean functional gain, its standard deviation, a confidence interval, or a p-value. It also reports 0 analyses. As a result, neither the magnitude of the measured contrast nor its statistical precision can be assessed from the registry information. A result cannot be inferred from the study title, completion status, or list of intended outcomes.
The design also affects what a measured difference would mean. The comparison is between unaided and aided measurements in people already fitted with the device, and no randomized control group is described. Such a contrast can describe differences in the recorded threshold conditions, but it does not alone establish that the device caused every difference. The retrospective use of clinical routine visits can also mean that the availability and completeness of measurements vary across participants; the extent of such variation is not reported.
The registry lists additional outcomes, including speech recognition, quality of life, air-to-bone gap, skin condition, and individual-level evaluation. It does not report results for these outcomes either. Without outcome estimates, variability, analysis populations, and the handling of missing observations, readers cannot judge consistency across outcome types or how representative the analyzed records might be of all 57 enrolled participants.
Accordingly, the posted information is best read as a description of a completed post-market study and its planned outcome definitions, not as a report of evidence for the size or reliability of a hearing change. A confidence interval, if reported, would help show the range of effects compatible with the data; a single mean would not communicate that precision by itself. No interval estimate is reported in the registry record.
9. Statistical Methods Explained
The primary measure is continuous: it records threshold differences on a dB scale. The registry specifies a mean and standard deviation as the summary form. A mean describes the average measured functional gain in the analyzed observations. A standard deviation describes how spread out individual observations are around that mean; it is not the same as the uncertainty in the mean. The registry record does not report either numerical summary for the primary endpoint.
What does the endpoint compare?
The endpoint takes average unaided air-conduction thresholds and compares them with average aided bone-conduction thresholds. Each average covers 500, 1000, 2000 and 4000 Hz. The registry calls this functional gain and describes the primary outcome as a change in thresholds. For participants fitted bilaterally, the best ear is selected. The record does not further explain how the best ear was selected or how any ties or unavailable measurements were handled.
Because the two threshold conditions are recorded for users of the device, the conceptual comparison is paired within individuals, rather than a comparison of two independently assigned groups. A paired analysis can account for the fact that measurements from the same participant are related. The specific statistical test or model used for the primary comparison is not reported in the registry record, so it is not possible to confirm whether a paired method was used in the sponsor's analysis.
How should uncertainty be understood?
In general, a confidence interval describes a range of values compatible with the observed data under the assumptions of the analysis. It gives information about precision that a point estimate alone cannot convey. A narrow interval indicates greater precision than a wide interval, all else being equal. This general interpretation does not supply an estimate for this study: no confidence interval or primary endpoint estimate is reported in the registry record.
In general, statistical significance and practical importance are different questions. A p-value, when reported, summarizes how compatible the data are with a specified null hypothesis under a statistical model; it does not measure the size or importance of an effect. The registry provides no p-value or hypothesis test result for the primary endpoint. It also does not report a prespecified clinically meaningful threshold for interpreting functional gain.
What do the planning calculations represent?
Planning illustrations are not observed study outcomes and should not be read as observed power. In general, sample-size calculations depend on the effect being targeted, variability assumptions, significance level, allocation, and analysis method. The listed illustration assumptions use a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. The registry record does not report the trial's own sample-size justification or establish that its retrospective, single-group data collection followed this two-arm planning setup. Those illustrations do not establish that the study had a particular probability of detecting an effect.
Over-dispersion is a concern mainly when a statistical model assumes less variability than the data contain; in general, excess variability can make standard errors and tests unreliable if not accommodated. The primary endpoint is continuous, and the registry does not report a model or evidence of over-dispersion. It would therefore be inappropriate to claim that over-dispersion was present or that a particular correction was used.
What analysis details are unavailable?
The registry record does not report the primary analysis method, covariate adjustment, assumptions checking, handling of outliers, or rules for incomplete measurements. It also does not report an analysis population or the number with data at Visit 2. Those details matter because retrospective records can be incomplete and because results may depend on which observations enter an analysis. The registry lists 57 enrolled participants, but enrollment alone does not show how many contributed to each endpoint.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary endpoint and several additional outcomes, covering functional gain, speech recognition in quiet and noise, compensation for hearing loss, quality of life, individual-level evaluation, air-to-bone gap, and skin condition. It does not report how many hypotheses were formally tested, whether outcomes were organized into a testing hierarchy, or whether any adjustment for multiple comparisons was planned. When several outcomes are examined, the chance of finding at least one apparently notable result can increase; in general, a prespecified hierarchy or multiplicity adjustment can help control that risk. No such procedure is reported in the registry record.
The record reports 0 analyses and gives no numerical outcome results. It therefore does not identify which outcomes were analyzed or whether any planned outcome was omitted. The registry does not report missing-data rates, reasons for missingness, imputation methods, or sensitivity analyses. It also does not state whether all enrolled participants were included in each outcome analysis or define analysis populations beyond describing the target populations.
These omissions limit interpretation even if results are available elsewhere: the number of participants contributing to an endpoint, the handling of incomplete routine records, and the multiplicity approach affect how estimates and uncertainty should be read. The enrollment of 57 participants cannot be assumed to be the denominator for every outcome. Missing-data handling, analysis populations, and multiplicity procedures are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| All Enrolled Participants | 0 | 57 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| All Enrolled Participants | 0 of 57 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| All Enrolled Participants | 0 of 57 |
The registry reports 57 participants at risk for serious adverse events and 0 participants affected by serious adverse events. It also reports 57 at risk for other adverse events and 0 affected. The reported death count is 0, and no top serious adverse-event terms are listed. These figures describe what is recorded in the registry for the enrolled group; they do not establish that every possible adverse event was systematically assessed or captured.
A zero count means no events of that category were reported in the registry record. It is not proof that an event could never occur, nor does it show that there was no risk outside the recorded observation. The record does not give detailed safety ascertainment methods, event definitions, observation time for safety, or participant-level follow-up completeness. The study description says data were collected retrospectively from routine clinical visits and that there were no study visits for treatment or follow-up.
These safety counts should therefore be interpreted as registry reporting, not as a comparison of safety between groups. No separate control group is described, and no comparative safety analysis is reported.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a completed retrospective post-market study examined Ponto 3 SuperPower users and specified functional gain as its primary endpoint for participants with CHL and/or MHL. It defines the threshold conditions, frequencies, unit, follow-up time, and best-ear rule for bilateral fittings. It also reports enrollment of 57 participants and gives safety counts.
It does not report the primary endpoint estimate, standard deviation, confidence interval, or inferential analysis. Thus, the record cannot quantify the functional gain observed in the study or the precision of that estimate. It cannot establish whether an observed difference was statistically distinguishable from no difference, because no test result is reported. Nor does it provide enough information to assess whether the measurement differences were clinically important.
Even if a within-participant threshold contrast were available, this retrospective routine-care design would describe the observed contrast rather than prove that the device alone caused it. There is no randomized control group described, and the registry does not report adjustments for other factors or detailed rules for selecting available observations.
The additional outcome list indicates a broad set of hearing, speech, quality-of-life, and skin-related measures, but the registry does not report their results. Likewise, zero recorded adverse events should be understood as a registry count, not as proof of absence of risk. The meaningful conclusion from this record is therefore about the study's design and measurement scope, not the magnitude, consistency, or causal interpretation of outcomes.
13. Why This Trial Matters Statistically
This study is statistically notable for using retrospective clinical routine data to describe a device already used in practice. Such designs can provide information based on routine fitting and follow-up procedures, but interpretation depends on the completeness and comparability of those records. The registry identifies the relevant measurement occasions and defines a functional-gain endpoint, allowing readers to understand what was intended to be measured even though numerical results are not reported.
The endpoint combines thresholds across 500, 1000, 2000 and 4000 Hz and contrasts unaided air-conduction with aided bone-conduction measurements. That definition matters: a result would pertain to this specified average and comparison, not automatically to every aspect of hearing or to every listed outcome. The best-ear rule for bilateral fittings also identifies a choice in how participants' measurements are represented.
At the same time, the absence of reported analyses is consequential. Without an estimate and its uncertainty, readers cannot judge how much individual observations varied or how precisely the average contrast was estimated. Without analysis-population and missing-data details, enrollment cannot be equated with the number contributing to each outcome. The lack of a described control group also limits causal interpretation.
Finally, the range of listed outcomes raises questions about prespecification and multiplicity, but the registry record does not document how those issues were addressed. The record is useful for understanding the intended clinical question and data-collection context; it is not a complete statistical results report.
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 main limitation for statistical interpretation is that the registry record reports no primary endpoint estimate or analysis. The mean and standard deviation are specified as the intended summary, but their values are absent, as are confidence intervals and p-values. The record reports 0 analyses. Consequently, the magnitude, variability, and precision of the primary comparison cannot be evaluated.
The design is retrospective and based on clinical routine visits. The registry does not report how records were selected, how many participants had complete data at each visit, or how missing threshold measurements were handled. Although enrollment is 57, the number contributing to the primary endpoint or other outcomes is not reported. The registry also does not give an analysis population definition or sensitivity analyses.
No randomized control group or allocation method is described. The primary contrast is between unaided and aided threshold conditions, so any observed difference would need to be interpreted in light of the observational design. The record does not report adjustment for other factors, the detailed statistical method, or a clinically meaningful threshold for interpreting the endpoint.
The registry names multiple additional outcomes but does not report how multiplicity was handled or whether every listed outcome was analyzed. The sample-size justification and the study's own statistical plan are not reported in the registry record. Safety ascertainment details and the completeness of adverse-event follow-up are also not described. These limitations are specific to the information recorded and prevent a fuller assessment of the study's estimates and their reliability.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Investigating Hearing With Ponto 3 SuperPower, a Bone Anchored Hearing Aid - Investigating Hear — NCT04803279.
- Registry record last updated 2025-08-26; status last verified 2025-08.
- Results first posted 2025-08-26.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT04803279 is a completed, retrospective post-market clinical follow-up study sponsored by Oticon Medical. It enrolled 57 Ponto 3 SuperPower users and collected information from clinical routine visits rather than adding study visits for treatment or follow-up.
The primary outcome concerns functional gain in users with CHL and/or MHL, comparing unaided air-conduction and aided bone-conduction threshold averages at Visit 2, 3 months. The registry defines the measurement but reports no numerical endpoint results and 0 analyses. Additional outcomes include speech, quality-of-life, hearing, and skin measures, with no results reported in the registry record. The listed serious and other adverse-event counts are 0 affected participants, with 57 at risk for each category.