N/A
Completed N=57
Investigating Hearing With Ponto 3 SuperPower, a Bone Anchored Hearing Aid - Investigating Hear
Hearing Loss, Conductive · Hearing Loss Mixed · Hearing Disability · Conductive Hearing Loss
Source: ClinicalTrials.gov NCT04803279 ↗
Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: 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). — 70.2; 64.2; 35.6; 35.2 dB
Summary
The study is part of the Post Market Clinical Follow (PMCF) activity. The investigational device is the CE-marked Ponto 3 SuperPower (available on the market since December 2016) already fitted to the subjects, and data is collected retrospectively from clinical routine visits.
The study is a retrospective study. Therefore there will be no study visits for treatment or follow-up in the study.
Subject inclusion for this clinical investigation will be performed among subjects who has been fitted with the Ponto 3 SuperPower. To have a wide representative selection of subjects, enrollment will be spread over the 4 years since the device was available on the market since December 2016.
The endpoints in the study will investigate the improvement of hearing with the Ponto 3 SuperPower.
The data will be collected from the subjects in the time period from the clinical routine visit where the Ponto 3 SuperPower where fitted or just prior, and from the clinical routine visit following the fitting, where audiologic fitting follow-up procedures are performed (approximately 3 months).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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). |
70.2; 64.2; 35.6; 35.2; 36.0; 31.9 | — |
| SECONDARY Functional Gain With the Ponto 3 SuperPower for Patients With CHL/MHL. |
38.3; 35.0; 37.4; 35.7; 31.7; 26.4 | — |
| SECONDARY Improvement of Speech Recognition in Quiet and in Noise With Ponto 3 SuperPower for Patients With CHL/MHL |
73.5; 66.5; 88.6; 91.5; 67.6; 59.0 | — |
| SECONDARY Speech Recognition in Noise Improvements With Ponto 3 SuperPower on for Patients With SSD |
60.0; 36.7; 30.0; 80.0; 91.3; 5.40 | — |
| SECONDARY Degree of Compensation for Hearing Loss on the Implanted Ear(s) With the Ponto 3 SuperPower for Patients With CHL/MHL. |
-0.22; -0.36; 4.09; 5.71; -2.42; -2.14 | — |
| SECONDARY Quality of Life Improvements With the Ponto 3 SuperPower |
53.9; 56.4; 41.9 | — |
| SECONDARY Individual Level Evaluation of Objectives 1-6; Improved Hearing |
33; 7; 1 | — |
| SECONDARY Air to Bone Gap (PTA3) on the Implanted Ear(s) for Patients With CHL/MHL |
33.6; 21.7; 37.7; 25.0; 37.4; 30.0 | — |
| SECONDARY Skin Condition Assessment Around the Abutment |
35; 15; 2; 1; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who have consented to Section 3 of the document: "GDPR - what this means to you" (Appendix A) as part of a clinical routine visit.
- Fitted unilaterally or bilaterally with the Ponto 3 SuperPower(s) on abutment(s)
- Adult subjects (18 years or older)
- Patient has attended a clinical routine visit where fitting of Ponto 3 SuperPower has been performed and at least one following clinical routine visit where audiological measurements has been performed
Exclusion Criteria
There are no exclusion criteria in this study due to the retrospective nature of the study.
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Data sourced from ClinicalTrials.gov (NCT04803279). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.