N/A
Completed N=20
Investigating Hearing With the Ponto 4, a Bone Anchored Hearing Aid
Hearing Loss, Conductive · Hearing Loss, Mixed
Source: ClinicalTrials.gov NCT04761926 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcomePrimary: To Investigate the Improvement in Hearing With the Ponto 4 (s) on the Implanted Ear for Patients Within Intended Use. — 31.5 [dB]
Summary
The study is a combined retrospective (fitting visit) and prospective (study visit), multi-center, single arm study The study is part of the Post Market Clinical Follow (PMCF) activity. The investigational device used in this study is the Ponto 4 already fitted to the subjects prior to the study. The device is CE marked and available on the market since June 2019.
Treatment is not provided in the study therefore risks are limited to the audiological measurements. The audiological measurements in the study are standard non-invasive measurements already familiar to the clinics.
The hearing with Ponto 4 will be evaluated via speech and hearing tests, and patient reported outcomes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Investigate the Improvement in Hearing With the Ponto 4 (s) on the Implanted Ear for Patients Within Intended Use. |
31.5 | — |
| SECONDARY B. To Assess the Improvement of Hearing With the Ponto 4 on the Implanted Ear(s). |
14.2; 28.7; 36.6; 28.6; 32.9; 32.8 | — |
| SECONDARY C. To Assess the Improvement of Speech Recognition With Ponto 4 on the Implanted Ear(s). |
55.9 | — |
| SECONDARY G. To Assess the Degree to Which the Ponto 4 Compensates for the BC Hearing Loss on the Implanted Ear(s). |
22.0; 7.14; 3.21; 2.86; 10.20; 13.8 | — |
| SECONDARY H. To Evaluate the Above Objectives on Individual Levels |
100; 100; 100 | — |
| SECONDARY I. To Assess the Degree of Inner Ear Hearing Loss Degradation on the Implanted Ear(s) (for SSD the Stimulated Ear). |
0.114; 1.75 | — |
| SECONDARY J. To Assess if a Patient's With CHL/MHL Hearing Loss Has Degraded to Being Outside Fitting Range on the Implanted Ear(s). |
— | — |
| SECONDARY K. To Asses if Patients' With CHL/MHL Air to Bone Gap (PTA4) Has Increased/Decreased on the Implanted Ear(s) |
45.8; 50.2 | — |
Eligibility Criteria
Inclusion Criteria
- Signed Informed Consent Form
- 12 years old and above
- Subjects with hearing loss fitted unilaterally or bilaterally with the Ponto 4(s) on abutment at least 1.5 months prior to being enrolled in the study
- Fluent in local language, as judged by the investigator
Exclusion Criteria
- Participation in another clinical investigation which might cause interference with study participation.
- Subjects who do not have the ability or are un-willing to follow investigational procedures/requirements, e.g. to complete patient related outcome (PRO's) according to investigators discretion
Data sourced from ClinicalTrials.gov (NCT04761926). 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.