N/A
Completed N=52
Ponto Implantation Using a Minimally Invasive Surgical Technique
Source: ClinicalTrials.gov NCT04606823 ↗Enrolled (actual)
52
Serious AEs
2.0%
Results posted
Jan 2026
Primary outcomePrimary: Number of Implants With Reliable Anchorage for a Sound Processor — 49 Implants
Summary
This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Sweden, Denmark and the Netherlands). In total, 50 adult patients with a hearing loss that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study.
The purpose of the study is to investigate the rate of successful BAHS use after implantation of the Ponto implant system using a minimally invasive surgical technique.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Implants With Reliable Anchorage for a Sound Processor |
46 | — |
| SECONDARY Number of Implants With Reliable Anchorage for a Sound Processor |
46 | — |
| SECONDARY Implant Survival |
48 | — |
| SECONDARY Implant Stability |
48 | — |
| SECONDARY Holgers Score Distribution |
205; 53; 6; 1; 0; 35 | — |
| SECONDARY Max Holgers Score |
17; 29; 5; 1; 0 | — |
| SECONDARY Mild/Adverse Skin Reaction |
258; 7 | — |
| SECONDARY IPS (Inflammation, Pain, Skin Height) Scores |
195; 55; 13; 2; 0; 209 | — |
| SECONDARY Wound Healing |
37; 15; 45; 4; 48; 1 | — |
| SECONDARY Skin Overgrowth |
0; 52; 0; 49; 0; 49 | — |
| SECONDARY Post-operative Events Around Abutment |
240; 3; 1; 18; 7; 39 | — |
| SECONDARY Patient-perceived Presence of Pain Around Abutment |
204; 62; 31; 21; 39; 10 | — |
| SECONDARY Patient-perceived Presence of Numbness Around Abutment |
254; 12; 48; 4; 46; 3 | — |
| SECONDARY Duration of Surgery |
10.0 | — |
| SECONDARY Sound Processor Usage |
13.0 | — |
| SECONDARY Subjective Benefit After Surgery |
26.8; 37.7; 9.1; 1.45 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Patient indicated for surgical intervention with a bone anchored hearing system
- Signed informed consent
- Adequate bone quality to allow for a Ponto implant insertion, as judged by the investigator, and an expected bone thickness above 5 mm, where no complications during surgery are expected
- Skin thickness of 12 mm or less at the implant site
Exclusion Criteria
- Patient undergoing re-implantation
- Patient who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales
- Known condition or previous treatment that could jeopardize skin condition and wound healing over time as judged by the investigator (e.g. uncontrolled diabetes, previous radiotherapy in the area of interest)
- Known medical condition that contraindicate surgery as judged by the investigator
- Known and/or planned pregnancy at time of surgery
- Any other known condition that the investigator determines could interfere with compliance or investigation assessments
- Simultaneous participation in another clinical investigation with pharmaceutical and/or medical device which might cause interference with investigation participation
Data sourced from ClinicalTrials.gov (NCT04606823). 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.