NCT04606823

Ponto Implantation Using a Minimally Invasive Surgical Technique

Completed NA Results posted Last updated 29 January 2026

What this trial tests

NA trial testing Minimally invasive surgery in Hearing Loss in 52 participants. Completed in 26 April 2023.

Timeline

4 November 2020

Primary endpoint
9 August 2022

26 April 2023

Quick facts

Lead sponsor	Oticon Medical
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	52
Start date	4 November 2020
Primary completion	9 August 2022
Estimated completion	26 April 2023
Sites	7 locations across Denmark, Netherlands, United Kingdom, Sweden

Drugs / interventions tested

• Minimally invasive surgery
• Glasgow Benefit Inventory (GBI)
• Additional follow-up visits after surgery

Conditions studied

• Hearing Loss — all drugs for Hearing Loss →

Sponsor

Oticon Medical

Who can join

18 and older, any sex, with Hearing Loss. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Implants With Reliable Anchorage for a Sound Processor Primary · 3 months after implant surgery

The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin overgrowth and pain preventing use of the sound processor. For a positive outcome of the primary endpoint (reliable anchorage), the implant should be in place and stable without any adverse skin reactions, skin overgrowth or pain preventing usage of the sound processor.

Group	Value	95% CI
Single-arm	49

Number of Implants With Reliable Anchorage for a Sound Processor Secondary · 12 months after implant surgery

The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin overgrowth and pain preventing use of the sound processor. For a positive outcome (reliable anchorage), the implant should be in place and stable without any adverse skin reactions, skin overgrowth or pain preventing usage of the sound processor.

Group	Value	95% CI
Single-arm	46

Implant Survival Secondary · 12 months after implant surgery

Implant survival will be assessed by the investigator by means of a Yes/No question: Implant in place \[Yes/No\]

Group	Value	95% CI
Single-arm	48

Implant Stability Secondary · 12 months after implant surgery

Clinical assessment of implant stability by the investigator by means of a Yes/No question: Implant stable \[Yes/No\]

Group	Value	95% CI
Single-arm	48

Holgers Score Distribution Secondary · 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits

Distribution of Holgers score ratings assigned by investigator across all study visits. The Holgers score is used to grade skin reactions around the skin-penetrating abutment on a scale from 0 to 4, where 0 indicates a reaction-free area whereas 4 indicates a severe infection often requiring removal of the implant. The results are presented based on Holgers score distribution across all study visits, as well as separate for each study visit and for unplanned visits.

All study visits : Holgers 0

Group	Value	95% CI
Single-arm	205

All study visits : Holgers 1

Group	Value	95% CI
Single-arm	53

All study visits : Holgers 2

Group	Value	95% CI
Single-arm	6

All study visits : Holgers 3

Group	Value	95% CI
Single-arm	1

All study visits : Holgers 4

Group	Value	95% CI
Single-arm	0

9 days : Holgers 0

Group	Value	95% CI
Single-arm	35

9 days : Holgers 1

Group	Value	95% CI
Single-arm	17

9 days : Holgers 2

Group	Value	95% CI
Single-arm	0

Max Holgers Score Secondary · 12 months after implant surgery

Max Holgers score rating per patient across study visits. The Holgers score is used to grade skin reactions around the skin-penetrating abutment on a scale from 0 to 4, where 0 indicates a reaction-free area whereas 4 indicates a severe infection often requiring removal of the implant.

Group	Value	95% CI
Single-arm	17
Single-arm	29
Single-arm	5
Single-arm	1

Mild/Adverse Skin Reaction Secondary · 12 months after implant surgery

Mild/Adverse skin reaction per patient across study visits, where adverse skin reaction is defined as Holgers ≥ 2 on at least one follow-up visit. The Holgers score is used to grade skin reactions around the skin-penetrating abutment on a scale from 0 to 4, where 0 indicates a reaction-free area whereas 4 indicates a severe infection often requiring removal of the implant.

No or minor skin reaction (Holgers 0-1)

Group	Value	95% CI
Single-arm	258

Adverse skin reaction (Holgers 2-4)

Group	Value	95% CI
Single-arm	7

IPS (Inflammation, Pain, Skin Height) Scores Secondary · 9 days, 5 weeks, 3-, 6- and 12 months after implant surgery, and unplanned visits

Distribution of IPS scores assigned by investigator across all study visits. The IPS scale is used to assess soft tissue status including inflammation (I), pain (P), and skin height (S) for a skin-penetrating implant, with scores ranging from 0 to 4 for the I-scale, and from 0 to 2 for the P- and S-scales. The IPS score is presented as \[Ix Px Sx\] with x being the individual score for each parameter. A higher score reflects a more severe complication. The results are presented based on IPS score distribution across all study visits, as well as separate for each study visit and unplanned visi

All study visits : I-score 0

Group	Value	95% CI
Single-arm	195

All study visits : I-score 1

Group	Value	95% CI
Single-arm	55

All study visits : I-score 2

Group	Value	95% CI
Single-arm	13

All study visits : I-score 3

Group	Value	95% CI
Single-arm	2

All study visits : I-score 4

Group	Value	95% CI
Single-arm	0

All study visits : P-score 0

Group	Value	95% CI
Single-arm	209

All study visits : P-score 1

Group	Value	95% CI
Single-arm	38

All study visits : P-score 2

Group	Value	95% CI
Single-arm	18

Wound Healing Secondary · 9 days, 5 weeks and 3 months after implant surgery, and unplanned visits

Investigator assessment of wound being completely healed by means of a Yes/No question. The results are presented for each study visit and for unplanned visits.

Group	Value	95% CI
Single-arm	37
Single-arm	15
Single-arm	45
Single-arm	4

Skin Overgrowth Secondary · 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits

Skin overgrowth over implant/abutment complex judged by the investigator by means of a Yes/No question. The results are presented for each study visit and for unplanned visits.

9 days : Yes

Group	Value	95% CI
Single-arm	0

9 days : No

Group	Value	95% CI
Single-arm	52

5 weeks : Yes

Group	Value	95% CI
Single-arm	0

5 weeks : No

Group	Value	95% CI
Single-arm	49

3 months : Yes

Group	Value	95% CI
Single-arm	0

3 months : No

Group	Value	95% CI
Single-arm	49

6 months : Yes

Group	Value	95% CI
Single-arm	0

6 months : No

Group	Value	95% CI
Single-arm	45

Post-operative Events Around Abutment Secondary · 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits

Assessment of post-operative events by investigator into five different categories: None, Bleeding and/or hematoma, Hair in-growth, Skin dehiscence around abutment, and Other. The results are presented based on post-operative event distribution across all study visits, as well as separate for each study visit and unplanned visits.

All study visits: None

Group	Value	95% CI
Single-arm	240

All study visits : Bleeding and/or hematoma

Group	Value	95% CI
Single-arm	3

All study visits : Hair in-growth

Group	Value	95% CI
Single-arm	1

All study visits : Skin dehiscence around abutment

Group	Value	95% CI
Single-arm	18

All study visits : Other

Group	Value	95% CI
Single-arm	7

9 days : None

Group	Value	95% CI
Single-arm	39

9 days : Bleeding and/or hematoma

Group	Value	95% CI
Single-arm	0

9 days : Hair in-growth

Group	Value	95% CI
Single-arm	0

Patient-perceived Presence of Pain Around Abutment Secondary · 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits

Assessment of presence of patient-perceived pain by means of a Yes/No question to the subject.

All study visits : No

Group	Value	95% CI
Single-arm	204

All study visits : Yes

Group	Value	95% CI
Single-arm	62

9 days : No

Group	Value	95% CI
Single-arm	31

9 days : Yes

Group	Value	95% CI
Single-arm	21

5 weeks : No

Group	Value	95% CI
Single-arm	39

5 weeks : Yes

Group	Value	95% CI
Single-arm	10

3 months : No

Group	Value	95% CI
Single-arm	36

3 months : Yes

Group	Value	95% CI
Single-arm	13

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Single-arm

Serious: 1/51 (2%)

Deaths: 0/51

Serious adverse events (1 terms)

Reaction	System	Single-arm
Pain (abdomen, back)	Nervous system disorders	—

Other adverse events (4 terms — click to expand)

Reaction	System	Single-arm
Pain	Nervous system disorders	—
Infection	Infections and infestations	—
Bleeding	Blood and lymphatic system disorders	—
Inflammation	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: Pain (abdomen, back).

Data from ClinicalTrials.gov NCT04606823 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.