Hearing LossNCT04606823
Ponto Implantation Using a Minimally Invasive Surgical Technique
A study testing Minimally invasive surgery, Glasgow Benefit Inventory (GBI) and Additional follow-up visits after surgery in people with Hearing Loss, run by Oticon Medical at 7 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Minimally invasive surgery, Glasgow Benefit Inventory (GBI) and Additional follow-up visits after surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 4 Nov 2020to 26 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
United Kingdom3 sites
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2WB
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
Netherlands2 sites
Univerisity Medical Center Groningen
Groningen
Radboud University Medical Center
Nijmegen, 6525EX
About this study
Official title: Evaluation of Clinical Performance of Ponto Implantation Using a Minimally Invasive Surgical Technique - a Prospective Multicentre Study
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.
Read the detailed 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. The implant, coupled to a skin-penetrating abutment, is implanted in the bone behind the ear and is later loaded with a sound processor which transforms sound waves to sound vibrations that can be sent directly to the inner ear via the skull bone. The primary objective of this study is to investigate the proportion of implant/abutment complexes providing a reliable anchorage for a sound processor three months after implantation/surgery.
- Conditions
- Hearing Loss
- Being tested
- Minimally invasive surgery, Glasgow Benefit Inventory (GBI), Additional follow-up visits after surgery
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive surgeryProcedure or surgery
The subjects will be implanted with a bone anchored hearing system using a minimally invasive surgery.
Glasgow Benefit Inventory (GBI)Other
A quality of life-questionnaire is to be completed by the subjects at one occasion.
Additional follow-up visits after surgeryOther
There are 1-3 additional follow-up visits after surgery (compared to the routine clinical practice of the surgeons/clinics).
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Other | In this single-arm study the patients will be undergoing a minimally invasive surgery after which they will re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery. Receives: Procedure: Minimally invasive surgery; Other: Glasgow Benefit Inventory (GBI); Other: Additional follow-up visits after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Implants With Reliable Anchorage for a Sound Processor
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.
Measured: 3 months after implant surgery
Secondary outcomes (15)
Number of Implants With Reliable Anchorage for a Sound Processor
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.
Measured: 12 months after implant surgery
Implant Survival
Implant survival will be assessed by the investigator by means of a Yes/No question: Implant in place [Yes/No]
Measured: 12 months after implant surgery
Implant Stability
Clinical assessment of implant stability by the investigator by means of a Yes/No question: Implant stable [Yes/No]
Measured: 12 months after implant surgery
Holgers Score Distribution
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.
Measured: 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits
Max Holgers Score
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.
Measured: 12 months after implant surgery
Mild/Adverse Skin Reaction
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.
Measured: 12 months after implant surgery
IPS (Inflammation, Pain, Skin Height) Scores
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 visits.
Measured: 9 days, 5 weeks, 3-, 6- and 12 months after implant surgery, and unplanned visits
Wound Healing
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.
Measured: 9 days, 5 weeks and 3 months after implant surgery, and unplanned visits
Skin Overgrowth
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.
Measured: 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits
Post-operative Events Around Abutment
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.
Measured: 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits
Patient-perceived Presence of Pain Around Abutment
Assessment of presence of patient-perceived pain by means of a Yes/No question to the subject.
Measured: 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits
Patient-perceived Presence of Numbness Around Abutment
Assessment of presence of patient-perceived numbness by means of a Yes/No question to the patient.
Measured: 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits
Duration of Surgery
Length of surgery measured in minutes.
Measured: 3 months after implant surgery
Sound Processor Usage
Average sound processor usage time.
Measured: 12 months after implant surgery
Subjective Benefit After Surgery
The Glasgow Benefit Inventory (GBI) is a validated, 18-item patient-reported questionnaire that assesses changes in health-related quality-of-life following otorhinolaryngological (ENT) interventions. The questionnaire evaluates the perceived benefit after a procedure and generates a Total Score and three subscale scores: General (12 items), Social Support (3 items), and Physical Health (3 items). Each score ranges from -100 to +100, where positive values indicate improvement, negative values indicate deterioration, and zero reflects no change. The Total Score is calculated as the mean of all item scores (not a sum of subscale scores), while each subscale score is calculated as the mean of the items belonging to that subscale.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start4 Nov 2020
- Primary completion9 Aug 2022
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Harry Powell, MD, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606823
- Sponsor's protocol ID
- BC108
- Status last verified
- Jan 2026
- First submitted
- 22 Oct 2020
- Last updated
- 29 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Teunissen EM, Aukema TW, Banga R, Eeg-Olofsson M, Hol MKS, Hougaard DD, Tysome JR, Johansson ML, Svensson S, Powell HRF. Evaluation of Clinical Performance of Ponto Implantation Using a Minimally Invasive Surgical Technique-A Prospective Multicenter Study. Otol Neurotol. 2024 Oct 1;45(9):1037-1044. doi: 10.1097/MAO.0000000000004315. Epub 2024 Aug 26.
PubMed 39186326
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Performance of Ponto Implantation Using a Minimally Invasive Surgical Technique - a Prospective Multicentre Study
- ClinicalTrials.gov ID
- NCT04606823
- Acronym / sponsor ID
- BC108
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 9 Aug 2022 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 28 Oct 2020 (actual)
- Results
- Posted 29 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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. The implant, coupled to a skin-penetrating abutment, is implanted in the bone behind the ear and is later loaded with a sound processor which transforms sound waves to sound vibrations that can be sent directly to the inner ear via the skull bone. The primary objective of this study is to investigate the proportion of implant/abutment complexes providing a reliable anchorage for a sound processor three months after implantation/surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Other | Procedure: Minimally invasive surgery, Other: Glasgow Benefit Inventory (GBI), Other: Additional follow-up visits after surgeryIn this single-arm study the patients will be undergoing a minimally invasive surgery after which they will re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive surgeryThe subjects will be implanted with a bone anchored hearing system using a minimally invasive surgery. | Procedure or surgery | Single-arm |
| Glasgow Benefit Inventory (GBI)A quality of life-questionnaire is to be completed by the subjects at one occasion. | Other | Single-arm |
| Additional follow-up visits after surgeryThere are 1-3 additional follow-up visits after surgery (compared to the routine clinical practice of the surgeons/clinics). | Other | Single-arm |
Primary outcome
Number of Implants With Reliable Anchorage for a Sound Processor
Time frame: 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.
15 secondary outcomes
Number of Implants With Reliable Anchorage for a Sound Processor
Time frame: 12 months after implant surgery
Implant Survival
Time frame: 12 months after implant surgery
Implant Stability
Time frame: 12 months after implant surgery
Holgers Score Distribution
Time frame: 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits
Max Holgers Score
Time frame: 12 months after implant surgery
Mild/Adverse Skin Reaction
Time frame: 12 months after implant surgery
IPS (Inflammation, Pain, Skin Height) Scores
Time frame: 9 days, 5 weeks, 3-, 6- and 12 months after implant surgery, and unplanned visits
Wound Healing
Time frame: 9 days, 5 weeks and 3 months after implant surgery, and unplanned visits
Skin Overgrowth
Time frame: 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits
Post-operative Events Around Abutment
Time frame: 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits
Patient-perceived Presence of Pain Around Abutment
Time frame: 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits
Patient-perceived Presence of Numbness Around Abutment
Time frame: 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits
Duration of Surgery
Time frame: 3 months after implant surgery
Sound Processor Usage
Time frame: 12 months after implant surgery
Subjective Benefit After Surgery
Time frame: 3 months after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39186326Teunissen EM, Aukema TW, Banga R, Eeg-Olofsson M, Hol MKS, Hougaard DD, Tysome JR, Johansson ML, Svensson S, Powell HRF. Evaluation of Clinical Performance of Ponto Implantation Using a Minimally Invasive Surgical Technique-A Prospective Multicenter Study. Otol Neurotol. 2024 Oct 1;45(9):1037-1044. doi: 10.1097/MAO.0000000000004315. Epub 2024 Aug 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry Powell, MD principal investigator
Guy's and St Thomas' NHS Foundation Trust
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive surgery, Glasgow Benefit Inventory (GBI) and Additional follow-up visits after surgery in people with Hearing Loss, run by Oticon Medical at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom, Netherlands, Denmark, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Implants With Reliable Anchorage for a Sound Processor (time frame: 3 months after implant surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04606823, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.