Hearing LossNCT04310202
Multi-Centre Study on the Performance of the Ponto BHX Implant System (in Adult Patients)
An observational study of Hearing Loss, run by Oticon Medical at 6 sites in 3 countries.
Trial summary
This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Spain, Denmark). Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. 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?
- Abbreviated Profile of Hearing Aid Benefit (APHAB), Glasgow Benefit Inventory (GBI) and Additional follow-up visits after surgery
- How many people
- 50 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 17 Jan 2021to 20 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients presenting to participating clinics who meet clinical indications for surgical intervention with a bone anchored hearing system
Who may be able to join
- 18 years of age or older
- Patients indicated for surgical intervention with a bone anchored hearing system according to local clinic's standard guidelines
- Adequate bone quality to allow for a Ponto BHX implant insertion, as judged by the investigator, and an expected bone thickness above 3 mm, where no complications during surgery are expected
Who cannot join
- Patients undergoing re-implantation
- Patients who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales.
- Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus
- Known conditions (e.g. uncontrolled diabetes) that could jeopardize skin condition and wound healing over time as judged by the investigator
- Any other known condition that the investigator determines could interfere with compliance or study assessments
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Denmark2 sites
Aalborg University Hospital
Aalborg, 9000
Rigshospitalet
Copenhagen, 2100
Spain2 sites
Hospital Universitario de Donostia
San Sebastián, Gipuzkoa, 20014
Hospital Clinico Universitario de Valencia
Valencia, 46010
United Kingdom2 sites
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2WB
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
About this study
Official title: A Prospective Multi-Centre Study on the Performance of the Ponto BHX Implant System
This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Spain, Denmark). Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. A total of 50 patients will be included in the study.
The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Biohelix (BHX) Implant system.
Read the detailed description
This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Spain, Denmark). Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. A total of 50 patients will be included in the study.
The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto BHX Implant system. 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, 3 months after implantation/surgery.
- Conditions
- Hearing Loss
- Being tested
- Abbreviated Profile of Hearing Aid Benefit (APHAB), 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.
Abbreviated Profile of Hearing Aid Benefit (APHAB)Other
An intervention in this study which is outside the routine clinical practice of the clinics is the APHAB questionnaire that will be completed by the subjects on two occasions.
Glasgow Benefit Inventory (GBI)Other
An intervention in this study which is outside the routine clinical practice of the clinics is the GBI questionnaire that will be completed by the subjects on two occasions.
Additional follow-up visits after surgeryOther
There are 1-2 additional follow-up visits after surgery (compared to the routine clinical practice of the surgeons/clinics).
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | In this single-arm study, the only interventions compared to routine clinical practice are the completion of two patient questionnaires (APHAB and GBI) and additional follow-up visits after surgery. Receives: Other: Abbreviated Profile of Hearing Aid Benefit (APHAB); 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.
Implant/abutment complex capability to provide a reliable Anchorage for a sound processor
The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin over-growth 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 or skin over-growth and pain preventing usage of the sound processor.
Measured: 3 months after implant surgery
Secondary outcomes (18)
Implant/abutment complex capability to provide reliable anchorage for sound processor
The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin over-growth 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 or skin over-growth and 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/abutment complex 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 ratings
Distribution of Holgers score ratings (scale 0-4) where a higher score corresponds to a poorer outcome, assigned by investigator
Measured: 12 months after implant surgery
IPS (Inflammation, Pain, Skin height) scores
Distribution of IPS (Inflammation [total score 0-4], Pain [score 0-2], Skin height [score 0-2]) scores assigned by investigator. The IPS score is presented as [Ix Px Sx] with x being the individual score for each parameter. A higher score corresponds to a poorer outcome
Measured: 12 months after implant surgery
Patient-perceived presence of pain around implant/abutment
Assessment of presence of patient-perceived pain by means of a Yes/No question to the subject
Measured: 12 months after implant surgery
Patient-perceived magnitude of pain around implant/abutment
Assessment of magnitude of patient-perceived pain using a numerical rating scale (NRS) (range 0-10) where a higher rating corresponds to a poorer outcome
Measured: 12 months after implant surgery
Patient-perceived presence of numbness around implant/abutment
Assessment of presence of patient-perceived numbness by means of a Yes/No question to the subject
Measured: 12 months after implant surgery
Patient-perceived magnitude of numbness around implant/abutment
Assessment of magnitude of patient-perceived numbness using a numerical rating scale (NRS) (range 0-10) where a higher rating corresponds to a poorer outcome
Measured: 12 months after implant surgery
Skin/soft tissue overgrowth
Skin overgrowth over implant/abutment complex judged by the investigator by means of a Yes/No question
Measured: 12 months after implant surgery
Duration of surgery
Length of surgery measured in minutes
Measured: At implant surgery
Wound dehiscence
Prevalence of wound dehiscence measured as millimeters of dehiscence
Measured: 12 months after implant surgery
Wound healing time
Average healing time [days] from surgery when the wound is considered healed
Measured: 12 months after implant surgery
Implant/abutment usage
Mean hours of use of a sound processor on the implant/abutment
Measured: 12 months after implant surgery
Subjective benefit after implant surgery
Abbreviated Profile Hearing Aid Benefit (APHAB) questionnaire score (1-99) where a global higher score corresponds to a poorer outcome
Measured: At screening visit (visit before surgery)
Subjective benefit after implant surgery
Abbreviated Profile Hearing Aid Benefit (APHAB) questionnaire score (1-99) where a global higher score corresponds to a poorer outcome
Measured: 6 months after implant surgery
Subjective benefit after implant surgery
Glasgow Benefit Inventory (GBI) questionnaire score (-100 to +100) where [-100] means maximum adverse effect, [0] means no effect, and [+100] means maximum positive effect
Measured: 3 months after implant surgery
Subjective benefit after implant surgery
Glasgow Benefit Inventory (GBI) questionnaire score (-100 to +100) where [-100] means maximum adverse effect, [0] means no effect, and [+100] means maximum positive effect
Measured: 12 months after implant surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start17 Jan 2021
- Primary completion24 Apr 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rupan Banga, MD, PhD, Principal investigator, University Hospital Birmingham NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310202
- Sponsor's protocol ID
- Doc-00066211
- Status last verified
- Aug 2024
- First submitted
- 12 Mar 2020
- Last updated
- 29 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-Centre Study on the Performance of the Ponto BHX Implant System
- ClinicalTrials.gov ID
- NCT04310202
- Acronym / sponsor ID
- Doc-00066211
- Conditions
- Hearing Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2021 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
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, Spain, Denmark). Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. A total of 50 patients will be included in the study.
The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Biohelix (BHX) Implant system.
Detailed description
This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Spain, Denmark). Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. A total of 50 patients will be included in the study.
The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto BHX Implant system. 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, 3 months after implantation/surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm | – | Other: Abbreviated Profile of Hearing Aid Benefit (APHAB), Other: Glasgow Benefit Inventory (GBI), Other: Additional follow-up visits after surgeryIn this single-arm study, the only interventions compared to routine clinical practice are the completion of two patient questionnaires (APHAB and GBI) and additional follow-up visits after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to participating clinics who meet clinical indications for surgical intervention with a bone anchored hearing system
Key inclusion criteria (3 listed)
- 18 years of age or older
- Patients indicated for surgical intervention with a bone anchored hearing system according to local clinic's standard guidelines
- Adequate bone quality to allow for a Ponto BHX implant insertion, as judged by the investigator, and an expected bone thickness above 3 mm, where no complications during surgery are expected
Key exclusion criteria (5 listed)
- Patients undergoing re-implantation
- Patients who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales.
- Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus
- Known conditions (e.g. uncontrolled diabetes) that could jeopardize skin condition and wound healing over time as judged by the investigator
- Any other known condition that the investigator determines could interfere with compliance or study assessments
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 |
|---|---|---|
| Abbreviated Profile of Hearing Aid Benefit (APHAB)An intervention in this study which is outside the routine clinical practice of the clinics is the APHAB questionnaire that will be completed by the subjects on two occasions. | Other | Single-arm |
| Glasgow Benefit Inventory (GBI)An intervention in this study which is outside the routine clinical practice of the clinics is the GBI questionnaire that will be completed by the subjects on two occasions. | Other | Single-arm |
| Additional follow-up visits after surgeryThere are 1-2 additional follow-up visits after surgery (compared to the routine clinical practice of the surgeons/clinics). | Other | Single-arm |
Primary outcome
Implant/abutment complex capability to provide a 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 over-growth 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 or skin over-growth and pain preventing usage of the sound processor.
18 secondary outcomes
Implant/abutment complex capability to provide reliable anchorage for 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 ratings
Time frame: 12 months after implant surgery
IPS (Inflammation, Pain, Skin height) scores
Time frame: 12 months after implant surgery
Patient-perceived presence of pain around implant/abutment
Time frame: 12 months after implant surgery
Patient-perceived magnitude of pain around implant/abutment
Time frame: 12 months after implant surgery
Patient-perceived presence of numbness around implant/abutment
Time frame: 12 months after implant surgery
Patient-perceived magnitude of numbness around implant/abutment
Time frame: 12 months after implant surgery
Skin/soft tissue overgrowth
Time frame: 12 months after implant surgery
Duration of surgery
Time frame: At implant surgery
Wound dehiscence
Time frame: 12 months after implant surgery
Wound healing time
Time frame: 12 months after implant surgery
Implant/abutment usage
Time frame: 12 months after implant surgery
Subjective benefit after implant surgery
Time frame: At screening visit (visit before surgery)
Subjective benefit after implant surgery
Time frame: 6 months after implant surgery
Subjective benefit after implant surgery
Time frame: 3 months after implant surgery
Subjective benefit after implant surgery
Time frame: 12 months after implant surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
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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.
Rupan Banga, MD, PhD principal investigator
University Hospital Birmingham NHS Foundation Trust
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by Oticon Medical at 6 sites in 3 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 3 inclusion and 5 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 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark, Spain, United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Implant/abutment complex capability to provide a 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?
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 Aug 2024.