Hearing LossNCT03723161
Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population
An observational study of Hearing Loss and Conductive Hearing Loss, run by Oticon Medical at 1 site in Sweden.
Trial summary
The purpose of this study is to in a proactive manner collect high quality data from a pediatric patients who have undergone a bone anchored hearing solution, using the Ponto BHX implant, in clinical practice. This to further increase the knowledge of using the system. Read more about this study
- Who is it for?
- Ages 30 months to 18 years
- Conditions the study is for
- Hearing Loss, Conductive Hearing Loss, Atresia
- What is being tested?
- Bone Achored Hearing surgery
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 4 Sep 2018to 31 Jan 2024
- 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 30 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients eligible for a bone anchored solution.
Who may be able to join
- Patients who have decided to undergo a Bone Anchored Hearing Surgery
- Diagnosed with atresia
- Signed informed consent
- Patients between 2,5 - 18 years of age
- Patients eligible for one stage surgery
Who cannot join
- Not fluent in Swedish or English; subject and/or legal guardian
- Unwillingness to participate in follow up visits
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to in a proactive manner collect high quality data from a pediatric patients who have undergone a bone anchored hearing solution, using the Ponto BHX implant, in clinical practice. This to further increase the knowledge of using the system.
- Conditions
- Hearing Loss, Conductive Hearing Loss, Atresia
- Being tested
- Bone Achored Hearing surgery
- Medical subject headings
- Hearing Loss, Hearing Loss, Conductive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Achored Hearing surgeryDevice
This is a observational study of pediatric patients undergoing bone anchored hearing surgery. The collected data will be used to assess the implant stability development of the Ponto BHX implant during up tp 24 months after implantation in a pediatric population undergoing bone anchored hearing surgery.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Bone Anchored Hearing surgery using a BHX implant manufactured by Oticon Medical Receives: Device: Bone Achored Hearing surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability 12 months
The development of implant stability during the first 12 months after implantation; as measured by difference in mean of (Implant Stability Quotient) ISQ low 12 months compared to surgery.
Measured: 12 months post surgery
Secondary outcomes (11)
Stability 24 months
Difference in mean of ISQ low at 24 months compared to surgery
Measured: 24 months post surgery
Implant survival rate
Implant survival rate in percent compared to litterature
Measured: 24 months post surgery
Performance audibility PTA4
The difference between abutment-aided and softband-aided sound field Pure Tone Average of thresholds at frequencies 500, 1000, 2000 and 4000 Hz (PTA 4) in preoperative condition and at fitting.
Measured: 1 month post surgery
Performance audibility
Difference between abutment-aided and softband-aided sound field Pure Tone thresholds at frequencies 500, 1000, 2000, 4000, 6000 and 8000 Hz) in preoperative condition and at fitting
Measured: 1 month post surgery
Performance speech intelligibility
Difference between abutment-aided and softband-aided speech intelligibility in SNR in preoperative condition and at fitting.
Measured: 1 month post surgery
Functional assessment
Functional assessment as measured by change in Pediatric Evaluation of Aural/Oral Performance of Children (PEACH)
Measured: 12 months, 24 months
Skin conditions Holger
Skin assessment as assessed with maximum Holgers score per patient. Maximum score 4. 0= no adverse skin reaction, 4=maximum adverse skin reaction.
Measured: 7-10 days,12 months, 24 months post surgery
Skin conditions IPS evaluation
Skin condition as assessed by (Inflammation, Pain, Skin height/numbness (IPS) score. I scale randing from 0-4, Pain scale ranging from 0-2, Height scale ranging from 0-2. Total score 8, 0=no adverse skin reaction, 8=maximum adverse skin reaction
Measured: 7-10 days,12 months, 24 months post surgery
Sustainability of audibility PTA4 performance
Difference between abutment aided sound field PTA 4 over time
Measured: 1 month, 12 months, 24 months post surgey
Sustainability of audibility performance
Difference between abutment aided sound field Pure Tone thresholds at frequencies 500, 1000, 2000, 4000, 6000 and 8000 Hz over time
Measured: 1 month, 12 months, 24 months post surgey
Sustainability of speech intelligibility performance
Difference between abutment aided speech intelligibility over time
Measured: 1 month, 12 months, 24 months post surgey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start4 Sep 2018
- Primary completion10 Jan 2023
- Study completion31 Jan 2024
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Karolinska University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723161
- Sponsor's protocol ID
- C64
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2018
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population
- ClinicalTrials.gov ID
- NCT03723161
- Acronym / sponsor ID
- C64
- Conditions
- Hearing Loss, Conductive Hearing Loss, Atresia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Karolinska University Hospital
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 29 Oct 2018 (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.
The purpose of this study is to in a proactive manner collect high quality data from a pediatric patients who have undergone a bone anchored hearing solution, using the Ponto BHX implant, in clinical practice. This to further increase the knowledge of using the system.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Device: Bone Achored Hearing surgeryBone Anchored Hearing surgery using a BHX implant manufactured by Oticon Medical |
Who may qualify
- Ages
- 30 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients eligible for a bone anchored solution.
Key inclusion criteria (5 listed)
- Patients who have decided to undergo a Bone Anchored Hearing Surgery
- Diagnosed with atresia
- Signed informed consent
- Patients between 2,5 - 18 years of age
- Patients eligible for one stage surgery
Key exclusion criteria (2 listed)
- Not fluent in Swedish or English; subject and/or legal guardian
- Unwillingness to participate in follow up visits
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 |
|---|---|---|
| Bone Achored Hearing surgeryThis is a observational study of pediatric patients undergoing bone anchored hearing surgery. The collected data will be used to assess the implant stability development of the Ponto BHX implant during up tp 24 months after implantation in a pediatric population undergoing bone anchored hearing surgery. | Device | Treatment |
Primary outcome
Stability 12 months
Time frame: 12 months post surgery
The development of implant stability during the first 12 months after implantation; as measured by difference in mean of (Implant Stability Quotient) ISQ low 12 months compared to surgery.
11 secondary outcomes
Stability 24 months
Time frame: 24 months post surgery
Implant survival rate
Time frame: 24 months post surgery
Performance audibility PTA4
Time frame: 1 month post surgery
Performance audibility
Time frame: 1 month post surgery
Performance speech intelligibility
Time frame: 1 month post surgery
Functional assessment
Time frame: 12 months, 24 months
Skin conditions Holger
Time frame: 7-10 days,12 months, 24 months post surgery
Skin conditions IPS evaluation
Time frame: 7-10 days,12 months, 24 months post surgery
Sustainability of audibility PTA4 performance
Time frame: 1 month, 12 months, 24 months post surgey
Sustainability of audibility performance
Time frame: 1 month, 12 months, 24 months post surgey
Sustainability of speech intelligibility performance
Time frame: 1 month, 12 months, 24 months post surgey
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 31 Oct 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss and Conductive Hearing Loss, run by Oticon Medical at 1 site in Sweden.
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 2 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 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
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?
Stability 12 months (time frame: 12 months post 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 31 Oct 2024.