Hearing Impaired (Partially)NCT03289845
Clinical Survey of Oticon Medical Ponto BHX Implant
A study testing BHX implant (Bone anchored hearing system) in people with Hearing Impaired (Partially) and Hearing Impairment, Conductive, run by Oticon Medical at 2 sites in Denmark.
Trial summary
Investigation of stability of the BHX implant in adult patients indicated and counselled for a bone anchored hearing aid system. Patients are followed according to clinical practice for a total of 12 months in the study. Stability of the implant is evaluated by implant stability quotient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Impaired (Partially), Hearing Impairment, Conductive, Deafness Unilateral
- What is being tested?
- BHX implant (Bone anchored hearing system)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesDenmark
- Study dates
- 5 Nov 2015to Dec 2017
- Phase
- Interventional
- 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
Who may be able to join
- Patients eligible for treatment with a bone anchored hearing aid
- 18 years or older
Who cannot join
- Inability to participate in follow-up
- Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Oto-Rhino-Laryngology & Audiology Aalborg University Hospital
Aalborg
Dept. of Otolaryngology - Head & Neck Surgery and Audiology, Gentofte/Rigshospitalet,
Hellerup, Copenhagen, 2900
About this study
Investigation of stability of the BHX implant in adult patients indicated and counselled for a bone anchored hearing aid system. Patients are followed according to clinical practice for a total of 12 months in the study. Stability of the implant is evaluated by implant stability quotient.
- Being tested
- BHX implant (Bone anchored hearing system)
- Medical subject headings
- Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Unilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHX implant (Bone anchored hearing system)Device
Bone anchored hearing system for hearing rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| BHX implant | Other | All patients implanted with BHX implant Receives: Device: BHX implant (Bone anchored hearing system) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability quotient (ISQ) at surgery
Initial implant stability measured directly after surgery
Measured: At surgery
Secondary outcomes (4)
Surgical torque setting measured in Ncm
The surgical torque setting used to install the implant
Measured: At surgery
Possibility to fit the sound processor, yes/no
Fitting of the sound processor at 5-12 days post-surgery
Measured: 5-12 days post surgery
Implant stability quotient (ISQ) after 12 months of follow up
Long term stability development
Measured: 12 months post surgery
Implant survivability measured as percentage successful implants after 12 months
Implant survivability
Measured: 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start5 Nov 2015
- Primary completion4 Jan 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Impaired (Partially)Studies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289845
- Sponsor's protocol ID
- C55
- Status last verified
- Feb 2018
- First submitted
- 31 Aug 2017
- Last updated
- 22 Feb 2018
- 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 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Survey of Oticon Medical Ponto BHX Implant
- ClinicalTrials.gov ID
- NCT03289845
- Acronym / sponsor ID
- C55
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2015 (actual)
- Primary completion
- 4 Jan 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 21 Sep 2017 (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.
Investigation of stability of the BHX implant in adult patients indicated and counselled for a bone anchored hearing aid system. Patients are followed according to clinical practice for a total of 12 months in the study. Stability of the implant is evaluated by implant stability quotient.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BHX implant | Other | Device: BHX implant (Bone anchored hearing system)All patients implanted with BHX implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients eligible for treatment with a bone anchored hearing aid
- 18 years or older
Key exclusion criteria (2 listed)
- Inability to participate in follow-up
- Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
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 |
|---|---|---|
| BHX implant (Bone anchored hearing system)Bone anchored hearing system for hearing rehabilitation | Device | BHX implant |
Primary outcome
Implant stability quotient (ISQ) at surgery
Time frame: At surgery
Initial implant stability measured directly after surgery
4 secondary outcomes
Surgical torque setting measured in Ncm
Time frame: At surgery
Possibility to fit the sound processor, yes/no
Time frame: 5-12 days post surgery
Implant stability quotient (ISQ) after 12 months of follow up
Time frame: 12 months post surgery
Implant survivability measured as percentage successful implants after 12 months
Time frame: 12 months post 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 22 Feb 2018.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BHX implant (Bone anchored hearing system) in people with Hearing Impaired (Partially) and Hearing Impairment, Conductive, run by Oticon Medical at 2 sites in Denmark.
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 2 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 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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 stability quotient (ISQ) at surgery (time frame: At 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 22 Feb 2018.