Back to resultsClinical Survey of Oticon Medical Ponto BHX Implant
Primary Purpose
Hearing Impaired (Partially), Hearing Impairment, Conductive, Deafness Unilateral
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
BHX implant (Bone anchored hearing system)
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Impaired (Partially)
Eligibility Criteria
Inclusion Criteria:
- Patients eligible for treatment with a bone anchored hearing aid
- 18 years or older
Exclusion Criteria:
- 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.
Sites / Locations
- Dept. of Otolaryngology - Head & Neck Surgery and Audiology, Gentofte/Rigshospitalet,
- Department of Oto-Rhino-Laryngology & Audiology Aalborg University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
BHX implant
Arm Description
All patients implanted with BHX implant
Outcomes
Primary Outcome Measures
Implant stability quotient (ISQ) at surgery
Initial implant stability measured directly after surgery
Secondary Outcome Measures
Surgical torque setting measured in Ncm
The surgical torque setting used to install the implant
Possibility to fit the sound processor, yes/no
Fitting of the sound processor at 5-12 days post-surgery
Implant stability quotient (ISQ) after 12 months of follow up
Long term stability development
Implant survivability measured as percentage successful implants after 12 months
Implant survivability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03289845
Brief Title
Clinical Survey of Oticon Medical Ponto BHX Implant
Official Title
Clinical Survey of Oticon Medical Ponto BHX Implant
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 5, 2015 (Actual)
Primary Completion Date
January 4, 2016 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oticon Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Impaired (Partially), Hearing Impairment, Conductive, Deafness Unilateral
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BHX implant
Arm Type
Other
Arm Description
All patients implanted with BHX implant
Intervention Type
Device
Intervention Name(s)
BHX implant (Bone anchored hearing system)
Intervention Description
Bone anchored hearing system for hearing rehabilitation
Primary Outcome Measure Information:
Title
Implant stability quotient (ISQ) at surgery
Description
Initial implant stability measured directly after surgery
Time Frame
At surgery
Secondary Outcome Measure Information:
Title
Surgical torque setting measured in Ncm
Description
The surgical torque setting used to install the implant
Time Frame
At surgery
Title
Possibility to fit the sound processor, yes/no
Description
Fitting of the sound processor at 5-12 days post-surgery
Time Frame
5-12 days post surgery
Title
Implant stability quotient (ISQ) after 12 months of follow up
Description
Long term stability development
Time Frame
12 months post surgery
Title
Implant survivability measured as percentage successful implants after 12 months
Description
Implant survivability
Time Frame
12 months post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients eligible for treatment with a bone anchored hearing aid
18 years or older
Exclusion Criteria:
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.
Facility Information:
Facility Name
Dept. of Otolaryngology - Head & Neck Surgery and Audiology, Gentofte/Rigshospitalet,
City
Hellerup
State/Province
Copenhagen
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Department of Oto-Rhino-Laryngology & Audiology Aalborg University Hospital
City
Aalborg
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Survey of Oticon Medical Ponto BHX Implant
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