Stability, long term survival and tolerability of a novel Baha® implant system, a multi-centre investigation.
Completed
- Conditions
- implant stabilitylocal skin reactions1001924310040792
- Registration Number
- NL-OMON31607
- Lead Sponsor
- Cochlear BAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
The patient must meet the following criteria to be included;
• Adult patients, i.e. >=18 years
• Written informed consent
• Eligible for the Baha system
• Bone thickness at the implant site of at least 4 mm
• Eligible for implantation with the two fixtures; 3,75 alternatively 4,5 mm wide
• No known disease or treatment that compromises / will compromise the bone quality at the implant site
Exclusion Criteria
The patient should meet none of the following criteria
• Unable to follow investigational procedures
• Simultaneous participation in another investigation with pharmaceuticals and/or devices
• Any factor, at the discretion of the investigator that is considered to contraindicate participation.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method