Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421766
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-04-23
Brief Title:
Retrospective Study of Outcomes With 3 mm Implant for Percutaneous BAHS Procedures
Sponsor:
Oticon Medical
Organization:
Oticon Medical
Study Overview
Official Title:
Retrospective Study of Outcomes With 3 mm Implant for Percutaneous Bone-anchored Hearing System BAHS Procedures
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This retrospective study is conducted to gain more knowledge on use and complications of 3mm long implants used in percutaneous through the skin bone-anchored hearing system BAHS surgeries in adults Patients included have already been treated and recieved an implant with the wide diameter Ø 45 mm design either of 3- or 4mm length The main purpose of the study is to investigate implant survival three months after implantation
Detailed Description:
BAHS systems are intended for patients with conductive or mixed hearing loss and for patients with single-sided deafness In BAHS surgery an implant - coupled to a skin-penetrating abutment - is implanted in the bone behind the ear and is later loaded with a sound processor The sound processor transforms sound waves to sound vibrations that are transferred through the skull bone to the inner earscochlea Thus sound can be transmitted directly to the cochlea and bypass any problems in the ear canal or middle ear Today more than 400000 implantations have been made around the world and the long-term success rate of BAHS surgery is high with a low rate of major complications
Over the years both implant design and surgical techniques have developed with improved patient outcomes as a result Wider diameter implants 45mm in diameter increased the implant stability and have become standard The implants exist in two different lengths 3- and 4mm to accomodate for different bone thickness The shorter implant has primarily been used for young children and for adults with thinner bone The aim of this restrospective study is to investigate the outcomes after implantation of a 3mm implant in an adult population
Over the years both implant design and surgical techniques have developed with improved patient outcomes as a result Wider diameter implants 45mm in diameter increased the implant stability and have become standard The implants exist in two different lengths 3- and 4mm to accomodate for different bone thickness The shorter implant has primarily been used for young children and for adults with thinner bone The aim of this restrospective study is to investigate the outcomes after implantation of a 3mm implant in an adult population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None