Alabama Ear Specialists
Birmingham, Alabama, 25233, United States
NCT Number: NCT06421766
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: 4.5 mm) design, either of 3- or 4mm length. The main purpose of the study is to investigate implant survival three months after implantation.
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Notify Me19 year and older
All sexes
Observational
Birmingham, Alabama, 25233, United States
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 ear(s)/cochlea. Thus, sound can be transmitted directly to the cochlea and bypass any problems in the ear canal or middle ear. Today, more than 400,000 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, 4.5mm 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Implantation of a percutaneous bone-anchored hearing system
Time frame: 3 months after implant surgery
Implant in place in skull bone at 3 months (Yes/No).
Time frame: Through study completion, with minimum 3 months
Implant in place in skull bone at end of observation (Yes/No).
Time frame: During surgery
Assessment of intraoperative events during surgery by the investigator. Will be presented in a frequency table.
Time frame: Up to 3 months
Assessment of postoperative events during the initial postoperative period (0-3 months) by the investigator. Will be presented in a frequency table.
Time frame: Up to 3 months
Time from surgery to sound processor loading
Oticon Medical
Industry
Retrospective Study of Outcomes With 3 mm Implant for Percutaneous Bone-anchored Hearing System (BAHS) Procedures
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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