Hearing Loss
Conditions
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: 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.
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 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.
Interventions
DEVICEBAHS
Implantation of a percutaneous bone-anchored hearing system
Sponsors
Oticon Medical
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patient (≥19 years) receiving percutaneous BAHS treatment using an implant with the wide diameter (Ø: 4.5 mm) design.
Exclusion criteria
* Patient undergoing re-implantation due to previous failure of osseointegration or other spontaneous implant loss. * Patient undergoing conversions from passive transcutaneous devices (i.e. BAHA Attract) to active percutaneous devices (using an abutment), using the same implant for attachment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant survival | 3 months after implant surgery | Implant in place in skull bone at 3 months (Yes/No). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant survival | Through study completion, with minimum 3 months | Implant in place in skull bone at end of observation (Yes/No). |
| Number and type of intraoperative events | During surgery | Assessment of intraoperative events during surgery by the investigator. Will be presented in a frequency table. |
| Number and type of postoperative events | 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 to sound processor loading | Up to 3 months | Time from surgery to sound processor loading |
Countries
United States
Outcome results
None listed