Clinical trial NCT06421766: Retrospective Study of Outcomes With 3 mm Implant for Percutaneous BAHS Procedures
Official title: Retrospective Study of Outcomes With 3 mm Implant for Percutaneous Bone-anchored Hearing System (BAHS) Procedures
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hearing Loss
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2024-05-20
Enrollment: 240
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that have already obtained surgical intervention with a percutaneous bone anchored hearing system.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Implant survival
timeFrame: 3 months after implant surgery
Secondary outcomes:
measure: Implant survival
timeFrame: Through study completion, with minimum 3 months
measure: Number and type of intraoperative events
timeFrame: During surgery
measure: Number and type of postoperative events
timeFrame: Up to 3 months
measure: Time to sound processor loading
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Ear Specialists
state: Alabama
Study officials:
affiliation: Alabama Ear Specialists
name: Dennis G Pappas, MD
role: PRINCIPAL_INVESTIGATOR
References: