Retrospective Study of Outcomes With 3 mm Implant for Percutaneous BAHS Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

234 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-08

Study Completion Date

2024-09-25

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hearing Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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3mm implant

Patients recieving a 3mm long implant

BAHS

Intervention Type DEVICE

Implantation of a percutaneous bone-anchored hearing system

4mm implant

Patients recieving a 4mm long implant

BAHS

Intervention Type DEVICE

Implantation of a percutaneous bone-anchored hearing system

Interventions

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BAHS

Implantation of a percutaneous bone-anchored hearing system

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No