Skip to main content
OpenTrials
Completed

NCT Number: NCT06421766

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alabama Ear Specialists

Birmingham, Alabama, 25233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BAHS

Device

Implantation of a percutaneous bone-anchored hearing system

Primary outcomes

  1. Implant survival

    Time frame: 3 months after implant surgery

    Implant in place in skull bone at 3 months (Yes/No).

Secondary outcomes

  1. Implant survival

    Time frame: Through study completion, with minimum 3 months

    Implant in place in skull bone at end of observation (Yes/No).

  2. Number and type of intraoperative events

    Time frame: During surgery

    Assessment of intraoperative events during surgery by the investigator. Will be presented in a frequency table.

  3. Number and type of postoperative events

    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.

  4. Time to sound processor loading

    Time frame: Up to 3 months

    Time from surgery to sound processor loading

Sponsors and collaborators

Lead sponsor

Oticon Medical

Industry

Registry information

Official study title

Retrospective Study of Outcomes With 3 mm Implant for Percutaneous Bone-anchored Hearing System (BAHS) Procedures

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 20, 2024
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.