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

Completed

Conditions studied: Hearing Loss

In brief

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.

Key facts

Study ID

NCT06421766

Run by

Oticon Medical

People needed

234

Starts

2024-03-08

Expected to finish

2024-09-25

Last updated by the study team

2025-07-31

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patient (≥19 years) receiving percutaneous BAHS treatment using an implant with the wide diameter (Ø: 4.5 mm) design.

You may not qualify if…

• 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.

Where it is running

• Alabama Ear Specialists — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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