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

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

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: BAHS

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.

• Study Type: Observational
• Enrollment (Actual): 234

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 25233
      • Alabama Ear Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients that have already obtained surgical intervention with a percutaneous bone anchored hearing system.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
3mm implant; Patients recieving a 3mm long implant	Device: BAHS; Implantation of a percutaneous bone-anchored hearing system
4mm implant; Patients recieving a 4mm long implant	Device: BAHS; Implantation of a percutaneous bone-anchored hearing system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant survival	Implant in place in skull bone at 3 months (Yes/No).	3 months after implant surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant survival	Implant in place in skull bone at end of observation (Yes/No).	Through study completion, with minimum 3 months
Number and type of intraoperative events	Assessment of intraoperative events during surgery by the investigator. Will be presented in a frequency table.	During surgery
Number and type of postoperative events	Assessment of postoperative events during the initial postoperative period (0-3 months) by the investigator. Will be presented in a frequency table.	Up to 3 months
Time to sound processor loading	Time from surgery to sound processor loading	Up to 3 months

Collaborators and Investigators

• Sponsor: Oticon Medical
• Investigators: Principal Investigator: Dennis G Pappas, MD, Alabama Ear Specialists

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2024
• Primary Completion (Actual): September 25, 2024
• Study Completion (Actual): September 25, 2024

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: BC122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes