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

NCT06421766 | Completed FDA Device

• 1 other identifier: BC122
• Study Type: observational
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Implant survival

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

  3 months after implant surgery

Secondary Outcomes (4)

• Implant survival

  Through study completion, with minimum 3 months

• Number and type of intraoperative events

  During surgery

• Number and type of postoperative events

  Up to 3 months

• Time to sound processor loading

  Up to 3 months

Study Arms (2)

3mm implant

Patients recieving a 3mm long implant

Device: BAHS

4mm implant

Patients recieving a 4mm long implant

Device: BAHS

Interventions

BAHS DEVICE

Implantation of a percutaneous bone-anchored hearing system

3mm implant; 4mm implant

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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.

Sponsors & Collaborators

• Oticon Medical: lead

Study Sites (1)

Alabama Ear Specialists

Birmingham, Alabama, 25233, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dennis G Pappas, MD

  Alabama Ear Specialists

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 20, 2024
• Study Start: March 8, 2024
• Primary Completion: September 25, 2024
• Study Completion: September 25, 2024
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)