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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06421766
• Other study ID #: BC122
• Status: Recruiting
• Start date: March 8, 2024
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: Oticon Medical
• Contact: Sara Svensson, PhD
• Phone: +46735042041
• Email: ssve[@]oticonmedical.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• BAHS
Implantation of a percutaneous bone-anchored hearing system

Locations

Country	Name	City	State
United States	Alabama Ear Specialists	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Oticon Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survival	Implant in place in skull bone at 3 months (Yes/No).	3 months after implant surgery
Secondary	Implant survival	Implant in place in skull bone at end of observation (Yes/No).	Through study completion, with minimum 3 months
Secondary	Number and type of intraoperative events	Assessment of intraoperative events during surgery by the investigator. Will be presented in a frequency table.	During surgery
Secondary	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
Secondary	Time to sound processor loading	Time from surgery to sound processor loading	Up to 3 months