Retrospective Study of Outcomes With 3 mm Implant for Percutaneous BAHS Procedures
Launched by OTICON MEDICAL · May 14, 2024
Trial Information
Current as of February 19, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how well a specific type of hearing implant works for adults with hearing loss. The researchers are focusing on 3mm long implants used in a procedure called percutaneous bone-anchored hearing system (BAHS) surgeries, which help people hear better by connecting directly to the bone behind the ear. They want to find out how often these implants are still functioning three months after they are placed. This study is important because it will help understand the safety and effectiveness of these implants.
To participate in the study, you need to be an adult who is at least 19 years old and has already received a wide-diameter implant (4.5 mm) during your BAHS treatment. However, if you have had problems with your previous implants or are switching from a different type of hearing device, you won’t be eligible. If you join the study, you’ll be part of a review of outcomes based on your past experiences with the implant, and your information will help improve future treatments for others with similar hearing loss.
Gender
ALL
Eligibility criteria
- 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.
Trial Officials
Dennis G Pappas, MD
Principal Investigator
Alabama Ear Specialists
About Oticon Medical
Oticon Medical is a leading global innovator in the field of hearing solutions, dedicated to improving the quality of life for individuals with hearing loss. As a subsidiary of the well-established Oticon brand, Oticon Medical specializes in the development and manufacture of advanced auditory devices, including bone-anchored hearing systems and implantable solutions. Committed to research and development, the company actively sponsors clinical trials to evaluate the efficacy and safety of its products, ensuring that cutting-edge technology continues to meet the evolving needs of patients and healthcare professionals. With a focus on evidence-based practices, Oticon Medical strives to enhance auditory experiences and foster better communication for those affected by hearing impairment.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Birmingham, Alabama, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0