Hearing Loss - Conductive | Stability of the Cochlear Baha BI300/BA400 Implant System Loaded From 1 Week Post-surgery
Hearing Loss - Conductive research study
What is the primary objective of this study?
Objectives - To evaluate the safety of processor loading of the Cochlear BI300/BA400 implant system 1 week after implantation - To evaluate the short term soft tissue healing and the long term skin reaction, with the new Cochlear BI300/BA400 implant system using the linear incision without subcutaneous tissue reduction. - To produce reference data regarding the stability of the BI300/BA400 implant system. Study design: Prospective cohort study. Patients: 24 adults with anticipated normal skin and bone quality eligible for bone anchored implant surgery. Intervention: Loading of the sound processor one week after surgery Main outcome measures: Implant stability, soft tissue reaction, skin overgrowth, pain and numbness will be assessed. It is hypothesized that implant loading can be performed one week after surgery without any changes in implant stability, soft tissue reaction, skin overgrowth, pain or numbness around implant.
Who is eligible to participate?
Inclusion Criteria: - Patients ≥ 18 years of age, with normal intelligence. - Absence of previous radiotherapy to the implant area. - Absence of active skin disease in the implant area. - Absence of diabetes. - Absence of osteoporosis - Absence of any relevant medical history or current disease/treatment/medication that may affect bone or skin quality in the implant area. Exclusion Criteria: - No further
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Hearing Loss - Conductive
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:One week loading of Bone Anchored Hearing Aid (BAHA)Patients in this arm will be fitted with the BAHA one week after surgery.
Device:Cochlear Baha BI300/BA400 Implant System
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
One week loading of Bone Anchored Hearing Aid (BAHA)Bone Anchored Hearing Aid (BAHA) loading after one week
Start Date: March 2014
Completed Date: September 2015
Primary Outcome: Implant stability
Secondary Outcome: Soft tissue status
Study sponsors, principal investigator, and references
Principal Investigator: Lars V Johansen, D.MSc.
Lead Sponsor: Aarhus University Hospital
Dun CA, de Wolf MJ, Hol MK, Wigren S, Eeg-Olofsson M, Green K, Karlsmo A, Flynn MC, Stalfors J, Rothera M, Mylanus EA, Cremers CW. Stability, survival, and tolerability of a novel baha implant system: six-month data from a multicenter clinical investigation. Otol Neurotol. 2011 Aug;32(6):1001-7. doi: 10.1097/MAO.0b013e3182267e9c.