Stability, Survival, and Tolerability of an Auditory Osseointegrated Implant for Bone Conduction Hearing

Abstract

Objective:To compare implant stability, survival, and soft tissue reactions for a novel (test) and previous generation (control) percutaneous auditory osseointegrated implant for bone conduction hearing at long-term follow-up of 5 years.Study Design:Single follow-up visit of a previously completed multicenter, randomized, controlled trial.Patients:Fifty-seven of the 77 participants of a completed randomized controlled trial on a new auditory osseointegrated implant underwent a single follow-up visit 5 years after implantation, which comprised implant stability measurements and collection of Holgers scores. Additionally, implant survival was recorded for all 77 patients from the original trial.Results:The test implant showed significantly higher implant stability quotient (ISQ) values compared with the control implant throughout the 5-year follow-up. Mean area under the curve of ISQ high from baseline to 5 years was 71.6 (standard deviation [SD] ±2.0) and 66.7 (SD ±3.4) for the test and control implant, respectively (p < 0.0001). For both implants, the mean ISQ value recorded at 5 years was higher compared with implantation (test group +2.03 [SD ±2.55, within group p < 0.0001] and control group +2.25 [SD ±4.95, within group p = 0.12]). No difference was noticed in increase from baseline between groups (p = 0.64). Furthermore, evaluation of soft tissue reactions continued to show superiority of the test implant. At the 5-year follow-up visit, one patient (2.5%) presented with a Holgers grade 2 in the test group, compared with four patients (23.5%) in the control group (p = 0.048); no patient presented with more severe soft tissue reactions. Excluding explantations, the survival rate was 95.8% for the test group and 95.0% for the control group. The corresponding rates including explantations were 93.9 and 90.0%.Conclusion:The test implant showed superiority in terms of higher mean ISQ values and less adverse soft tissue reactions, both at the single 5-year follow-up visit and during the complete follow-up. In addition, both implants showed an equally high implant survival.

Three-year Outcomes of a Randomized Controlled Trial Comparing a 4.5-mm-Wide to a 3.75-mm-Wide Titanium Implant for Bone Conduction Hearing

“…In the first study, the decrease occurred 2 years after surgery, but was overcome a year later ( 13 ). In the second study, a decrease occurred at the 3-year follow-up, but was also overcome at the 5-year visit ( 9 , 20 ). The dips were also minor and have not corresponded to clinically observed instability or implant loss.…”

Multicenter Clinical Investigation of a New Active Osseointegrated Steady-State Implant System

“…The investigational device introduces piezoelectric technology as a new way to deliver sound vibrations to the skull bone and to overcome the need for significant bone excavation that is associated with current implantable electromagnetic transducers ( 2 ). The flat piezoelectric actuator is placed on the bone surface, firmly attached to the same type of osseointegrated fixture used in percutaneous ( 7 ) and passive transcutaneous BCHIs ( 8 ). While no bone cavity is required, in the present investigation a certain degree of bone removal was performed in most subjects to create a flat bone surface underneath the actuator.…”

“…While percutaneous BCHIs are highly effective, one drawback is that local adverse reactions and revision operations in the area of the skin-penetration may occur. Recent publications report a single mild skin reaction in 20 to 30% of the implants and no revision surgery in a 3 to 5 year follow-up ( 7 , 30 ). Transcutaneous systems have been shown to be associated with less skin complications ( 31 ).…”

“…The piezoelectric element consists of a slim ceramic sandwich-structure, which is contained within a titanium casing that can be fixated on top of—instead of in—the bone, thus reducing surgical complexity. For efficient transmission of sound vibrations to the bone and the cochlea, the system uses the same osseointegrated platform as current percutaneous ( 7 ) and passive transcutaneous ( 8 ) BCHIs.…”

Complications of bone-anchored prostheses for individuals with an extremity amputation: A systematic review

“…[ 27 – 29 ] Bone-anchored hearing aids have been developed using this technique and have been applied on a world–wide scale since 1977, with 5-year implant survival rates of 90–95%. [ 30 ] Since its first introduction in 1990 in individuals with amputation, bone-anchored prostheses offer multiple potential benefits for the treatment of selected individuals with amputations experiencing socket-related problems. These potential benefits include improved osseoperception, prosthesis wearing time, a larger hip range of motion, and reduced oxygen consumption while walking,[ 31 – 36 ] which are associated with an improved mobility level, walking ability and overall quality of life.…”