OBJECTIVE: The primary objective was to report on experiences regarding the safety and efficacy of the Vibrant Soundbridge (VSB) using a floating mass transducer (FMT)-partial/total ossicular replacement prosthesis (PORP/TORP) assembly as a treatment for conductive and mixed hearing losses of mild-to-moderate/severe degree. The secondary objective was to gather information regarding device fitting, as well as to refine surgical procedures.
PATIENTS: Five German-speaking adults from 2 European study sites were implanted with a VSB using an FMT-PORP/TORP assembly and evaluated before and after surgery for air-and bone-conduction thresholds and speech recognition performance.
MAIN OUTCOME MEASURES: Evaluating the safety and efficacy of the VSB in combination with a PORP or TORP to treat conductive and mixed hearing loss.
RESULTS: Residual cochlear hearing was unaffected by implantation with the device. Functional gain (measured as the difference between preoperative unaided and postoperative VSB-aided thresholds) could be calculated in 2 of 5 subjects, demonstrating that the VSB is effective in treating bone-conduction hearing losses of moderate/severe degree. Word recognition tests in quiet and noise showed good improvement in 3 of the cases. One patient experienced several other medical problems, making her audiological outcomes limited. One patient was excluded from the study owing to insufficient benefit and subsequently underwent revision surgery with FMT placement at the round window.
CONCLUSION: The use of the VSB, implanted using the FMT-PORP/TORP assembly, was safe in all and efficacious in 3 of the 5 cases in this study. These are patients who may have few, if any, other options to manage their hearing loss.