CONCLUSIONS: The round window (RW) approach in the use of the Vibrant Soundbridge(®) (VSB) is a safe and effective treatment of conductive and mixed hearing losses for a period of more than 3 years of device use. OBJECTIVE: To investigate the long-term safety and efficacy as well as user satisfaction of patients with conductive and mixed hearing losses implanted with the VSB using RW vibroplasty. METHODS: Twelve patients with conductive and mixed hearing losses were evaluated after 40 months of daily VSB use. Safety was assessed by evaluating reports of postoperative medical and surgical complications as well as by changes in bone conduction hearing thresholds. Efficacy outcome measures included aided and unaided hearing thresholds, speech recognition in quiet and in noise and subjective benefit questionnaires. RESULTS: The safety results revealed no significant medical complications. One subject experienced sudden hearing loss after 18-24 months of device use, but still continues to wear the device to her satisfaction. With regard to efficacy, there were no significant changes from short- to long-term results in aided word understanding, functional gain or speech recognition threshold, suggesting that the outcomes are stable over time. Subjective questionnaires revealed either the same or better results compared with the short-term data.
CONCLUSIONS: The round window (RW) approach in the use of the Vibrant Soundbridge(®) (VSB) is a safe and effective treatment of conductive and mixed hearing losses for a period of more than 3 years of device use. OBJECTIVE: To investigate the long-term safety and efficacy as well as user satisfaction of patients with conductive and mixed hearing losses implanted with the VSB using RW vibroplasty. METHODS: Twelve patients with conductive and mixed hearing losses were evaluated after 40 months of daily VSB use. Safety was assessed by evaluating reports of postoperative medical and surgical complications as well as by changes in bone conduction hearing thresholds. Efficacy outcome measures included aided and unaided hearing thresholds, speech recognition in quiet and in noise and subjective benefit questionnaires. RESULTS: The safety results revealed no significant medical complications. One subject experienced sudden hearing loss after 18-24 months of device use, but still continues to wear the device to her satisfaction. With regard to efficacy, there were no significant changes from short- to long-term results in aided word understanding, functional gain or speech recognition threshold, suggesting that the outcomes are stable over time. Subjective questionnaires revealed either the same or better results compared with the short-term data.
Authors: Astrid Wolf-Magele; Viktor Koci; Johannes Schnabl; Patrick Zorowka; Herbert Riechelmann; Georg Mathias Sprinzl Journal: Eur Arch Otorhinolaryngol Date: 2015-09-19 Impact factor: 2.503