European Archives of Oto-Rhino-Laryngology | 2021
Long-term audiological benefit with an active transcutaneous bone-conduction device: a retrospective cohort analysis
Abstract
To evaluate long-term audiological, surgical and safety outcomes of a complex patient cohort treated with an active transcutaneous bone-conduction device (tBCD). This retrospective, monocentric cohort analysis involves 31 adults with conductive (CHL) and mixed hearing loss (MHL). For outcome analysis, study results were divided into short-term follow-up data (<\u200912 months) and long-term follow-up data (>\u200912 months). 31 patients with a total person-time of 90.4 years and an average number of 3.2\u2009±\u20091.5 preoperatively performed surgeries on the implanted side were investigated. Mean BCD-aided PTA4 thresholds were significantly lower than unaided PTA4AC before surgery (64.7\u2009±\u200916.1 dB HL; CHL 50.6\u2009±\u200910.6 dB HL; MHL 72.8\u2009±\u200912.8 dB HL) and did not change between short-term (42.3\u2009±\u200913.1 dB HL; CHL 35.8\u2009±\u20096.8 dB HL; MHL 45.2\u2009±\u200914.3 dB HL) and long-term (43.4\u2009±\u200910.0 dB HL; CHL 35.8\u2009±\u20094.3 dB HL; MHL 48.1\u2009±\u20099.6 dB HL) follow-up periods. Speech intelligibility in the Freiburg monosyllables test at 65 dB improved significantly, from 16.3\u2009±\u200921.5% (CHL 26.8\u2009±\u200919.0%; MHL 8.7\u2009±\u200920.5%) in the unaided condition to 82.7\u2009±\u200915.5% (CHL 90.0\u2009±\u200912.2%; MHL 79.4\u2009±\u200916.3%) in the short-term and 85.5\u2009±\u200913.2% (CHL 93.8\u2009±\u20097.9%; MHL 79.5\u2009±\u200913.3%) BCD-aided in the long-term follow-up periods. Ten minor procedure-related and 6 implant-related (5 minor, 1 major) AEs occurred over the total follow-up period. The device provides satisfactory audiological and speech benefit over long-term follow-up periods, up to 7 years. Explant rates were very low, while the overall rate of manageable AEs was high in this complex patient cohort. The device is considered a safe and effective option in the long-term hearing rehabilitation of patients with CHL and MHL.