Vagle Mai, Bille Michael, Gordon Jensen Ramon
Faculty of Health and Medical Sciences, University of Copenhagen, 2200 Copenhagen, Denmark.
Copenhagen Hearing and Balance Center, Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Copenhagen University Hospital, 2100 Copenhagen, Denmark.
J Clin Med. 2024 May 26;13(11):3111. doi: 10.3390/jcm13113111.
: To examine the surgical, audiological and patient-reported outcomes of the Osia 2 implant. : Data from 14 consecutive subjects undergoing implantation between April 2022 and November 2023 were reviewed. Ten subjects had conductive hearing loss, three had mixed hearing loss and one had single-sided deafness (SSD). Warble tone thresholds, Pure Tone Average (PTA) and Speech Discrimination Score (SDS) in quiet and in noise were determined unaided and aided. The subjective outcome was determined from two standardized questionnaires: (1) International Outcome Inventory for Hearing Aids (IOI-HA) and (2) Speech, Spatial and Qualities of Hearing Scale 12 (SSQ12b). : Unexpected postoperative pain was found in four cases. The warble tone thresholds exhibited a consistent reduction across all frequencies, contributing to a mean decrease of 27 dB in the aided PTA. SDS demonstrated notable improvements, with a 57.3% increase at 50 dB and a 55.6% increase at 65 dB. In noise, SDS exhibited a 43.9% improvement. The mean IOI-HA Score was 3.8, and the mean overall score for SSQ12b was 6.6, with consistent findings across the subgroups. : The Osia device emerges as a promising recommendation for individuals with conductive or mixed hearing loss, possibly also for those with SSD. Its safety and efficacy profile aligns with the broader category of active transcutaneous devices, demonstrating a reduced risk of wound infection compared to percutaneous alternatives. Both audiological assessments and subjective evaluations revealed positive outcomes.
: 研究Osia 2植入体的手术、听力学及患者报告结局。 : 回顾了2022年4月至2023年11月期间连续14例接受植入手术的受试者的数据。10例受试者为传导性听力损失,3例为混合性听力损失,1例为单侧耳聋(SSD)。在未佩戴和佩戴辅助设备的情况下,分别测定了啭音阈值、纯音平均听阈(PTA)以及安静和噪声环境下的言语辨别得分(SDS)。主观结局由两份标准化问卷确定:(1)助听器国际结局量表(IOI-HA)和(2)言语、空间和听力质量量表12(SSQ12b)。 : 4例出现意外的术后疼痛。啭音阈值在所有频率上均呈现一致下降,使佩戴辅助设备后的PTA平均下降27 dB。SDS有显著改善,在50 dB时提高了57.3%,在65 dB时提高了55.6%。在噪声环境下,SDS提高了43.9%。IOI-HA平均得分为3.8,SSQ12b的总体平均得分为6.6,各亚组结果一致。 : Osia设备对于传导性或混合性听力损失患者,可能对SSD患者也是一个有前景的推荐。其安全性和有效性特征与更广泛的有源经皮设备类别相符,与经皮替代设备相比,伤口感染风险降低。听力学评估和主观评价均显示出积极结果。