Department of Otolaryngology, The University of Melbourne, Melbourne, Australia.
Cochlear Limited, Sydney, Australia.
Eur Arch Otorhinolaryngol. 2024 Feb;281(2):683-691. doi: 10.1007/s00405-023-08133-3. Epub 2023 Aug 8.
To investigate 2-year post-operative hearing performance, safety, and patient-reported outcomes of hearing-impaired adults treated with the Osia 2 System, an active osseointegrated bone-conduction hearing implant that uses piezoelectric technology.
A prospective, multicenter, open-label, single-arm, within-subject clinical study conducted at three tertiary referral clinical centers located in Melbourne, Sydney and Hong Kong. Twenty adult recipients of the Osia 2 System were enrolled and followed up between 12 and 24 months post-implantation: 17 with mixed or conductive hearing loss and 3 with single-sided sensorineural deafness. Safety data, audiological thresholds, speech recognition thresholds in noise, and patient-reported outcomes were collected and evaluated. In addition, pre-and 6-month post-implantation data were collected retrospectively for this recipient cohort enrolled into the earlier study (ClinicalTrials.gov NCT04041700).
Between 6- and 24-month follow-up, there was no statistically significant change in free-field hearing thresholds or speech reception thresholds in noise (p = > 0.05), indicating that aided improvements were maintained up to 24 months of follow-up. Furthermore, improvements in health-related quality of life and daily hearing ability, as well as clinical and subjective measures of hearing benefit remained stable over the 24-month period. No serious adverse events were reported during extended follow-up.
These study results provide further evidence to support the longer term clinical safety, hearing performance, and patient-related benefits of the Osia 2 System in patients with either a conductive hearing loss, mixed hearing loss, or single-sided sensorineural deafness.
ClinicalTrials.gov Identifier: NCT04754477. First posted: February 15, 2021.
研究使用压电技术的主动骨整合骨导听力植入物 Osia 2 系统治疗听力受损成年人的 2 年术后听力表现、安全性和患者报告的结果。
这是一项在墨尔本、悉尼和香港的三个三级转诊临床中心进行的前瞻性、多中心、开放性、单臂、自身对照的临床研究。共招募了 20 名 Osia 2 系统植入者，并在植入后 12 至 24 个月进行随访：17 名患有混合性或传导性听力损失，3 名患有单侧感音神经性耳聋。收集并评估了安全性数据、听力阈值、噪声下言语识别阈值和患者报告的结果。此外，还回顾性地收集了该接受者队列在早期研究（ClinicalTrials.gov NCT04041700）中的植入前和 6 个月后的数据。
在 6 至 24 个月的随访期间，自由场听力阈值或噪声下言语识别阈值没有统计学上的显著变化（p>0.05），表明辅助改善可维持 24 个月的随访。此外，健康相关生活质量和日常听力能力以及听力获益的临床和主观测量在 24 个月的随访期间保持稳定。在延长随访期间，没有报告严重不良事件。
这些研究结果提供了进一步的证据，支持 Osia 2 系统在患有传导性听力损失、混合性听力损失或单侧感音神经性耳聋的患者中的长期临床安全性、听力表现和患者相关获益。
ClinicalTrials.gov 标识符：NCT04754477。首次发布：2021 年 2 月 15 日。
