Marx Mathieu, Costa Nadège, Lepage Benoit, Taoui Soumia, Molinier Laurent, Deguine Olivier, Fraysse Bernard
1Service d'Oto-Rhino-Laryngologie, d'Oto-Neurologie et d'ORL Pédiatrique, Centre Hospitalier Universitaire de Toulouse, Place du Dr Baylac, 31059 Toulouse Cedex 9, France.
Université de Toulouse, CerCo UMR 5549 CNRS, Université Paul Sabatier, Place du Dr Baylac, 31059 Toulouse Cedex 9, France.
BMC Ear Nose Throat Disord. 2019 Feb 4;19:1. doi: 10.1186/s12901-019-0066-7. eCollection 2019.
Single-sided deafness (SSD) and asymmetric hearing loss (AHL) have recently been proposed as a new indication for cochlear implantation. There is still no recommended treatment for these hearing deficits, and most options considered rely on the transfer of sound from the poor ear to the better ear, using Contralateral Routing of the Signal (CROS) hearing aids or bone conduction (BC) devices. In contrast, cochlear implantation allows the poor ear to be stimulated and binaural hearing abilities to be partially restored. Indeed, most recently published studies have reported an improvement in the spatial localisation of an incoming sound and better speech recognition in noisy environments after cochlear implantation in SSD/AHL subjects. It also provides consistent relief of tinnitus when associated. These encouraging hearing outcomes raise the question of the cost-utility of this expensive treatment in an extended indication.
The final endpoint of this national multicentre study is to determine the incremental cost-utility ratio (ICUR) of cochlear implantation in comparison to the current standard of care in France through simple observation, using a randomised controlled trial. Firstly, the study comprises a prospective and descriptive part, where 150 SSD/AHL subjects try CROS hearing aids and a BC device for three weeks each. Secondly, the choice is made between CROS hearing aids, BC implanted device and cochlear implantation. Hearing outcomes and quality of life measurements are described after 6 months for the subjects who chose CROS, BC or declined any option. The subjects who opt for cochlear implantation are randomised between one group where the cochlear implant is inserted without delay and one group of simple initial observation. Hearing outcomes and quality of life measurements are compared after 6 months.
The present study was designed to assess the efficiency of cochlear implantation in SSD/AHL. A favourable cost-utility ratio in this extended indication would strengthen the promising clinical results and justify a reimbursement by the health insurance. The efficiency of other options (CROS, BC) will also be described.
This research has been registered in ClinicalTrials.gov (http://www.clinicaltrials.gov/), the 29th July 2014 under the n°NCT02204618.
单侧耳聋（SSD）和不对称听力损失（AHL）最近被提议作为人工耳蜗植入的新适应症。对于这些听力缺陷仍没有推荐的治疗方法，大多数考虑的选择依赖于使用对侧信号路由（CROS）助听器或骨传导（BC）设备将声音从听力较差的耳朵传递到较好的耳朵。相比之下，人工耳蜗植入可以刺激听力较差的耳朵并部分恢复双耳听力能力。事实上，最近发表的大多数研究都报告称，SSD/AHL受试者在人工耳蜗植入后，传入声音的空间定位得到改善，在嘈杂环境中的语音识别能力也有所提高。当伴有耳鸣时，人工耳蜗植入还能持续缓解耳鸣。这些令人鼓舞的听力结果引发了这样一个问题，即在扩大适应症的情况下，这种昂贵治疗的成本效益如何。
这项全国性多中心研究的最终终点是通过一项随机对照试验，通过简单观察来确定与法国当前标准治疗相比，人工耳蜗植入的增量成本效益比（ICUR）。首先，该研究包括一个前瞻性描述性部分，150名SSD/AHL受试者分别试用CROS助听器和骨传导设备三周。其次，在CROS助听器、植入式骨传导设备和人工耳蜗植入之间做出选择。对于选择CROS、骨传导或拒绝任何选择的受试者，在6个月后描述听力结果和生活质量测量情况。选择人工耳蜗植入的受试者被随机分为两组，一组立即植入人工耳蜗，另一组进行简单的初始观察。6个月后比较听力结果和生活质量测量情况。
本研究旨在评估人工耳蜗植入在SSD/AHL中的有效性。在这个扩大适应症的情况下，有利的成本效益比将加强有前景的临床结果，并证明医疗保险报销的合理性。其他选择（CROS、骨传导）的有效性也将得到描述。
本研究已于2014年7月29日在ClinicalTrials.gov（http://www.clinicaltrials.gov/）注册，注册号为NCT02204618。
