Pulcherio Janaina Oliveira Bentivi, Bittencourt Aline Gomes, Burke Patrick Rademaker, Monsanto Rafael da Costa, de Brito Rubens, Tsuji Robinson Koji, Bento Ricardo Ferreira
Department of Otolaryngology, Hospital Central da Polícia Militar, Rio de Janeiro, Brazil.
Department of Otolaryngology, University of São Paulo School of Medicine, São Paulo, Brazil.
PLoS One. 2014 Oct 17;9(10):e110636. doi: 10.1371/journal.pone.0110636. eCollection 2014.
To review the outcomes of the fully implantable middle ear devices Carina and Esteem regarding the treatment of hearing loss.
PubMed, Embase, Scielo, and Cochrane Library databases were searched.
Abstracts of 77 citations were screened, and 43 articles were selected for full review. From those, 22 studies and two literature reviews in English directly demonstrating the results of Carina and Esteem were included.
There were a total of 244 patients ranging from 18 to 88 years. One hundred and 10 patients were implanted with Carina and with 134 Esteem. There were registered 92 males and 67 females. Five studies provided no information about patients' age or gender. From the data available, the follow-up ranged from 2 to 29.4 months.
The comparison of the results about word recognition is difficult as there was no standardization of measurement. The results were obtained from various sound intensities and different frequencies. The outcomes comparing to conventional HAs were conflicting. Nevertheless, all results comparing to unaided condition showed improvement and showed a subjective improvement of quality of life.
There are still some problems to be solved, mainly related to device functioning and price. Due to the relatively few publications available and small sample sizes, we must be careful in extrapolating these results to a broader population. Additionally, none of all these studies represented level high levels of evidence (i.e. randomized controlled trials).
回顾完全植入式中耳装置Carina和Esteem治疗听力损失的效果。
检索了PubMed、Embase、Scielo和Cochrane图书馆数据库。
筛选了77篇引文的摘要，选择43篇文章进行全文审查。其中，纳入了22项直接展示Carina和Esteem结果的英文研究以及两篇文献综述。
共有244例患者，年龄在18至88岁之间。110例患者植入了Carina，134例植入了Esteem。登记的男性有92例，女性有67例。五项研究未提供患者年龄或性别的信息。根据现有数据，随访时间为2至29.4个月。
由于测量没有标准化，因此难以对单词识别结果进行比较。结果是从各种声音强度和不同频率获得的。与传统助听器相比的结果相互矛盾。然而，与未佩戴助听器的情况相比，所有结果均显示有改善，且生活质量有主观改善。
仍有一些问题有待解决，主要与设备功能和价格有关。由于可用的出版物相对较少且样本量较小，我们在将这些结果推广到更广泛的人群时必须谨慎。此外，所有这些研究均未代表高水平的证据（即随机对照试验）。
