Comparison of Bilateral and Unilateral Cochlear Implantation in Adults A Randomized Clinical Trial

被引:43
|
作者
Smulders, Yvette E. [1 ,2 ]
van Zon, Alice [1 ,2 ]
Stegeman, Inge [1 ,2 ]
Rinia, Albert B. [1 ]
van Zanten, Gijsbert A. [1 ,2 ]
Stokroos, Robert J. [3 ]
Hendrice, Nadia [3 ]
Free, Rolien H. [4 ,5 ]
Maat, Bert [4 ,5 ]
Frijns, Johan H. M. [6 ,7 ]
Briaire, Jeroen J. [6 ,7 ]
Mylanus, Emmanuel A. M. [8 ,9 ]
Huinck, Wendy J. [8 ,9 ]
Smit, Adriana L. [1 ,2 ]
Topsakal, Vedat [1 ,2 ]
Tange, Rinze A. [1 ,2 ]
Grolman, Wilko [1 ,2 ]
机构
[1] Univ Med Ctr Utrecht, Dept Otorhinolaryngol Head & Neck Surg, G05-129,POB 85500, NL-3508 GA Utrecht, Netherlands
[2] Univ Med Ctr Utrecht, Brain Ctr Rudolf Magnus, Utrecht, Netherlands
[3] Maastricht Univ, Med Ctr, Dept Otorhinolaryngol Head & Neck Surg, NL-6200 MD Maastricht, Netherlands
[4] Univ Groningen, Univ Med Ctr Groningen, Dept Otorhinolaryngol, NL-9713 AV Groningen, Netherlands
[5] Univ Groningen, Univ Med Ctr Groningen, Grad Sch Med Sci, Res Sch Behav & Cognit Neurosci, NL-9713 AV Groningen, Netherlands
[6] Leiden Univ, Med Ctr, Dept Otorhinolaryngol Head & Neck Surg, Leiden, Netherlands
[7] Leiden Univ, Med Ctr, Leiden Inst Brain & Cognit, Leiden, Netherlands
[8] Radboud Univ Nijmegen, Med Ctr, Dept Otorhinolaryngol Head & Neck Surg, NL-6525 ED Nijmegen, Netherlands
[9] Radboud Univ Nijmegen, Med Ctr, Donders Inst Brain Cognit & Behav, NL-6525 ED Nijmegen, Netherlands
关键词
SPEECH-INTELLIGIBILITY; COST-EFFECTIVENESS; DEAFENED ADULTS; SPATIAL HEARING; LOCALIZATION; NOISE; USERS; PERFORMANCE; PERCEPTION; DEAFNESS;
D O I
10.1001/jamaoto.2015.3305
中图分类号
R76 [耳鼻咽喉科学];
学科分类号
100213 ;
摘要
IMPORTANCE The cost of bilateral cochlear implantation (BCI) is usually not reimbursed by insurance companies because of a lack of well-designed studies reporting the benefits of a second cochlear implant. OBJECTIVE To determine the benefits of simultaneous BCI compared with unilateral cochlear implantation (UCI) in adults with postlingual deafness. DESIGN, SETTING, AND PARTICIPANTS A multicenter randomized clinical trial was performed. The study took place in 5 Dutch tertiary referral centers: the University Medical Centers of Utrecht, Maastricht, Groningen, Leiden, and Nijmegen. Forty patients eligible for cochlear implantation met the study criteria and were included from January 12, 2010, through November 2, 2012. The main inclusion criteria were postlingual onset of hearing loss, age of 18 to 70 years, duration of hearing loss of less than 20 years, and a marginal hearing aid benefit. Two participants withdrew from the study before implantation. Nineteen participants were randomized to undergo UCI and 19 to undergo BCI. INTERVENTIONS The BCI group received 2 cochlear implants during 1 surgery. The UCI group received 1 cochlear implant. MAIN OUTCOMES AND MEASURES The primary outcome was the Utrecht Sentence Test with Adaptive Randomized Roving levels (speech in noise, both presented from straight ahead). Secondary outcomes were consonant-vowel-consonant words in silence, speech-intelligibility test with spatially separated sources (speech in noise from different directions), sound localization, and quality of hearing questionnaires. Before any data were collected, the hypothesis was that the BCI group would perform better on the objective and subjective tests that concerned speech intelligibility in noise and spatial hearing. RESULTS Thirty-eight patients were included in the study. Fifteen patients in the BCI group used hearing aids before implantation compared with 19 in the UCI group. Otherwise, there were no significant differences between the groups' baseline characteristics. At 1-year follow-up, there were no significant differences between groups on the Utrecht Sentence Test with Adaptive Randomized Roving levels (9.1 dB, UCI group; 8.2 dB, BCI group; P = .39) or the consonant-vowel-consonant test (median percentage correct score 85.0% in the UCI group and 86.8% in the BCI group; P = .21). The BCI group performed significantly better than the UCI group when noise came from different directions (median speech reception threshold in noise, 14.4 dB, BCI group; 5.6 dB, BCI group; P < .001). The BCI group was better able to localize sounds (median correct score of 50.0% at 60 degrees, UCI group; 96.7%, BCI group; P <. 001). These results were consistent with the patients' self-reported hearing capabilities. CONCLUSIONS AND RELEVANCE This randomized clinical trial demonstrates a significant benefit of simultaneous BCI above UCI in daily listening situations for adults with postlingual deafness.
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收藏
页码:249 / 256
页数:8
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