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Original Investigation |

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

Yvette E. Smulders, MD1,2; Alice van Zon, MD1,2; Inge Stegeman, PhD1,2; Albert B. Rinia, MD1; Gijsbert A. Van Zanten, PhD1,2; Robert J. Stokroos, MD, PhD3; Nadia Hendrice, MSc3; Rolien H. Free, MD, PhD4,5; Bert Maat, MSc4,5; Johan H. M. Frijns, MD, PhD6,7; Jeroen J. Briaire, PhD6,7; Emmanuel A. M. Mylanus, MD, PhD8,9; Wendy J. Huinck, PhD8,9; Adriana L. Smit, MD1,2; Vedat Topsakal, MD, PhD1,2; Rinze A. Tange, MD, PhD1,2; Wilko Grolman, MD, PhD1,2
[+] Author Affiliations
1Department of Otorhinolaryngology–Head and Neck Surgery, University Medical Center Utrecht, Utrecht, the Netherlands
2Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, the Netherlands
3Department of Otorhinolaryngology–Head and Neck Surgery, Maastricht University Medical Center, Maastricht, the Netherlands
4Department of Otorhinolaryngology–University Medical Center Groningen, Groningen, the Netherlands
5Graduate School of Medical Sciences, Research School of Behavioral and Cognitive Neurosciences, University Medical Center Groningen, Groningen, the Netherlands
6Department of Otorhinolaryngology–Head and Neck Surgery, Leiden University Medical Center, Leiden, the Netherlands
7Leiden Institute for Brain and Cognition, Leiden University Medical Center, Leiden, the Netherlands
8Department of Otorhinolaryngology–Head and Neck Surgery, Radboud University Medical Center, Nijmegen, the Netherlands
9Donders Institute for Brain, Cognition, and Behavior, Radboud University Medical Center, Nijmegen, the Netherlands
JAMA Otolaryngol Head Neck Surg. 2016;142(3):249-256. doi:10.1001/jamaoto.2015.3305.
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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°, 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.

Trial Registration  trialregister.nl Identifier: NTR1722

Figures in this Article

Figures

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Figure 1.
Flowchart of Enrollment

This flowchart shows the number of patients eligible for cochlear implantation in whom the study criteria were assessed. The participants were randomly allocated to unilateral cochlear implantation (UCI) or bilateral cochlear implantation (BCI). All were available for follow-up.

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Figure 2.
The AB-York Crescent of Sound Test Setup

This setup was used to conduct the Utrecht Sentence Test with Adaptive Randomized Roving levels, speech intelligibility test with spatially separated sources, and localization tests. The numbers on the screens represent the answer options, and the numbers above the speakers represent degrees of angle.

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Figure 3.
Quality of Hearing Questionnaires

Preoperative and 1-year postoperative results on 3 quality of hearing questionnaires in 19 patients in the unilateral cochlear implantation (UCI) group and 19 in the bilateral cochlear implantation (BCI) group are shown. NCIQ indicates Nijmegen Cochlear Implant Questionnaire; SSQ, Speech, Spatial, and Qualities Hearing Scale; SSQ1, speech understanding in silence, in background noise, in resonating environments, and on the telephone; SSQ2, spatial listening; SSQ3, quality of hearing; TTO, time trade-off; VAS, visual analog scale.

aSignificant difference at P < .05.

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