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Randomized Controlled Trial
. 2021;26(6):414-424.
doi: 10.1159/000514085. Epub 2021 Mar 31.

Cochlear Implantation and Other Treatments in Single-Sided Deafness and Asymmetric Hearing Loss: Results of a National Multicenter Study Including a Randomized Controlled Trial

Affiliations
Randomized Controlled Trial

Cochlear Implantation and Other Treatments in Single-Sided Deafness and Asymmetric Hearing Loss: Results of a National Multicenter Study Including a Randomized Controlled Trial

Mathieu Marx et al. Audiol Neurootol. 2021.

Abstract

Introduction: Cochlear implantation is a recent approach proposed to treat single-sided deafness (SSD) and asymmetric hearing loss (AHL). Several cohort studies showed its effectiveness on tinnitus and variable results on binaural hearing. The main objective of this study is to assess the outcomes of cochlear implantation and other treatment options in SSD/AHL on quality of life.

Methods: This prospective multicenter study was conducted in 7 tertiary university hospitals and included an observational cohort study of SSD/AHL adult patients treated using contralateral routing of the signal (CROS) hearing aids or bone-anchored hearing systems (BAHSs) or who declined all treatments, and a randomized controlled trial in subjects treated by cochlear implantation, after failure of CROS and BAHS trials. In total, 155 subjects with SSD or AHL, with or without associated tinnitus, were enrolled. After 2 consecutive trials with CROS hearing aids and BAHSs on headband, all subjects chose any of the 4 treatment options (abstention, CROS, BAHS, or cochlear implant [CI]). The subjects who opted for a CI were randomized between 2 arms (CI vs. initial observation). Six months after the treatment choice, quality of life was assessed using both generic (EuroQoL-5D, EQ-5D) and auditory-specific quality-of-life indices (Nijmegen Cochlear implant Questionnaire [NCIQ] and Visual Analogue Scale [VAS] for tinnitus severity). Performances for speech-in-noise recognition and localization were measured as secondary outcomes.

Results: CROS was chosen by 75 subjects, while 51 opted for cochlear implantation, 18 for BAHSs, and 11 for abstention. Six months after treatment, both EQ-5D VAS and auditory-specific quality-of-life indices were significantly better in the "CI" arm versus "observation" arm. The mean effect of the CI was particularly significant in subjects with associated severe tinnitus (mean improvement of 20.7 points ± 19.7 on EQ-5D VAS, 20.4 ± 12.4 on NCIQ, and 51.4 ± 35.4 on tinnitus). No significant effect of the CI was found on binaural hearing results. Before/after comparisons showed that the CROS and BAHS also improved significantly NCIQ scores (for CROS: +7.7, 95% confidence interval [95% CI] = [4.5; 10.8]; for the BAHS: +14.3, 95% CI = [7.9; 20.7]).

Conclusion: Cochlear implantation leads to significant improvements in quality of life in SSD and AHL patients, particularly in subjects with associated severe tinnitus, who are thereby the best candidates to an extension of CI indications.

Keywords: Asymmetric hearing loss; Bone-anchored hearing system; Cochlear implants; Contralateral routing of the signal hearing Aids; Quality of life.

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Conflict of interest statement

The authors have no conflicts of interest to declare.

Figures

Fig. 1
Fig. 1
Flowchart of the study. Number of subjects included, allocated to intervention, lost during follow-up with explanation for the dropouts, and number included in the statistical analysis. SSD, single-sided deafness; AHL, asymmetric hearing loss; CROS, contralateral routing of the signal; BAHS, bone-anchored hearing system; CI, cochlear implant.
Fig. 2
Fig. 2
a–c Comparisons between the “CI” arm and “observation” arm in all subjects of the group RCI, for EQ-5D score (a), EQ-5D VAS (b), NCIQ score (c), at 6-month follow-up. d Comparison between the 2 arms in subjects with severe tinnitus (i.e., baseline VAS ≥60, n = 20). * Statistical significant differences (p < 0.05). CI, cochlear implant; EQ-5D, EuroQoL-5D; NCIQ, Nijmegen Cochlear implant Questionnaire; VAS, Visual Analogue Scale; RCI, randomized for CI.

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