Table 2.

Hearing outcomes at 6-month follow-up in the group RCI

	Arm CI (N = 21) (mean ± SD)	Arm observation (N = 23) (mean ± SD)	p value*	CI versus “observation” mean difference adjusted for baseline value, estimations at 6-month follow-up†
				mean difference	95% CI	p value
Speech-in-noise recognition (SNR50 in dB at baseline)
SpeNbe	3.7±9.7	5.6±9.6
S0N0	1.4±8.2	1.7±3.8
SbeNpe	−0.6±10	2.2±11.1
Speech-in-noise recognition (SNR50 in dB at 6-month follow-up)
SpeNbe	−1.0±8	2.2±7.9	0.05	−2.35	(−6.59; 1.89)	0.27
S0N0	−0.9±4.3	0±3.2	0.19	−1.17	(−3.14; 0.80)	0.24
SbeNpe	−3.8±4.5	−3.1±6	0.64	−0.31	(−3.22; 2.61)	0.83
Localization (RMSE in ° at baseline)	73.2±20.7	76.6±20
Localization (RMSE in ° at 6-month follow-up)	63.3±23.4	63.8±19.3	0.80	0.22	(−14.63; 15.07)	0.98

Data are presented as mean ± SD. N, intention-to-treat sample size with 6-month follow-up. CI, cochlear implant; SD, standard deviation; 95% CI, 95% confidence interval; SpeNbe, speech presented to the poor ear and noise to the better ear; SbeNpe, noise presented to the poor ear and speech to the better ear; RCI, randomized for CI; SNR50, signal-to-noise ratio for 50% correct word recognition; S0N0, speech and noise collocated and presented from the loudspeaker in front of the subject; RMSE, root mean square error. * Wilcoxon rank-sum test.

^†Estimations are obtained from linear regressions adjusted for the baseline value of the outcome, with a robust estimator of the variance.