Comparison Of Early Auditory Ability And Speech Perception In Mandarin-speaking Prelingually Children Between Bilateral Implantation And Unilateral Cochlear Implantation:a Prospective Non-randomized Clinical Trial

Objective To determine the benefits of bilateral cochlear implantation(BCI)compared with unilateral cochlear implantation(UCI)in Mandarin-speaking prelingually children.Methods A single-center prospective non-randomized clinical trial was performed in Peking Union Medical Hospital(PUMCH).Thirty patients in PUMCH from November 2016 to December 2016 were thought to be eligible for cochlear implantation and meet the study criteria.The main inclusion criteria were severe to profound bilateral sensorineural hearing loss,age of 12 and 18 months when performing cochlear implantation and mandarin as the primary language at home.According to the non-randomized method,the patients' parents chose the style of cochlear implantation by themselves.Therefore,20 patients were assigned to undergo BCI and 10 to undergo UCI.The BCI group received 2 cochlear implants while the UCI group received 1 cochlear implant.The primary outcome was score of the spatial hearing of the Speech,Spatial and Qualities of Hearing Scale for parents(SSQ-P).Secondary outcomes were scores on Categories of Auditory Performance(CAP),Speech Intelligibility(SIR),LittlEARS Auditory Questionnaire(LEAQ)and other domains of SSQP questionnaire,speech perception in quiet evaluated with Mandarin Early Speech Perception(MESP)test,speech perception in noise evaluated with Mandarin Pediatric Speech Intelligibility(MPSI)test and spatial hearing evaluated with the Reaching for sound(RFS)test.Results Twenty-nine patients were included in the study because one patient in BCI group withdrew from the study after 6-month follow-up.There were no significant differences between the group's baseline characteristics.At 6-month follow-up,there were no significant differences between groups on CAP(median score,4.00,UCI group;4.00,BCI group;P=0.668),SIR(median score,2.00,UCI group;2.00,BCI group;P=0.573),LEAQ(median score,26.50,UCI group;28.00,BCI group;P=0.769)and partial domains of SSQ-P[median score of spatial hearing,34.86,UCI group;39.03,BCI group;P=0.115;median score of speech perception;60.62,UCI group;58.22,BCI group;P=0.573].The BCI group was better than the UCI group on other qualities of hearing(median score on other qualities of hearing,30.52,UCI group;BCI group;39.75,P=0.012).The UCI group could not be evaluated with the MESP test while only one patient in the BCI group could be tested(average category of MESP,1.0 UCI group;1.0,BCI group).None of the patients in the two groups could be evaluated with MPSI test and RFS test.Both the two groups performed better on CAP,SIR,LEAQ and all domains of SSQ-P than preoperative conditions(P<0.05).At 12-month follow-up,there were no significant differences between groups on CAP(median score,5.00,UCI group;5.00,BCI group;P=0.286),SIR(median score,4.00,UCI group;3.00,BCI group;P=0.164),LEAQ(median score,33.50,UCI group;32.00,BCI group;P=0.126)and partial domains of SSQ-P[median score of speech perception,70.50,UCI group;72.00,BCI group;P=0.330;median score on other qualities of hearing,54.93,UCI group;53.76,BCI group;P=0.910].The BCI group performed significant better than the UCI group on spatial hearing(median score of spatial hearing,36.00,UCI group;44.00,BCI group;P=0.027).5 patients in the UCI group and 8 patients in the BCI group could be evaluated with the MESP test(average category of MESP,3.6,UCI group;3.5,BCI group).1 patient in the UCI group and 3 patients could be assessed by MPSI test.None of the patients in both two groups could participate in the RFS test.Both the two groups performed better than 6-month postoperative recovery on CAP,SIR,LEAQ,and SSQ-P except the spatial hearing domain(P<0.05).There was no significant difference on spatial hearing of SSQ-P between 6-month and 12-month postoperative recovery(UCI group,P=0.799;BCI group,P=0.170).Conclusions This clinical trial demonstrates that there is a significant benefit of BCI above UCI in spatial hearing for Mandarin-speaking prelingually children.In addition,the early auditory ability and speech perception will be improved over time after cochlear implantation.