Stable benefits of bilateral over unilateral cochlear implantation after two years: A randomized controlled trial

Zon, Alice van; Smulders, Yvette E.; Stegeman, Inge; Ramakers, Geerte G. J.; Kraaijenga, Véronique J. C.; Koenraads, Simone P.C.; Zanten, G. A. Van; Rinia, Albert B.; Stokroos, Robert J.; Free, Rolien; Frijns, Johan H. M.; Huinck, Wendy J.; Mylanus, Emmanuel A. M.; Tange, R. A.; Smit, A.L.; Thomeer, Hans G. X. M.; Topsakal, Vedat; Grolman, Wilko

doi:10.1002/lary.26239

Cited by 34 publications

(47 citation statements)

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“…Between December 2009 and September 2012, 38 participants were included in this study. Nineteen participants were allocated to the simultaneous group and 19 participants to the sequential group ( 14 , 15 , 21 ). Table 1 shows the baseline characteristics.…”

Section: Resultsmentioning

confidence: 99%

“…Data for the current study were collected as a secondary outcome measure as part of a multicenter randomized controlled trial (RCT). The aim of this RCT was comparing simultaneous bilateral cochlear implantation (simultaneous group) to sequential bilateral cochlear implantation with an inter-implant period of 2 years (sequential group) in adult participants with severe to profound bilateral postlingual SNHL ( 14 , 15 ).…”

Section: Methodsmentioning

confidence: 99%

“…Tinnitus burden was a secondary outcome of the original RCT ( 14 , 15 ). The sample size of this RCT was based on the primary outcome, which was the speech-intelligibility-in-noise.…”

Section: Methodsmentioning

confidence: 99%

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Tinnitus after Simultaneous and Sequential Bilateral Cochlear Implantation

et al. 2017

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ImportanceThere is an ongoing global discussion on whether or not bilateral cochlear implantation should be standard care for bilateral deafness. Contrary to unilateral cochlear implantation, however, little is known about the effect of bilateral cochlear implantation on tinnitus.ObjectiveTo investigate tinnitus outcomes 1 year after bilateral cochlear implantation. Secondarily, to compare tinnitus outcomes between simultaneous and sequential bilateral cochlear implantation and to investigate long-term follow-up (3 years).Study designThis study is a secondary analysis as part of a multicenter randomized controlled trial.MethodsThirty-eight postlingually deafened adults were included in the original trial, in which the presence of tinnitus was not an inclusion criterion. All participants received cochlear implants (CIs) because of profound hearing loss. Nineteen participants received bilateral CIs simultaneously and 19 participants received bilateral CIs sequentially with an inter-implant interval of 2 years. The prevalence and severity of tinnitus before and after simultaneous and sequential bilateral cochlear implantation were measured preoperatively and each year after implantation with the Tinnitus Handicap Inventory (THI) and Tinnitus Questionnaire (TQ).ResultsThe prevalence of preoperative tinnitus was 42% (16/38). One year after bilateral implantation, there was a median difference of −8 (inter-quartile range (IQR): −28 to 4) in THI score and −9 (IQR: −17 to −9) in TQ score in the participants with preoperative tinnitus. Induction of tinnitus occurred in five participants, all in the simultaneous group, in the year after bilateral implantation. Although the preoperative and also the postoperative median THI and TQ scores were higher in the simultaneous group, the median difference scores were equal in both groups. In the simultaneous group, tinnitus scores fluctuated in the 3 years after implantation. In the sequential group, four patients had an additional benefit of the second CI: a total suppression of tinnitus compared with their unilateral situation.ConclusionWhile bilateral cochlear implantation can have a positive effect on preoperative tinnitus complaints, the induction of (temporary or permanent) tinnitus was also reported.Clinical Trial RegistrationDutch Trial Register NTR1722.

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Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Tinnitus after Simultaneous and Sequential Bilateral Cochlear Implantation

et al. 2017

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“…Implantation of a second CI can increase access to these cues, and thereby improve sound-localisation accuracy (although it should be noted that sensitivity often remains severely limited) 4 , 17 – 19 . This has led some researchers and clinicians to argue for much more widespread second implantation 20 , 21 . However, a second implant is expensive, risks vestibular dysfunction and the loss of residual acoustic-hearing, and limits access to future treatments and technologies.…”

Section: Introductionmentioning

confidence: 99%

Haptic sound-localisation for use in cochlear implant and hearing-aid users

Fletcher

Zgheib

2020

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Users of hearing-assistive devices often struggle to locate and segregate sounds, which can make listening in schools, cafes, and busy workplaces extremely challenging. A recent study in unilaterally implanted CI users showed that sound-localisation was improved when the audio received by behindthe-ear devices was converted to haptic stimulation on each wrist. We built on this work, using a new signal-processing approach to improve localisation accuracy and increase generalisability to a wide range of stimuli. We aimed to: (1) improve haptic sound-localisation accuracy using a varied stimulus set and (2) assess whether accuracy improved with prolonged training. Thirty-two adults with normal touch perception were randomly assigned to an experimental or control group. The experimental group completed a 5-h training regime and the control group were not trained. Without training, haptic sound-localisation was substantially better than in previous work on haptic sound-localisation. It was also markedly better than sound-localisation by either unilaterally or bilaterally implanted CI users. After training, accuracy improved, becoming better than for sound-localisation by bilateral hearing-aid users. These findings suggest that a wrist-worn haptic device could be effective for improving spatial hearing for a range of hearing-impaired listeners. Users of hearing-assistive devices, such as hearing aids and cochlear implants, often struggle to locate and segregate sounds 1-4. As well as impairing threat detection, this makes listening in complex acoustic environmentssuch as, schools, cafes, and busy workplaces-highly challenging. Cochlear implants (CIs) enable severely-toprofoundly deaf individuals to perceive sound by electrically stimulating the auditory nerve. Recently, it has been shown that this electrical stimulation can be augmented by providing missing sound information through haptic stimulation ("electro-haptic stimulation") 5-11. Historically, a small number of studies in young normal-hearing listeners have explored the possibility of using haptic stimulation on the fingertips to locate sounds 12-15 , but research in this area is extremely sparse. In a recent study by Fletcher et al., it was shown that sound-localisation can be substantially improved in CI users by augmenting the CI signal with haptic stimulation on the wrists 10. This haptic stimulation was derived from audio signals that would be received by behind-the-ear hearing aids or CIs. Localisation accuracy increased after 30 min of training, with the same speech-sample used for both testing and training. In this study, we developed a new signal-processing strategy for haptic sound-localisation, which incorporated linked multi-band compression and wrist sensitivity correction. This was intended to improve haptic sound-localisation accuracy and increase the generalisability of the approach to a wide range of stimuli. The first aim of this study was to assess localisation accuracy with this new signal-processing strategy. To ensure that results were gen...

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“…In 2016, our research group published the first results of a RCT comparing outcomes of BiCI to UCI (with or without contralateral hearing aid (HA), e.g., bimodal). It showed conclusive evidence that BiCI patients have superior results over UCI patients on speech perception in noise and localization of sounds using various behavioral and self-reported outcome measures (Smulders et al, 2016; van Zon et al, 2016). UCI patients in that study received a second CI after 2 years of unilateral CI use, enabling researchers to not only investigate the difference between BiCI and UCI (and bimodal), but also evaluate performances between simultaneous BiCI (simBiCI) and sequential BiCI (UCI/BiCI).…”

Section: Introductionmentioning

confidence: 90%

No Difference in Behavioral and Self-Reported Outcomes for Simultaneous and Sequential Bilateral Cochlear Implantation: Evidence From a Multicenter Randomized Controlled Trial

et al. 2019

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Objective: The primary aim of this study was to longitudinally compare the behavioral and self-reported outcomes of simultaneous bilateral cochlear implantation (simBiCI) and sequential BiCI (seqBiCI) in adults with severe-to-profound postlingual sensorineural hearing loss. Design: This study is a multicenter randomized controlled trial with a 4-year follow-up period after the first moment of implantation. Participants were allocated by randomization to receive bilateral cochlear implants (CIs) either, simultaneously (simBiCI group) or sequentially with an inter-implant interval of 2 years (UCI/seqBiCI group). All sequential patients where encouraged to use their hearing aid on the non-implanted ear over of the first 2 years. Patients were followed-up on an annual basis. The primary outcome was speech perception in noise coming from a source directly in front of the patient. Other behavioral outcome measures were speech intelligibility-in-noise from spatially separated sources, localization and speech perception in quiet. Self-reported outcome measures encompassed questionnaires on quality of life, quality of hearing and tinnitus. All outcome measures were analyzed longitudinally using a linear or logistic regression analysis with an autoregressive residual covariance matrix (generalized estimating equations type). Results: Nineteen participants were randomly allocated to the simBiCI group and 19 participants to the UCI/seqBiCI group. Three participants in the UCI/seqBiCI group did not proceed with their second implantation and were therefore unavailable for follow-up. Both study groups performed equally well on speech perception in noise from a source directly in front of the patient longitudinally. During all 4 years of follow-up the UCI/seqBiCI group performed significantly worse compared to the simBiCI group on spatial speech perception in noise in the best performance situation (8.70 dB [3.96 – 13.44], p < 0.001) and localization abilities (largest difference 60 degrees configuration: -44.45% [-52.15 – -36.74], p < 0.0001). Furthermore, during all years of follow-up, the UCI/seqBiCI group performed significantly worse on quality of hearing and quality of life questionnaires. The years of unilateral CI use were the reason for the inferior results in the UCI/SeqBiCI group. One year after receiving CI2, the UCI/seqBiCI group performance did not statistically differ from the performance of the simBiCI group on all these outcomes. Furthermore, no longitudinal differences were seen in tinnitus burden prevalence between groups. Finally, the complications that occurred during this trial were infection, dysfunction of CI, facial nerve palsy, tinnitus and vertigo. Conclusion: This randomized controlled trial on bilaterally severely hearing impaired participants found a significantly worse longitudinal performance of UCI/seqBiCI compared to simBiCI on multiple behavioral and self-repo...

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Stable benefits of bilateral over unilateral cochlear implantation after two years: A randomized controlled trial

Abstract: 1b Laryngoscope, 127:1161-1168, 2017.

Cited by 34 publications

References 25 publications

Tinnitus after Simultaneous and Sequential Bilateral Cochlear Implantation

Tinnitus after Simultaneous and Sequential Bilateral Cochlear Implantation

Haptic sound-localisation for use in cochlear implant and hearing-aid users

No Difference in Behavioral and Self-Reported Outcomes for Simultaneous and Sequential Bilateral Cochlear Implantation: Evidence From a Multicenter Randomized Controlled Trial

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