CINGLE-trial: cochlear implantation for siNGLE-sided deafness, a randomised controlled trial and economic evaluation

Abstract

BackgroundIndividuals with single-sided deafness (SSD) have problems with speech perception in noise, localisation of sounds and with communication and social interaction in their daily life. Current treatment modalities (Contralateral Routing of Sound systems [CROS] and Bone Conduction Devices [BCD]) do not restore binaural hearing. Based on low level of evidence studies, CROS and BCD do not improve speech perception in noise or sound localisation. In contrast, cochlear implantation (CI) may overcome the limitations of CROS and BCD, as binaural input can be restored. Promising results have previously been achieved on speech perception in noise, sound localisation, tinnitus and quality of life.Methods and designA single-center Randomised Controlled Trial (RCT) was designed to compare all treatment strategies for SSD. One hundred and twenty adult single-sided deaf patients (duration of deafness >3 months and maximum 10 years; pure tone average at 0.5, 1, 2, 4 kHz, deaf ear: threshold equal to or more than 70 dB, better ear: threshold of maximum 30 dB) will be included in this trial and randomised to CI, ‘first BCD, then CROS’ or ‘first CROS, then BCD’-groups. After the trial period, patients in the two latter groups may choose with which treatment option they continue. Outcomes of interest are speech perception in noise, sound localization, tinnitus and quality of life. These outcomes will be measured during a baseline visit and at follow up visits, which will take place at 6, 12, 18, 24, 36, 48 and 60 months after onset of treatment. Furthermore, an economic evaluation will be performed and adverse events will be monitored.DiscussionThis RCT allows for a comparison between the two current treatment modalities for single-sided deafness and a new promising treatment strategy, CI, on a range of health outcomes: speech perception in noise, sound localization, tinnitus and quality of life. Additionally, we will be able to answer the question if the additional costs of CI are justified by increased benefits, when compared to current treatment strategies. This study will inform health policy makers with regard to reimbursement of CI.Trial registrationNetherlands Trial Register (www.trialregister.nl): NTR4580.

Comparison of Place-versus-Pitch Mismatch between a Perimodiolar and Lateral Wall Cochlear Implant Electrode Array in Patients with Single-Sided Deafness and a Cochlear Implant

“…One of the inclusion criteria of the study is a pure tone average threshold in the better ear (PTA be ; 500, 1,000, 2,000, and 4,000 Hz) of maximum 30 dB HL in the better ear and of at least 70 dB HL in the poor ear. For details about other inclusion and exclusion criteria, see the study protocol [Peters et al, 2015]. All patient characteristics are summarized in Table 1.…”

Towards a Unified Testing Framework for Single-Sided Deafness Studies: A Consensus Paper

“…The need for reaching a consensus on indication criteria, assessment methods, and outcome measures for generating high-level evidence for implantable and conventional treatment options of SSD and AHL is substantiated in a number of recent publications that have proposed (1) quality standards and minimum outcome measures for every medical discipline [Koroshetz, 2015] and, in particular, for CI in adults and children [Bruce et al, 2015;Kleine Punte and Van de Heyning, 2013], (2) study protocols for the evaluation of the benefits of CI, BCD, and CROS/BiCROS-HAs in treating SSD [Kitterick et al, 2014;Peters et al, 2015a], and (3) recommendations for the identification and evaluation of CI candidates with AHL [Vincent et al, 2015]. The aim of the present paper is to propose a set of guidelines and minimum outcome measures for the evaluation of benefits (or decrements) of CI use -or the use of other conventional treatmentsin subjects with SSD or AHL.…”

Cochlear Implant in Single-Sided Deafness Children and Adults

“…A hypothesis is that routine daily use of the implant leads to residual tinnitus inhibition with prolonged time constants. In some patients this residual inhibition could last overnight (i.e., the switch-off period) and occasionally provides full tinnitus inhibition during day and night as reported regularly in studies with conventional CI candidates with less burdensome tinnitus [43][44][45][46].…”