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

BACKGROUND: Individuals 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 DESIGN: A 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.

DISCUSSION: This 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 REGISTRATION: Netherlands Trial Register (www.trialregister.nl): NTR4580.