ABSTRACT
BACKGROUND: Individuals with a unilateral severe-to-profound hearing loss, or single-sided deafness, report difficulty with listening in many everyday situations despite having access to well-preserved acoustic hearing in one ear. The standard of care for single-sided deafness available on the UK National Health Service is a contra-lateral routing of signals hearing aid which transfers sounds from the impaired ear to the non-impaired ear. This hearing aid has been found to improve speech understanding in noise when the signal-to-noise ratio is more favourable at the impaired ear than the non-impaired ear. However, the indiscriminate routing of signals to a single ear can have detrimental effects when interfering sounds are located on the side of the impaired ear. Recent published evidence has suggested that cochlear implantation in individuals with a single-sided deafness can restore access to the binaural cues which underpin the ability to localise sounds and segregate speech from other interfering sounds. METHODS/DESIGN: The current trial was designed to assess the efficacy of cochlear implantation compared to a contra-lateral routing of signals hearing aid in restoring binaural hearing in adults with acquired single-sided deafness. Patients are assessed at baseline and after receiving a contra-lateral routing of signals hearing aid. A cochlear implant is then provided to those patients who do not receive sufficient benefit from the hearing aid. This within-subject longitudinal design reflects the expected care pathway should cochlear implantation be provided for single-sided deafness on the UK National Health Service. The primary endpoints are measures of binaural hearing at baseline, after provision of a contra-lateral routing of signals hearing aid, and after cochlear implantation. Binaural hearing is assessed in terms of the accuracy with which sounds are localised and speech is perceived in background noise. The trial is also designed to measure the impact of the interventions on hearing- and health-related quality of life. DISCUSSION: This multi-centre trial was designed to provide evidence for the efficacy of cochlear implantation compared to the contra-lateral routing of signals. A purpose-built sound presentation system and established measurement techniques will provide reliable and precise measures of binaural hearing. TRIAL REGISTRATION: Current Controlled Trials http://www.controlled-trials.com/ISRCTN33301739 (05/JUL/2013).
ABSTRACT
CONCLUSION: The Harmony processor was found to be reliable, comfortable and offered a substantially increased battery life compared with the previous generation processor. No significant improvement in speech understanding with HiRes was demonstrated from objective measures, but the majority of subjects showed a clear subjective preference for the combination HiRes 120/Harmony processor. OBJECTIVES: To evaluate experience with the Harmony™ sound processor, together with the HiRes 120 strategy. METHODS: Postlingually deafened adults implanted with a CII or HiRes 90K were included and divided into three groups: (1) experienced users using the Platinum body-worn processor; (2) experienced users who had been using other processors; (3) new users with the Harmony processor from first fitting. The latter group entered a randomized crossover protocol where half were initially fitted with HiRes and half with HiRes 120. The initial strategy was used for 3 months and the alternative for a further 3 months. Speech perception tests and questionnaires were performed. RESULTS: The study included 65 subjects. Implementing HiRes 120 was straightforward. The speech test group results did not show significant differences between HiRes and HiRes 120. However, the questionnaires showed significantly higher ratings for HiRes 120 in some instances. Subjects were highly satisfied with the Harmony processor.
