Topic: Ear
Conditions
Interventions
Contra-lateral routing of signals (CROS): All participants will undergo a 3-month trial of a CROS hearing aid. This device is the current standard of care for single-sided deafness.
Cochlear implantation (CI): Following the trial of the CROS hearing aid, participants may elect to undergo cochlear implantation. This device is the alternative intervention for single-sided deafness
Study Entry : Registration only.
Sponsors
Nottingham University Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years of age or older at the time of entry to the study 2. Able and willing to undertake all assessments required by the study 3. Good understanding of written and spoken English 4. Normal anatomy of the cochlea and auditory system on MRI scanning 5. Medical fitness to undergo general anaesthesia 6. Poorer ear (ear to be implanted): 6.1. Acquired (postl-ingual) severe to profound sensorineural hearing loss of greater than 6 months and 90dB HL at 1 & 4 kHz, and no better than 65 dB HL at 500 Hz 6.2. Minimal benefit from hearing aids defined as scoring less than 50% on Bamford-Kowal-Bench (BKB) sentences presented at 70 dB SPL 7. Better ear (contralateral ear): Normal or near-normal hearing. For the purposes of this study this is defined as hearing thresholds with a pure-tone average (PTA) of = 30 dB HL at 500, 1000, and 2000 Hz Target Gender: Male & Female ; Lower Age Limit 18 years
Exclusion criteria
Exclusion criteria: 1. Evidence of middle-ear pathology based on otologic examination and immitance testing (NB: it is possible that some such cases might be resolvable by medical/surgical treatment, so that the subject may be eventually included) 2. Medical or psychological conditions that contraindicate undergoing surgery 3. Tinnitus as primary motivation for treatment 4. Abnormal anatomy of the cochlea that might prevent complete insertion of the electrode array and abnormalities of the auditory system 5. Hearing loss of neural or central origin, including auditory neuropathy and neurofibromatosis type II 6. Additional handicaps that would prevent or restrict participation in the audiological evaluations 7. Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations which are inherent to the surgical procedure and prosthetic device 8. Any known factor which would limit the benefit obtainable from a cochlear implant device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Sound localisation; Timepoint(s): Before treatment (baseline), after 3 months of CROS use, after 9 months of CI use 2. Speech perception in noise; Timepoint(s): Before treatment (baseline), after 3 months of CROS use, after 9 months of CI use | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. EuroQoL; Timepoint(s): Before treatment (baseline), after 1 and 3 months of CROS use, after 3 and 9 months of CI use 2. Glasgow Benefits Inventory; Timepoint(s): After 1 and 3 months of CROS use, after 3 and 9 months of CI use 3. Glasgow Hearing Aid Benefit Profile; Timepoint(s): Before treatment (baseline), after 1 and 3 months of CROS use, after 3 and 9 months of CI use 4. Health Utilities Index Mark 3; Timepoint(s): Before treatment (baseline), after 1 and 3 months of CROS use, after 3 and 9 months of CI use 5. Speech Spatial Qualities; Timepoint(s): Before treatment (baseline), after 1 and 3 months of CROS use, after 3 and 9 months of CI use 7. Tinnitus Functional Index; Timepoint(s): Before treatment (baseline), after 1 and 3 months of CROS use, after 3 and 9 months of CI use | — |
Countries
United Kingdom
Outcome results
None listed