Cochlear implantation in patients with single-sided deafness

Not Applicable

Completed

• Conditions: Topic: Ear; Subtopic: Ear (all Subtopics); Disease: Ear, nose & throat; Ear, Nose and Throat

• Registration Number: ISRCTN33301739
• Lead Sponsor: ottingham University Hospitals NHS Trust (UK)

Brief Summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25152694

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-05
• Study Completion: 2014-04-01
• Last Update Posted: 10 December 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

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 <10 years duration. Severe to profound deafness defined as having hearing thresholds >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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Sound localisation; Timepoint(s): Before treatment (baseline), after 3 months of CROS use, after 9 months of CI use<br> 2. Speech perception in noise; Timepoint(s): Before treatment (baseline), after 3 months of CROS use, after 9 months of CI use<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. EuroQoL; Timepoint(s): Before treatment (baseline), after 1 and 3 months of CROS use, after 3 and 9 months of CI use<br> 2. Glasgow Benefits Inventory; Timepoint(s): After 1 and 3 months of CROS use, after 3 and 9 months of CI use<br> 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<br> 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<br> 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<br> 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<br>