Severe hearing loss Ear, Nose and Throat Hearing loss, unspecified
Conditions
Interventions
This trial aims to find out whether a certain group of adults who are not currently offered a cochlear implant on the NHS would benefit more from a cochlear implant than they would from using hearing
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years or older 2. Patients with a severe sensorineural hearing loss in both ears (pure-tone audiometric threshold equal to or greater than 70 dB HL) at two or more frequencies (500 Hz, 1,000 Hz, 2,000 Hz, 3,000 Hz and 4,000 Hz) bilaterally without acoustic hearing aids 3. Patients with appropriate hearing aid devices and prescriptions, with a minimum of 3 months having elapsed since any change in devices or prescriptions 4. Patients with a phoneme score = 50% on the AB Word test when tested in quiet at 70 dBA with acoustic hearing aids), or both (as per recommendation 1.5, NICE TA566) 7. Patients who are capable of speaking and understanding the English language 8. Patients who are capable and willing to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Patient characteristics falling outside the indications for use of the trial devices as per their CE marking 2. Inability to undergo speech perception testing and/or inability of audiologist to obtain an accurate measurement of speech perception abilities 3. Patients who would not be able to adhere to trial procedures or complete the trial questionnaires 4. Patients whose hearing loss is suspected or confirmed to be wholly or partly unexplained by anatomic or physiologic abnormalities (non-organic hearing loss) 5. Patients who have a congenital severe hearing loss 6. Any known factor that may restrict the full insertion of the electrode array 7. Patients with any known contraindication for cochlear implantation 8. Patients whose primary concern is the suppression of tinnitus 9. Patients in whom cochlear implantation would present an unacceptable risk to balance function 10. Any serious concerns about medical fitness for surgery or cochlear implantation 11. Participation in other research related to hearing loss while participating in the trial (i.e., until collection of primary outcome), including research that involves any changes to or use of hearing devices, changes to hearing care/management, or duplication of trial outcome assessments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The perception of phonemes as quantified by the phoneme score on the AB word test (a measure of speech understanding) presented at 60 dBA in the best-aided condition (i.e., using the devices that the participant considers will help them hear as well as possible); Timepoint(s): 9 months post first treatment activation (intervention arm: first CI activation; comparator arm: first HA fitting/optimisation) measured by independent blinded assessors. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Phoneme perception measured using the AB Word test at 60 dBA; Timepoint(s): 3, 6 and 9 months following first treatment activation, measured by the audiologist 2. Word perception measured using the AB Word test at 60 dBA; Timepoint(s): 3, 6 and 9 months following first treatment activation 3. Phoneme perception measured using the AB Word test at 70 dBA; Timepoint(s): 9 months following first treatment activation 4. Word perception measured using the AB Word test at 70 dBA; Timepoint(s): 9 months following first treatment activation 5. Sentence perception in quiet measured using the BKB sentence test at 70 dBA; Timepoint(s): 3, 6 and 9 months following first treatment activation 6. Sentence perception in noise measured using the Adaptive BKB sentence test; Timepoint(s): 3, 6 and 9 months following first treatment activation 7. Speech sound discrimination measured using the Phoneme discrimination test; Timepoint(s): 9 months following first treatment activation 8. Device usage measured using device logging; Timepoint(s): 3, 6, and 9 months 9. Audiometric thresholds (aided and unaided) measured using clinical equipment; Timepoint(s): On the day of treatment activation and at 3, 6 (unaided only) and 9 months following first treatment activation 10. Difficulty with listening measured using the 12-item Speech Spatial and Qualities of listening scale (SSQ12); Timepoint(s): 1, 3, 6, and 9 months post first treatment activation 11. Listening effort and fatigue measured using the Effort Assessment Scale (EAS), Fatigue Assessment Scale (FAS), Listening Effort Questionnaire-Cochlear Implant (LEQ-CI); Timepoint(s): 1, 3, 6, and 9 months post first treatment activation 12. Tinnitus severity measured using the Tinnitus Functional Index (TFI); Timepoint(s): 1, 3, 6, and 9 months post first treatment activation 13. Tinnitus loudness measured using the Visual Analogue Scale of Loudness (VAS-L); Timepoint(s): Immediately before and after first treatment activation and at 1, 3, 6, a | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed