Comparing cochlear implants with hearing aids in adults with severe hearing loss

Not Applicable

Active, not recruiting

• Conditions: Severe hearing loss; Ear, Nose and Throat; Hearing loss, unspecified

• Registration Number: ISRCTN15352106
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Last Update Posted: 2 September 2024
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 130

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 <60% on the AB Word test when tested in quiet at 70 dBA with acoustic hearing aids
5. Patients in whom history, examination and pre-operative imaging suggests a healthy middle ear in the ear to be implanted, and a structurally normal and fully patent cochlea with no evidence of a widened vestibular aqueduct
6. Patients for whom unilateral cochlear implantation is not recommended by NICE either because they do not meet the definition of severe to profound deafness (pure-tone audiometric threshold equal to or greater than 80 dB HL at two or more frequencies between 500 Hz, 1,000 Hz, 2,000 Hz, 3,000 Hz and 4,000 Hz), or because they meet the definition of adequate benefit from HAs (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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.