Introduction
The aim of the HTA Programme is to ensure that high quality research information on the clinical effectiveness, cost-effectiveness and broader impact of healthcare treatments and tests are produced in the most efficient way for those who plan, provide or receive care from NHS and social care services. The commissioned workstream invites applications in response to calls for research on specific questions which have been identified and prioritised for their importance to the NHS, patients and social care.
Research Question
Are the benefits of a simultaneous bilateral cochlear implantation over unilateral cochlear implantation both clinically relevant and cost effective?
- Patient group: Adults with severe to profound post-lingual deafness who are receiving cochlear implants. Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field.
- Intervention: Simultaneous bilateral cochlear implantation.
- Comparator: Unilateral cochlear implantation.
- Important outcomes: Quality of hearing questionnaire (to include adverse events such as tinnitus); assessment of Quality of Life that includes measures of social participation/wellbeing.
Other outcomes: Speech-intelligibility test with spatially separated sources; rate of complications of surgery/rate of post operative infection; economic evaluation.
Existing Core Outcomes should be included amongst the list of outcomes unless a good rationale is provided to do otherwise.
Applicants are encouraged to report recruitment and findings disaggregated by sex (and other demographic factors where relevant). Applicants are encouraged to use sub-group analysis to examine outcomes affected by age or length of time with hearing impairment. - Setting: Secondary Care – Hospital.
- Study design: A randomised controlled trial with an internal pilot phase to test key trial processes such as recruitment and adherence. Clear stop/go criteria should be provided to inform progression from pilot to full trial.
- Minimum duration of follow-up: 6 months.
Longer-term follow up: If appropriate, researchers should consider obtaining consent to allow potential future follow-up through efficient means (such as routine data) as part of a separately funded study.
Rationale
Although hearing loss in adults does not result in increased mortality, for those used to functioning in a hearing environment, deafness can have a significant impact on quality of life.
The development of deafness in adulthood can be the result of many factors including excessive exposure to noise, infections or genetic factors, and there are more than half a million people older than 16 with severe to profound deafness, representing around 3% of people older than 50 and 8% of those older than 70 years. In many cases these adults gain benefits from acoustic hearing aids but where these do not provide adequate improvement in hearing, they may be recommended for cochlear implants on the NHS.
Current NHS guidance recommends that children who are receiving cochlear implants receive one for each ear (a bilateral cochlear implant), but for adults who have no additional condition that increases their reliance on auditory stimuli for spatial awareness, only one implant is recommended (a unilateral cochlear implant). The number of adults (aged 18 or over) predicted to receive cochlear implants in 2023/24 is 1570.
The use of a bilateral cochlear implant has been shown to have a more positive effect on directional sounds awareness and quality of life than a unilateral cochlear implant, but has a higher cost implication in the immediate term. The National Institute for Health and Care Excellence (NICE) also reports that while bilateral implantation is associated with improved auditory outcomes, it is also associated with an increase in adverse events, namely the development of tinnitus. NICE has therefore called for a trial that examines the benefits of bilateral cochlear implants in adults on patient quality of life and long-term cost implications.
Additional background information
A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.
Making an application
If you would like to apply for this funding opportunity, you can begin your application via the funding opportunity page.
Your application must be submitted online no later than 1pm on the 27th November 2024. Applications will be considered by the HTA Funding Committee at its meeting in January 2025.
Guidance notes and supporting information for HTA Programme applications are available
Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in May 2025.
For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team, other than in unusual circumstances (for example, a lead from a named charity or a unique national expert in a condition).
For such exceptions, each application needs to state the case as to why the same person is included. The shared co-applicant should not divulge application details between teams, and both teams should acknowledge in their application that they are aware of the situation, and that study details have not been shared.
Should you have any queries please contact htacommissioning@nihr.ac.uk.