Thank you.

The aim of the exercise is to bring together everyone with an interest in who should be able to receive cochlear implants on the National Health Service in the United Kingdom.

This includes adults who have received cochlear implants, the parents/carers of implanted children, individuals who have been refused cochlear implants, representatives from charities who represent individuals with hearing loss and cochlear implant users, and clinical professionals involved in the delivery of cochlear implantation services in the United Kingdom.

The goal of the exercise is to achieve a consensus within the clinical and patient communities on who should be considered eligible to receive a cochlear implant based on the latest evidence from research, clinical experience, and the lived experiences of patients.

The purpose of the exercise is to create a single unified message about who could benefit from cochlear implantation to guide any future changes to service provision in the UK.

Executive summary
Cochlear implants restore important aspects of hearing in people whose degree of hearing loss means that they cannot benefit from conventional acoustic hearing aids. The British Cochlear Implant Group (BCIG) represents providers of cochlear implantation services for adults and children across the United Kingdom. The BCIG candidacy working group ran a national exercise to find out if there was agreement among the major stakeholders in cochlear implantation (patients, clinicians, national organisations, charities, manufacturers and commissioners) on who should be able to receive a cochlear implant on the NHS in the UK. The provision of cochlear implants in the UK currently follows guidance from the National Institute for Health and Care Excellence (NICE) that recommends cochlear implants for adults and children with profound deafness in both ears who do not receive sufficient benefit from acoustic hearing aids.

Consensus was reached among representatives from over 30 stakeholder organisations. The key points on which consensus was reached were:

• Expanding candidacy to include some groups of adults and children with less profound forms of hearing loss would be appropriate because the benefits would outweigh the risks.
• The current assessment used to determine whether someone receives sufficient benefit from their hearing aids (the BKB sentence test) does not adequately assess the difficulties with listening that adults and children experience in everyday life.
• The process to determine whether someone receives sufficient benefit from their hearing aids should be revised to better assess real-world listening difficulties.
• Assessment procedures should be chosen based on evidence that they are reliable and valid for determining candidacy for cochlear implantation. Different procedures may therefore need to be adopted for different sub-groups of patients who are potential candidates.

Summary of the consensus process
The exercise involved over 30 organisations including cochlear implant centres from around the UK, organisations that represent those with hearing loss and those who use cochlear implants, organisations that represent the clinical professionals involved in providing cochlear implantation, organisations conducting research for cochlear implants, manufacturers of cochlear implants, and those who commission cochlear implantation services.

A stakeholder panel made up of representatives from those organisations were asked to indicate if they considered cochlear implantation appropriate for 600 different patient scenarios. By appropriate, we mean whether the benefits of cochlear implantation outweigh the risks. The stakeholder panel also voted on a range of statements about candidacy.

The choice of patient scenarios for consideration and statements for voting was based on responses to an online survey. The survey asked for views on who should be able to receive a cochlear implant. The survey was completed by 161 individuals including cochlear implant users & parents of implanted children, people who had been refused an implant or would like one, and clinicians and researchers.

Each member of the stakeholder panel first considered their views independently, and then met in person to discuss the patient scenarios and statements. The stakeholders were allowed to change their views after these discussions. The exercise used established scientific methodologies to identify where consensus was reached on the appropriateness of cochlear implantation across the patient groups and on agreement with the statements.

Results of the consensus process
Consensus was reached on the following points:

Appropriateness of cochlear implantation

1. The range of patient groups in which cochlear implantation is appropriate is considerably broader than the range of groups who are currently eligible according to NICE guidance.
2. Cochlear implantation is appropriate for less profound degrees of hearing loss than currently permitted according to NICE guidance.
3. Cochlear implantation can be appropriate where the degree of hearing loss is different in the two ears, and in patient groups where only one ear would be considered appropriate for implantation.
4. Cochlear implantation is not only appropriate when a patient receives insufficient benefit from their hearing aids when listening in quiet, but can also be appropriate when hearing aids provide insufficient benefit only when listening in background noise. Cochlear implantation can also be appropriate in patient groups where speech understanding is not possible or appropriate to measure.
5. Cochlear implantation is not only appropriate where the primary motivation for treatment is the restoration of speech understanding but can also be appropriate where it is for the alleviation of tinnitus.
6. Unilateral and bilateral cochlear implantation can be appropriate for both children and adults. The appropriateness of bilateral implantation varies based on factors including age, degree of hearing loss, whether deafness was acquired early and later in life, whether the patient has an additional sensory impairment, and whether there is a known risk of hearing declining further.
7. Adult patients at risk of ossification (bone growth within the cochlea that could prevent insertion of the implant electrode) should be considered for bilateral implantation.
8. Providing a second cochlear implant is appropriate in some patient groups who have already received one cochlear implant.
9. Counselling on expectations is especially important in cases of unilateral deafness and tinnitus.
10. The time between implantation and the patient experiencing benefit will vary for different patient groups.
11. Benefit from bimodal aiding (the combined use of a cochlear implant in one ear and a hearing aid in the other ear) is likely to increase in the near future.

Access to cochlear implantation

12. The distance that a patient lives from their nearest provider of cochlear implantation services should not be a barrier to accessing cochlear implantation services.
13. A diagnosis of auditory neuropathy spectrum disorder (ANSD) should not be a barrier to accessing cochlear implantation.
14. Reduced mental or physical abilities, or mental health issues, should not be a barrier to accessing cochlear implantation.
15. Children who are borderline candidates and not eligible to be implanted, and who are delayed in their development of speech, language and listening skills suffer because of their lack of access to cochlear implants.

Candidacy assessment process

16. Candidacy criteria in the UK should better align with changes in candidacy that are taking place in other countries.
17. Duration of deafness should be considered as part of the candidacy assessment process.
18. The impact of hearing loss on quality of life should be considered as part of the candidacy assessment process.
19. The way in which candidacy criteria are applied should account for how reliable or unreliable audiometry and speech testing methods are.
20. The multi-disciplinary team (MDT) should have discretion to offer cochlear implantation to patients whose hearing thresholds and/or speech test scores are so close to current candidacy criteria that there is genuine uncertainty over whether they are truly outside the criteria or not.
21. Bilateral hearing aids should be provided routinely to adults with bilateral hearing loss that is of at least a severe degree.

Audiometric definition of eligible patient groups

22. The audiometric frequencies used to determine candidacy should vary depending on the nature of the patient’s audiogram (e.g. different frequencies for rising/reverse slope, flat, and downward-sloping losses).
23. Other frequencies should be considered apart from 2 & 4 kHz.
24. The Speech intelligibility index (SII) should be available as an alternative criterion to the audiogram.

Determining sufficient benefit from acoustic hearing aids

25. The Bamford-Kowal-Bench (BKB) sentence test administered in quiet when the patient is in their best-aided condition is not an accurate way of assessing whether a patient is receiving sufficient benefit from hearing aids.
26. The best-aided condition does not always involve the use of acoustic hearing aids.
27. The assessment of whether a patient is receiving sufficient benefit from their hearing aids should use listening tests that more closely recreate the demands of everyday listening than the BKB sentence test.
28. A combined assessment based on multiple speech tests would be a more appropriate way of determining whether a patient receives sufficient benefit from their hearing aids than an assessment based on a single speech test.
29. The most appropriate listening test for assessing whether a patient is receiving sufficient benefit from their hearing aids varies depending on the characteristics of the patient.
30. Word-based listening tests are more appropriate than sentence-based listening tests for assessing sufficient benefit from hearing aids in some patients.
31. Speech tests are too unreliable to use to establish a specific criterion or cut-off for candidacy, but their results should be considered by the multi-disciplinary team (MDT).
32. The choice of appropriate listening test and cut-off scores for determining insufficient benefit from hearing aids should not be specified in NICE guidance but should instead be defined and updated by a professional group such as the BCIG.