1. Proposals to NICE for revised eligibility criteria
Debi Vickers
UCL Speech, Hearing and Phonetic Sciences
Carl Verschuur
Southampton Auditory Implant Programme
Padraig Kitterick
Nottingham Biomedical Research Unit
National Cochlear Implant Users Association, 2018

2. Members of British Cochlear Implant Group (BCIG)
said that candidacy issues are the most important
factor that BCIG council should work on

3. Established BCIG candidacy working group
Aim: to acquire and evaluate evidence on implant candidacy
Members: Debi Vickers, Padraig Kitterick, Carl Verschuur, Carolina Leal, Louise Jenkinson
Compile evidence on the BCIG website:
Update BCIG council
Work with the Adult Cochlear Implant Alliance, providing evidence to support candidacy campaign

4. NICE guidance NICE guidance (2009) based on work published in 2004
Data from adults received implants between 1988 and 2000
Adults had poor hearing (PTA = 115 dB HL in better ear!)
No data from children
Patients implanted after NICE guidance likely to have:
Larger and healthier population of nerve cells
Greater access to hearing in non-implanted ear
UKCISG (2004) Ear Hear, 25,

5. Justification for work
NICE may update one of the recommendations in TAG166
Evidence suggests that eligibility criteria in section no longer reflect clinical practice and should be updated
As 1.5 is not linked to 1.1 to 1.4, we propose an update without the need for a Multiple Technology Appraisal
Instead, the update of recommendation 1.5 would take place via consultation with relevant stakeholders
Technology appraisal guidance

6. Goals of work
To determine appropriate audiometric thresholds for future cochlear implant (CI) candidacy criteria in UK
To determine most appropriate frequencies to include
To prepare recommendations for feedback to NICE
To determine the best speech test to use
The criteria are intended as a guide to clinicians, and do not remove the need for assessment by a MDT prior to implantation.

7. Sources of Evidence
Findings ‘Longitudinal comparison of outcomes for children with bilateral hearing aids (HAs) or bilateral CIs’
CII supplement on ‘Issues in CI candidacy’
Adults service evaluation
Consensus meeting on appropriate candidacy criteria
Literature review on important speech frequencies

8. Rosie Lovett, Quentin Summerfield & Deborah Vickers
EVIDENCE SOURCE 1
Longitudinal comparison of outcomes for children with bilateral hearing aids (HAs) or bilateral CIs
Rosie Lovett, Quentin Summerfield & Deborah Vickers
For the past three years, I’ve been coordinating a research project that was run by UCL, in collaboration with NHS hospitals and the University of York. Your department kindly helped to recruit participants into the study. Today, I’m going to describe the background to the study and explain our results.

9. Threshold criteria Mild hearing impairment Profound hearing impairment
In this talk, I’ll be using the phrase ‘criteria of candidacy for cochlear implantation’. I thought I’d start by defining what that means! So the horizontal blue line represents the spectrum of HI.

10. Threshold criteria Hearing aids Cochlear implants
Mild hearing impairment
Profound hearing impairment
Intuitively, one would expect that children with mild to moderate hearing impairment should be provided with HA, and those with profound HI with CI.

11. Criterion of candidacy
Threshold criteria
Hearing aids
Cochlear implants
Mild hearing impairment
Profound hearing impairment
The criteria of candidacy can be represented by the vertical red line- children whose hearing is worse than the criteria are offered cochlear implants, and children with hearing better than the criteria are offered hearing aids.
Specified by unaided PTA.
Criterion of candidacy

12. Research design 43 children with bilateral hearing aids
Mild to profound hearing impairment
28 children with bilateral cochlear implants
Severe to profound hearing impairment

13. Research design 43 children with bilateral hearing aids
Mild to profound hearing impairment
28 children with bilateral cochlear implants
Severe to profound hearing impairment
Assessment one
Children aged 3 to 6 years
Assessment two
Children aged 4 to 7 years

14. Outcome measures Speech perception in quiet Speech perception in noise
Speech perception in babble
Language skills
Sound-source localisation
Health-related quality of life
Chear Auditory Perception Test
Courtesy of Dr Josephine Marriage

15. Outcome measures Speech perception in quiet Speech perception in noise
Speech perception in babble
Language skills
Sound-source localisation
Health-related quality of life

16. Two-frequency audiogram
Summary
Outcome measure
Two-frequency audiogram
Speech perception in quiet
79-83
Speech perception in noise
88-92
Speech perception in babble
78-80
 Unaided two-frequency audiogram ≥ 80 dB HL bilaterally
Lovett, Vickers, Summerfield (2015) Ear Hear

17. EVIDENCE SOURCE 2

18. Residual hearing
Need to consider fitting hearing aids for contralateral ear
With improved techniques for preserving hearing, this is a critical area of consideration
Candidacy needs to be appropriate for Electroacoustic stimulation candidates
Assymetric losses and unusual configurations
Fielden, 2016; Kitterick and Lucas 2016; Sadadcharam, 2016; Verschuur, 2016; Wilson, 2016;

19. Audiometric criteria too restrictive
Hearing aids
Cochlear implants
Mild hearing impairment
Profound hearing impairment
The criteria of candidacy can be represented by the vertical red line- children whose hearing is worse than the criteria are offered cochlear implants, and children with hearing better than the criteria are offered hearing aids.
Specified by unaided PTA.
Criterion of candidacy
Hanvey et al, 2016; Wilson et al., 2016; Leal et al., 2016

20. Audiometric criteria too restrictive
Hearing aids
Cochlear implants
Lower cut-off to 80 dB HL
Need to
consider
unusual
audiograms
Mild hearing impairment
Profound hearing impairment
The criteria of candidacy can be represented by the vertical red line- children whose hearing is worse than the criteria are offered cochlear implants, and children with hearing better than the criteria are offered hearing aids.
Specified by unaided PTA.
Criterion of candidacy
Hanvey et al, 2016; Wilson et al., 2016; Leal et al., 2016

21. Compare to other countries

22. Use of guidelines
Greater flexibility in using criteria when CIs are privately or locally funded
National guidelines associated with National funding

23. Audiometry A range audiometric criteria (bilaterally):
Australia - mean thresholds > 70 dB HL above 1.5 kHz
Sweden - 4FA (0.5, 1, 2 and 4 kHz) ≥70 dBHL (best ear)
Finland – 3FA (0.5, 1 and 2 kHz) ≥ 75 dB HL
Belgium - mean thresholds > 85 dB HL at .5, 1.0, and 2.0 kHz
UK – thresholds > 90 dB HL at both 2 and 4 kHz
Typical pattern - mean thresholds > 70–80 dB HL above 1 kHz

24. Speech testing 85% countries have adult speech-based criteria
76% use word tests in assessment

25. EVIDENCE SOURCE 3: Adult Service Evaluation
Set up adult service evaluation to :
Has current day performance improved since criteria derived
Are word or sentence tests best pre-operative assessment

26. UK Adult Service Evaluation
BCIG service evaluation with 10 UK centres
Assessments in adult CI users at:
pre-implant,
3 months post switch on
9-12 months switch on
Collecting:
Word scores (ABs); scored by word and phoneme
BKB sentences; scored by key word correct

27. UK Adult Service Evaluation
Determine whether current day performance has improved
Mean scores at both 3 and 9-12 months higher than 55%

28. UK Adult Service Evaluation
Determine whether word or sentence tests are best pre-operative assessment

29. UK Adult Service Evaluation
Strong relationship between BKB sentences and AB scores (both word and phoneme)
A BKB score of 50% is equivalent to an AB word score of 19% and an AB phoneme score of 35%
If moved BKB criteria to 70% the approximate AB word score would be 27% and AB phoneme score of 50%
Current criteria
Suggested change

30. Candidacy consensus EVIDENCE SOURCE 4 https://www.cicandidacy.co.uk/
160 stakeholders provided opinions on the candidacy criteria in the UK
41 Individuals from 30 stakeholder organisations completed questionnaires and voted on candidacy statements

31. Appropriateness analysis
Respondents reviewed clinical scenarios (600) to determine if appropriate for implantation and also if necessary
Appropriate (benefits outweigh any harms)
Necessary (improper care not to provide implantation)
≥ 70 dB HL
≥ 80 dB HL
> 90 dB HL
Type of scenarios captured by criteria:
Appropriate and necessary
96%
Appropriate but unnecessary 4%
Inappropriate 0%
80dB HL captures an additional scenarios where it is appropriate but not necessary

32. Appropriateness analysis
Respondents reviewed clinical scenarios (600) to determine if appropriate for implantation and also if necessary
Appropriate (benefits outweigh any harms)
Necessary (improper care not to provide implantation)
≥ 70 dB HL
≥ 80 dB HL
> 90 dB HL
Type of scenarios captured by criteria:
Appropriate and necessary
97%
96%
Appropriate but unnecessary 3% 4%
Inappropriate 0%
80dB HL captures an additional scenarios where it is appropriate but not necessary

33. Appropriateness analysis
Respondents reviewed clinical scenarios (600) to determine if appropriate for implantation and also if necessary
Appropriate (benefits outweigh any harms)
Necessary (improper care not to provide implantation)
≥ 70 dB HL
≥ 80 dB HL
> 90 dB HL
Type of scenarios captured by criteria:
Appropriate and necessary
76%
97%
96%
Appropriate but unnecessary
12% 3% 4%
Inappropriate 0%
80dB HL captures an additional scenarios where it is appropriate but not necessary

34. Literature on Important Speech Frequencies
EVIDENCE SOURCE 5
Literature on Important Speech Frequencies
All configurations of losses should be catered for
Retain two-frequency rule but selected from a range
Low frequency dead regions have devastating impact on speech understanding
Crucial speech frequencies between Hz
Transmit vowel formants
Slightly lower for sentences and running speech
Majority of other countries consider lower frequencies
Vinay et al. (2008); Kates 2013

35. Recommendations to NICE
Amend hearing threshold criteria to ≥80dBHL at two or more frequencies from 500Hz, 1000Hz, 2000Hz, 3000Hz and 4000Hz bilaterally without acoustic hearing aids.
Amend speech criteria for adults to a phoneme score of <50% on the Arthur Boothroyd (AB) monosyllabic word test
For children retain the rule that, speech, language and listening skills less than expected for age and cognitive ability
For all candidates, the multidisciplinary clinical team should consider that cochlear implantation is likely to provide additional benefit beyond conventional hearing aids.

36. Thank you