Q & A - updated following the NICE final appraisal determination

The NICE appraisal committee’s determination becomes guidance to the NHS which PCTs are expected to follow. The Secretary of State has directed that the NHS provides funding and resources for medicines and treatments that have been recommended by NICE technology appraisals normally within three months from the date that NICE publishes the guidance.

The answer will be subject to the process outlined above and the child meeting the overall candidature criteria for CIs. Because the NICE recommendations are now actual guidance, CI centres and PCTs would be expected to make decisions in the light of the NICE report, not least because simultaneous CI procedures will avoid the need for a second procedure and additional patient risk later.

Possibly. The NICE report recognises that “some children who have previously received unilateral implants may now be considered to have met the criteria in the current guidance for simultaneous bilateral implantation.” It goes on to state: “in situations where the responsible clinician considers that an additional contralateral cochlear implant would provide sufficient benefit, children should have the option of an additional contralateral implant.” This is also the case for adults who are blind or who have other disabilities that increase their reliance on auditory stimuli.

The NICE report emphasises that a sequential CI implant should only be offered after “a fully informed discussion between the individual person, their carers and clinicians involved in their care.” It also uses the term “sufficient benefit” and it is likely that clinicians will draw on available research and their caseload experience to judge which candidates are likely to derive “sufficient benefit.”

In NHS terms, children usually are defined as becoming adults at the age of 19. The NICE report states that “the Committee was mindful that the duration of deafness and length of time since unilateral implantation could reduce the benefits of any additional contralateral cochlear implant.” However, the word ‘could’ should be noted and the gap between first and second implants is not automatically a key factor. A recent research study conducted by a leading expert in the field, Professor Susan Waltzman at New York State University, concluded that “significant improvement was seen in the second implanted ear and in the bilateral condition for children and adults despite time between implantations or length of deafness. Age at first implantation was a significant variable among children – i.e. the younger the child was implanted with the first CI, the better the performance in the second CI despite length of deafness and time between implantations.” However, there are cases of good outcomes with a second CI even where the first CI was introduced relatively late. This all emphasises the importance of clinical judgement based on the specific case circumstances.

The most important thing is to discuss your circumstances with your clinician and CI centre. However, bear in mind that you will not be only person or family wanting to do this and that CI centres will, inevitably, have to manage a higher caseload and level of enquiries.

Some families have done exactly that. The case for a simultaneous bilateral CI is very strong where there is evidence that second ear would not gain any significant benefit from a hearing aid. The medical case is even stronger for babies and children deafened by meningitis. The cost to the NHS is minimised if the two CIs are implanted simultaneously and the gains to the patient, in terms of early habilitation and only one operation, are maximised.

See answer to earlier question. Many of the children and young adults in the UK who have had second CIs have had a long time interval (up to 15 years) between operations. The international medical consensus paper states: “The maximum delay between the two surgeries in order to avoid contralateral cortical atrophy is not yet known. The duration of deafness is not considered a contraindication for bilateral cochlear implantation because monoaural input may maintain some stimulation of the auditory pathways….Although the time interval between the two surgeries does not seem to be as critical in postlingually deaf adults as in children it should not exceed 12 years”

While bilateral CIs are likely to increasingly become the norm for the future generation, there are many thousands of cochlear implant users around the world who are gaining and will continue to gain immense benefit from one CI alone. A single CI will serve these people very well.

The British Cochlear Implant Group’s web site outlines the risks associated with a CI operation and use of CIs. Anyone contemplating a CI should seek advice from their CI team and their consultant about risks and any matters that concern them.

The important thing is to seek advice from your CI team and consultant. The idea of ‘preserving’ an unimplanted ear for future medical breakthroughs such as cochlea hair cell regeneration has to be weighed against a number of considerations. The key consideration is the advantages of gaining and maximising auditory stimulation on that side vs the uncertainty of having no or minimal auditory stimulation with the associated risk of atrophy. Another key factor is the fact that developments such as hair cell regeneration remain a theoretical, uncertain and distant prospect rather than a near-term prospect. Finally, in the light of an increasing knowledge base arising from explants and reinsertions, you might want to ask your consultant’s advice about the effect of the presence of a modern electrode in the cochlea if you are worried about its effect on the viability of future hair cell regeneration.