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1 EXECUTIVE SUMMARY Academic in Confidence data removed Cochlear Europe Limited supports this appraisal into the provision of cochlear implants (CIs) in England and Wales. Inequity of access to CIs is a critical issue, with demonstrable differences between regions and disparity occurring based on age. Evidence clearly supports the clinical and cost effectiveness of CIs in adults and children with bilateral severe to profound sensorineural hearing loss who receive limited or no benefit from hearing aids (HAs). Despite this, the current level and method of provision remains inadequate. Many children and adults who could benefit from CIs are unable to gain access within the NHS current target waiting time of 18-weeks. Lack of funding is of major concern, even for unilateral implants and particularly for adults. Many centres in England are provided with insufficient funds by budget holders to cover CIs for both adults and children, resulting in the prioritisation of children over adults. Of particular concern, the Welsh Assembly Government has completely stopped funding adult cochlear implantation. Virtually no bilateral implants are funded for children or adults. Due to the current level of funding, penetration (in terms of prevalence) is low, at 1% for adults and 50% for children, and overall only 5% of these are bilaterals. In an examination of CI recipients per million population, the UK has 52 implanted children per million population and 45 implanted adults. These overall numbers are significantly lower than that of other major European countries, with 52 children and 78 adults for Sweden, and 65 children and 53 adults for Germany. When looking specifically at the availability of paediatric bilaterals, the rate of 5% for this group compares unfavourably with estimated rates of 70% in Sweden and 85% in Norway, where bilateral implantation, rather than unilateral implantation, is now rapidly becoming the default for children. There is an urgent requirement for these issues to be addressed in England and Wales. In order to improve patient care, it is essential that the current level of service provision is increased and postcode variation removed. Improving provision over the next 5 years to ensure that all eligible children are funded for implantation and the provision for adults is increased by approximately 30% would result in a total increase in the NHS budget of 9.5 million in Year 1 rising to 65.8 million in Year 5. Penetration would then start to rise towards 7.5% for eligible adults and approach 100% for eligible children. Introduction to deafness There are approximately 613,000 severely or profoundly deaf adults in England and Wales. Prevalence increases with age, with 3% of those over 50 years of age and 8% of those over 70 being severely to profoundly deaf. It is likely that these figures will increase in line with the current ageing population. An estimated 646 children are born in the UK with severe to profound deafness. In children prevalence increases with age with approximately one in every 1,000 children being severely or profoundly deaf at 3 years of age, rising to 2 in every 1,000 children aged 9 to 16 years. Burden of deafness Severe to profound deafness has an impact on a number of areas for both children and adults. Disability ranges from being unable to hear everyday sounds to difficulty in understanding speech at conversational levels and in any level of background noise. A child with severe to profound hearing loss does not receive sufficient sound input and as a consequence, experiences difficulty in hearing language (receptive skills) and developing spoken language (expressive skills), both of which severely impact on the child s communication skills, educational placement and attainment and quality of life. Adults with moderate to profound deafness experience high levels of unemployment and one third rely on government benefits. In addition, in adults who become profoundly deaf the loss of hearing and the associated loss in the ability to communicate have a major impact on their quality of life including their ability to participate in family and community life. Cochlear Implants CIs are individually programmed devices designed to increase the patient s audible threshold level and provide the patient with hearing sensitivity within the normal speech range. A major objective of cochlear implantation is to improve the patient s capacity for understanding speech (speech perception) and for being understood while speaking. A further objective in children is to enable acquisition and retention of speech and language at an age appropriate rate.

2 A range of CIs are currently available that vary on a range of factors including: the reliability of the internal device, processing of sound input, coding of this sound into speech signals, the safety and design of the electrode that delivers these sounds to the cochlea and the cosmetic appearance and usability of the speech processor. Of these, reliability is an important issue for patients, clinicians and budget holders. A high degree of reliability required to avoid both patient distress and the issues and costs associated with device failure and subsequent. Reliability for CIs as a collective group is approximately 92% but does vary considerably between devices. Binaural hearing is an essential goal in providing patients access to sound. The current practice of funding only unilateral implantation provides a unilateral hearing solution for what is a bilateral hearing loss condition. For those patients for whom a contralateral HA is not suitable, bilateral CIs are the only way to provide effective binaural hearing. Bilateral implants can provide significant benefits over a unilateral implant in both adults and children. Speech perception is improved in typical noisy environments as it enables the patient to localise sound, which is critical in employment and educational settings. Benefits of CIs The benefits of CIs in children and adults are considerable and in both groups include improved hearing, speech perception and quality of life. In children additional benefits include improvements in speech production, expressive and receptive language and reading. Studies have also demonstrated the benefits of cochlear implantation in enabling children to enter and succeed in mainstream schooling. A deaf child attending a mainstream school limits the additional cost of educational support required compared with attendance at a special (non mainstream) school. Long term benefits relate to the superior educational outcomes achieved by children and improvements in the level of employment in adults. In both adults and children duration of deafness inversely correlates with outcome; the longer the duration of deafness the poorer the outcome. Patients therefore need to be implanted as soon as possible following diagnosis. In children, strong evidence supports implantation at an early age with children implanted before the age of 2 years both outperforming children implanted at an older age and having the capacity to produce and understand language at a rate and level equal to that of their normally-hearing peers. Current service provision Within England and Wales CIs are currently provided by 20 centres. Within each of these centres clinical management involves four phases: patient selection, surgical implantation, initial tuning and rehabilitation and ongoing maintenance. Patients receive all four phases at a single centre with treatment provided by a multidisciplinary team comprising of physicians, audiologists speech-language therapists, pathologists and rehabilitation specialists. As aforementioned, there is a disparity in the level of service provision across England and Wales. No guidelines exist for service provision and future emphasis must be placed on ensuring a consistent quality of service throughout all centres. Nucleus cochlear implants Nucleus CIs were the first of the multichannel CIs to be developed and commercially released and as a result have the longest efficacy and reliability history. To date over 84,000 patients have received a Nucleus implant worldwide. Following the development of the first Nucleus implant in 1978 there has been a continual improvement of implant systems and speech processor programmes. New systems have been designed with the capacity to implement advanced speech processing technology, to work with improved battery technologies and with options for miniaturising the external sound processor. Cochlear has demonstrated a commitment to developing new speech processors that are compatible with older implants, providing existing patients with the opportunity to upgrade and achieve improved audiological outcomes, an important consideration for budget holders. Currently marketed Nucleus systems include: Nucleus Freedom implant with a straight or curly electrode array, together with Freedom Speech processor (BTE and/or BWP option) Nucleus 24 Double Array implant with a split electrode array, together with SPrint, ESPrit 3G or Freedom Speech processor. This implant is indicated only for patients with cochlear ossification/obliteration.

3 Nucleus Freedom Device benefits and features Nucleus Freedom is the most recent Nucleus system, consisting of a new implant, a new range of external modular speech processors and advanced programming software. Both the implant and speech processor have a number of key features that provide additional benefits to the patient and/or clinician. The implant demonstrates a high level of reliability with cumulative survival percentages of 100% in adults and 99.8% in children at 1.5 years. In addition, the Nucleus Freedom implant is the only CI to provide the clinician with automated Neural Response Telemetry (AutoNRT TM ) that automatically measures electrical thresholds from the auditory nerve in situ and allows the clinician to create an audible program (MAP) before the patient s first programming session and removes reliance on the patient having to provide feedback on threshold levels. AutoNRT is useful for children and difficult-to-fit patients where it is difficult to obtain the required threshold and comfort levels for MAP creation. Both NRT and AutoNRT have been shown to reduce the clinic time required to produce a MAP for the speech processor. The modular Freedom speech processor is available as a body worn, behind the ear (BTE) or mini BTE and provides the patient with a range of flexible speech processing options including SmartSound TM pre-processing, a range of stimulation rates and modes, and a range of speech coding strategies. In clinical studies 67% of patients preferred using slower rates of stimulation when compared to higher rates of stimulation for speech understanding with no statistical difference observed in speech perception scores with the different rates of stimulation. SmartSound TM is a collection of four intelligent input processing technology options which gives patients access to clearer sound in a range of noisy and quiet everyday situations providing additional listening advantages over standard programmes. Each of these options can be tailored to suit the individual s listening needs ensuring maximum hearing benefit in a wide range of listening environments. In clinical studies 85% of patients demonstrated a preference for using SmartSound pre-processing options in noisy situations in order to improve their speech perception. Nucleus Clinical Effectiveness Post-lingual Adults Unilateral CIs Nucleus unilateral implants are clinically effective in improving patients speech perception with patients showing an increase both in word and sentence recognition score tests after implantation. The benchmark study for the current Nucleus implant system (Nucleus Freedom) evaluated postlinguistic adults with bilateral severe-to-profound sensorineural hearing loss with no congenital component. Selection criteria for the trial included: Consonant-Nucleus-Consonant (CNC) word recognition scores of 30% in the best aided condition or Hearing in Noise Test in quiet (HINT-Q) scores of 50% in the ear to be implanted and 60% in the best aided condition. This was the first trial where candidacy inclusion was based on pre-operative CNC word scores rather than sentence scores and as a consequence. CNC word scores in quiet (at 60 db SPL) increased from XXXXXXXXXXXX 3-months postimplantation. The Freedom study was the first time in the history of CIs that CNC word scores above 50% have been achieved by severe to profound users after only 3-months of device use. In line with Cochlear s continuing development programme, the audiological outcomes achieved with Nucleus Freedom were superior compared with the previous Nucleus 24 Contour system: o o Speech understanding (defined as CNC monosyllabic word scores presented at 70 db SPL) in quiet was significantly higher with Nucleus Freedom compared with Nucleus 24 Contour at both 3- XXXXXXXXXXXXXXXXXXXXXXXXX post-implantation. The results for Nucleus Freedom at 3-months were significantly superior to the 6-month scores achieved with Nucleus 24 Contour (p<0.05). In addition to achieving improvements in speech perception, Nucleus implants have also been shown to improve patients quality of life compared with pre-implant levels. Bilateral implants Normal hearing listeners use binaural hearing everyday to understand speech in noisy or reverberant environments and to locate where sound is coming from. It is considered the standard of care to fit suitable patients with bilateral amplification however, while bilateral fittings in children and adults are accepted as standard in the provision of hearing aid (HAs), the provision of bilateral CIs is not. The

4 current practice of providing a unilateral solution for a bilateral condition is in stark contrast to other bilateral conditions as such orthopaedics and corneal grafts. In unilateral CI patients who have good performance with a HA in the non-implanted ear, bilateral auditory input can be obtained by fitting a conventional HA. For CI patients who have poor or no residual hearing in their non-implanted ear the only way to provide effective binaural hearing is with bilateral CIs. The benefits of Nucleus bilateral implants have been shown in adults, with bilateral implants resulting in improved subjective performance and speech recognition (in quiet and in noise) with improvements in speech perception over the unilateral ear in certain noisy listening conditions of up to 50%. Localisation ability is improved from a level where it is only possible to tell which side the sound is from to accuracy within 24 degrees of the actual sound location. Nucleus Clinical Effectiveness Pre-Lingual Children Unilateral CIs In profoundly hearing-impaired children Nucleus implants have been shown to improve speech perception, speech production, intelligibility and language development. In the original Nucleus 24 Contour study following 3-months of implant use: The mean scores for a closed-set speech perception test (ESP test) for children aged 25 months to 4 years (n=75) improved by 36.5% on pattern perception, 44.2% on spondee identification and 35.4% on monosyllable identification. In children 5 years and above (n=98) mean performance for a range of more challenging open-set speech perception tasks improved by 37.1% for the Glendonald Auditory Screening Procedure(GASP), 34.5% for the Lexical Neighbourhood Test (LNT) word recognition and 49.5% for the Hearing in Noise Test (HINT). In addition compared with children with no pre-operative speech perception ability, children with residual hearing pre-operatively demonstrated significantly greater improvements in LNT word recognition post-operatively (p=0.28 at 3-months and p=0.038 at 6-months). Age at implantation has been shown to inversely correlate strongly with the degree of outcome benefits achieved. Children implanted with a Nucleus implant before the age of 2 years show better speech perception and production when compared with those implanted at an older age and may attain normal language skills. However, children implanted after the age of 2 years still gain benefit from a Nucleus implant with evidence that over 50% of those implanted before the age of 5 years exhibit age appropriate language skills similar to those of normal hearing children. Bilateral implants Bilaterally implanted children demonstrate binaural auditory abilities only possible through binaural hearing ability. Studies show improved benefits of bilateral Nucleus implants compared with either a unilateral implant or a unilateral CI plus a HA with regard to speech understanding in quiet and noise and sound localisation. Children fitted with bilateral implants show improved speech perception in quiet and in noise and for sound localisation, this is particularly important when moving into more challenging environments such as secondary schooling. Nucleus Clinical Effectiveness Special patient groups In addition to post-lingual adults and pre-lingual children, Nucleus implants have also been shown to significantly improve open-set speech perception in both pre-lingual adolescents and adults. Children and adults with additional disabilities have also demonstrated to gain significant benefits from implantation compared with their pre-operative baseline. Nucleus Reliability Reliability is a key feature of any CI and must be an essential consideration in the choice of device for both the patient and clinic. A high level of reliability ensures avoidance of additional surgery for removal of a failed device and re-implantation of a new device. The cumulative survival percentage (CSP) for the Nucleus Freedom over a 1.5 year period is 100% for adults and 99.8% for children with cumulative failure percentages of 0% and 0.2% (i.e. for children only 2 in every 1000 implants fail after 1.5 years). Each successive device has shown improved reliability reflecting Cochlear s continuing commitment to development and improvement.

5 Comparison of devices using percentage failures demonstrates the superior reliability of Cochlear s Nucleus implants over other CIs available, with percentage failure rates of 1.97% for Nucleus, 3.23% for Neurelec, 6.98% for Advanced Bionics and 9.01% for MED-EL. Cost Effectiveness An economic analysis, incorporating previous published work, comparing unilateral implantation with standard of care and bilateral implantation in adults and children was conducted. The model used clinical trial data from the main Nucleus studies and mapped the word scores from these to estimate expected changes in utility. The cost per QALY for unilateral Nucleus implants (compared with standard care) was estimated to be 7,145 in adults and 10,542 in children. The cost savings of special schooling in the model for children would reduce the cost per QALY for children to around 5,000. The cost per QALY for Nucleus implants of bilateral implantation compared with unilateral implantation was estimated to be 32,909 in adults and 39,049 in children. The costs for children would be lower taking into account the education cost savings. Budget impact In order to address the current levels of inequity of treatment and reduce the length of waiting times, the level of service provision for CIs needs to be urgently addressed and increased to meet patient demand and improve patient outcomes. All eligible children rather than the current 50% should have access to and receive a CI within the critical time period required to achieve optimum outcomes, while the poor level of penetration for adults should be radically increased. Increasing the level of service provision over the next 5 years to ensure that all eligible children (with bilateral to severe to profoundly sensorineural hearing loss) are funded for implantation and that the level of service provision for adults (with severe to profoundly sensorineural hearing loss) is increased by around 30% will cost the NHS an additional 9.5 million in year 1 increasing to 65.8 in Year 5. This level of provision, if sustained, would allow around 7.5 times as many eligible adults to benefit from implants as is possible at the currently level of implantation and around 100% of eligible children. Conclusion Cochlear Europe supports this appraisal into the provision of CIs in England and Wales. Inequity of access to CIs is a critical issue, with demonstrable differences between regions and disparity occurring based on age. Many children and adults who could benefit from CIs are unable to gain access within the NHS current target waiting time of 18-weeks. Lack of funding is of major concern particularly for adults. Many centres in England are provided with insufficient funds to cover CIs for both adults and children, resulting in the prioritisation of children over adults. Of particular concern, the Welsh Assembly Government has completely stopped funding adult cochlear implantation. Due to the current level of funding, penetration in terms of prevalence is low, at 1% for adults and 50% for children, a rate significantly lower than that of other major European countries. In order to improve patient care there is an urgent requirement for access and funding issues to be addressed and resolved. Improving provision over the next 5 years to ensure that all eligible children are implanted and the provision for adults is increased by around 30% each year would cost the NHS an additional 9.5 million in Year 1 increasing to 65.8 million in Year 5. This would improve current penetration from 1% to 7.5% for adults and would ensure that both adults and children have increased access to both unilateral and bilateral implants. Evidence clearly supports the clinical and cost-effectiveness of CIs in adults and children with bilateral severe to profound sensorineural hearing loss who receive little or no benefit from hearing aids (HAs). Of the CI systems available Nucleus implants have the longest effectiveness and reliability data. The recently released Nucleus Freedom system, consisting of a new implant and external speech processor, provides patients with an advanced implant which has superior reliability when compared with other CIs and a speech processor which, via a range of flexible speech processing options, optimises the potential for maximum hearing benefit in a wide range of listening environments.

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