Module two: How and when to refer a patient to an implant clinic (NICE guidance) Date of preparation: November 2015

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1 Module two: How and when to refer a patient to an implant clinic (NICE guidance)

2 Module summary Description: This document outlines how and when to refer a patient to an implant clinic based on current clinical guidance and will also look at the candidacy criteria for cochlear implants, bone conduction implants and middle ear implants. This module is broken down into the following topics: 1. Candidacy criteria for hearing implants 2. Who can refer to an implant programme? 3. How an implant programme is structured 4. What happens during an assessment for three different types of hearing implants? Duration: 60 minutes Credits: 1 credit; 60 minutes Author: MED-EL Target audience: Audiologists, clinical scientists and other relevant healthcare professionals in the field of audiology, as well as GP s and healthcare professionals with an interest in auditory implants.

3 Module summary Module overview As part of this module, you will be introduced to the process of referring a patient to an implant clinic for different types of hearing implants. The content aims to optimise consultations with your adult patients who are experiencing hearing loss. After clicking through the presentation, you will then be asked to complete a multiple choice learning quiz. If you answer 80% of all questions correctly, you will be able to download a CPD certificate to certify that you have completed this online training module. Key learning outcomes After completing the module you will be better able to: Understand the criteria for implantation for cochlear, bone conduction and middle ear implants Know who can refer patients to an implant programme when they present with hearing loss, and when and how to refer them Understand how the programme is structured and what happens during an assessment for different hearing implants

4 Candidacy criteria for auditory implants

5 Candidacy criteria for cochlear implants When referring a patient for a cochlear implant assessment at an implant clinic, specific criteria should be met according to NICE guidelines. For people with severe to profound deafness who do not receive adequate benefits from acoustic hearing aids, unilateral cochlear implantation is recommended For adults who are blind, are living with other disabilities and have severe to profound deafness who are not receiving adequate benefit from acoustic hearing aids, simultaneous bilateral cochlear implantation is recommended Severe to profound deafness is defined as: Hearing only sounds that are louder than 90 db HL at frequencies of 2 and 4 khz without acoustic hearing aids Adequate benefit from acoustic hearing aids is defined for this guidance as: A score of 50% or greater on Bamford Kowal Bench (BKB) sentence testing at a sound intensity of 70 db SPL

6 Candidacy criteria for bone conduction implants When referring a patient for a bone conduction assessment at an implant clinic, the following criteria should be met: Unilateral implantation criteria: Permanent bilateral conductive or mixed hearing loss Bilateral conductive or mixed hearing loss where one ear works better than the other Unilateral conductive hearing loss with ear canal stenosis that is unlikely to benefit from meatoplasty; or patients who have had revision surgery and failed to tolerate an air conduction hearing aid Profound unilateral sensorineural hearing loss Otological criteria: Congenital malformations of the middle/external ear like atresia or microtia Where reconstructive surgery for ear canal atresia cannot be performed Chronically discharging ears which do not allow the use of an air-conduction hearing aid Single-sided deafness combined with contralateral conductive hearing loss due to ossicular diseases

7 Candidacy criteria for bone conduction implants Audiological criteria: Average bone-conduction thresholds (0.5-4kHz) should be better than 45dB HL for an ear-level or better than 60dB HL for a bodyworn hearing device Air conduction pure tone average not better than 40 db The speech recognition score should be better than 60% when using a phonetically balanced word list Anatomical and biological criteria: Diseases that might jeopardise osseintegration are a formal contraindication for implant surgery

8 Candidacy criteria for middle ear implants When referring a patient for a middle ear implant assessment at an implant clinic, the following two groups are likely to see benefit: adults with mild to severe sensorineural hearing loss and adults with conductive and mixed hearing loss For adults with mild to severe sensorineural hearing loss, the following criteria should be met: Mild to severe sensorineural hearing loss within the specified shaded range (see picture below) Air Bone gap <10dB Non-progressive hearing loss Inability to wear conventional hearing aids Speech understanding score of 50% or better on recorded monosyllabic word test At 65 dbspl in freefield using hearing aids At the Most Comfortable Listening (MCL) level with headphones Normal middle ear anatomy and function as shown by audiometric, tympanometry, acoustic reflexes test results Absence of retrocochlear or central involvement No skin conditions preventing the attachment of the external audio processor to the head Diagram illustrating mild to severe sensorineural hearing loss within the specified shaded range

9 Candidacy criteria for middle ear implants In the second group, the middle ear implant is used to treat adults with conductive and mixed hearing loss and the following criteria should be met: Mild to severe sensorineural hearing loss within the specified shaded range (see picture below) Air Bone gap <10dB Non-progressive hearing loss Inability to wear conventional hearing aids Speech understanding score of 50% or better on recorded monosyllabic word test At 65 dbspl in freefield using hearing aids At the Most Comfortable Listening (MCL) level with headphones Normal middle ear anatomy and function as shown by audiometric, tympanometry, acoustic reflexes test results Absence of retrocochlear or central involvement No skin conditions preventing the attachment of the external audio processor to the head Diagram to illustrate bone conduction thresholds for conductive and mixed hearing loss, within the shaded range

10 Who can refer to an implant programme?

11 Who can refer to an implant programme Ear, nose and throat (ENT) consultant, audiological physician or audiologist can refer an adult for a hearing implant to an implant clinic.. Some clinics also accept referrals from a general practitioner (GP). The referral is then checked by a locality team lead within an implant programme and if a candidate meets the NICE guidelines for a specific type of implant, the referral can be processed. A map showing all UK and Ireland cochlear implant clinics. A full list including contact details of clinic coordinators is available at: There are 20 implant clinics across UK and Ireland that patients can be referred to if they meet the criteria for implantation: Belfast Regional Cochlear Implant Centre Cardiff Adult Cochlear Implant Programme Dublin Cochlear Implant Programme Emmeline Centre, Cambridge Great Ormond Street Cochlear Implant Programme The Richard Ramsden Centre for Hearing Implants (Manchester) The Midlands Hearing Implant Programme (Adults Service) North East Cochlear Implant Programme North Wales Cochlear Implant Programme Nottingham Auditory Implant Programme The Oxford Cochlear Implant Programme Portland Hospital Cochlear Implant Programme Royal National Throat Nose and Ear Hospital, (London) Adult and Paediatric Cochlear Implant Programme Scottish Cochlear Implant Programme South Wales Cochlear Implant Programme, Bridgend St George s Hospital Auditory Implant Service St Thomas Hospital Hearing Implant Centre University of Southampton Auditory Implant Service West of England Hearing Implant Programmme Yorkshire Auditory Implant Service

12 How an implant programme is structured

13 A typical assessment at an implant clinic A typical assessment in an implant clinic for a patient consists of pre-operative and post-operative stages: Assessment Consultation with ENT surgeons and consultant in audiovestibular medicine Evaluation by the audiological scientists Speech and language assessment CT and MRI scans Other investigations as required For children, home or school visits from the teacher of the hearing impaired Surgical implantation The surgery for insertion of the implant is performed under general anaesthesia and typically lasts 2.5 to 3hrs Intensive support after the operation Regular device programming Hearing and speech language sessions with a speech and language therapist For children, a teacher of the hearing impaired will also support the family Long term management and support Programming ( mapping ) the device Providing on-going assessments to monitor progress Supplying loan equipment and some replacement parts Linking with other professionals involved in the ongoing care of a patient

14 The assessment process

15 Overview of the assessment process When a patient is referred for an auditory implant, the first stage includes a comprehensive assessment. This involves a series of appointments and may take place on several separate occasions. The assessment will indicate whether they are a suitable candidate for an auditory implant, with the expected length of assessment, from referral to operation, usually taking around 18 weeks. This time may vary depending on the needs and situation of the patient, however they must be prepared to commit to the full assessment process if they want to be considered. All UK clinics comply with the relevant guidelines to determine whether a patient is a candidate for an implant. If the assessment indicates that the patient would benefit from, the implant clinics would apply for funding on the patient s behalf.

16 Overview of the assessment process Assessment is a patient-centred, multidisciplinary process that is undertaken by an experienced and specialist team. The aim of the assessment is to identify whether implantation is audiologically and medically suitable for the patient. Core to each unit are clinical scientists in audiology, audiologists, surgeons, speech and language therapists and hearing therapists. As patients with different degrees of hearing loss will be assessed, it is important to understand whether the patient s access to useful hearing will improve significantly. The patient s social and educational environments also need to be evaluated as well as what they themselves expect from the treatment in terms of clinical outcomes. Collaboration and input from patients, families, schools, audiologists, speech and hearing therapists and surgeons will lead to a successful outcome for the candidate.

17 Cochlear implant assessment process Specialist staff experienced in working with the severe/profoundly deaf and in the area of cochlear implantation will carry out a skilled pre-operative assessment made up of the following key components: Medical examination Hearing tests A patient will be sent for an appointment to see a consultant ENT Surgeon, who will have cochlear implant experience The ENT surgeon will carry out an examination of the ears and assess the overall medical fitness of the patient The cause or aetiology of deafness is determined where feasible and the potential impact it could have on health and development is assessed Hearing tests and hearing aid trial are to determine if the patient is likely to gain more auditory benefit from a cochlear implant than conventional hearing aids By doing so, one can determine whether a patient s performance is likely to improve with a cochlear implant Radiological examination Imaging of the cochlear and auditory nerve anatomy of the patient prior to surgery is needed. This is to: Assess whether there are any anatomical problems that can affect the decision to implant Assess what depth of electrode array is possible A CT scan will take place to discover whether an electrode could be inserted into the cochlea NB pregnant women or patients who have recently had another CT scan should not undertake this An MRI (Magnetic Resonance Image) scan may also take place Auditory brainstem response This test involves recording the electrical activity of the patient s hearing pathway, to assess patients with profound hearing loss Responses are measured by placing small recording pads onto the patient s head whilst loud clicks are played via headphones

18 Cochlear implant assessment process (cont.) Hearing aid benefit and lipreading assessment Patients may also take part in an evaluation of their ability to understand speech with and without lipreading. This involves: The patient watching a speaker on a TV screen who says various sentences and repeating back what they have heard The patient being tested using lipreading alone and then lipreading and sound together - this reveals how much a patient relies on lipreading to understand speech and how much their hearing aid(s) support their lipreading Communication assessment The patient will be asked to see a speech and language therapist to evaluate if there are changes in his or her voice quality after receiving an implant The patient will be asked to make a recording of their speech by reading or speaking a short passage which may be recorded Questionnaires Patients are also asked to complete a number of different questionnaires online as a way of: Conveying how a patient feels about their deafness How they think it affects the quality of their life What they are expecting from a cochlear implant Psychology Patients may sometimes be referred to a clinical psychologist or psychiatrist by cochlear implant teams to analyse the psychological status of patient before implantation Patients are asked to discuss their reasons for wanting an implant The purpose of a psychological evaluation is to: Establish that a patient s expectations are realistic Help a patient make a decision on whether or not they would like an implant and whether they would benefit from one

19 Middle ear implant assessment process For a middle ear implant the expected length of assessment from referral to the final consent appointment is usually 18 weeks. The assessment is made up of the following stages: Initial screening appointment The patient will have an initial meeting with an audiological scientist who will: Explain the assessment process and take a detailed case history Discuss the middle ear implant and issues surrounding implantation, expectations and potential outcomes Conduct audiological testing If the patient is suitable to continue then s/he will undergo a full assessment Audiological assessment: The patient is further assessed with regards to their hearing, amplification needs and functional aided hearing abilities. The number of appointments can vary but typically includes: Pre-operative questionnaires Speech Perception tests Medical assessment The meeting with the ENT surgeon involves discussion regarding: Medical history Decisions made regarding any further assessments required Checking the integrity of the cochleae and hearing nerves, so that Magnetic Resonance Imaging (MRI) and possibly Computer Tomography (CT) may be discussed and booked Final ENT consultation The final appointment with the surgeon will involve discussion of: Medical issues surrounding the middle ear implant surgery Surgical risks and side effects (temporary taste disturbance, tinnitus, dizziness, balance impairment, infection, device failure, etc.) Surgical consent

20 Bone conduction implant assessment process A pre-operative assessment for a bone conduction implant normally takes 60 to 90 minutes and involves a number of specialists who make up the multidisciplinary team. These include consultant ENT surgeons, ENT advanced nurse practitioner, audiologist and speech and language therapist. The first appointment normally involves an assessment where a patient is asked a number of questions surrounding the problems being faced. Information is then given about how a bone conduction implant works, how it s fitted, what it looks like, the surgery required, and the advantages, lifestyle limitations and potential disadvantages that come out of the implantation. The patient can also try a bone conduction implant using an external temporary fitting, to give them an indication of what sounds will be like through the device. Please note that not all bone conduction implants are fitted at hearing implant clinics and some are based in audiology departments.

21 Bone conduction implant assessment process The assessment is also likely to involve an audiological assessment, comprised of two main hearing tests: Pure Tone Audiometry (air conduction and bone conduction) The bone conduction implant works by conducting sound directly to the cochlea by bone conduction The bone conduction implant will still work even if the structures of the outer ear, eardrum or ossicles are missing altogether However, at least one working cochlea (inner ear) is needed The hearing ability of the inner ear is measured by the bone conduction thresholds of the pure tone audiogram As the sound quality is not as clear as the actual bone conduction implant, muffling occurs The ability to hear the muffled sound quite well will indicate that the patient s hearing will improve with an implant Some patients may have the opportunity to take the headband home for a week to experience what life would be like with a bone conduction implant. A headband test (simulation of a bone conduction implant) The headband is used to provide patients with a sample of what their hearing will be like with a bone conduction implant A photo to illustrate a headband

22 References National Institute for Health and Care Excellence. NICE technology appraisal guidance [TA166] Available at: Last accessed: Septemer 2010 University of Southampton. Bone Anchored Hearing Aid Programme. Available at Last accessed September 2015 Martini A, Stephens D, Read A, Genes, Hearing, and Deafness: From Molecular Biology to Clinical Practice. Boneconduction implant surgery: 247, Guy s and St. Thomas NHS Trust. Auditory Implant Programme The Middle Ear Implant (MEI) Information for Referrers. Available at: Last accessed: September 2015 Guy s and St. Thomas NHS Trust. Cochlear implant referral criteria. Available at: Last accessed: September 2015 Guy s and St Thomas NHS Trust. Cochlear implants (CI). Available at: Last accessed September 2015 University of Southampton. Guidelines for referral of cochlear implant patients. Available at Last accessed September 2015 St George s Healthcare NHS Trust. St George s Cochlear Implant Programme. Available at fhttps:/ Last accessed September 2015 British Cochlear Implant Group. Implant centres. Available at Last accessed September 2015 National Institute for Health and Care Excellence. Health Technology Appraisal Cochlear Implants for Deafness in Children and Adults. Candidacy for cochlear implantation Available at Last accessed September 2015

23 References ENT Kent Partnership. BAHA Bone Anchored Hearing Aids Patients Information. Available at Last accessed September 2015 Patient.co.uk. Cochlear implants. Available at Last accessed September 2015 Guy s and St Thomas NHS Foundation Trust. Auditory Implant Programme Assessment for Baha Referral Information. Available at cwm0iriahwbwrokhzdqdwc&url=http%3a%2f%2fwww.guysandstthomas.nhs.uk%2fresources%2fourservices%2fsurgery%2faudiology%2fbaha-referral-criteria.pdf&usg=afqjcnfevz6qaexiukxyfxgb-fjns-st5q. Last accessed September 2015 The Newcastle upon Tyne Hospitals NHS Foundation Trust. What Newcastle BAHA Centre does. Available at Last accessed September 2015 South Devon Healthcare NHS Foundation Trust. Patient information, Bone Anchoring Hearing Aid Assessment. Available at Last accessed September 2015 Gloucestershire Hospitals NHS Trust. Bone Anchored Hearing Aids (Baha) Information and Advice for patients, family, their carers and friends. Available at v3oriahvmvhokhcctbqc&url=http%3a%2f%2fwww.gloshospitals.nhs.uk%2fsharepoint111%2fhearing%2520services%2 520Web%2520Documents%2FGHPI1034_08_10.pdf&usg=AFQjCNHrnO3Ye2d01ZvCsCYBOjKQtAiEFA&bvm=bv ,d.d2s. Last accessed September 2015 NHS Commissioning Board. Clinical Commissioning Policy: Bone Anchored Hearing Aids April Available at Last accessed September 2015 Bradford Teaching Hospitals NHS Foundation Trust. Assessment (adults). Available at Last accessed September 2015 MED-EL. Cochlear Implant Pre-Counseling: What to Know. Available at Last accessed September 2015

24 Next steps Now you have completed this learning module, you are now able to move on to the learning quiz for this topic. Following successful completion of these questions (80% or above) you will be able to download an accredited CPD certificate.

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