Interpreting Changes to China’s Cochlear Implant Guidelines Cochlear implants have been performed in mainland China for more than 15 years. After 2009, with the launch of the national cochlear implant program for poor deaf children, cochlear implants have been introduced in some municipal hospitals with the support of the China Deaf Medical Program. By the end of 2012, nearly 100 clinical centers in mainland China are technically equipped to implant cochlear implants, and the number of patients implanted with cochlear implants has exceeded 20,000. In the midst of the above clinical practice, the development and improvement of guidelines for cochlear implantation is also on the agenda. At the 2005 conference in Changsha, participating otologic surgeons, audiologists, and audiologic rehabilitation staff discussed and developed the first version of the Chinese cochlear implant guidelines; in 2013, a new version of the guidelines was discussed and shaped. The most significant change between the two editions is the change in the implantation criteria. In the 2005 edition of the guidelines, the patient selection criteria for cochlear implants was “severe or profound sensorineural deafness,” but in the 2013 edition, the criteria for adult postlingual deafness was further clarified as “pure tone air conduction hearing threshold measurement >80 dBHL in both ears. If the hearing loss is greater than or equal to 75 dB, a cochlear implant may be considered”. The above changes are in line with the current trend of active interest in adult postlingual deafness cases in China. Domestic cochlear implants have been available for more than 15 years; a large number of children who are deaf have been given free cochlear implants, by the National Cochlear Implant Relief Program for Poor Deaf Children, after it was launched in 2009. The 2013 edition of the guidelines clarifies the auditory indications for cochlear implantation in adults with postlingual deafness, which helps clinicians to provide correct auditory rehabilitation advice to deaf patients; at the same time, the clarification of the criteria also facilitates the emphasis of national financial, disability assistance and medical insurance to the adult postlingual deafness group. Attached: Guidelines for Cochlear Implantation in China (2013). Article source: Chinese Journal of Otolaryngology (2013-03) A cochlear implant is a biomedically engineered device that can help deaf people regain their ability to hear and communicate verbally. Since cochlear implantation is a new technology in the field of medicine and rehabilitation, there is a need for a reference standard for the selection of indications, pre- and post-operative evaluation, surgery, post-operative tuning and auditory speech rehabilitation. The purpose of this guideline is to provide guidance to clinicians, audiologists and speech and language rehabilitators who are involved in this work, so that cochlear implantation in China can be standardized and standardized, thereby improving outcomes and avoiding unnecessary risks. Cochlear implantation involves many fields such as medicine, audiology, biomedical engineering, education, psychology and sociology, and requires the collaboration of otologists, audiologists, speech therapists, rehabilitation teachers, engineers and parents to form a cochlear implant team. Selection of Indications I. Patient Selection Criteria Cochlear implantation is an option for those with severe or profound deafness in both ears, with the lesion localized and diagnosed in the cochlea. Selection criteria for patients with prelingual deafness: 1. severe or profound sensorineural deafness in both ears; 2. the best age should be 12 months to 5 years; 3. wearing appropriate hearing aids and no significant improvement in auditory language ability after 3 to 6 months of aural rehabilitation training; 4. no contraindications to surgery; 5. the family and/or the implant recipient themselves have a correct understanding of the cochlear implant and appropriate expectations; 6. conditions for aural language rehabilitation education The implantation of the cochlear implant should be carried out in accordance with the following conditions The younger the patient is at the time of surgical implantation, the better the outcome, as this maximizes the potential for avoiding auditory sensory deprivation and expanding speech and language skills before the critical period of brain plasticity. Children or adolescents older than 6 years of age need to have some auditory-verbal foundation, a history of hearing aid wear and a history of hearing or speech training since childhood. Ineffective or very poor hearing aids are defined as open phrase recognition ≤ 30% or two-word word recognition ≤ 70% in the best hearing aid listening environment. 2. Selection criteria for patients with postlingual deafness: ①Patients of all ages with postlingual deafness; ②Severe or very severe sensorineural deafness in both ears; ③Ineffective or very poor hearing aids and open phrase recognition rate ≤30%; ④No contraindication to surgery; ⑤Good psychological quality and subjective motivation, correct understanding of cochlear implants and appropriate expectations; ⑥Support from family. The age of onset and duration of deafness of post-speech deafness patients are closely related to the outcome after surgery. Generally speaking, those with early age of onset and longer duration of deafness have poorer results after surgery. In addition, the listening environment in life and work after surgery can also affect the outcome of cochlear implantation. 3. Contraindications to surgery: (1) absolute contraindications, including severe malformations of the inner ear, such as Micheal malformation and cochlear malformation; auditory nerve deficiency; severe mental retardation; inability to cooperate with language training; severe mental illness; acute and chronic inflammation of the middle ear mastoid that has not been cleared; (2) relative contraindications, including poor general condition of the body; uncontrollable epilepsy; and no reliable rehabilitation training conditions. Secretory otitis media and glue ear are not contraindications to surgery. In chronic otitis media with tympanic membrane perforation, if the inflammation is controlled, one-stage or staged surgery can be chosen. One-stage surgery is to cure the middle ear mastoid lesion, repair the tympanic membrane (or fill the mastoid cavity with temporal muscle and close the external ear canal) and perform cochlear implantation at the same time. Staged surgery means removing the lesion first, repairing the tympanic membrane perforation or closing the external ear canal, and performing cochlear implantation 3-6 months later. Pre-operative evaluation 1. Medical history taking: Take medical history and examination to understand the cause of the disease. The focus of otologic history should be on the etiology and pathogenesis of deafness. The patient’s hearing history, history of tinnitus and vertigo, history of ototoxic drug exposure, history of noise exposure, history of systemic acute and chronic infections, past otologic history, developmental factors (systemic or local developmental abnormalities, intellectual development, etc.), family history of deafness, history of hearing aid wear, and other causes such as epilepsy and psychiatric conditions should be understood. Children with deafness should also include: maternal pregnancy history, pediatric birth history, pediatric growth history, and speech development history. The patient’s language ability (e.g., articulation characteristics, clarity of constructions) and language comprehension and communication ability (e.g., oral, lip reading, sign language, written, guessing, etc.) should also be understood. 2.Otological examination includes auricle, external auditory canal, tympanic membrane and eustachian tube, etc. 3, Audiological examination: ① subjective hearing threshold determination: children under 6 years old can use pediatric behavioral audiometry, including behavioral observation audiometry, visual reinforcement audiometry and play audiometry; ② acoustic conductance measurement: including tympanic chamber pressure curve and stapedius muscle reflex; ③ auditory brainstem response (ABR), 40Hz correlation potential (or multi-frequency steady-state evoked potentials); ④ otoacoustic emissions (transient evoked otoacoustic emissions or aberration products (5) speech audiometry: speech threshold test is the threshold of speech perception and speech recognition; speech recognition test includes speech test word list and pediatric speech test word list; (6) hearing aid matching: professional audiologists are required to match hearing aids, which are usually worn in both ears, and after matching, hearing threshold test and speech recognition test should be done, and then auditory language training should be performed for 3-6 months; (7) vestibular function examination (history of vertigo); (8) tympanic capsule examination (for those with vertigo); (9) vestibular function examination (for those with vertigo) The test includes threshold, dynamic range, frequency discrimination, interval discrimination and temporal discrimination, and other psychophysical examinations. Audiological evaluation criteria:①Patients with postlingual deafness:Binaural pure tone air conduction hearing threshold measurement >80dBHL (average of 0.5, 1, 2, 4kHz, WHO standard). A cochlear implant may also be considered if the good ear has less than 30% open phrase recognition and the hearing loss is greater than or equal to 75 dB [see FDA supplemental criteria]; ②Patients with prelingual deafness: For infants and young children, a comprehensive assessment is required after multiple objective audiometric examinations and behavioral audiometry, including: no auditory response at sound output on ABR (120 dBS PL); no response at the loudest output above 2 kHz and >100 dB below 1 kHz for 40 Hz correlation potential detection; no response at 105 dB HL above 2 kHz for multi-frequency steady-state audiometry; no response at all frequencies in both ears for aberration product otoacoustic emissions; no response at the auditory language area (banana chart) for hearing threshold above 2 kHz for helpful sound field audiometry, and speech recognition rate (two-word words) (3) For patients without any residual hearing, cochlear implantation can still be considered if there is a clear auditory response to electrical stimulation of the tympanic capsule. If there is no auditory response to electrical stimulation of the tympanic capsule, the patient or parents should be informed of the situation and they should assume the surgical risk. 4. Imaging evaluation: Imaging is a crucial test for patient selection. A thin layer CT scan of the temporal bone should be routinely done, and if necessary, cranial magnetic resonance, three-dimensional reconstruction of the cochlea and a cross-sectional scan of the inner ear canal should be done. 5. Language ability assessment: For patients with certain language experience or ability, speech ability assessment (language structure and function) should be done, including speech clarity, vocabulary, comprehension, grammar, expression and communication ability; for uncooperative children less than 3 years old, the “parent-child game” video observation method should be used for evaluation. For children younger than 3 years of age who were uncooperative, a “parent-child play” video was used to evaluate the patient’s language ability at this stage. 6.Psychological, intellectual and learning ability assessment: For children over 3 years old who lack language ability, the Schneider Learning Ability Test can be used, and for those under 3 years old, the Greifers Mental Developmental Behavior Assessment Scale can be used. For those suspected of having mental retardation (IQ < 68 on the Hine Learning Ability Assessment and mental developmental quotient < 70 on the Greifers Test) or abnormal psychological behavior, patients should be advised to go to an authoritative institution for further observation, diagnosis and identification. Patients with socio-cultural mental retardation may be considered for cochlear implantation; while patients with non-socio-cultural mental retardation, or ADHD, autism and other mental retardation should be explained to their parents the great difficulties such disorders may bring to their post-operative rehabilitation, and parents should be helped to establish objective psychological expectations. 7. Pediatric or internal medicine evaluation: do a general physical examination and relevant auxiliary examinations. 8. Family conditions and rehabilitation conditions: Families who have received professional training or have regular guidance from a language training teacher can conduct auditory language training for the child at home; otherwise, the child should be sent to a rehabilitation school or institution for deaf children. Preparation for auditory language rehabilitation Patients, parents and teachers should be made aware of the importance of auditory language rehabilitation after cochlear implantation, especially the preparation of how to conduct postoperative rehabilitation training for children with pre-speech deafness and the choice of rehabilitation sites. Pre-operative rehabilitation should be implemented according to the age and hearing and language level of different children. The content of the rehabilitation training should focus on the establishment of auditory awareness and the understanding of the definition of things, so as to prepare the patient for the behavioral experience and learning psychology for the post-operative start-up and rehabilitation training.