International Consensus Statements on Intraoperative Testing for Cochlear Implantation Surgery.

OBJECTIVES: A wide variety of intraoperative tests are available in cochlear implantation. However, no consensus exists on which tests constitute the minimum necessary battery. We assembled an international panel of clinical experts to develop, refine, and vote upon a set of core consensus statements. DESIGN: A literature review was used to identify intraoperative tests currently used in the field and draft a set of provisional statements. For statement evaluation and refinement, we used a modified Delphi consensus panel structure. Multiple interactive rounds of voting, evaluation, and feedback were conducted to achieve convergence. RESULTS: Twenty-nine provisional statements were included in the original draft. In the first voting round, consensus was reached on 15 statements. Of the 14 statements that did not reach consensus, 12 were revised based on feedback provided by the expert practitioners, and 2 were eliminated. In the second voting round, 10 of the 12 revised statements reached a consensus. The two statements which did not achieve consensus were further revised and subjected to a third voting round. However, both statements failed to achieve consensus in the third round. In addition, during the final revision, one more statement was decided to be deleted due to overlap with another modified statement. CONCLUSIONS: A final core set of 24 consensus statements was generated, covering wide areas of intraoperative testing during CI surgery. These statements may provide utility as evidence-based guidelines to improve quality and achieve uniformity of surgical practice.

Audiological practice and COVID-19: recommendations that audiological centers can use to maintain the safety and quality of service-expert opinion.

PURPOSE: Audiology is an essential service for some patient groups and some interventions. This article sets forth experience-based recommendations for how audiological centers can continue to safely and effectively function during COVID-19. METHODS: The recommendations are the result of panel discussion and are based on the clinical experience of the panelists/authors. RESULTS: The recommendations cover which patient groups and which interventions should be treated when and whether this can be performed in the clinic or remotely; how to maintain the safety of workplace via optimizing patient flow within the clinic and the sanitation of rooms and equipment; and overcoming communication challenges that COVID-19 intensifies. CONCLUSION: For essential audiological services to continue under COVID-19, safety measures must be implemented and maintained, and treatment and communication strategies must be adapted to offset communication difficulties due to personal protective equipment (PPE) and social distancing and to bolster patient confidence. In short, it is vital that staff feel safe, that patients either feel the clinic is safe enough to visit or that remote treatment may be an option, and that clinics and patients have a broad agreement on the urgency of any needed service. We hope that these recommendations help clinics effectively accomplish these goals.

Auditory brainstem implantation (ABI) in children without neurofibromatosis type II (NF2): communication performance and safety after 24 months of use.

Objectives: To assess the safety and communication performance of auditory brainstem implant (ABI) provision in children who were contraindicated for cochlear implantation and do not have neurofibromatosis type II (NF2).Methods: Communication performance was assessed via a battery of tests up to 24 months after first fitting. Safety was assessed intra-operatively and via post-operative adverse event reports.Results: Ten children participated in the study. The mean communication skills on all 8 tests for which inferential statistics were possible increased significantly from pre-operatively to 12 months and either again increased significantly or remained stable from 12 to 24 months. Communication development was variable: some children achieved high scores while others did not. Two serious adverse events that were device or procedure-related were reported and successfully resolved.Discussion: ABI provision in this population group was safe. Participants' auditory abilities were significantly better after 24 months of ABI use than at pre-implantation. Development was slower than that of children with a cochlear implant but may continue progressing after 24 months of use.Conclusion: ABI provision and use is safe and allows significant auditory development in children without NF2 who are contradicted for cochlear implantation.

Hearing preservation cochlear implantation in children: The HEARRING Group consensus and practice guide.

OBJECTIVES: To provide multidisciplinary cochlear implant teams with a current consensus statement to support hearing preservation cochlear implantation (HPCI) in children, including those children with symptomatic partial deafness (PD) where the intention is to use electric-acoustic stimulation (EAS). The main objectives are to provide guidelines on who is a candidate, how to assess these children and when to implant if Med-El Flex electrode arrays are chosen for implantation. METHODS: The HEARRING group reviewed the current evidence and practice regarding the management of children to be considered for HPCI surgery emphasizing the assessment needed prior to implantation in order to demonstrate the benefits in these children over time. The consensus statement addresses following three key questions: (1) Should these children be treated? (2) How to identify these children? (3) How to manage these children? SUMMARY: The HEARRING group concludes that irrespective of the degree of residual hearing present, the concepts of hearing and structure preservation should be applied in every child undergoing cochlear implantation and that HPCI is a safe and reliable treatment option. Early detection and multidisciplinary assessment are key to the identification of children with symptomatic PD, these children should undergo HPCI as early as possible.

Patient management for cochlear implant recipients in audiology departments: A practice review.

OBJECTIVES: To determine and evaluate the time clinics needed to complete the sub-processes involved in the first-fitting and follow-up fitting of people with a cochlear implant. METHODS: Eight HEARRING clinics completed a questionnaire recording how long it took to complete the sub-processes involved in first-fitting and follow-up fitting cochlear implant recipients. The mean times of clinics and procedures were then compared. RESULTS: Questionnaires on 77 patients were completed. Clinics varied widely on time spent on each sub-process in both first- and follow-up fittings. Total first-fitting times were similar across clinics. Follow-up fitting times varied more across clinics although this may have been due to differences in questionnaire interpretation. DISCUSSION: If a patient management plan can help increasingly busy cochlear implant clinics provide high-quality care more efficiently, essential first steps are determining which procedures are generally performed and how long their performance takes. Until reliable data are gathered, constructing a patient management plan or reaping the potential benefits of its use will remain elusive; clinics will have to find what solutions they can to meet rising workload demands. CONCLUSION: The variation in time spent on each sub-process may suggest that some clinics have more efficient workflow procedures. Compiling a best practice for each process could be instrumental in creating a professional process management plan that would increase efficiency without sacrificing quality of care.

Towards a Unified Testing Framework for Single-Sided Deafness Studies: A Consensus Paper.

BACKGROUND: While hearing aids for a contralateral routing of signals (CROS-HA) and bone conduction devices have been the traditional treatment for single-sided deafness (SSD) and asymmetric hearing loss (AHL), in recent years, cochlear implants (CIs) have increasingly become a viable treatment choice, particularly in countries where regulatory approval and reimbursement schemes are in place. Part of the reason for this shift is that the CI is the only device capable of restoring bilateral input to the auditory system and hence of possibly reinstating binaural hearing. Although several studies have independently shown that the CI is a safe and effective treatment for SSD and AHL, clinical outcome measures in those studies and across CI centers vary greatly. Only with a consistent use of defined and agreed-upon outcome measures across centers can high-level evidence be generated to assess the safety and efficacy of CIs and alternative treatments in recipients with SSD and AHL. METHODS: This paper presents a comparative study design and minimum outcome measures for the assessment of current treatment options in patients with SSD/AHL. The protocol was developed, discussed, and eventually agreed upon by expert panels that convened at the 2015 APSCI conference in Beijing, China, and at the CI 2016 conference in Toronto, Canada. RESULTS: A longitudinal study design comparing CROS-HA, BCD, and CI treatments is proposed. The recommended outcome measures include (1) speech in noise testing, using the same set of 3 spatial configurations to compare binaural benefits such as summation, squelch, and head shadow across devices; (2) localization testing, using stimuli that rove in both level and spectral content; (3) questionnaires to collect quality of life measures and the frequency of device use; and (4) questionnaires for assessing the impact of tinnitus before and after treatment, if applicable. CONCLUSION: A protocol for the assessment of treatment options and outcomes in recipients with SSD and AHL is presented. The proposed set of minimum outcome measures aims at harmonizing assessment methods across centers and thus at generating a growing body of high-level evidence for those treatment options.

Quality standards for bone conduction implants.

CONCLUSION: Bone conduction implants are useful in patients with conductive and mixed hearing loss for whom conventional surgery or hearing aids are no longer an option. They may also be used in patients affected by single-sided deafness. OBJECTIVES: To establish a consensus on the quality standards required for centers willing to create a bone conduction implant program. METHOD: To ensure a consistently high level of service and to provide patients with the best possible solution the members of the HEARRING network have established a set of quality standards for bone conduction implants. These standards constitute a realistic minimum attainable by all implant clinics and should be employed alongside current best practice guidelines. RESULTS: Fifteen items are thoroughly analyzed. They include team structure, accommodation and clinical facilities, selection criteria, evaluation process, complete preoperative and surgical information, postoperative fitting and assessment, follow-up, device failure, clinical management, transfer of care and patient complaints.

Public health implications of obstructive sleep apnea burden.

OBJECTIVE: To assess the implications of obstructive sleep apnea (OSA) burden among Indian children. METHODS: MonteCarlo simulations were performed in order to estimate the number of OSA related obesity cases among Indian children (1-14 y of age) and the number of cases of stroke, coronary heart disease (CHD) and type 2 diabetes, considered as main adverse outcomes of OSA related childhood obesity, according to untreated and treated [adenotonsillectomy (AT) alone and AT associated to continuous positive airway pressure (CPAP)] pediatric OSA. Data used to perform MonteCarlo simulations were derived from a review about current literature exploring OSA related obesity. RESULTS: The analysis on the number of adverse outcomes according to treated and untreated obesity related to OSA showed that treatments reduce the number of obesity cases, resulting in a great reduction of the amount of stroke, CHD and type 2 diabetes cases. However, the cost for treating adverse outcome was higher in patients treated for obesity related to OSA compared to those not receiving any treatment. CONCLUSIONS: The reduction in the number of adverse outcomes due to treatment of obesity related OSA implicates the urgent need for public health policies in providing screening for OSA among children population: an early detection and a consequently prompt reaction to pediatric OSA could improve the burden of OSA related obesity.