Evolution of the candidacy requirements and patient perioperative assessment protocols for cochlear implantation.

Cochlear implantation as an approved clinical therapy ushered in an exciting era of innovation for the treatment of hearing loss. The U.S. Food and Drug Administration approved the use of cochlear implants as a treatment option for adults with profound sensorineural hearing loss in 1985. The landscape for treating adults and children with significant hearing loss has changed dramatically over the last three decades. The purpose of this paper is to examine the evolving regulatory process and changes to clinical care. A significant emerging trend in cochlear implantation is the consideration of steroids to preserve hearing during and following surgery. This parallels the quest for hearing preservation in noise-induced hearing disorders, especially considering the current interest in biological drug therapies in this population. The future will likely usher in an era of combination therapeutics utilizing drugs and cochlear implantation. For over 30+ years and following regulatory compliance, the Rocky Mountain Ear Center has developed an extensive candidacy and outcome assessment protocol. This systematic approach evaluates both unaided and aided auditory performance during candidacy stages and post-implantation. Adjunctive measures of cognition and quality-of-life augment the auditory assessment in specific populations. Practical insights into lessons learned have directed further clinical research and have resulted in beneficial changes to clinical care.

Comprehensive hearing aid assessment in adults with bilateral severe-profound sensorineural hearing loss who present for Cochlear implant evaluation.

PURPOSE: To comprehensively assess and describe functional auditory performance in a group of adults with bilateral, moderate sloping to profound sensorineural hearing loss who were dissatisfied users of well-fit bilateral hearing aids and presented for Cochlear implant evaluation. Participants were evaluated with bilateral hearing aids and after six months of bimodal (Cochlear implant and a contralateral hearing aid) hearing experience with a Cochlear implant and contralateral hearing aid. METHODS: Study participants were assessed using pure tone audiometry, aided speech understanding in quiet (CNC words) and in noise (AzBio sentences at +10 and +5 dB SNR) in the sound field with unilateral and bilateral hearing aids fit to target. Participants completed subjective scales of quality of life, (Health Utilities Index Mark 3), hearing disability, (Speech, Spatial and Qualities of Hearing Scale) and a device use satisfaction scale. Participants ≥55 years were administered the Montreal Cognitive Assessment screening tool. One-hundred enrolled individuals completed baseline evaluations. RESULTS: Aided bilateral mean speech understanding scores were 28% for CNC words and 31%, and 17% for AzBio sentences at a +10 dB, and +5 dB SNR, respectively. Mean scale ratings were 0.46 for overall quality of life and 3.19 for functional hearing ability. Ninety percent of participants reported dissatisfaction with overall hearing performance. CONCLUSIONS: Evaluation results, including functional performance metrics quantifying the deleterious effects of hearing loss for overall wellbeing, underscore that bilateral hearing aids are not an effective treatment for individuals with bilateral, moderate sloping to profound sensorineural hearing loss. Individuals with this degree of hearing impairment, who demonstrate poor aided speech understanding and dissatisfaction with hearing abilities in everyday life, require timely referral to a Cochlear implant clinic for further evaluation.

A Consensus to Revise the Minimum Speech Test Battery-Version 3.

PURPOSE: The Minimum Speech Test Battery (MSTB) for adults was introduced in 1996 (Nilsson et al., 1996) and subsequently updated in 2011 (Advanced-Bionics et al., 2011). The MSTB has been widely used by clinicians as a guide for cochlear implant (CI) candidacy evaluations and to document post-operative speech recognition performance. Due to changes in candidacy over the past 10 years, a revision to the MSTB was needed. METHOD: In 2022, the Institute for Cochlear Implant Training (ICIT) recruited a panel of expert CI audiologists to update and revise the MSTB. This panel utilized a modified Delphi consensus process to revise the test battery and to improve its applicability considering recent changes in CI care. RESULTS: This resulted in the MTSB-Version 3 (MSTB-3), which includes test protocols for identifying not only traditional CI candidates but also possible candidates for electric-acoustic stimulation and patients with single-sided deafness and asymmetric hearing loss. The MSTB-3 provides information that supplements the earlier versions of the MSTB, such as recommendations of when to refer patients for a CI, recommended patient-reported outcome measures, considerations regarding the use of cognitive screeners, and sample report templates for clinical documentation of pre- and post-operative care. Electronic versions of test stimuli, along with all the materials described above, will be available to clinicians via the ICIT website (https://www.cochlearimplanttraining.com). CONCLUSION: The goal of the MSTB-3 is to be an evidence-based test battery that will facilitate a streamlined standard of care for adult CI candidates and recipients that will be widely used by CI clinicians.

Considerations for a Revised Adult Cochlear Implant Candidacy Evaluation Protocol.

OBJECTIVE: To compare the current metrics used in adult cochlear implant candidacy evaluations for consistency and applicability, and to make a recommendation for an updated assessment battery. STUDY DESIGN: Prospective, multicenter, within-subject clinical trial. SETTING: North American cochlear implant programs including private practices, universities, and hospital centers. PATIENTS: One hundred adult hearing aid users scoring 40% or less on monosyllabic words in quiet in the aided test ear who presented for cochlear implantation evaluation. INTERVENTION: Subjects underwent unilateral cochlear implantation. MAIN OUTCOME MEASURES: Speech perception measured via Consonant-Nucleus-Consonant words in quiet and AzBio sentences in noise. Patient-reported hearing disability measured via the Speech, Spatial, and Qualities of Hearing Scale administered preoperatively and at 6 months postoperatively. RESULTS: Significant group mean improvement on all speech perception measures and SSQ subscales postoperatively with possible floor effects observed in objective background noise testing preoperatively and a broad range of variability seen postoperatively. CONCLUSIONS: Consonant-Nucleus-Consonant words are an effective tool to clinically evaluate hearing ability over time. Adjustment of cochlear implant screening protocols to prioritize monosyllabic words over sentences in noise as the chief determining factor appears justified, and this test can be supplemented by the SSQ for a holistic and applicable assessment of cochlear implant candidacy.

Unilateral Cochlear Implants for Severe, Profound, or Moderate Sloping to Profound Bilateral Sensorineural Hearing Loss: A Systematic Review and Consensus Statements.

Importance: Cochlear implants are a treatment option for individuals with severe, profound, or moderate sloping to profound bilateral sensorineural hearing loss (SNHL) who receive little or no benefit from hearing aids; however, cochlear implantation in adults is still not routine. Objective: To develop consensus statements regarding the use of unilateral cochlear implants in adults with severe, profound, or moderate sloping to profound bilateral SNHL. Design, Setting, and Participants: This study was a modified Delphi consensus process that was informed by a systematic review of the literature and clinical expertise. Searches were conducted in the following databases: (1) MEDLINE In-Process & Other Non-Indexed Citations and Ovid MEDLINE, (2) Embase, and (3) the Cochrane Library. Consensus statements on cochlear implantation were developed using the evidence identified. This consensus process was relevant for the use of unilateral cochlear implantation in adults with severe, profound, or moderate sloping to profound bilateral SNHL. The literature searches were conducted on July 18, 2018, and the 3-step Delphi consensus method took place over the subsequent 9-month period up to March 30, 2019. Main Outcomes and Measures: A Delphi consensus panel of 30 international specialists voted on consensus statements about cochlear implantation, informed by an SR of the literature and clinical expertise. This vote resulted in 20 evidence-based consensus statements that are in line with clinical experience. A modified 3-step Delphi consensus method was used to vote on and refine the consensus statements. This method consisted of 2 rounds of email questionnaires and a face-to-face meeting of panel members at the final round. All consensus statements were reviewed, discussed, and finalized at the face-to-face meeting. Results: In total, 6492 articles were identified in the searches of the electronic databases. After removal of duplicate articles, 74 articles fulfilled all of the inclusion criteria and were used to create the 20 evidence-based consensus statements. These 20 consensus statements on the use of unilateral cochlear implantation in adults with SNHL were relevant to the following 7 key areas of interest: level of awareness of cochlear implantation (1 consensus statement); best practice clinical pathway from diagnosis to surgery (3 consensus statements); best practice guidelines for surgery (2 consensus statements); clinical effectiveness of cochlear implantation (4 consensus statements); factors associated with postimplantation outcomes (4 consensus statements); association between hearing loss and depression, cognition, and dementia (5 consensus statements); and cost implications of cochlear implantation (1 consensus statement). Conclusions and Relevance: These consensus statements represent the first step toward the development of international guidelines on best practices for cochlear implantation in adults with SNHL. Further research to develop consensus statements for unilateral cochlear implantation in children, bilateral cochlear implantation, combined electric-acoustic stimulation, unilateral cochlear implantation for single-sided deafness, and asymmetrical hearing loss in children and adults may be beneficial for optimizing hearing and quality of life for these patients.

Remote Programming of Cochlear Implants.

OBJECTIVE: This study investigated the safety and efficacy of remote programming of cochlear implants. STUDY DESIGN: Single-subject design SETTING:: Four North American clinical sites PATIENTS:: Forty cochlear implant recipients aged 12 years or older INTERVENTION:: Subjects had their cochlear implants programmed at a location that was remote from their audiologist using telecommunication with and without the support of a facilitator. MAIN OUTCOME MEASURES: Consonant-Nucleus-Consonant (CNC) word scores and the Speech, Spatial, and Qualities of Hearing Scale-C (SSQ-C) were compared using the subject's in-office MAP (program) and MAPs programmed remotely with and without the assistance of a facilitator. Additional subjective preference data were gathered from subjects and audiologists via questionnaires. RESULTS: MAPs programmed via the three different models did not yield significantly different group mean CNC word scores. No device/procedure-related adverse events occurred. SSQ-C questionnaire results indicated that recipients received similar subjective benefit from familiar in-office, remote-facilitated, and remote-unassisted MAPs. CONCLUSIONS: Remote programming is an effective means of cochlear implant service delivery. The practice was approved by the FDA on November 17, 2017 supported by the results of this study.

Upgrade to Nucleus® 6 in Previous Generation Cochlear™ Sound Processor Recipients.

BACKGROUND: The Nucleus® 6 sound processor is now compatible with the Nucleus® 22 (CI22M)-Cochlear's first generation cochlear implant. The Nucleus 6 offers three new signal processing algorithms that purportedly facilitate improved hearing in background noise. PURPOSE: These studies were designed to evaluate listening performance and user satisfaction with the Nucleus 6 sound processor. RESEARCH DESIGN: The research design was a prospective, single-participant, repeated measures design. STUDY SAMPLE: A group of 80 participants implanted with various Nucleus internal implant devices (CI22M, CI24M, Freedom® CI24RE, CI422, and CI512) were recruited from a total of six North American sites. DATA COLLECTION AND ANALYSIS: Participants had their external sound processor upgraded to the Nucleus 6 sound processor. Final speech perception testing in noise and subjective questionnaires were completed after four or 12 weeks of take-home use with the Nucleus 6. RESULTS: Speech perception testing in noise showed significant improvement and participants reported increased satisfaction with the Nucleus 6. CONCLUSION: These studies demonstrated the benefit of the new algorithms in the Nucleus 6 over previous generations of sound processors.

Method of Speech Stimulus Presentation Impacts Pediatric Speech Recognition: Monitored Live Voice Versus Recorded Speech.

OBJECTIVE: To characterize the potential differences in speech understanding performance on word and sentence tests assessed using live voice and recorded speech measures for pediatric cochlear implant (CI) recipients. STUDY DESIGN: This clinical study used a combination of retrospective and prospective study designs exploring within-subject performance for recorded versus monitored-live-voice presentation methods on pediatric word and sentence measures. METHODS: Word and/or sentence recognition was obtained for 29 pediatric CI recipients using both recorded stimuli and monitored-live-voice (MLV) within a single-test session with a single experimenter for each session. The difference score was calculated for word and sentence measures allowing a comparison across conditions. SETTING: Ambulatory. PATIENTS: Pediatric patients aged 4 to 17 years. INTERVENTION(S): Cochlear implants. MAIN OUTCOME MEASURE(S): Speech recognition testing. RESULTS: There was a significant difference between recorded and MLV speech understanding with mean recorded word scores being 13-percentage points lower than those obtained via MLV. CONCLUSIONS: The results of this project suggest that the use of MLV for the assessment of speech perception in the pediatric Audiology clinic may overinflate children's performance and thereby runs the risk of failing to identify poorer or at-risk performance.

CENTRAL AUDTIORY DEVELOPMENT IN CHILDREN WITH HEARING LOSS: CLINICAL RELEVANCE OF THE P1 CAEP BIOMARKER IN HEARING-IMPAIRED CHILDREN WITH MULTIPLE DISABILITIES.

OBJECTIVE: First, we review the development and plasticity of the central auditory pathways in infants and children with hearing loss who are fitted with cochlear implants (CIs). Second, we describe case studies demonstrating the clinical utility of the P1 central auditory evoked potential (CAEP) for evaluating cortical auditory maturation in the rapidly increasing number of cochlear-implanted children who have multiple disabilities. STUDY DESIGN: Children who receive CIs provide a platform to examine the trajectories of deprivation-induced and experience-dependent plasticity in the central auditory system. We review the evidence for, and time limits of sensitive periods for cortical auditory maturation framing an optimal period for cochlear implantation. Finally, we evaluate the use of the P1 biomarker as an objective assessment tool in the special case of children with multiple disabilities. RESULTS: The P1 response was useful in assessing central auditory maturation in patients with CHARGE association, ANSD, and Pallister-Killian Syndrome concomitant with hearing loss. CONCLUSION: The presence of co-existing disabilities in addition to hearing loss poses unique challenges regarding both pre-intervention evaluation and post-intervention rehabilitation for children with multiple disabilities. When combined with a standard audiological test battery, the P1 CAEP biomarker has a useful role in objectively evaluating the maturation of central auditory pathways to determine the effectiveness of various intervention strategies in hearing-impaired children with multiple disabilities.