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.

Holistic assessment of cochlear implant outcomes using the international classification of functioning disability and health model: data analysis of a longitudinal prospective multicenter study.

PURPOSE: To study outcome after cochlear implantation using the Cochlear Implant (CI) outcome assessment protocol based on the International Classification of Functioning, Disability and Health (ICF) model (CI-ICF). METHODS: Raw data of a prospective, longitudinal, multicenter study was analyzed. Seventy-two CI candidates were assessed preoperatively and six months postoperatively using the CI-ICF protocol. Following tools were used: (1) Work Rehabilitation Questionnaire (WORQ), (2) Abbreviated Profile of Hearing Aid Benefit (APHAB), (3) Audio Processor Satisfaction Questionnaire (APSQ), (4) Speech, Spatial, and Qualities of Hearing Scale (SSQ12), (5) Hearing Implant Sound Quality Index (HISQUI19), (6) Nijmegen CI Questionnaire (NCIQ) (7) pure tone audiometry, (8) speech audiometry, (9) sound localization. RESULTS: There was a significant improvement of speech discrimination in quiet (p = 0.015; p < 0.001) and in noise (p = 0.041; p < 0.001), sound detection (p < 0.001), tinnitus (p = 0.026), listening (p < 0.001), communicating with-receiving-spoken messages (p < 0.001), conversation (p < 0.001), family relationships (p < 0.001), community life (p = 0.019), NCIQ total score and all subdomain scores (p < 0.001). Subjective sound localization significantly improved (p < 0.001), while psychometric sound localization did not. There was no significant subjective deterioration of vestibular functioning and no substantial change in sound aversiveness. CI users reported a high level of implant satisfaction postoperatively. CONCLUSION: This study highlights the positive impact of cochlear implantation on auditory performance, communication, and subjective well-being. The CI-ICF protocol provides a holistic and comprehensive view of the evolution of CI outcomes.

Development and validation of the audio processor satisfaction questionnaire (APSQ) for hearing implant users.

Objective: The satisfaction experienced with using an audio processor is very important to hearing implant system users. Currently there are no measures that can be used to assess user satisfaction with an audio processor. This study aims to develop and validate a specific and standardised questionnaire that focuses on user satisfaction with their audio processor.Design: A preliminary version of the questionnaire was initially developed by experts in the field. Following validation of these results, the final version of the Audio Processor Satisfaction Questionnaire (APSQ) was developed consisting of 15 items. Item analyses and questionnaire validation measurements were assessed.Study sample: Sixty-nine subjects were recruited and asked to complete the APSQ twice within 2-4 weeks.Results: Subjects reported a high user satisfaction with the questionnaire and with their audio processor. The questionnaire had good reliability and results for test-retest reliability were high and significant across all items and across subscale analyses.Conclusion: Item analyses and reliability analyses show that the questionnaire is a valid and reliable tool to assess user satisfaction across different audio processors and hearing implant systems. The APSQ is a quick and easy tool to measure user satisfaction with their audio processor.

Validation of the Arabic language version of the Audio Processor Satisfaction Questionnaire (APSQ) for hearing implant users.

OBJECTIVE: Audio processors (AP) are the external components of hearing implants. User satisfaction with the performance and comfort of their AP is a critical factor in ensuring daily use, which leads to improved hearing outcomes. The aim of this study was to construct and validate an Arabic language translation of the APSQ for use among Arabic-speaking clinicians and patients. DESIGN: The original APSQ was translated into the Arabic language using cross-cultural adaptation measures. The final questionnaire was administered to CI users in electronic form. STUDY SAMPLE: 117 CI users (64 female) participated. A total of 179 ears were assessed. RESULTS: High levels of satisfaction with audio processors were observed among CI users. Item and scale analyses indicate that this version of the APSQ measure a homogeneous and valid construct. CONCLUSION: The Arabic version of the APSQ captures user satisfaction with hearing implant audio processors.

A Good Practice Guide for Organizing the Scientific Program of International Conferences.

This paper provides a step-by-step guide for organizing the scientific program (OSP) of international conferences. Through informal discussions, a panel of experts organizing international conferences came up with this guide, which includes a flowchart, checklist, and detailed discussions of each step. Subsequently, additional specialists were invited to evaluate this synopsis and provide their input. All of the participants approved the final version after the outline was improved. This guide proposes the following six steps: 1) preparation, 2) recruitment, 3) building the agenda, 4) cross-checking the program, 5) reviewing and finalizing, and 6) in-conference refining. Thirteen items are specified across the six main steps in a detailed checklist. This OSP guide includes a flowchart and a checklist for providing a comprehensive manual for establishing, conducting, and organizing international scientific conferences. Understanding the procedures that are expected to be followed when holding a scientific conference enables the involved parties to organize and assign tasks to one another as well as create a schedule that allows them to finish their work on time. This guide can be used at any kind of scientific conference to describe an organized process, resulting in a professional and distinguished scientific program.

EARS® (Evaluation of Auditory Responses to Speech): an internationally validated assessment tool for children provided with cochlear implants.

OBJECTIVES: The use of cochlear implants in the rehabilitation of hearing-impaired patients is now widely established and offers great benefits for children. To evaluate these benefits, the Evaluation of Auditory Responses to Speech (EARS®) assessment tool was designed in 1995. The objectives of this study were to assess the auditory perceptual skills in a large paediatric population over time, as well as to provide standardised values. METHODS: An international multicentre study was conducted in 35 clinics from 1996 to 2009. During this period, 765 children were assessed with the EARS in 10 test intervals: pre-operative, first fitting and then 1, 3, 6, and 12 months after the first fitting and annually thereafter, up to a maximum period of 5 years. RESULTS: The auditory skills improved significantly over time for all speech perception tests and questionnaires as well as between single test intervals: pre-operative to 6 months, 6 months to 1 year and 1 year to 2 years. Standardised values of the children stratified according to their age at implantation were calculated. CONCLUSIONS: The auditory perceptual skills significantly improved over time. The standardised values will help professionals set therapeutic goals and counsel parents accordingly.

Clinical trial results with the MED-EL fine structure processing coding strategy in experienced cochlear implant users.

OBJECTIVES: To assess the subjective and objective performance of the new fine structure processing strategy (FSP) compared to the previous generation coding strategies CIS+ and HDCIS. METHODS: Forty-six adults with a minimum of 6 months of cochlear implant experience were included. CIS+, HDCIS and FSP were compared in speech perception tests in noise, pitch scaling and questionnaires. The randomized tests were performed acutely (interval 1) and again after 3 months of FSP experience (interval 3). The subjective evaluation included questionnaire 1 at intervals 1 and 3, and questionnaire 2 at interval 2, 1 month after interval 1. RESULTS: Comparison between FSP and CIS+ showed that FSP performed at least as well as CIS+ in all speech perception tests, and outperformed CIS+ in vowel and monosyllabic word discrimination. Comparison between FSP and HDCIS showed that both performed equally well in all speech perception tests. Pitch scaling showed that FSP performed at least as well as HDCIS. With FSP, sound quality was at least as good and often better than with HDCIS. CONCLUSIONS: Results indicate that FSP performs better than CIS+ in vowel and monosyllabic word understanding. Subjective evaluation demonstrates strong user preferences for FSP when listening to speech and music.

Psychometric properties of the English version of the Audio Processor Satisfaction Questionnaire (APSQ).

OBJECTIVE: The Audio Processor Satisfaction Questionnaire (APSQ) is a standardized tool to measure a user's satisfaction with their audio processor(s). It was first developed and validated in the German language. The purpose of the current study was to validate the English version of the APSQ. DESIGN: The 15 items of the APSQ were translated into English. Item and scale analyses assessed the quality of individual items and of the questionnaire in its entirety. STUDY SAMPLE: Sixty-seven adults with hearing implants participated. Forty-six of them completed the questionnaire twice within 2-4 weeks. RESULTS: High mean values were obtained with total scores and with scores of the comfort, social life, and usability domains, indicating that users are generally satisfied with their audio processors. The questionnaire achieved good test-retest reliability with high internal consistency. A significant positive correlation between time since implantation and user satisfaction was found. CONCLUSION: Results of the item and reliability analyses suggest that the English version of the APSQ is a valid and reliable tool to assess user satisfaction with their audio processor(s).

Towards a Consensus on an ICF-Based Classification System for Horizontal Sound-Source Localization.

The study aimed to develop a consensus classification system for the reporting of sound localization testing results, especially in the field of cochlear implantation. Against the background of an overview of the wide variations present in localization testing procedures and reporting metrics, a novel classification system was proposed to report localization errors according to the widely accepted International Classification of Functioning, Disability and Health (ICF) framework. The obtained HEARRING_LOC_ICF scale includes the ICF graded scale: 0 (no impairment), 1 (mild impairment), 2 (moderate impairment), 3 (severe impairment), and 4 (complete impairment). Improvement of comparability of localization results across institutes, localization testing setups, and listeners was demonstrated by applying the classification system retrospectively to data obtained from cohorts of normal-hearing and cochlear implant listeners at our institutes. The application of our classification system will help to facilitate multi-center studies, as well as allowing better meta-analyses of data, resulting in improved evidence-based practice in the field.

Evaluating the Revised Work Rehabilitation Questionnaire in Cochlear Implant Users Cochlear Implant Outcome Assessment Based on the International Classification of Functioning, Disability, and Health (ICF).

OBJECTIVES: The 59-item Work Rehabilitation Questionnaire (WORQ) was developed based on the International Classification of Functioning, Disability and Health (ICF) core set for vocational rehabilitation to assess work related functioning. It was revised to include 17 questions, assigned to 14 ICF categories relevant to cochlear implant (CI) users. This cross-sectional multicenter study aimed to evaluate CI users' responses on the WORQ questions to describe and generate ICF qualifiers for the revised WORQ in CI users, forming part of a broader framework of CI outcome measures linked to the ICF. METHODS: One hundred seventy-seven adults over the age of 18 years with a minimum of one year's device experience were included in the analysis. The WORQ was completed by the participants at a routine visit to the clinic, via email, or via post. RESULTS: Most of the CI users perceived no problem on the WORQ questions (53.7%-91%), finished secondary school (54.2%) or obtained a college or university degree (32.8%) and are either employed (41.2%) or retired (34.5%). CI users that are currently working mostly have a full-time position (34.5%). Subjects reported no problem (91%) with sensation of falling, while handling communication devices and techniques (10.9%) and tinnitus (9.6%) showed the highest number of subjects reporting a complete problem. CONCLUSIONS: Overall, most of the CI users experienced no impairment, restriction or limitation on the WORQ questions and their assigned ICF categories. Their education level resembles the education level of the general population and they seem to integrate or reintegrate well in professional life postoperatively.

A music quality rating test battery for cochlear implant users to compare the FSP and HDCIS strategies for music appreciation.

OBJECTIVE: The purpose of this study was to develop a music quality rating test battery (MQRTB) and pilot test it by comparing appraisal ratings from cochlear implant (CI) recipients using the fine-structure processing (FSP) and high-definition continuous interleaved sampling (HDCIS) speech processing strategies. DESIGN: The development of the MQRTB involved three stages: (1) Selection of test items for the MQRTB; (2) Verification of its length and complexity with normally-hearing individuals; and (3) Pilot testing with CI recipients. STUDY SAMPLE: Part 1 involved 65 adult listeners, Part 2 involved 10 normally-hearing adults, and Part 3 involved five adult MED-EL CI recipients. RESULTS: The MQRTB consisted of ten songs, with ratings made on scales assessing pleasantness, naturalness, richness, fullness, sharpness, and roughness. Results of the pilot study, which compared FSP and HDCIS for music, indicated that acclimatization to a strategy had a significant effect on ratings (p < 0.05). When acclimatized to FSP, the group rated FSP as closer to 'exactly as I want it to sound' than HDCIS (p < 0.05), and that HDCIS sounded significantly sharper and rougher than FSP. However when acclimatized to HDCIS, there were no significant differences between ratings. There was no effect of song familiarity or genre on ratings. CONCLUSIONS: Overall the results suggest that the use of FSP as the default strategy for MED-EL recipients would have a positive effect on music appreciation, and that the MQRTB is an effective tool for assessing music sound quality.

Assessment of the subjective benefit of electric acoustic stimulation with the abbreviated profile of hearing aid benefit.

CONCLUSION: This study demonstrates that electric-acoustic stimulation (EAS) significantly decreases the subjective impairment in speech perception. OBJECTIVES: To assess the subjective benefit of EAS over the first 12 months after EAS fitting using the Abbreviated Profile of Hearing Aid Benefit (APHAB). METHOD: Twenty-three EAS users, implanted with either the PULSAR(CI)(100) FLEX(EAS) provided with the DUET EAS processor or the COMBI40+ Medium provided with the TEMPO+ speech processor, were included. Electric stimulation was activated about 1 month postoperatively; ipsilateral acoustic stimulation was added 2 months thereafter. EAS benefit was measured preoperatively with only a hearing aid and postoperatively at EAS fitting and then 3, 6 and 12 months after EAS fitting using the APHAB. RESULTS: Subjects reported significant improvements in the global score with a mean decrease in impairment from 74% preoperatively to 45% after 3 months of EAS use. Furthermore, clinical relevance was demonstrated in multiple subscales between preoperative and first fitting reflecting a true benefit of EAS with a probability of 95%.

Validation of LittlEARS® Early Speech Production Questionnaire in Arabic-speaking children with normal hearing.

OBJECTIVES: To validate an Arabic version of the LittlEARS® Early Speech Production Questionnaire (LEESPQ), which assesses the early development of speech and language in infants between 0 and 18 months, in Arabic-speaking children with normal hearing in Saudi Arabia. METHODS: This is a cross-sectional study conducted in the city of Riyadh, Saudi Arabia between September and December 2020. Parents completed the LEESPQ regarding their child's speech production development. To assess the ability of normal hearing children aged 0-18 months in developing speech and language production, a norm curve has been generated based on the standardized values that were calculated from the Arabic normal-hearing data set. RESULTS: A total of 198 questionnaires were analyzed. The total score on the LEESPQ correlated with age, gender, and bilingualism. A norm curve for early speech production in children with normal hearing was created. CONCLUSION: The Arabic version of LEESPQ appears to be a valid questionnaire that can be used in the assessment of early language and speech development of Arabic-speaking children with normal hearing in the age range of 0-18 months. The Arabic version of the LEESPQ might also be a useful tool to detect developmental delays and hearing disorders in young children.

Microphone directionality and wind noise reduction enhance speech perception in users of the MED-EL SONNET audio processor.

Objectives: Speech understanding in noise remains a challenge for many cochlear implant users. To improve this, the SONNET audio processor features three microphone directionality (MD) settings and three wind noise reduction (WNR) settings. The primary aim of this study was to assess if speech understanding in noise and hearing in real life was superior with the SONNET or with the OPUS 2, which does not feature MD or WNR.Methods: 31 of 33 participants completed the study. Speech understanding was assessed in two types of acoustic noise, in wind noise, and in quiet. A 4-speaker setup was used and speech was presented from 0° and noise from 90°, 180°, and 270°. Wind noise was simulated with a fan. Sound quality and hearing-related abilities were assessed via two subjective questionnaires.Results: Speech understanding in acoustic noise with the SONNET was significantly better or equal to than with the OPUS 2. Speech understanding in wind with the OPUS 2 was significantly better than with the SONNET in some settings. Sound quality and hearing-related abilities were both significantly better with the SONNET.Conclusions: The SONNET provides the same or significantly improved speech understanding than the OPUS 2 in quiet and in noise. While OPUS 2 was superior in wind than the SONNET in some settings, this was offset by SONNET's superiority in real-life listening situations. We therefore conclude that the front-end processing of the SONNET provides users with better hearing than does the OPUS 2.

Site of cochlear stimulation and its effect on electrically evoked compound action potentials using the MED-EL standard electrode array.

BACKGROUND: The standard electrode array for the MED-EL MAESTRO cochlear implant system is 31 mm in length which allows an insertion angle of approximately 720 degrees . When fully inserted, this long electrode array is capable of stimulating the most apical region of the cochlea. No investigation has explored Electrically Evoked Compound Action Potential (ECAP) recordings in this region with a large number of subjects using a commercially available cochlear implant system. The aim of this study is to determine if certain properties of ECAP recordings vary, depending on the stimulation site in the cochlea. METHODS: Recordings of auditory nerve responses were conducted in 67 subjects to demonstrate the feasibility of ECAP recordings using the Auditory Nerve Response Telemetry (ART) feature of the MED-EL MAESTRO system software. These recordings were then analyzed based on the site of cochlear stimulation defined as basal, middle and apical to determine if the amplitude, threshold and slope of the amplitude growth function and the refractory time differs depending on the region of stimulation. RESULTS: Findings show significant differences in the ECAP recordings depending on the stimulation site. Comparing the apical with the basal region, on average higher amplitudes, lower thresholds and steeper slopes of the amplitude growth function have been observed. The refractory time shows an overall dependence on cochlear region; however post-hoc tests showed no significant effect between individual regions. CONCLUSIONS: Obtaining ECAP recordings is also possible in the most apical region of the cochlea. However, differences can be observed depending on the region of the cochlea stimulated. Specifically, significant higher ECAP amplitude, lower thresholds and steeper amplitude growth function slopes have been observed in the apical region. These differences could be explained by the location of the stimulating electrode with respect to the neural tissue in the cochlea, a higher density, or an increased neural survival rate of neural tissue in the apex. TRIAL REGISTRATION: The Clinical Investigation has the Competent Authority registration number DE/CA126/AP4/3332/18/05.

Introducing real-life listening features into the clinical test environment: Part I: Measuring the hearing performance and evaluating the listening effort of individuals with normal hearing.

OBJECTIVE: Controlled clinical test environments are very different from real-life listening situations in which speaker and background noise level variations can hinder a person's ability to hear and follow conversations. This study was performed to evaluate the ability of people with normal hearing to follow a single speaker in the presence of background noise, and to explore relations between those measures and the listeners' subjective assessments, listening effort, and sound quality judgements. METHODS: A group of adults with normal hearing were evaluated using the following battery of tests: (i) Roving Level Test, (ii) the Just Understanding Speech Test, (iii) Performance Perceptual Test, (iv) the Visual Analogue Scale to evaluate listening effort, and (iv) with a sound quality questionnaire. RESULTS: The results show that people with normal hearing tend to accurately estimate their hearing abilities, and both the listening effort required and speech recognition thresholds tend to increase with increasing background noise. DISCUSSION: Implementing a battery of tests that evaluate speech-in-noise listening abilities, listening effort, and subjective hearing perception might provide greater insight into hearing performance than traditional measures. Additionally, the data generated in this study can be used for comparison with measures obtained from hearing impaired and hearing device listeners, and as such, has the potential to guide counselling and rehabilitation to a range of clinical populations. CONCLUSION: The examination of both the self-estimated and verified performance measurements in simulated real-life listening situations can provide audiologists with a comprehensive and realistic profile of a person's hearing performance.

Incapacitating unilateral tinnitus in single-sided deafness treated by cochlear implantation.

OBJECTIVES: Tinnitus is a well-known, difficult-to-treat symptom of hearing loss. Users of cochlear implants (CIs) have reported a reduction in tinnitus following implantation for bilateral severe-to-profound deafness. This study assessed the effect of electrical stimulation via a CI on tinnitus in subjects with unilateral deafness and ipsilateral tinnitus who underwent implantation in an attempt to treat tinnitus with the CI. METHODS: Twenty-one subjects who complained of severe intractable tinnitus that was unresponsive to treatment received a CI. Tinnitus loudness was measured with a Visual Analog Scale; loudness percepts were recorded with the device activated and deactivated. Tinnitus distress was measured with the Tinnitus Questionnaire before and after implantation. RESULTS: Electrical stimulation via a CI resulted in a significant reduction in tinnitus loudness (mean +/- SD; 1 year after implantation, 2.4 +/- 1.8; 2 years after implantation, 2.5 +/- 1.9; before implantation, 8.5 +/- 1.3). With the device deactivated, tinnitus loudness was still reduced to between 6.1 and 7.0 over 24 months. The Tinnitus Questionnaire revealed a significant positive effect of CI stimulation. CONCLUSIONS: Unilateral tinnitus resulting from single-sided deafness can be treated with electrical stimulation via a CI. The outcomes of this pilot study demonstrate a new method for treatment of tinnitus in select subjects, perhaps an important new indication for cochlear implantation.

Electric acoustic stimulation of the auditory system: results of a multi-centre investigation.

CONCLUSION: A high rate of hearing preservation during cochlear implantation for electric acoustic stimulation (EAS) is possible, even when surgery is conducted by a number of different surgeons. OBJECTIVES: This study aimed to determine the degree of hearing preservation using surgery for EAS in a European multi-centre clinical investigation. It also aimed to demonstrate the effect of EAS in individuals with residual low frequency hearing, both on speech perception and on subjective quality of life measures. PATIENTS AND METHODS: Eighteen patients with profound high frequency hearing loss were recruited in five participating European centres. Subjects were assessed based on an audiologic test battery, as well as on a subjective hearing aid benefit questionnaire. Each subject underwent attempted hearing preservation cochlear implantation using the MED-EL C40 + device with a Medium electrode. Residual ipsilateral hearing and speech discrimination abilities were assessed at defined intervals up to 12 months after the combined electric-acoustic mode was introduced. RESULTS: Results showed that some degree of hearing preservation was possible in 15718 patients. All subjects showed statistically significant benefit on all three speech perception tests over time. These significant benefits were also reflected in the subjective benefit outcomes.

TeenEARS: development of a pilot assessment battery for cochlear implanted adolescents.

Changes in selection criteria have led to the inclusion of pre-lingually deafened adolescents as potential cochlear implant candidates, depending on their degree of residual hearing, access to and use of acoustic amplification, use of oral communication, and other factors such as motivation and support. Outcomes results in adolescents vary widely, and it has become evident that there is a need for a test battery that can assess a wide range of skills over time. This article presents the development and validation of one such test battery: TeenEARS. Eleven tests were assessed for inclusion in the test battery. Consideration was given to the ability of the test to measure improvement over time; the fact that there needed to be easier and more difficult tests in terms of language, communication and listening; the need for closed and open-set assessments; and a range of listening tasks: from sounds to conversational language. Data on 23 adolescents assessed and judgment based on clinical experience resulted in eight tests being included in the TeenEARS test battery.

Partial deafness cochlear implantation in children.

OBJECTIVE: Partial deafness cochlear implantation and electric-acoustic stimulation have proven to be a useful method of treating adults with a ski-slope type hearing loss. Good hearing preservation and speech perception outcomes have been reported. This study aims to assess partial deafness cochlear implantation in children. METHOD: Nine children, ranging in age from 4.2 to 12 years, received a cochlear implant following the round window surgical technique for partial deafness cochlear implantation. Hearing preservation was assessed by pure-tone audiometry and speech perception outcomes were measured using monosyllable word tests in quiet and noise. Data are available for most children up to a period of 1 year. RESULTS: Hearing could be preserved partially in all cases, however, one child does not have sufficient preservation to make use of electric-acoustic stimulation. The eight children with sufficiently preserved hearing either use the natural low frequency hearing in combination with a cochlear implant to hear or use the DUET combined hearing system. Speech perception tests showed improvement in quiet and noise over time. CONCLUSION: Results suggest that partial deafness cochlear implantation is a viable treatment method in children. However, surgery should only be conducted by an experienced surgeon and parents need to be carefully counselled about the risks and benefits of partial deafness cochlear implantation.