Evaluation of factors predicting tinnitus outcomes following cochlear implantation: Protocol for a prospective quasi-experimental study.

Cochlear implantation is an effective intervention to restore useful aspects of hearing function in adults with severe-to-profound hearing loss. Tinnitus, the perception of sound in the absence of an external source, is common in people with severe-to-profound hearing loss. Existing evidence suggests cochlear implantation may be effective in reducing the negative impact of tinnitus in this population. However, this is contradicted by data suggesting that up to half of cochlear implant recipients experience tinnitus, and that some of these patients who did not have tinnitus before cochlear implantation experience it after surgery or cochlear implant activation. Most evidence on the effects of cochlear implantation on tinnitus comes from secondary data in cochlear implant studies primarily concerned with hearing-related outcomes. Hence, the quality of the evidence for effects on tinnitus is low and not suitable to inform clinical recommendations or decision-making. This study will systematically collect data on tinnitus and tinnitus-related outcomes from patients at multiple points during the cochlear implant pathway to characterise changes in tinnitus. This will improve our understanding of the effects of cochlear implantation for tinnitus in adults with severe to profound hearing loss and inform the design of clinical trials of cochlear implantation for tinnitus.

Cochlear implant referral patterns in the UK suggest a postcode lottery with inequitable access for older adults; results of a pilot audit in five Audiology sites.

OBJECTIVE: To use a standardised reporting tool to identify potential eligible candidates for cochlear implant (CI) referral and quantify the proportion of adults who had a CI referral discussion after presenting with an audiogram within United Kingdom (UK) audiometric criteria. DESIGN: Retrospective multicentre 6-month audit of Audiology clinic databases. STUDY SAMPLE: A total of 810 adults from five geographically diverse UK Audiology sites. RESULTS: Data were collected in late 2019 after UK CI audiometric candidacy criteria changed; one site collected only 3 months of data. The proportion of potential eligible adults (based only on audiometry) considered for CI referral was 64% (521 out of 810) and varied by site (from 50% to 83%). About 24% of patients (123 out of 521) declined CI referral; this also varied across sites (12-45%). The median age of patients where CI referral was not considered was 80 years - significantly higher than the group where CI referral was considered (73 years). CONCLUSIONS: CI referral is dependent on where adults live, and how old they are. Older adults are significantly less likely to be considered for CI referral by Audiologists. Audiology clinics need more support to empower staff to talk to patients about CI referral.

Telemedicine for Adults With Cochlear Implants in the United Kingdom (CHOICE): Protocol for a Prospective Interventional Multisite Study.

BACKGROUND: Cochlear implants provide hearing to approximately 750,000 people with deafness worldwide; these patients require lifelong follow-up. Care for adults with implants in the United Kingdom occurs at one of 19 centers, which may be far from the patients' homes. In a previous randomized controlled trial, we successfully introduced person-centered care. We designed, implemented, and evaluated the following remote care pathway: a personalized web-based support tool, home hearing check, self-device adjustment, and upgrading of sound processors at home rather than in the clinic. The remote care group had a significant increase in empowerment after using the tools, and the patients and clinicians were keen to continue. We would now like to scale up these improvements as an option for >12,000 UK adults using implants; we are commissioning an independent evaluation of this intervention and rollout to establish if it achieves its aims of more empowered and confident patients; more accessible and equitable care; stable hearing; more efficient, person-centered, and scalable service; and more satisfied and engaged patients and clinicians. OBJECTIVE: This study aims to evaluate the impact and rollout of a person-centered clinical care pathway via telemedicine for adults with cochlear implants in the United Kingdom, using both outcomes and process evaluation. METHODS: This project will scale up and evaluate a person-centered long-term follow-up pathway for adults using cochlear implants through a personalized website, including a home hearing check, uploading photos of cochlear implant site, listening in noise and music practice, ordering of spares, questionnaires, and other resources. Both quantitative and qualitative analyses will be conducted, and they will be both an outcome and process evaluation. RESULTS: As of July 2021, the trial is closed, and all data collection is complete. The evaluation report is expected to be published in December 2021, and the research data have not yet been analyzed. CONCLUSIONS: This project will present the results of the first scaling up of a remote care pathway for adults with cochlear implants in the United Kingdom. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number ISRCTN51668922; https://www.isrctn.com/ISRCTN51668922. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27207.

Remote check test battery for cochlear implant recipients: proof of concept study.

OBJECTIVES: (1) To investigate the remote check test battery, designed for self-administration by cochlear implant (CI) recipients, parents/caregivers, to determine if the results give adequate information for clinicians to decide the necessity of an appointment and to capture suggestions for improvement. (2) To gauge acceptance of remote monitoring by CI-recipients and their parents/caregivers. DESIGN: Prospective, multicentre, un-blinded, non-randomized, single-subject, repeated-measures evaluation. The test battery includes an implant-site photograph, impedance measurements, datalogs, questionnaires, speech perception and aided threshold tests. Clinicians reviewed test battery results, followed by a clinical appointment with each CI-recipient, and reported if the battery identified all the issues. Study sample: n = 93 CI-recipients (73 adults, 20 children) and 28 clinicians. RESULTS: The test battery identified 94% (615/656) of all issues. The test battery and clinician observations agreed in 99% (92/93) of cases on the need for a clinic visit. For 68% (63/93) of cases, the test battery identified all clinician observed issues. The majority (77%, 72/93) of recipients would be satisfied if clinic visits were based on their test battery results. A significantly high proportion agreed that remote monitoring was more convenient than clinic visits and could result in travel, time and cost reductions. CONCLUSION: This is the first comprehensive test battery designed for CI-recipient remote monitoring.

Feasibility of personalised remote long-term follow-up of people with cochlear implants: a randomised controlled trial.

INTRODUCTION: Substantial resources are required to provide lifelong postoperative care to people with cochlear implants. Most patients visit the clinic annually. We introduced a person-centred remote follow-up pathway, giving patients telemedicine tools to use at home so they would only visit the centre when intervention was required. OBJECTIVES: To assess the feasibility of comparing a remote care pathway with the standard pathway in adults using cochlear implants. DESIGN: Two-arm randomised controlled trial. Randomisation used a minimisation approach, controlling for potential confounding factors. Participant blinding was not possible, but baseline measures occurred before allocation. SETTING: University of Southampton Auditory Implant Service: provider of National Health Service care. PARTICIPANTS: 60 adults who had used cochlear implants for at least 6 months. INTERVENTIONS: Control group (n=30) followed usual care pathway.Remote care group (n=30) received care remotely for 6 months incorporating: home hearing in noise test, online support tool and self-adjustment of device (only 10 had compatible equipment). MAIN OUTCOME MEASURES: Primary: change in patient activation; measured using the Patient Activation Measure.Secondary: change in hearing and quality of life; qualitative feedback from patients and clinicians. RESULTS: One participant in the remote care group dropped out. The remote care group showed a greater increase in patient activation than the control group. Changes in hearing differed between the groups. The remote care group improved on the Triple Digit Test hearing test; the control group perceived their hearing was worse on the Speech, Spatial and Qualities of Hearing Scale questionnaire. Quality of life remained unchanged in both groups. Patients and clinicians were generally positive about remote care tools and wanted to continue. CONCLUSIONS: Adults with cochlear implants were willing to be randomised and complied with the protocol. Personalised remote care for long-term follow-up is feasible and acceptable, leading to more empowered patients. TRIAL REGISTRATION NUMBER: ISRCTN14644286.

Person-centred cochlear implant care: Assessing the need for clinic intervention in adults with cochlear implants using a dual approach of an online speech recognition test and a questionnaire.

OBJECTIVES: To evaluate the feasibility of adults with cochlear implants using an online speech recognition test and questionnaire at home to assess whether they need to come to the clinic or not. METHODS: A prospective single-centre feasibility study evaluating • An online speech recognition test (digit triplet test (DTT)). • A long-term follow-up questionnaire to assess aspects that a clinician would ask in a face-to-face appointment. • A satisfaction questionnaire to assess patient perception of remote speech recognition testing. • Seventeen people using cochlear implants aged from 34 to 84 years took part. RESULTS: • The majority of adults were able and willing to use tools at home to assess if they need to come to the centre. • The DTT speech reception threshold was repeatable on three occasions within 3 weeks. • The majority of adults felt positive about testing their own hearing using the DTT at home. However, only a minority (two out of 17) felt they preferred remote testing to clinic testing (the majority was undecided). CONCLUSION: The concept of a dual approach of online speech recognition test and questionnaire both done at home has potential to identify which adults with cochlear implants require clinic intervention, although sensitivity and specificity measures are unknown. A clinic visit remains the gold standard of care, but remote care may supplement traditional care pathways.

Factors Affecting Speech Perception Improvement Post Implantation in Congenitally Deaf Adults.

OBJECTIVES: To identify factors preimplantation associated with postimplantation speech perception improvement in the adult congenitally deaf population. DESIGN: Forty-four adult cochlear implant (CI) patients who had a severe to profound hearing loss from birth were identified from this centre's database. Eight preimplantation factors, speech intelligibility, preimplantation hearing levels, communication mode, preimplantation speech perception scores, progression of hearing loss, age at implantation, hearing aid use preimplantation, and gender, were recorded during the CI assessment process. These factors were investigated to determine their effect on speech perception improvement postimplantation. The outcome measures were the improvement in scores for the BKB Sentence test and CUNY Sentence test with lipreading after implantation. In the final analysis, 26 patients were included in the CUNY analysis, and 30 patients were included in the BKB analysis. RESULTS: Speech intelligibility rating, preimplantation hearing levels, and communication mode were shown to be significantly associated with improvements in speech perception postimplantation. CONCLUSION: Three factors were identified that affected speech perception improvement postimplantation: speech intelligibility, preimplantation hearing levels, and communication mode. These factors can be used to counsel CI patients regarding potential speech perception improvements from cochlear implantation, although these are based on average data and may not reflect individual performance.

Have Cochlear Implant, Won't Have to Travel: Introducing Telemedicine to People Using Cochlear Implants.

PURPOSE: This research note describes a planned project to design, implement, and evaluate remote care for adults using cochlear implants and compare their outcomes with those of individuals following the standard care pathway. METHOD: Sixty people with cochlear implants will be recruited and randomized to either the remote care group or a control group. The remote care group will use new tools for 6 months: remote and self-monitoring, self-adjustment of device, and a personalized online support tool. The main outcome measure is patient empowerment, with secondary outcomes of stability in hearing and quality of life, patient and clinician preference, and use of clinic resources. CONCLUSION: The clinical trial ends in summer 2016. Remote care may offer a viable method of follow-up for some adults with cochlear implants.

Personalised long-term follow-up of cochlear implant patients using remote care, compared with those on the standard care pathway: study protocol for a feasibility randomised controlled trial.

INTRODUCTION: Many resources are required to provide postoperative care to patients who receive a cochlear implant. The implant service commits to lifetime follow-up. The patient commits to regular adjustment and rehabilitation appointments in the first year and annual follow-up appointments thereafter. Offering remote follow-up may result in more stable hearing, reduced patient travel expense, time and disruption, more empowered patients, greater equality in service delivery and more freedom to optimise the allocation of clinic resources. METHODS AND ANALYSIS: This will be a two-arm feasibility randomised controlled trial (RCT) involving 60 adults using cochlear implants with at least 6 months device experience in a 6-month clinical trial of remote care. This project will design, implement and evaluate a person-centred long-term follow-up pathway for people using cochlear implants offering a triple approach of remote and self-monitoring, self-adjustment of device and a personalised online support tool for home speech recognition testing, information, self-rehabilitation, advice, equipment training and troubleshooting. The main outcome measure is patient activation. Secondary outcomes are stability and quality of hearing, stability of quality of life, clinic resources, patient and clinician experience, and any adverse events associated with remote care. We will examine the acceptability of remote care to service users and clinicians, the willingness of participants to be randomised, and attrition rates. We will estimate numbers required to plan a fully powered RCT. ETHICS AND DISSEMINATION: Ethical approval was received from North West-Greater Manchester South Research Ethics Committee (15/NW/0860) and the University of Southampton Research Governance Office (ERGO 15329). RESULTS: Results will be disseminated in the clinical and scientific communities and also to the patient population via peer-reviewed research publications both online and in print, conference and meeting presentations, posters, newsletter articles, website reports and social media. TRIAL REGISTRATION NUMBER: ISRCTN14644286; Pre-results.

The Intra-Cochlear Impedance-Matrix (IIM) test for the Nucleus® cochlear implant.

OBJECTIVE: To describe the principles and operation of a new telemetry-based function test for the Nucleus® cochlear implant, known as the CS19 Intra-Cochlear Impedance Matrix (IIM) and to present results from a multicentre clinical study to establish reproducibility (test-retest reliability) and normative ranges. METHOD: The IIM test measures bipolar impedances between all electrode pairs and employs a normalization procedure based on common ground impedances in order to identify abnormal current paths among electrodes. Six European clinics collected IIM data from a total of 192 devices. RESULTS: Reproducibility was high between initial and repeat measurements. The normative analysis demonstrated narrow ranges among devices after normalization of impedance data. The IIM is able to identify abnormal current paths that are not evident from standard impedance telemetry and may otherwise only be found utilising average electrode voltage measurements (AEV). CONCLUSIONS: The IIM test was found to be straightforward to perform clinically and demonstrated reproducible data with narrow ranges in normally-functioning devices. Because this test uses a very low stimulation level the IIM test is well suited for children or multiply handicapped CI users who cannot reliably report on their auditory percepts. The new algorithms show potential to improve implant integrity testing capabilities if implemented in future clinical software.

Cochlear implant programming: a global survey on the state of the art.

The programming of CIs is essential for good performance. However, no Good Clinical Practice guidelines exist. This paper reports on the results of an inventory of the current practice worldwide. A questionnaire was distributed to 47 CI centers. They follow 47600 recipients in 17 countries and 5 continents. The results were discussed during a debate. Sixty-two percent of the results were verified through individual interviews during the following months. Most centers (72%) participated in a cross-sectional study logging 5 consecutive fitting sessions in 5 different recipients. Data indicate that general practice starts with a single switch-on session, followed by three monthly sessions, three quarterly sessions, and then annual sessions, all containing one hour of programming and testing. The main focus lies on setting maximum and, to a lesser extent, minimum current levels per electrode. These levels are often determined on a few electrodes and then extrapolated. They are mainly based on subjective loudness perception by the CI user and, to a lesser extent, on pure tone and speech audiometry. Objective measures play a small role as indication of the global MAP profile. Other MAP parameters are rarely modified. Measurable targets are only defined for pure tone audiometry. Huge variation exists between centers on all aspects of the fitting practice.

Does acoustic fundamental frequency information enhance cochlear implant performance?

OBJECTIVES: Low-frequency information via an acoustic aid has been shown to increase speech intelligibility in noise for cochlear implant (CI) listeners. It has been suggested that fundamental frequency (F0) provides this advantage. This study aimed to investigate the contribution of F0. METHODS: Seven cochlear implant users having residual hearing at 125, 250, and 500 Hz contralateral to the implant were recruited. Speech intelligibility in noise was measured using an adaptive procedure for three listening conditions: (1) CI alone, (2) CI plus filtered acoustic information contralaterally, and (3) CI plus acoustic F0 contralaterally. In condition 2, the sentence material was low-passed at 500 Hz and presented via an insert earphone into the contralateral ear. In condition 3, F0 was extracted using Praat and presented as a sine wave with the same F0 variation over time as the original sentence. RESULTS: Although benefit was observed when low-frequency information was added for the majority of participants, on average no statistically significant difference was found for the three listening conditions. DISCUSSION: These results are not consistent with current literature. It is proposed that glimpsing cues may be responsible for the advantage observed in previous studies; in this study, both target and masker were presented in the acoustic condition and this may explain the discrepancy. CONCLUSION: The benefit of additional acoustic information may be highly variable and individual to participants, but on average no statistically significant difference was seen.

Managing cochlear implant patients with suspected insulation damage.

Six Nucleus® 24 Contour™ and five Nucleus® Freedom™ with Contour Advance™ cochlear implants examined at the South of England Cochlear Implant Centre have failed and were explanted because of insulation damage. Insulation damage occurs when the silicone elastomer coating surrounding the electrode array wires and electronics capsule fails, allowing fluid entry to the electrode lead bundle. In addition, four Nucleus® 24 Contour™, one Nucleus® Freedom™ with Contour Advance™, and one Nucleus® 24 devices have failed as a result of suspected insulation damage; two have been explanted but explant reports not yet been received from the device manufacturer, four have not been explanted. Sixteen other Nucleus® devices are suspected to have insulation damage but the patients have retained clinical benefit, with remapping to exclude some or all affected electrodes in 14 cases. Insulation damage does not cause a sudden loss of sound; instead, a progressive deterioration can occur, which can make management and detection challenging, particularly in young children or those with additional needs. Monitoring of both impedances and clinical benefit is recommended.

United Kingdom national paediatric bilateral cochlear implant audit: preliminary results.

Prior to 2009, United Kingdom (UK) public funding was mainly only available for children to receive unilateral cochlear implants. In 2009, the National Institute for Health and Care Excellence published guidance for cochlear implantation following their review. According to these guidelines, all suitable children are eligible to have simultaneous bilateral cochlear implants or a sequential bilateral cochlear implant if they had received the first before the guidelines were published. Fifteen UK cochlear implant centres formed a consortium to carry out a multi-centre audit. The audit involves collecting data from simultaneously and sequentially implanted children at four intervals: before bilateral cochlear implants or before the sequential implant, 1, 2, and 3 years after bilateral implants. The measures include localization, speech recognition in quiet and background noise, speech production, listening, vocabulary, parental perception, quality of life, and surgical data including complications. The audit has now passed the 2-year point, and data have been received on 850 children. This article provides a first view of some data received up until March 2012.

Comparison of bimodal and bilateral cochlear implant users on speech recognition with competing talker, music perception, affective prosody discrimination, and talker identification.

OBJECTIVES: Despite excellent performance in speech recognition in quiet, most cochlear implant users have great difficulty with speech recognition in noise, music perception, identifying tone of voice, and discriminating different talkers. This may be partly due to the pitch coding in cochlear implant speech processing. Most current speech processing strategies use only the envelope information; the temporal fine structure is discarded. One way to improve electric pitch perception is to use residual acoustic hearing via a hearing aid on the nonimplanted ear (bimodal hearing). This study aimed to test the hypothesis that bimodal users would perform better than bilateral cochlear implant users on tasks requiring good pitch perception. DESIGN: Four pitch-related tasks were used. 1. Hearing in Noise Test (HINT) sentences spoken by a male talker with a competing female, male, or child talker. 2. Montreal Battery of Evaluation of Amusia. This is a music test with six subtests examining pitch, rhythm and timing perception, and musical memory. 3. Aprosodia Battery. This has five subtests evaluating aspects of affective prosody and recognition of sarcasm. 4. Talker identification using vowels spoken by 10 different talkers (three men, three women, two boys, and two girls). Bilateral cochlear implant users were chosen as the comparison group. Thirteen bimodal and 13 bilateral adult cochlear implant users were recruited; all had good speech perception in quiet. RESULTS: There were no significant differences between the mean scores of the bimodal and bilateral groups on any of the tests, although the bimodal group did perform better than the bilateral group on almost all tests. Performance on the different pitch-related tasks was not correlated, meaning that if a subject performed one task well they would not necessarily perform well on another. The correlation between the bimodal users' hearing threshold levels in the aided ear and their performance on these tasks was weak. CONCLUSIONS: Although the bimodal cochlear implant group performed better than the bilateral group on most parts of the four pitch-related tests, the differences were not statistically significant. The lack of correlation between test results shows that the tasks used are not simply providing a measure of pitch ability. Even if the bimodal users have better pitch perception, the real-world tasks used are reflecting more diverse skills than pitch. This research adds to the existing speech perception, language, and localization studies that show no significant difference between bimodal and bilateral cochlear implant users.

Bimodal hearing benefit for speech recognition with competing voice in cochlear implant subject with normal hearing in contralateral ear.

OBJECTIVES: This project assessed electroacoustic benefit for speech recognition with a competing talker. DESIGN: Using a cochlear implant subject with normal hearing in the contralateral ear, the contribution of low-pass and high-pass natural sound to speech recognition was systematically measured. RESULTS: High-frequency sound did not improve performance, but low-frequency sound did, even when unintelligible and limited to frequencies below 150 Hz. CONCLUSIONS: The low-frequency sound assists separation of the two talkers, presumably using the fundamental frequency cue. Extrapolating this finding to regular cochlear implant users may suggest that using a hearing aid on the contralateral ear will improve performance, even with limited residual hearing.

Speech recognition with varying numbers and types of competing talkers by normal-hearing, cochlear-implant, and implant simulation subjects.

Cochlear-implant users perform far below normal-hearing subjects in background noise. Speech recognition with varying numbers of competing female, male, and child talkers was evaluated in normal-hearing subjects, cochlear-implant users, and normal-hearing subjects utilizing an eight-channel sine-carrier cochlear-implant simulation. Target sentences were spoken by a male. Normal-hearing subjects obtained considerably better speech reception thresholds than cochlear-implant subjects; the largest discrepancy was 24 dB with a female masker. Evaluation of one implant subject with normal hearing in the contralateral ear suggested that this difference is not caused by age-related disparities between the subject groups. Normal-hearing subjects showed a significant advantage with fewer competing talkers, obtaining release from masking with up to three talker maskers. Cochlear-implant and simulation subjects showed little such effect, although there was a substantial difference between the implant and simulation results with talker maskers. All three groups benefited from a voice pitch difference between target and masker, with the female talker providing significantly less masking than the male. Child talkers produced more masking than expected, given their fundamental frequency, syllabic rate, and temporal modulation characteristics. Neither a simulation nor testing in steady-state noise predicts the difficulties cochlear-implant users experience in real-life noisy situations.