Protocol for a multicentre randomised controlled trial of STeroid Administration Routes For Idiopathic Sudden sensorineural Hearing loss: The STARFISH trial.

Idiopathic sudden sensorineural hearing loss (ISSNHL) is the rapid onset of reduced hearing due to loss of function of the inner ear or hearing nerve of unknown aetiology. Evidence supports improved hearing recovery with early steroid treatment, via oral, intravenous, intratympanic or a combination of routes. The STARFISH trial aims to identify the most clinically and cost-effective route of administration of steroids as first-line treatment for ISSNHL. STARFISH is a pragmatic, multicentre, assessor-blinded, three-arm intervention, superiority randomised controlled trial (1:1:1) with an internal pilot (ISRCTN10535105, IRAS 1004878). 525 participants with ISSNHL will be recruited from approximately 75 UK Ear, Nose and Throat units. STARFISH will recruit adults with sensorineural hearing loss averaging 30dBHL or greater across three contiguous frequencies (confirmed via pure tone audiogram), with onset over a ≤3-day period, within four weeks of randomisation. Participants will be randomised to 1) oral prednisolone 1mg/Kg/day up to 60mg/day for 7 days; 2) intratympanic dexamethasone: three intratympanic injections 3.3mg/ml or 3.8mg/ml spaced 7±2 days apart; or 3) combined oral and intratympanic steroids. The primary outcome will be absolute improvement in pure tone audiogram average at 12-weeks following randomisation (0.5, 1.0, 2.0 and 4.0kHz). Secondary outcomes at 6 and 12 weeks will include: Speech, Spatial and Qualities of hearing scale, high frequency pure tone average thresholds (4.0, 6.0 and 8.0kHz), Arthur Boothroyd speech test, Vestibular Rehabilitation Benefit Questionnaire, Tinnitus Functional Index, adverse events and optional weekly online speech and pure tone hearing tests. A health economic assessment will be performed, and presented in terms of incremental cost effectiveness ratios, and cost per quality-adjusted life-year. Primary analyses will be by intention-to-treat. Oral prednisolone will be the reference. For the primary outcome, the difference between group means and 97.5% confidence intervals at each time-point will be estimated via a repeated measures mixed-effects linear regression model.

Experienced hearing aid users' perspectives of assessment and communication within audiology: a qualitative study using digital methods.

OBJECTIVE: To explore experienced hearing aid users' perspectives of audiological assessments and the patient-audiologist communication dynamic during clinical interactions. DESIGN: A qualitative study was implemented incorporating both an online focus group and online semi-structured interviews. Sessions were audio-recorded and transcribed verbatim. Iterative-inductive thematic analysis was carried out to identify themes related to assessment and communication within audiology practice. STUDY SAMPLES: Seven experienced hearing aid users took part in an online focus group and 14 participated in online semi-structured interviews (age range: 22 - 86 years; 9 males, 11 females). RESULTS: Themes related to assessment included the unaided and aided testing procedure and relating tests to real world hearing difficulties. Themes related to communication included the importance of deaf aware communication strategies, explanation of test results and patient centred care in audiology. CONCLUSION: To ensure hearing aid services meet the needs of the service users, we should explore user perspectives and proactively adapt service delivery. This approach should be ongoing, in response to advances in hearing aid technology. Within audiology, experienced hearing aid users' value (1) comprehensive, relatable hearing assessment, (2) deaf aware patient-audiologist communication, (3) accessible services and (4) a personalised approach to recommend suitable technology and address patient specific aspects of hearing loss.

Assessment of the cochlear implant pathway for newborn hearing screening referrals.

OBJECTIVE: To evaluate the cochlear implant (CI) assessment pathway for children referred through the newborn hearing screening programme (NHSP) and identify potential reasons for delay in CI surgery at a large UK centre. METHODS: Retrospective analysis of electronic notes of children referred through NHSP from 2016 to 2019. Key points in the assessment pathway from referral to switch-on were assessed. RESULTS: Of the 46 referrals, 44 went on to have CI surgery. Median age at CI surgery was 15 months (interquartile range (IQR) 13 to 17 months). Only 5% of referrals were implanted before the age of 12 months. Delayed referral and the presence of otitis media with effusion (OME) were associated with delayed implantation. The median period of monitoring for OME was 48 days (IQR 20 to 93 days), with a natural resolution rate of only 11%. The median time from surgery to switch-on was 5 weeks (IQR 4.1 to 5.4 weeks). CONCLUSION: Achieving implantation prior to the age of 12 months for NHSP referrals can be challenging for a variety of reasons. The delays in the system and the steps that our implant programme has taken to address these will be highlighted.

Objective assessment of electrode discrimination with the auditory change complex in adult cochlear implant users.

The spatial auditory change complex (ACC) is a cortical response elicited by a change in place of stimulation. There is growing evidence that it provides a useful objective measure of electrode discrimination in cochlear implant (CI) users. To date, the spatial ACC has only been measured in relatively experienced CI users with one type of device. Early assessment of electrode discrimination could allow auditory stimulation to be optimized during a potentially sensitive period of auditory rehabilitation. In this study we used a direct stimulation paradigm to measure the spatial ACC in both pre- and post-lingually deafened adults. We show that it is feasible to measure the spatial ACC in different CI devices and as early as 1 week after CI switch-on. The spatial ACC has a strong relationship with performance on a behavioural discrimination task and in some cases provides information over and above behavioural testing. We suggest that it may be useful to measure the spatial ACC to guide auditory rehabilitation and improve hearing performance in CI users.

Preliminary assessment of the feasibility of using AB words to assess candidacy in adults.

BACKGROUND: Adult cochlear implant (CI) candidacy is assessed in part by the use of speech perception measures. In the United Kingdom the current cut-off point to fall within the CI candidacy range is a score of less than 50% on the BKB sentences presented in quiet (presented at 70 dBSPL). GOAL: The specific goal of this article was to review the benefit of adding the AB word test to the assessment test battery for candidacy. RESULTS: The AB word test scores showed good sensitivity and specificity when calculated based on both word and phoneme scores. The word score equivalent for 50% correct on the BKB sentences was 18.5% and it was 34.5% when the phoneme score was calculated; these scores are in line with those used in centres in Wales (15% AB word score). CONCLUSION: The goal of the British Cochlear Implant Group (BCIG) service evaluation was to determine if the pre-implant assessment measures are appropriate and set at the correct level for determining candidacy, the future analyses will determine whether the speech perception cut-off point for candidacy should be adjusted and whether other more challenging measures should be used in the candidacy evaluation.

Assessment and Outcome in Non-Traditional Cochlear Implant Candidates.

The objectives of this study were to assess: (i) patient expectations met as a measure of outcome in early-deafened, late-implanted (non-traditional) cochlear implant recipients and (ii) pre-implantation predictive factors for postoperative speech perception. The notes of 13 recipients were retrospectively reviewed. The mean age at onset of profound deafness was 1.5 years (range 0-6). The mean age at implantation was 37 years (range 22-51 years). Patient expectations were assessed pre-operatively and 1 year after implantation. They were met or exceeded in 129/140 (92%) domains overall. A higher Speech Intelligibility Rating and audiovisual City University of New York sentence score before implantation were found to be positive predictive factors for improved speech discrimination after cochlear implantation.

Simultaneous Assessment of Speech Identification and Spatial Discrimination: A Potential Testing Approach for Bilateral Cochlear Implant Users?

With increasing numbers of children and adults receiving bilateral cochlear implants, there is an urgent need for assessment tools that enable testing of binaural hearing abilities. Current test batteries are either limited in scope or are of an impractical duration for routine testing. Here, we report a behavioral test that enables combined testing of speech identification and spatial discrimination in noise. In this task, multitalker babble was presented from all speakers, and pairs of speech tokens were sequentially presented from two adjacent speakers. Listeners were required to identify both words from a closed set of four possibilities and to determine whether the second token was presented to the left or right of the first. In Experiment 1, normal-hearing adult listeners were tested at 15° intervals throughout the frontal hemifield. Listeners showed highest spatial discrimination performance in and around the frontal midline, with a decline at more eccentric locations. In contrast, speech identification abilities were least accurate near the midline and showed an improvement in performance at more lateral locations. In Experiment 2, normal-hearing listeners were assessed using a restricted range of speaker locations designed to match those found in clinical testing environments. Here, speakers were separated by 15° around the midline and 30° at more lateral locations. This resulted in a similar pattern of behavioral results as in Experiment 1. We conclude, this test offers the potential to assess both spatial discrimination and the ability to use spatial information for unmasking in clinical populations.

Developing an assessment approach for perceptual changes to tinnitus sound characteristics for adult cochlear implant recipients.

OBJECTIVE: To investigate the impact of cochlear implantation on tinnitus suppression, characteristics, localization, and duration. DESIGN: A cochlear implant (CI) recipient-focused postal questionnaire survey. STUDY SAMPLE: The questionnaire was posted, with consent, to 100 adults who had received a unilateral CI at the RNTNEH between 1988 and 1999. All adults spoke English as their first language and were postlingually deafened. Sixty-eight adults (38 female, 29 male, one unspecified) aged 31-80 years (mean 61 years) completed and returned the questionnaire without interview. RESULTS: With the processor 'ON', CI recipients experienced total or partial suppression of tinnitus ipsilateral to their CI in 57% of cases, and in 43% where tinnitus was perceived contralateral to the CI. The percentage of CI recipients who experienced high tone tinnitus was reduced from 60% pre-implant to 29% post-implant with the processor 'ON' while pulsatile tinnitus was reduced from 38% pre-implant to 13% post-implant. CIs were also found to reduce the tonal complexity and duration, and change the source localization of tinnitus post-implantation. CONCLUSIONS: Perceptual changes to tinnitus can take place post-implantation. Changes can occur within the four categories explored: tinnitus suppression, characteristics, localization, and duration of awareness per day.