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Single-sided deafness (SSD) leads to difficulties with speech perception in noise, sound localisation, and sometimes tinnitus. Current treatments (Contralateral Routing of Sound hearing aids (CROS) and Bone Conduction Devices (BCD)) do not sufficiently overcome these problems. Cochlear implants (CIs) may help. Our aim was to evaluate these treatments in a Randomised Controlled Trial (RCT). Adult SSD patients were randomised using a web-based randomisation tool into one of three groups: CI; trial period of ‘first BCD, then CROS’; trial period of ‘first CROS, then BCD’. After these trial periods, patients opted for BCD, CROS, or No treatment. The primary outcome was speech perception in noise (directed from the front (S 0 N 0 )). Secondary outcomes were speech perception in noise with speech directed to the poor ear and noise to the better ear (S pe N be ) and vice versa (S be N pe ), sound localisation, tinnitus burden, and disease-specific quality of life (QoL). We described results at baseline (unaided situation) and 3 and 6 months after device activation. 120 patients were randomised. Seven patients did not receive the allocated intervention. The number of patients per group after allocation was: CI (n = 28), BCD (n = 25), CROS (n = 34), and No treatment (n = 26). In S 0 N 0 , the CI group performed significantly better when compared to baseline, and when compared to the other groups. In S pe N be , there was an advantage for all treatment groups compared to baseline. However, in S be N pe , BCD and CROS groups performed worse compared to baseline, whereas the CI group improved. Only in the CI group sound localisation improved and tinnitus burden decreased. In general, all treatment groups improved on disease-specific QoL compared to baseline. This RCT demonstrates that cochlear implantation for SSD leads to improved speech perception in noise, sound localisation, tinnitus burden, and QoL after 3 and 6 months of follow-up. For most outcome measures, CI outperformed BCD and CROS. Trial registration: Netherlands Trial Register ( www.trialregister.nl ): NTR4580 , CINGLE -trial.

The chorda tympani nerve (CTN) is a mixed nerve, which carries sensory and parasympathetic fibres. The sensory component supplies the taste sensation of the anterior two-thirds of the ipsilateral side of the tongue. During middle ear surgery the CTN is exposed and frequently stretched or sacrificed, because it lacks a bony covering as it passes through the middle ear. Injury may cause hypogeusia, ageusia or altered taste sensation of the ipsilateral side of the tongue. To date, there is no consensus regarding which type of CTN injury (sacrificing or stretching), during middle ear surgery, leads to the least burden for the patient. A double-blind prospective prognostic association study was designed in a single medical centre in the Netherlands to determine the effect of CTN injury on postoperative taste disturbance and quality of life. 154 patients, who will undergo primary stapes surgery or cochlear implantation will be included. The taste sensation, food preferences and quality of life of these patients will be evaluated preoperatively and at one week, six weeks and six months postoperatively using the Taste Strip Test, Electrogustometry, supplementary questionnaire on taste disturbance, Macronutrient and Taste Preference Ranking Task, Appetite, Hunger and Sensory Perception questionnaire and Questionnaire of Olfactory Disorders to assess the association of these outcomes with CTN injury. Evaluation of olfactory function will only take place preoperatively and at one week postoperatively using the Sniffin' Sticks. The patient and outcome assessor are blinded to the presence or absence of CTN injury. This study is the first to validate and quantify the effect of chorda tympani nerve injury on taste function. The findings of this study may lead to evidence-based proof of the effect of chorda tympani injury on taste function with consequences for surgical strategies. Netherlands Trial Register NL9791. Registered on 10 October 2021.

Cochlear implants (CI) restore hearing of severely hearing-impaired patients. Although this auditory prosthesis is widely considered to be very successful, structural cochlear trauma during cochlear implantation is an important problem, reductions of which could help to improve hearing outcomes and to broaden selection criteria. The surgical approach in cochlear implantation, i.e. round window (RW) or cochleostomy (CO), and type of electrode-array, perimodiolar (PM) or lateral wall (LW), are variables that might influence the probability of severe trauma. We investigated the effect of these two variables on scalar translocation (STL), a specific type of severe trauma. Thirty-two fresh frozen human cadaveric ears were evenly distributed over four groups receiving either RW or CO approach, and either LW or PM array. Conventional radiological multiplanar reconstruction (MPR) was compared with a reconstruction method that uncoils the spiral shape of the cochlea (UCR). Histological analysis showed that RW with PM array had STL rate of 87% (7/8), CO approach with LW array 75% (6/8), RW approach with LW array 50% (4/8) and CO approach with PM array 29% (2/7). STL assessment using UCR showed a higher inter-observer and histological agreement (91 and 94% respectively), than that using MPR (69 and 74% respectively). In particular, LW array positions were difficult to assess with MPR. In conclusion, the interaction between surgical approach and type of array should be preoperatively considered in cochlear implant surgery. UCR technique is advised for radiological assessment of CI positions, and in general it might be useful for pathologies involving the inner ear or other complex shaped bony tubular structures.

Sensorineural hearing loss (SNHL) is caused mainly by irreversible damage to sensory hair cells after noise exposure, ototoxic medication, and ageing, with men being more prone to developing SNHL than women are. For animal models, sex-related susceptibility to develop SNHL needs to be taken into account. Ototoxic trauma can be modeled in mice via the systemic administration of furosemide and kanamycin. Several other deafening models have shown differences in response to ototoxic medication between female and male mice. Differences in response to kanamycin-induced ototoxicity in male and female mice have not been studied. Here, we examined sex differences in susceptibility to kanamycin plus furosemide-induced ototoxicity in adult C57BL/6 J mice. Adult (postnatal day 40) female and male C57BL/6 J and Lgr5GFP (C57BL/6 J background) mice were used. The animals were deafened with a single dose of furosemide (100 mg/kg, i.v.) in combination with kanamycin (700 or 900 mg/kg, s.c.). Before deafening, seven and twenty-eight days after deafening, auditory brainstem responses (ABRs) to click stimuli were recorded to evaluate hearing performance. The cochleae were harvested seven or twenty-eight days after the induction of ototoxicity and processed for histology to evaluate hair cell loss. Male mice presented large ABR threshold shifts after ototoxic treatment with 700 mg/kg kanamycin (50 dB median hearing loss). In males, 9/12 mice had threshold shifts greater than 40 dB. However, female mice presented significantly less hearing loss in response to 700 mg/kg kanamycin, as observed via ABRs after ototoxic treatment (32 dB median hearing loss), and only 8/22 female mice presented threshold shifts greater than 40 dB. When treated with 900 mg/kg kanamycin, female mice presented large ABR threshold shifts after ototoxic treatment (50 dB median), and 11/16 mice presented threshold shifts greater than 40 dB. Female C57BL/6 J mice are less susceptible to kanamycin-induced hearing loss than males are and hence need higher doses of kanamycin to reach the same level of hearing loss. This finding is in line with the prevalence of disabling hearing loss in humans, which is 7.3% in males and 4.8% in females, where estrogens have been linked to increased hearing performance and protection against hearing loss.

Background Prednisolone has been suggested as a treatment for olfactory disorders after COVID-19, but evidence is scarce. Hence, we aimed to determine the efficacy of a short oral prednisolone treatment on patients with persistent olfactory disorders after COVID-19. Methods We performed a randomized, double-blind, placebo-controlled, single-centered trial in the Netherlands. Patients were included if they were > 18 years old and if they had persistent (> 4 weeks) olfactory disorders within 12 weeks after a confirmed COVID-19 test. The treatment group received oral prednisolone 40 mg once daily for 10 days and the placebo group received matching placebo. In addition, all patients performed olfactory training. The primary outcome was the objective olfactory function on Sniffin’ Sticks Test (SST) 12 weeks after the start of treatment, measured in Threshold-Discrimination-Identification (TDI) score. Secondary outcomes were objective gustatory function assessed by the Taste Strip Test (TST) and subjective self-reported outcomes on questionnaires about olfactory, gustatory and trigeminal function, quality of life, and nasal symptoms. The CONSORT 2010 guideline was performed . Results Between November 2021 and February 2022, we included 115 eligible patients, randomly assigned to the treatment ( n  = 58) or placebo group ( n  = 57). No difference in olfactory function between groups was obtained after 12 weeks. Median TDI score on SST was 26.8 (IQR 23.6-29.3) in the placebo group and 28.8 (IQR 24.0-30.9) in the prednisolone group, with a median difference of - 1.5 (-3.0 to 0.25). There was similar improvement on olfactory function in both groups after 12 weeks. Furthermore, on secondary outcomes, we obtained no differences between groups. Conclusions This trial shows that prednisolone does not improve olfactory function after COVID-19. Therefore, we recommend not prescribing prednisolone for patients with persistent olfactory disorders after COVID-19. Trial registration This trial is registered on the ISRCTN registry with trial ID ISRCTN70794078.

There is a lack of comprehensive and uniform data on head and neck paragangliomas (HNPGLs), and research is challenging due to its rarity and the involvement of multiple medical specialties. To improve current research data collection, we initiated the Head and Neck Paraganglioma Registry (HNPGL Registry). The aim of the HNPGL Registry is to a) collect extensive data on all HNPGL patients through a predefined protocol, b) give insight in the long term outcomes using patient reported outcome measures (PROMs), c) create uniformity in the diagnostic and clinical management of these conditions, and thereby d) help provide content for future (randomized) research. The HNPGL Registry is designed as a prospective longitudinal observational registry for data collection on HNPGL patients and carriers of (likely) pathogenic variants causative of HNPGLs. All patients, regardless of the received treatment modality, can be included in the registry after informed consent is obtained. All relevant data regarding the initial presentation, diagnostics, treatment, and follow-up will be collected prospectively in an electronic case report form. In addition a survey containing the EuroQol 5D-5L (EQ-5D-5L), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Modified Fatigue Impact Scale (MFIS), Short QUestionnaire to Assess Health-enhancing physical activity (SQUASH), Cancer Worry Scale (CWS) and Hospital Anxiety and Depression Scale (HADS) will be sent periodically. The registry protocol was approved by the Medical Ethical Review Board of the University Medical Center Utrecht. The HNPGL Registry data will be used to further establish the optimal management for HNPGL patients and lay the foundation for guideline recommendations and the outline of future research.

The subjective experiences were assessed of cochlear implant (CI) users either wearing or not wearing a hearing aid (HA) at the contralateral ear. Unilateral CI-recipients were asked to fill out a set of daily-life questionnaires on bimodal HA use, hearing disability, hearing handicap and general quality of life. Twenty-six CI-recipients who regularly use a contralateral HA (bimodal group) and twenty-two CI-recipients who do not use a HA in the contralateral ear (unilateral group). Comparisons between both groups (bimodal versus unilateral) showed no difference in self-rated disability, hearing handicap or general quality of life. However within the group of bimodal listeners, participants did report a benefit of bimodal hearing ability in various daily life listening situations. Bimodal benefit in daily life can consistently be experienced and reported within the group of bimodal users.

The results from different Cochrane studies justify considerable professional equipoise concerning different treatment options for tinnitus. In case of professional equipoise, Shared Decision Making (SDM) is an indispensable tool for guiding patients to the intervention that best fits their needs. To improve SDM we developed a method to assess the accuracy and utility of decisions made by tinnitus patients when freely choosing between different treatment options during their patient journey. The different treatment options were audiological care and psychosocial counseling. We developed a statistical model by combining Signal Detection Theory (SDT) with the Health Belief Model (HBM). HBM states that perceived severity of an illness is strongly related to sick-role behavior. As proxies for perceived severity, we selected hearing loss and Tinnitus Handicap Inventory (THI) score at baseline. Next, we used these proxies as predictors in linear regression models based on SDT to determine the likelihood ratio of true positive decisions (choosing a treatment option and experiencing an improvement of more than 7 points in THI-score) and false positive decisions (choosing a treatment option and experiencing an improvement of less than 7 points in THI-score) for audiological care and psychosocial counseling, respectively. Data was gathered in a prospective cohort of 145 adults referred for tinnitus care to an outpatient audiology clinic in the Netherlands. The participants were asked to decide freely on uptake of audiological care (provision of hearing aids with or without a sound generator) and uptake of psychosocial counseling. Logistic regression with Bayesian inference was used to determine the cumulative distribution functions and the probability density functions of true positive decisions and false positive decisions as function of hearing loss and baseline THI-score for both treatment options, respectively. With the cumulative distribution functions, we determined the accuracy of the decisions. With the probability density functions we calculated the likelihood ratios of true positive decisions versus false positive decisions as function of hearing loss and baseline THI-score. These likelihood ratio functions allow assessment of the utility of the decisions by relating a decision criterion to perceived benefits and costs. Baseline THI-score drives decisions about psychosocial counseling and hearing loss drives decisions about audiological care. Decisions about psychosocial counseling are more accurate than decisions about audiological care. Both decisions have a low accuracy (0.255 for audiological care and  - 0.429 for psychosocial counseling), however. For decisions about audiological care the unbiased decision criterion is 37 dB(HL), meaning that a lenient decision criterion (likelihood ratio < 1) is adopted by patients with a hearing loss below 37 dB and a strict criterion (likelihood ratio > 1) by patients with a hearing loss exceeding 37 dB. For psychosocial counseling uptake the decision criterion is always strict, regardless of baseline THI-score. The distributions of the populations, that do and do not experience a clinically important change in THI-score, have unequal variances for psychosocial counseling, while they have almost equal variances for audiological care. Combining SDT and HBM can help assess accuracy and utility of patient decisions and thus may provide valuable information that can help to improve SDM by combining patient related outcome measures, decision drivers, and perceived benefits and costs of a treatment.

The aim of this study was to estimate the prevalence and distress of tinnitus pre- and post-cochlear implantation in patients with bilateral severe to profound hearing loss. In this retrospective study, we included patients from a cochlear implant clinic in Perth, Western Australia. Pre- and post-cochlear implantation data from 300 implant recipients were collected on self-reported presence of tinnitus, tinnitus distress using the Tinnitus Reaction Questionnaire (TRQ), hearing-related quality of life using the Abbreviated Profile of Hearing Aid Benefit (APHAB), and consonant-nucleus vowel-consonant (CNC) word recognition test scores. Retrospectively, patients were grouped into those with or without tinnitus, and the grade of tinnitus distress. The potential factors associated with post-implantation changes in the presence of tinnitus and its distress were evaluated. Tinnitus prevalence was 55.8% pre-operatively and 44.3% post-implantation with a median TRQ score respectively of 12.0 (IQR: 1.0–28.0) and 3.5 (IQR: 0.0–16.2) points. Among the 96 patients experiencing tinnitus pre-implantation, 14.6% patients experienced moderate to catastrophic tinnitus distress pre-implantation compared to 6.3% post-implantation. To conclude, the pre- and post-implantation median TRQ score for the cohort population showed that tinnitus was a “slight” handicap. Tinnitus prevalence and its associated tinnitus distress decreased post-implantation. Patients with tinnitus post-implantation were significantly younger and had less severe pre-implantation hearing loss in the non-implanted ear than patients without tinnitus. Further research is needed to understand the factors influencing changes in tinnitus.

IntroductionCisplatin is a widely used chemotherapeutic anti-cancer drug. However, high-dose cisplatin is also known for its dose-limiting toxicities, including irreversible cisplatin-induced hearing loss (CIHL). Sodium thiosulphate (STS) can bind to cisplatin to form an inactive and harmless complex. A topical application is desired, allowing cisplatin to retain its systemic anti-cancer effect.Methods and analysisThe SOUND trial is an investigator-initiated randomised controlled multicentre phase III trial to study the efficacy of transtympanic administration of STS against CIHL in a cohort of 100 patients with head and neck cancer treated with cisplatin at a dose of ≥200 mg/m2. Each subject will receive transtympanic STS injections in one ear, chosen by randomisation, before each cisplatin infusion. The contralateral ear serves as an internal control. The primary objective is efficacy (ie, clinically relevant benefit) of transtympanic STS injections against CIHL, defined as a difference in threshold shift of ≥10 decibels between baseline and 3 months after treatment in favour of the STS-treated ear. Secondary objectives include the difference in mean threshold shifts on frequencies essential for speech and extended high frequencies, as well as the difference between both ears in the gradation of hearing loss as defined by ototoxicity grading scales.Ethics and disseminationThe medical ethics committee in the Netherlands approved the trial (Clinical Trials Information System (CTIS) 2023-503313-30-00). The results will be disseminated through the CTIS and peer-reviewed scientific journals.Trial registration numberCTIS 2023-503313-30-00 approved by Medical Research Ethics Committee NedMec.