Tinnitus reduction in patients with single-sided deafness: the effect of cochlear implantation, bone conduction devices, and contralateral routing of sound hearing aids investigated in a randomized controlled trial.

Objectives: Single-sided deafness (SSD) is often accompanied by tinnitus, resulting in a decreased quality of life. Currently, there is a lack of high level of evidence studies comparing different treatment options for SSD regarding tinnitus reduction. This randomized controlled trial (RCT) evaluated the effect of a cochlear implant (CI), bone conduction device (BCD), contralateral routing of sound (CROS), and no treatment on tinnitus outcomes in SSD patients, with follow-up extending to 24 months. Methods: A total of 120 adult SSD patients were randomized to three groups: CI, a trial period with first a BCD on a headband, then a CROS, or vice versa. After the trial periods, patients opted for a BCD, CROS, or no treatment. At the start of follow-up, 28 patients were implanted with a CI, 25 patients with a BCD, 34 patients had a CROS, and 26 patients chose no treatment. The Tinnitus Handicap Inventory (THI), Tinnitus Questionnaire (TQ), the Visual Analog Scale (VAS), and the Hospital Anxiety and Depression Scale (HADS) were completed at baseline and at 3, 6, 12, and 24 months of follow-up. Results: The CI and BCD groups showed significantly decreased tinnitus impact scores. The CI group showed the largest decrease, which was already observed at 3 months of follow-up. Compared to the baseline, the median THI score decreased by 23 points, the TQ score by 17 points, and the VAS score by 60 points at 24 months. In the BCD group, the TQ score decreased by 9 points, and the VAS decreased by 25 points at 24 months. The HADS anxiety and depression subscale showed no indication for anxiety or depression at baseline, nor at 24 months, for all groups. Conclusion: In this RCT, SSD patients treated with a CI or BCD showed an overall decrease in tinnitus impact scores up to 24 months compared to baseline. The CI group reported a stable and the largest reduction. Cochlear implants appear to be superior to BCD and CROS, and no treatment for achieving partial or complete resolution of tinnitus in patients with SSD. Clinical trial registration: Netherlands Trial Register, www.onderzoekmetmensen.nl/nl/trial/26952, NTR4457, CINGLE trial.

Choice of treatment evaluated after trial periods with bone conduction devices and contralateral routing of sound systems in patients with single-sided deafness.

Objectives: Patients with single-sided deafness (SSD) may experience difficulties with speech perception in noise, sound localization, have tinnitus and experience a reduced quality of life (QoL). contralateral routing of sound hearing aids (CROS) or bone conduction devices (BCD) may partly improve subjective speech communication and QoL in SSD patients. A trial period with these devices can help in making a well-informed choice of treatment. Our aim was to evaluate factors influencing the choice of treatment made after a BCD and CROS trial period in adult SSD patients. Methods: Patients were randomized in the: "first BCD, then CROS" or "first CROS, then BCD" trial period group. After the BCD on headband and CROS were tested for 6 weeks each, patients choose for BCD, CROS or no treatment. Primary outcome was the distribution of choice of treatment. Secondary outcomes included the association between the choice of treatment and patient characteristics, reasons for treatment acceptance or rejection, device usage during the trial periods, and disease-specific QoL outcomes. Results: Of 91 patients randomized, 84 completed both trial periods and made their choice of treatment: 25 (30%) BCD, 34 (40%) CROS, and 25 (30%) no treatment. No characteristics were found to be related to choice of treatment. Top three reasons for acceptance or rejection were: device (dis)comfort, sound quality and (dis)advantage of subjective hearing. Average daily device use during the trial periods was higher for CROS than for BCD. Choice of treatment was significantly related with both duration of device usage and greater improvement of QoL after the corresponding trial period. Conclusion: The majority of SSD patients preferred BCD or CROS over no treatment. Evaluating device usage, discussing treatment (dis)advantages and disease-specific QoL outcomes after trial periods are to be considered during patient counseling and could facilitate whether to choose one of these treatments. Level of evidence: 1B.

Image-based analysis of skeletal muscle mass predicts cisplatin dose-limiting toxicity in patients with locally advanced head and neck cancer.

PURPOSE: Evidence suggests that patients' skeletal muscle mass (SMM) can predict the patients at risk for cisplatin dose-limiting toxicities (DLT). Cisplatin is currently dosed on body surface area (BSA). The predictive value of SMM for cisplatin DLT in patients with locally advanced head and neck cancer (LA-HNC) is investigated. METHODS: Patients with LA-HNC treated with cisplatin-based chemoradiotherapy (CRT) were included. SMM was measured using pre-treatment scans. Logistic regression analysis was performed to identify the predictive impact of low SMM for DLT. RESULTS: In total, 343 patients were included of which 199 patients (58.0%) had low SMM and 154 patients (44.9%) experienced cisplatin DLT. In multivariate analysis, low SMM at diagnosis was the only predictive factor for DLT (HR 1.8, 95% CI 1.1-2.9). CONCLUSIONS: Low SMM was associated with an increased risk of DLT. Trials are needed to investigate cisplatin dosing with consideration of SMM rather than solely BSA.

Short-term outcomes of cochlear implantation for single-sided deafness compared to bone conduction devices and contralateral routing of sound hearing aids-Results of a Randomised controlled trial (CINGLE-trial).

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 (S0N0)). Secondary outcomes were speech perception in noise with speech directed to the poor ear and noise to the better ear (SpeNbe) and vice versa (SbeNpe), 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 S0N0, the CI group performed significantly better when compared to baseline, and when compared to the other groups. In SpeNbe, there was an advantage for all treatment groups compared to baseline. However, in SbeNpe, 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 Sound of a Cochlear Implant Investigated in Patients With Single-Sided Deafness and a Cochlear Implant.

HYPOTHESIS: A cochlear implant (CI) restores hearing in patients with profound sensorineural hearing loss by electrical stimulation of the auditory nerve. It is unknown how this electrical stimulation sounds. BACKGROUND: Patients with single-sided deafness (SSD) and a CI form a unique population, since they can compare the sound of their CI with simulations of the CI sound played to their nonimplanted ear. METHODS: We tested six stimuli (speech and music) in 10 SSD patients implanted with a CI (Cochlear Ltd). Patients listened to the original stimulus with their CI ear while their nonimplanted ear was masked. Subsequently, patients listened to two CI simulations, created with a vocoder, with their nonimplanted ear alone. They selected the CI simulation with greatest similarity to the sound as perceived by their CI ear and they graded similarity on a 1 to 10 scale. We tested three vocoders: two known from the literature, and one supplied by Cochlear Ltd. Two carriers (noise, sine) were tested for each vocoder. RESULTS: Carrier noise and the vocoders from the literature were most often selected as best match to the sound as perceived by the CI ear. However, variability in selections was substantial both between patients and within patients between sound samples. The average grade for similarity was 6.8 for speech stimuli and 6.3 for music stimuli. CONCLUSION: We obtained a fairly good impression of what a CI can sound like for SSD patients. This may help to better inform and educate patients and family members about the sound of a CI.

Low skeletal muscle mass is a predictive factor for chemotherapy dose-limiting toxicity in patients with locally advanced head and neck cancer.

OBJECTIVES: Low skeletal muscle mass (SMM) or sarcopenia is emerging as an adverse prognostic factor for chemotherapy dose-limiting toxicity (CLDT) and survival in cancer patients. Our aim was to determine the impact of low SMM on CDLT in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) treated with primary radiochemotherapy (RCT). PATIENTS AND METHODS: Consecutive patients diagnosed with LA-HNSCC and treated with primary RCT between 2007 and 2011 in our center were included. Clinical variables were retrospectively retrieved and SMM was measured at the level of the third cervical vertebra using pre-treatment head and neck CT-scans. After determining a cut-off value for low SMM, multivariate analysis was performed to identify prognostic factors for CDLT. RESULTS: Of 112 patients included, 30.4% experienced CDLT. The optimal cut-off value for low SMM as a predictor of CDLT was ≤43.2cm2/m2. Using this cut-off, 54.5% patients had low SMM. Patients with low SMM experienced CDLT more frequently than patients with normal SMM (44.3% vs. 13.7%, p<0.001) and received a higher dose of chemotherapy/kg lean body mass (estimated from SMM, p=0.044). At multivariate analysis, low SMM was independently inversely associated with CDLT (OR 0.93, 95%CI: 0.88-0.98). Patients experiencing CDLT had a lower overall survival than patients who did not (mean 36.6vs. 54.2months, p=0.038). CONCLUSION: Low SMM is an independent risk factor for CDLT in LA-HNSCC patients treated with primary RCT. Pre-therapeutic estimation of SMM using routine CT-scans of the head and neck region may identify patients at risk of CDLT.

Automatic Localization of Cochlear Implant Electrode Contacts in CT.

OBJECTIVES: Determining the exact location of cochlear implant (CI) electrode contacts after implantation is important, as it helps quantifying the relation between CI positioning and hearing outcome. Unfortunately, localization of individual contacts can be difficult, because the spacing between the electrode contacts is near the spatial resolution limit of high-resolution clinical computed tomography (CT) scanners. This study introduces and examines a simple, automatic method for the localization of intracochlear electrode contacts. CI geometric specifications may provide the prior knowledge that is essential to accurately estimate contact positions, even though individual contacts may not be visibly resolved. DESIGN: The prior knowledge in CI geometry is used to accurately estimate intracochlear electrode contact positions in high-resolution CT scans of seven adult patients implanted with a CI (Cochlear Ltd.). The automatically detected electrode contact locations were verified against locations marked by two experienced observers. The interobserver errors and the errors between the averaged locations and the automatically detected locations were calculated. The estimated contact positions were transformed to a cylindrical cochlear coordinate system, according to an international consensus, in which the insertion angles and the radius and elevation were measured. RESULTS: The linear correlation of the automatically detected electrode contact positions with the manually detected locations was high (R = 0.98 for the radius, and R = 1.00 for the insertion angle). The errors in radius and in insertion angle between the automatically detected locations and the manually detected locations were 0.12 mm and 1.7°. These errors were comparable to the interobserver errors. Geometrical measurements were in line with what is usually found in human cochleae. The mean insertion angle of the most apical electrode was 410° (range: 316° to 503°). The mean radius of the electrode contacts in the first turn of the cochlear spiral was 3.0 mm, and the mean radius of the remainder in the second turn was 1.7 mm. CONCLUSIONS: With implant geometry as prior knowledge, automatic analysis of high-resolution CT scans enables accurate localization of CI electrode contacts. The output of this method can be used to study the effect of CI positioning on hearing outcomes in more detail.

Systematic Review on the Trial Period for Bone Conduction Devices in Single-Sided Deafness: Rates and Reasons for Rejection.

OBJECTIVE: To systematically review the literature to evaluate the trial period of bone conduction devices (BCDs) for adult patients with single-sided deafness (SSD). DATA SOURCES: The PubMed, Embase, and Cochrane Library databases were searched from their inception up to August 15, 2016 for SSD, BCD, and their synonyms. STUDY SELECTION: In total, 523 articles were retrieved, of which 12 satisfied the eligibility quality criteria. Our outcomes of interest were: 1) the BCD implantation rejection percentage, 2) reasons to reject BCD implantation, and 3) possible prognostic factors predicting the trial outcome. DATA EXTRACTION AND SYNTHESIS: At critical appraisal, six studies (n = 471 patients) scored a moderate to high directness of evidence and a medium or low risk of bias and were selected for data extraction. Due to heterogeneity between studies, pooling of data for meta-analysis was not feasible. Therefore, results of studies were summarized per outcome: 1) after the BCD trial, 32.0 to 69.6% of SSD patients rejected BCD implantation, 2) the three main reasons for rejection were experiencing limited benefit from the device, patients fearing or being unfit for surgery and cosmetic aspects, 3) no clear prognostic factors predicting the trial outcome could be identified. CONCLUSION: Roughly half of patients rejected BCD implantation after a trial period. From the current literature it is unclear which patients could benefit most from BCD implantation. High level of evidence studies should be conducted to investigate possible prognostic factors that predict the BCD trial outcome.