Bernard Fraysse’s research while affiliated with Centre Hospitalier Universitaire de Toulouse and other places

Objectives To determine the Incremental Cost-Utility Ratio (ICUR) of cochlear implantation in the treatment of adult patients with single-sided deafness (SSD) and asymmetric hearing loss (AHL). Methods This prospective multicenter pragmatic study including a randomized controlled trial (RCT) enrolled 155 subjects with SSD or AHL. Subjects chose a treatment option between: abstention, Contralateral Routing Of the Signal hearing aids, Bone Conduction Device or Cochlear Implant (CI). Participants who opted for CI were then randomized between two arms: “immediate CI” where the cochlear implantation was performed within one month and “initial observation” where subjects were first observed. The ICUR of CI was determined at 6 months follow-up by comparing the two arms. Utility was measured using EuroQoL- 5 dimensions (EQ-5D), to calculate the gain in Quality-Adjusted Life Years (QALY). Individual costs were extracted from the French National Health Insurance database. A Markovian MultiState (MMS) model assessed the ICUR evolution over the lifetime horizon. Results Among the 155 included participants, 51 opted for a CI and were randomized. For a 6 months follow-up period, the ICUR was €422,279/QALY gained after CI. Using the MMS model, the ICUR of CI decreased to €57,561/QALY at 10 years follow-up, €38,006/QALY at 20 years, and dropped to €26,715 at 50 years. In the participants with severe tinnitus, mean ICUR was €31,105/QALY at 10 years. Conclusions CI can be considered as an efficient treatment in SSD and AHL from 20 years follow-up in the global population, and before 10 years follow-up in patients with severe associated tinnitus.

Objective: To compare the outcomes of patients with unilateral otosclerosis treated consecutively by a hearing aid then stapedotomy. Study design: Monocentric, nonrandomized, prospective, longitudinal, cohort study. Setting: Tertiary university hospital. Patients: Adult patients with a unilateral conductive hearing loss of at least 30 dB caused by otosclerosis. Interventions: Consecutive treatment by an external hearing aid followed by stapedotomy. Main outcome measures: Differences between hearing aids and stapedotomy in quality of life, pure-tone audiometry, binaural hearing, tinnitus severity, and patient satisfaction. Results: Twenty-two patients were included, of which 20 (91%) underwent stapedotomy. Stapedotomy demonstrated increased quality of life according to Glasgow Health Status Inventory scores versus hearing aids (+10.4 ± 9.4 [p = 0.0001]). Stapedotomy versus hearing aids showed improved pure-tone averages (-11.1 ± 11.0 dB [p = 0.002]) and air-bone gaps (-11.8 ± 10.7 dB [p = 0.0006]). Stapedotomy was superior to hearing aids for speech-in-noise recognition in the reverse dichotic condition (-8.4 ± 26.9 dB [p = 0.004]) and showed improved sound localization accuracy in root mean square error (-14.5 ± 24.5 degrees [p = 0.02]). Stapedotomy, but not hearing aids, showed improved patient self-evaluated tinnitus after baseline adjustment according to the Tinnitus Handicap Inventory (-8.0 ± 13.4 [p = 0.02]) and visual analog scale for tinnitus intensity (-28.7 ± 34.1 [p = 0.006]). Overall, patients were more satisfied with surgery versus hearing aids. Conclusions: Stapedotomy remains more effective compared with hearing aids with greater improvements in quality of life, patient satisfaction, hearing outcomes, and self-evaluated tinnitus.

Nowadays, several options are available to treat patients with conductive or mixed hearing loss. Whenever surgical intervention is not possible or contra-indicated, and amplification by a conventional hearing device (e.g., behind-the-ear device) is not feasible, then implantable hearing devices are an indispensable next option. Implantable bone-conduction devices and middle-ear implants have advantages but also limitations concerning complexity/invasiveness of the surgery, medical complications, and effectiveness. To counsel the patient, the clinician should have a good overview of the options with regard to safety and reliability as well as unequivocal technical performance data. The present consensus document is the outcome of an extensive iterative process including ENT specialists, audiologists, health-policy scientists, and representatives/technicians of the main companies in this field. This document should provide a first framework for procedures and technical characterization to enhance effective communication between these stakeholders, improving health care.

Introduction: Cochlear implantation is a recent approach proposed to treat single-sided deafness (SSD) and asymmetric hearing loss (AHL). Several cohort studies showed its effectiveness on tinnitus and variable results on binaural hearing. The main objective of this study is to assess the outcomes of cochlear implantation and other treatment options in SSD/AHL on quality of life. Methods: This prospective multicenter study was conducted in 7 tertiary university hospitals and included an observational cohort study of SSD/AHL adult patients treated using contralateral routing of the signal (CROS) hearing aids or bone-anchored hearing systems (BAHSs) or who declined all treatments, and a randomized controlled trial in subjects treated by cochlear implantation, after failure of CROS and BAHS trials. In total, 155 subjects with SSD or AHL, with or without associated tinnitus, were enrolled. After 2 consecutive trials with CROS hearing aids and BAHSs on headband, all subjects chose any of the 4 treatment options (abstention, CROS, BAHS, or cochlear implant [CI]). The subjects who opted for a CI were randomized between 2 arms (CI vs. initial observation). Six months after the treatment choice, quality of life was assessed using both generic (EuroQoL-5D, EQ-5D) and auditory-specific quality-of-life indices (Nijmegen Cochlear implant Questionnaire [NCIQ] and Visual Analogue Scale [VAS] for tinnitus severity). Performances for speech-in-noise recognition and localization were measured as secondary outcomes. Results: CROS was chosen by 75 subjects, while 51 opted for cochlear implantation, 18 for BAHSs, and 11 for abstention. Six months after treatment, both EQ-5D VAS and auditory-specific quality-of-life indices were significantly better in the "CI" arm versus "observation" arm. The mean effect of the CI was particularly significant in subjects with associated severe tinnitus (mean improvement of 20.7 points ± 19.7 on EQ-5D VAS, 20.4 ± 12.4 on NCIQ, and 51.4 ± 35.4 on tinnitus). No significant effect of the CI was found on binaural hearing results. Before/after comparisons showed that the CROS and BAHS also improved significantly NCIQ scores (for CROS: +7.7, 95% confidence interval [95% CI] = [4.5; 10.8]; for the BAHS: +14.3, 95% CI = [7.9; 20.7]). Conclusion: Cochlear implantation leads to significant improvements in quality of life in SSD and AHL patients, particularly in subjects with associated severe tinnitus, who are thereby the best candidates to an extension of CI indications.

Objective To evaluate the treatments’ consequences for unilateral hearing loss in children. Design Systematic review and meta-analysis (CRD42018109417). The MEDLINE, CENTRAL, ISRCTN and ClinicalTrials databases were searched between September 2018 and May 2019. Articles were screened and data were collected independently by two authors following the Cochrane and Preferred Reporting Items for Systematic review and Meta-Analysis guidelines. The risk of bias was evaluated using the Cochrane tool, the Newcastle-Ottawa Scale, the National Institute of Health, USA tool and considering the risk of confounding. In the studies with the lowest risk of bias, a meta-analysis was conducted. Interventions Validated hearing rehabilitation devices. Patients 6–15 years old children with moderate to profound unilateral hearing loss. Main outcome measures The primary study outcome was children’s quality of life. Academic performances were studied as an additional outcome. Results 731 unique articles were identified from the primary search. Of these, 18 articles met the Population, Intervention, Control, Outcomes and Study design selection criteria. In the eight studies with the lowest risk of bias, two meta-analysis were conducted. There was not enough data on academic results to conduct a meta-analysis. In 73 children included in a fixed effect meta-analysis (two studies), no effect of treatment could be shown (g=−0.20, p=0.39). In 61 children included in a random-effect meta-analysis (six studies), a strong positive effect of hearing treatment on quality of life was demonstrated (g=1.32, p<0.05). Conclusions The treatment of unilateral hearing loss seems to improve children’s quality of life. Further research is needed to identify the most effective treatment and its corresponding indications.

Objective Vertigo and dizziness are a frequent reason for medical consultation. However, diagnostic and therapeutic management is sometimes limited, and clinicians are faced with many unmet needs. The purpose of this study was to identify and prioritize these needs. Methods A questionnaire methodology was used to determine the need for innovation in vestibular disorder management. The questionnaire was sent to 19 teams in French-speaking ENT centers. We measured the concordance of the panel of experts on 56 questions related to the different vestibular pathologies encountered and the desired modalities of innovations. Results Thirteen questions were identified as priorities. The needs expressed by the experts had better knowledge of the pathophysiological mechanisms of the main diseases encountered and the development of new treatment modalities. Particular attention was paid to inner ear imaging techniques and the development of specific electrophysiology techniques. Discussion Some of the anticipated innovations are already under development, such as new inner ear fluid imaging techniques (hydrops visualization using MRI) or in situ treatments (transtympanic dexamethasone or gentamicin injections). Others, such as new electrophysiological techniques, are still not fully developed Conclusion This study provides a snapshot of the needs of the medical profession in vestibular disorder management. It highlights a real concern of the attending personnel, as well as a critical need to optimize the means of diagnosing and treating patients with vestibular disorders.

Objectives To describe the treatment choice in a cohort of subjects with single‐sided deafness (SSD) and asymmetric hearing loss (AHL). To assess the reliability of the treatment trials. Design In this national, multi‐centre, prospective study, the choice of subjects was made after two consecutive trials of Contralateral Routing Of the Signal (CROS) hearing aids and a Bone Conduction Device (BCD) on a headband. Subjects could proceed with one of these two options, opt for cochlear implantation or decline all treatments. Setting Seven tertiary university hospitals. Participants 155 subjects with SSD or AHL fulfilling the candidacy criteria for cochlear implantation, with or without associated tinnitus. Main outcome measures After the two trials, the number of subjects choosing each option was described. Repeated assessments of both generic and auditory‐specific quality of life were conducted, as well as hearing assessments (speech recognition in noise and horizontal localization). Results CROS was chosen by 75 subjects, followed by cochlear implantation (n=51), BCD (n=18) and abstention (n=11). Patients who opted for cochlear implantation had a poorer quality of life (p=0.03). The improvement of quality of life indices after each trial was significantly associated with the final treatment choice (p=0.008 for generic indices, p=0.002 for auditory specific indices). The follow‐up showed that this improvement had been overestimated in the CROS group, with a long‐term retention rate of 52.5%. Conclusions More than one third of SSD/AHL subjects are unsatisfied after CROS and BCD trials. Repeated quality of life assessments help counselling the patient for his/her treatment choice.