[Ethical considerations in ENT during the COVID-19 pandemic: Qualitative analysis of open-ended questions]. / Questionnements éthiques en ORL pendant la pandémie COVID-19 : étude qualitative de témoignages.

INTRODUCTION: The current new SARS-CoV-2 pandemic has had a profound impact on medical practice. The objective was to analyse the ethical questions raised by the French ENT community during the first wave of COVID-19 infections. METHODS: Four open-ended questions concerning ethical considerations in ENT were sent out in April 2020: (i) difficulties to care for COVID-19 positive patients; (ii) impact of the health crisis on COVID-19 negative patients; (iii) communication within the healthcare teams and with hospital staff; and (iv) management of information by the press, or national ENT societies. A thematic analysis was carried out and crossed with the epidemiological data of each respondent. RESULTS: Thirty-one responses from 13 different French Departments, including 21 from public institutions and 10 from private practice, median age of 45 and 17 men for 14 women, were analysed. The main ethical considerations concerned the management by ENTs of COVID-19 positive patients, the modification of practices in consultation and in the operating room, the fear of loss of chance for COVID-19 negative patients, the appropriate use of teleconsultations and teleworking and the consequences of fake-news for the population. CONCLUSION: In preparation of possible future pandemic outbreaks, key ethical aspects are to adapt patient management to local resources and infection prevalence, and circulate clear institutional guidelines.

The French Cochlear Implant Registry (EPIIC): Perception and language results in infants with cochlear implantation under the age of 24 months.

OBJECTIVE: Multi-centre study of the National French Registry (EPIIC) of patients with cochlear implants, focusing on infants who were operated-on under the age of 24 months between 2012 and 2016. PATIENTS AND METHODS: A total of 615 profoundly deaf infants, who received cochlear implants (CIs) before their second birthday, were included in the registry by different CI centers. Epidemiological, surgical, speech therapy and school, follow-up data were included in the registry, 12, 24, 36 and 48 months thereafter. The following parameters were studied: type of implantation (uni- or bilateral), complications, cause of deafness, category of auditory perception (CAP), Open-set word recognition score (OSW), speech intelligibility rating, lexical comprehension with EVIP (Peabody), communication mode and type of schooling. Bilateral simultaneous CI (BiCI) and unilateral CI (UniCI) groups were compared. RESULTS: There were 744 implantations. The explantation-reimplantation rate, within the four-year follow-up, was just 3.6%. Mean implantation age was 16.0 months, and similar in the two groups (BiCI/UniCI). A total of 51% of children had their first implant between 12 and 18 months, and 15% before 12 months. Implantation was unilateral in 52% of cases. Fifty-six percent of the bilateral procedures were sequential, with a mean delay of 16.8 months for the second implantation. The cause of deafness was unknown in 52% of cases. Of the 48% (297/615) of attributed cases, 32% had clear genetic causes. The remaining deafness was due to cytomegalovirus (CMV, 8%), inner-ear malformation (5%) and meningitis (3%). The main complications were from infections (47%) and internal device failure (25%). Four years post-operation, 84% of the UniCI and 75% of BiCl groups had a CAP≥5, and 83% of UniCl and 100% BiCI had OSW≥80%. Furthermore 74% of UniCI and 77% of BiCI communicated orally and 85% of UniCI and 90% of BiCI integrated into mainstream schooling. CONCLUSION: The French Registry of cochlear implants (EPIIC) is the only such national registry in the world. Our analysis illustrates the immediate benefits of, either single or double, cochlear implantation for language, perception skills and schooling.

The French National Cochlear Implant Registry (EPIIC): Cochlear explantation and reimplantation.

This study aims to determine the frequency and causes of cochlear explants with re-implantation (ERI) after 5 years' follow up of the patients included in the French national EPIIC (étude post-inscription des implants cochléaires) registry tracking patients with cochlear implantation. This multicenter, descriptive prospective study was conducted on 5051 patients enrolled in the EPIIC database between January 2012 and December 2016. Ninety-five patients (1.9%) received a primary implant and an ERI during the study. Of these, four benefitted from two ERIs. The number of ERIs was significantly higher in the pediatric population than among adults. The explantation and reimplantation were performed simultaneously in 86% of cases. The reasons for explantation were: in 46.4% of cases linked to a malfunction of the implant, and in 39.3% of cases for medical or surgical reasons. The number of electrodes inserted was significantly higher after the ERI than after the first implantation. There was just one post-ERI infection for these 95 explanted and re-implanted patients. As well as explantation with reimplantation rarely being necessary, it generally presents no major surgical difficulty and in most cases it allows a better integration than in the first implantation.

The French National Cochlear Implant Registry (EPIIC): Results, quality of life, questionnaires, academic and professional life.

This study concerns the results of cochlear implantation in children and adults from French cochlear implantation centers, monitored at one, two and three years by the Cochlear Implant French Registry EPIIC. This multicenter study enrolled 2603 subjects (1667 adults and 936 children) implanted in one ear. The following parameters were studied: hearing overall performances, monosyllabic or dissyllabic word perception, speech intelligibility, self-assessment questionnaire of Cochlear Implant (CI) benefits (Abbreviated profile of Hearing aid Benefit); professional activity and schooling. This study confirms the ceiling effect in adults' performances after the 1st year and the progressive growth in children's performances. It also shows that the contralateral hearing aid enhances performances compared to the CI alone condition, in all follow-up sessions. The French register of CIs is the only worldwide register of systematic follow-up on a period of three years and more of all adults and children implanted in a country.

The French National Cochlear Implant Registry (EPIIC): Cochlear implantation in adults over 65years old.

OBJECTIVES: To analyze the performance of cochlear implants in French patients aged 65 and over, implanted between 2012 and 2016, using data from the French national registry for cochlear implants (EPIIC). MATERIALS AND METHODS: The French national registry incorporates patient data from before implantation and for three years after implantation, stratified in different age groups (18-39, 40-64years, 65-74years and>75years). Here, we assessed the latter two categories. Hearing was assessed using mono- and disyllabic words in a silent background. The Category of Auditory Performance (CAP) scale was also implemented and subjects took the Abbreviated Profile of Hearing Aid Benefit (Aphab) questionnaire. RESULTS: The population aged over 65 accounted for 38% (n=1193) of the 3178 adult implanted patients. The performance for mono- and disyllabic words in silence, the CAP scores and the APHAB questionnaire answers for ease of communication, background noise and reverberation were dramatically improved at one year post-implantation (P<0.0001 for each score) and remained stable between one and three years thereafter. The percentage improvement was similar across all age groups. The scores for loud-noise intolerance did not change after cochlear implantation in any age group. CONCLUSION: Cochlear implants improve hearing and communication in subjects aged 65 and over, with comparable efficiency to that achieved in younger subjects. Cochlear implantation should thus be proposed whenever hearing aids provide only limited benefit. However, between 2012 and 2016, cochlear implantation was given to less than 1% of the French population aged 65 and over with profound deafness.

The French Cochlear Implant Registry (EPIIC): Cochlear implant candidacy assessment of off-label indications.

OBJECTIVE: Evaluate in France the outcomes of cochlear implantation outside the selection criteria, off-label. MATERIAL AND METHODS: This is a prospective cohort study including adults and children having received a cochlear implant (CI) in an off-label indication, that is outside the criteria established by the "Haute Autorité de santé (HAS)" in 2012. The data was collected from the "EPIIC" registry on recipients who received CIs in France between 2011 and 2014. Speech audiometry was performed at 60dB preimplantation and after one year of CI use, as well as an evaluation of the scores of the quality of life with the APHAB questionnaire, the scores for CAP and the professional/academic status in pre- and post-implantation conditions. Major and minor complications at surgery have been recorded. RESULTS: In total, 590 patients (447 adults and 143 children) with an off-label indication for CIs were included in this study from the EPIIC registry (11.7% of the whole cohort of EPIIC). For adults, the median percentage of comprehension using monosyllabic word lists was 41% in preimplantation condition versus 53% after one year of CI use (P<0.001) and 60% versus 71% in dissyllabic word lists (P<0.001). The CAP scores were 5 versus 6 in pre- and post-implantation conditions respectively (P<0.001) and the APHAB scores were statistically lower after implantation (P<0.001). In the children cohort, the median percentage of comprehension using monosyllabic word lists was 51% in preimplantation condition and 65% after CI (P<0.001), and 48% versus 82% (P<0.001) for dissyllabic word lists. The CAP scores were 5 versus 7 respectively in pre- and post-CI conditions (P<0.001). Thirty-two minor complications (5.4%) and 17 major complications (2.8%) were reported in our panel of off-label indication patients. CONCLUSION: These results suggest that a revision of the cochlear implantation candidacy criteria is necessary to allow more patients with severe or asymmetric hearing loss to benefit from a CI when there is an impact on quality of life despite the use of an optimal hearing aid.

The French National Cochlear Implant Registry (EPIIC): Bilateral cochlear implantation.

OBJECTIVES: Assessment of the incidence and results of bilateral cochlear implantation in adults and children in France. MATERIALS AND METHODS: Multicenter retrospective study of data in the French national registry of cochlear implantations from January 1st 2012 to December 31st 2016. Functional results from CAP (Category of Auditory Performance) questionnaires and speech audiometry tests, with mono- and di-syllabic word-lists, were compared before and after implantation. Speech audiometry tests were carried out against a noisy background, except before simultaneous implantations. RESULTS: Nine hundred and forty two bilateral cochlear implantations were performed during this period, that is, 16.4% of all cochlear implantations. Five hundred and eighty eight bilateral implantations were performed sequentially. 59% of the bilateral implantations were performed in children. Bilateral implants significantly improved CAP scores in all cases (P<0.001). Auditory performance, with the two types of word-list, were significantly improved after simultaneous implantation (P<0.01). After sequential implantation, the speech discrimination score, already very good with the first implant, reached 63±26% [0-100] with monosyllabic word lists, and 72±28% [0-100] with dissyllabic words. There were more complications due to surgery in bilateral cases than in the entire population of cochlear recipients (9.1% vs 6.4%, P<0.02). CONCLUSION: Hearing is significantly improved by simultaneous cochlear implantation. For sequential implantation, at one year, when auditory results were already excellent from the first implant, in the bimodal condition CAP scores were significantly improved, although there was no further change in speech audiometry in noise.

The French Cochlear Implant Registry (EPIIC): Cochlear implantation complications.

OBJECTIVES: The aim of this study was to evaluate peri- and post-operative complications related to cochlear implantations. We searched for risk factors predicting these complications and analyzed the complications in the youngest and most elderly. STUDY DESIGN: Retrospective analysis of cochlear implant patients. MATERIALS AND METHODS: All patients who underwent cochlear implantation in France between January 2012 and December 2016 were anonymized and registered in the EPIIC database. This population included 3483 adults and 2245 children. Their demographic and surgical data and their incidence of peri- or post-operative complications, including their severity, whether major or minor, were all indicated. RESULTS: The global complication rate was 6.84%. The risk of complication was higher in initial implantation versus reimplantation (P<0.0001). The risk was also higher for bilateral implantation versus unilateral (P<0.0001). Complications were more frequent for patients with cochlear malformation (P=0.002). There was no difference in complication rates across age groups; babies under 1 year old, and the elderly over 80 and even over 90, did not have more complications than the rest of the population. Patients treated in the daily care unit had no more complications than those who were hospitalized for one night or more (P=0.64). CONCLUSION: Cochlear implantation is a safe technique with a low incidence of complications. The absence of increased risk in patients at the extremes of the age spectrum justifies offering this solution to all, without age limitation.

Consensus statement. Corticosteroid therapy in ENT in the context of the COVID-19 pandemic.

This consensus statement about the indications and modalities of corticosteroid treatment in the context of the COVID-19 pandemic was jointly written by experts from the French Association of Otology and Oto-Neurology (AFON) and from the French Society of Otorhinolaryngology, Head and Neck Surgery (SFORL). There is currently not enough data in favour of danger or benefit from corticosteroids in COVID-19, so until this matter is resolved it is advisable to limit their indications to the most serious clinical pictures for which it is well established that this type of treatment has a positive impact on the progression of symptoms. In Grade V and VI Bell's palsy according to the House-Brackmann grading system, a week's course of oral corticosteroids is recommended. Corticosteroid therapy is also recommended in cases of sudden hearing loss of more than 60dB, either in the form of intratympanic injections or a week's course of oral medication. In rhinology, there is no indication for systemic corticosteroid therapy in the current situation. However, patients are advised to continue with their local corticosteroid therapy in the form of a nasal spray or by inhalation. Treatments with corticosteroid nasal sprays can still be prescribed if there is no alternative. Finally, systemic or local corticosteroid therapy is not indicated for bacterial ENT infections.

Construct, Face, and Content Validation on Voxel-Man® Simulator for Otologic Surgical Training.

Objective. To assess the face, content, and construct validity of the Voxel-Man TempoSurg Virtual Reality simulator. Participants and Methods. 74 ear, nose, and throat (ENT) surgeons participated. They were assigned to one of two groups according to their level of expertise: the expert group (n = 16) and the novice group (n = 58). The participants performed four temporal bone dissection tasks on the simulator. Performances were assessed by a global score and then compared to assess the construct validity of the simulator. Finally, the expert group assessed the face and content validity by means of a five-point Likert-type scale. Results. experienced surgeons performed better (p < .01) and faster (p < .001) than the novices. However, the groups did not differ in terms of bone volume removed (p = .11) or number of injuries (p = .37). 93.7% of experienced surgeons stated they would recommend this simulator for anatomical learning. Most (87.5%) also thought that it could be integrated into surgical training. Conclusion. The Voxel-Man TempoSurg Virtual Reality simulator constitutes an interesting complementary tool to traditional teaching methods for training in otologic surgery.

Diagnostic and therapeutic strategy in Menière's disease. Guidelines of the French Otorhinolaryngology-Head and Neck Surgery Society (SFORL).

OBJECTIVES: The authors present the guidelines of the French Otorhinolaryngology-Head and Neck Surgery Society (Société française d'oto-rhino-laryngologie et de chirurgie de la face et du cou: SFORL) for diagnostic and therapeutic strategy in Menière's disease. METHODS: A work group was entrusted with a review of the scientific literature on the above topic. Guidelines were drawn up, then read over by an editorial group independent of the work group. The guidelines were graded according to the literature analysis and recommendations grading guide published by the French National Agency for Accreditation and Evaluation in Health (January 2000). RESULTS: Menière's disease is diagnosed in the presence of the association of four classical clinical items and after eliminating differential diagnoses on MRI. In case of partial presentation, objective audiovestibular tests are recommended. Therapy comprises medical treatment and surgery, either conservative or sacrificing vestibular function. Medical treatment is based on lifestyle improvement, betahistine, diuretics or transtympanic injection of corticosteroids or gentamicin. The main surgical treatments, in order of increasing aggressiveness, are endolymphatic sac surgery, vestibular neurotomy and labyrinthectomy.

Pre-operative vestibular pattern and balance compensation after vestibular schwannoma surgery.

This longitudinal study aimed to assess the sensorimotor balance strategies before and after vestibular schwannoma (VS) surgery according to the degree of pre-operative vestibular lesion. Thirty-eight VS patients were split in three groups according to caloric vestibular test results before surgery; nine had a symmetrical vestibular response (vestibular normoreflexy), 19 with a decreased response of more than 20% of the affected side (vestibular hyporeflexy) and 10 with an absent caloric response on the side of the affected labyrinth (vestibular areflexy). They underwent pendular rotary vestibular testing (RVT), allowing to evaluate gain and directional preponderance of the vestibulo-ocular reflex, and a sensory organisation test (SOT), evaluating balance control in six conditions (C1 to C6). These tests were performed shortly before, and 8 and 90 days after surgery. Directional preponderance performances of patients with vestibular normoreflexy or hyporeflexy followed a classical time-course with a huge asymmetry just after surgery and a recovery to pre-operative performances at 90 days; patients with vestibular areflexy were relatively stable in time. Variation in SOT performances of patients with vestibular normoreflexy, especially in the more complex C4 to C6, followed a classical time-course with an important postural degradation just after surgery and a recovery to pre-operative performances at 90 days. Patients with vestibular areflexy showed no balance degradation just after surgery and a marked increase in performances at 90 days after surgery, especially in C5 and C6. Performances of patients with vestibular hyporeflexy were intermediate, close to performances of patients with vestibular normoreflexy before surgery and close to performances of patients with vestibular areflexy at 8 and 90 days after surgery. Pre-operative vestibular function alteration triggers an adaptive process, characterized by a restoration of the symmetry of the vestibular nuclei activity and by sensory substitution and new behavioural strategies, allowing the anticipation of unilateral vestibular deafferentation effects.

[Advantages of the L-menthol test in assessing chronic nasal obstruction]. / Intérêt du test au L-menthol dans le bilan d'une obstruction nasale chronique.

OBJECTIVES: In normal and anosmic patients, l-menthol inhalation is responsible for the subjective sensation of increased nasal permeability, related to a stimulation of the internal nasal nerve (branch of trigeminal nerve) endings connected with cold pressor receptors. At present, routine assessment of nasal obstruction does not include the l-menthol test. The aim of this case report was to show the advantages of this test in chronic nasal obstruction evaluation. MATERIAL AND METHODS: The example of a patient with a medical history of facial trauma and anosmia for sequela is reported. This patient complained of chronic nasal obstruction that persisted despite several septorhinoplasties and that conflicted with clinical examination and rhinomanometry data. RESULTS: An l-menthol test did not induce any mint smell recognition, any improvement of nasal permeability sensation, or any freshness sensation. CONCLUSION: The authors suggest that the nasal obstruction sensation could result, in this case, from post-trauma anesthesia of the trigeminal nerve, particularly its internal nasal nerve branch. The l-menthol test could be a predictive test that may prevent recurrent functional failures of surgical treatment proposed for nasal obstruction.

Visual sensorial preference delays balance control compensation after vestibular schwannoma surgery.

BACKGROUND: Balance control performance after vestibular schwannoma surgical removal follows a course that is characterised by a deterioration in postural performance immediately after unilateral vestibular deafferentation (uVD) and a recovery process (vestibular compensation). However, sensory strategies for balance vary during tumoral growth, which could lead to differences in the preferential use of sensory afferences. This longitudinal study aimed to assess the post-operative sensorimotor strategies of postural regulation according to sensory preference of balance control before surgery. METHODS: Twenty-two patients with vestibular schwannoma (11 relying less on vision (G1), 11 relying more on vision (G2), to control balance before surgery), underwent vestibular, subjective visual vertical (SVV), static posturography and sensory organisation (SOT) tests, before and 8 days, 1 and 3 months after surgery. RESULTS: In G1 patients, little static posturographic and SOT performance deterioration after uVD was observed, despite vestibular test and SVV modifications. In G2 patients, uVD-related modifications followed a time-course characterised by a degradation in posturographic and SOT, vestibular and SVV performances immediately after uVD and a progressive restoration and even improvement 1 month and particularly 3 months after surgery. CONCLUSIONS: High preference for vision before surgery intervenes in postural degradation immediately after surgery, thus delaying the short-term effects of vestibular compensation on postural control. Long-term performance being similar whatever the visual status before surgery, the time-dependent implementation of the central adaptive mechanisms due to neuroplasticity leads to a modification of neurosensory information hierarchy, allowing reliance on appropriate information, the gain varying according to the postural task to be performed.