Search

Objectives: This document presents the fundamentals of speech audiometry in noise, general requirements for implementation and criteria for choice among the tests available in French according to the health-professional's needs., Material and Methods: The recommendations are based on a systematic analysis of the literature carried out by a multidisciplinary group of doctors, audiologists and audioprosthetists from all over France. They are graded A, B, C or expert opinion according to decreasing level of scientific evidence., Results: Eight tests of speech audiometry in noise can be used in France., Conclusion: To be complete, evaluation of hearing status requires testing understanding of speech in noise. The examination must begin with a minimum of two measurements familiarizing the subject with the test procedure. For initial diagnosis, adaptive procedures establishing the 50% speech reception threshold (SRT50) in noise are to be preferred in order to obtain a rapid and standardized measurement of perception of speech in noise. When the aim is to measure real-life speech comprehension, tests based on sentences, cocktail-party noise and free-field stimulation are to be preferred. Prosthetic gain is evaluated exclusively in free field. This is the only way to evaluate the contribution of binaurality and to measure perception in noise in an environment as close as possible to real life. In order to avoid acoustic interference in free field, at least five loudspeakers should be used, in particular for evaluating the effectiveness of directional microphones, CROS devices enabling sounds picked up in the damaged ear to be rerouted to the functional ear, or bimodal fitting (i.e., when hearing is enabled by two modalities: for example, hearing aid for one ear, cochlear implant for the other)., (Copyright © 2021 Elsevier Masson SAS. All rights reserved.)

Purpose: To highlight the advantages of real time fluoroscopy guided electrode-array (EA) insertion (FGI) during cochlear implants surgery., Methods: All surgical procedures were performed in a dedicated operating room equipped with a robotic C-arm cone beam device, allowing for intraoperative real time 2D FGI and postoperative 3D imaging. Only straight EAs were used. Patients were sorted out in three groups: ANAT, with anatomical concerns; HP, with residual hearing; NPR: patients with no particular reason for FGI. In all cases the angle of EA-insertion was measured. In the HP group pre and postoperative hearing were compared. The radiation delivered to the patient was recorded., Results: Fifty-three cochlear implantation procedures were achieved under fluoroscopy in 50 patients from November 2015 to January 2020 (HP group: n = 10; ANAT group: n = 13; NPR group: n = 27). In the ANAT group, FGI proved to be helpful in 8 cases (61.5%), successfully guiding the surgeon during EA -insertion. On average, the angle of insertion was at 424° ± 55°. In the HP group, a controlled smooth EA-insertion was carried out in all cases but one. The targeted 360° angle of insertion was always reached. Hearing preservation was possible with an eventual average drop of 30 ± 1.5 dB. In the NPR group, FGI helped control the quality of insertion in all cases and appeared very informative in five (17.8%): one EA-misrouting, three stuck EAs, and one case with hidden electrodes out of the cochlea in revision surgery. Final 3D cone beam CT scan double-checked the EA position in all adults. The radiation dose was equivalent to a bit less than four digital subtract radiographs., Conclusion: The FGI is a very useful adjunct in cochlear implantation in all cases of expected surgical pitfalls, in patients with residual hearing, and even in case without preoperative particular reason, with low irradiation.

Purpose For cochlear implant users, the ability to use the telephone is often seen as an important landmark during rehabilitation and an indicator of cochlear implant benefit. The goal of this study was to develop a short questionnaire exploring the ability to use the telephone in cochlear implant users, named Telislife, and test it in a group of experienced users. Method This prospective multicenter study was based on the completion of self-administrated questionnaires. The Telislife includes 20 items using a 5-point Likert scale for answers. Speech recognition scores were obtained with monosyllabic word lists at 70 dB HL. Quality of life was evaluated with the Nijmegen Cochlear Implant Questionnaire. This study included 55 adult patients wearing a cochlear implant for over 1 year. Results The Telislife questionnaire showed excellent reliability (Cronbach's α = .91). A significant correlation was found between Telislife scores and Nijmegen Cochlear Implant Questionnaire scores ( r = .69, p < .001) and speech recognition scores ( r = .35, p = .007). Conclusion Given significant correlations between Telislife scores and both speech recognition and quality of life and given its short form, the Telislife questionnaire appears to be a reliable tool to evaluate cochlear implant outcomes in clinical practice. Supplemental Material https://doi.org/10.23641/asha.13322873.

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., (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)

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., (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)

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 1 st 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., (Copyright © 2020. Published by Elsevier Masson SAS.)

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., (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)

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., (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)

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., (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)

Cochlear and brainstem implants have been included on the list of reimbursable products (LPPR) in France since March of 2009. The implants were initially inscribed for 5 years, after which an application for renewal with the French National Commission for the Evaluation of Medical Devices and Health Technologies (Commission Nationale d'évaluation des dispositifs médicaux et des technologies de santé - CNEDiMTS) was required [Haute Autorité de santé, 2009]. Upon registration to the list of reimbursable products, the companies and the reference centers for cochlear and brainstem implants were asked to set up a post-registration registry called EPIIC. This article reports the evolution in the EPIIC registry of the general indicators for 5051 patients over the five years from 2012-2016., (Copyright © 2020. Published by Elsevier Masson SAS.)

Objectives: The advent of hybrid electro-acoustic implants requires precise positioning of the electrode-array (EA) within the cochlea. The cochlea size, that is, the length of the cochlear scala tympani, is often indirectly estimated from distance A by Escudé's method. This technique has been confirmed by anatomical studies, in a bunch of cadaveric specimens, but it is not yet widely established in the field of computed tomography (CT). We compared cochlear duct length obtained by Escudé's method to those directly acquired on CT images., Materials and Methods: The lengths of cochlear scala tympani were directly measured on CT scans by contouring the external cochlear wall (contouring technique-CoT). In fifteen patients implanted with a straight EA, the length of the EA and the measured length of the cochlea by the CoT were compared, to check the reliability of the CoT. Then, in 200 CT-scans, the length of the cochlear duct was measured by the CoT then compared to Escudé's method., Results: In the 200 CT-scans which served for cochlear length measurements, a significant variability between the cochleae were observed, as expected. At 360°, the correlation between the measurements of the length of the cochlear scala tympani between the two techniques differed, with a difference of 0.2 ± 0.7 mm at 360° (extreme: 2 mm; p < 0.001) and 2.2 ± 1.2 mm at 540° (extreme: 5.6 mm; p < 0.001)., Conclusion: The CoT can predict with accuracy the length of EA-insertion depth, more precisely than estimation methods such as Escudé's.

Objective: To determine whether surgical pitfalls can be anticipated through a preoperative CT-Scan in case of middle ear implantation with a semi-implantable middle ear ossicular stimulator from Otologics (SIMOS). A second outcome measure was to assess the auditory gain obtained in the series., Materials and Methods: A retrospective analysis of 19 consecutive surgical procedure for a SIMOS implantations was achieved. Preoperative Ct-Scans were analyzed and several measurements of the mastoid were taken out from axial transverse views, ie. the distance between the incus and the cortical mastoid bone [d(i-c)], the distance between the sigmoid sinus and the incus [d(i-ss)], the distance between the sigmoid sinus and the cortical bone of the mastoid [d(c'-ss)]. On coronal images, the dura of the middle fossa was described as procident if it was lower than the head of malleus and/or body incus. Auditory gain was calculated on pure tone and speech audiometry with bisyllabic words., Results: All cases were successfully implanted. d(i-c) was on average at 33.1 +/- 2.6 mm in cases easy to implant. One case of contracted mastoid was difficult and led to the impaction of the sigmoid sinus. In this case the distance d(i-c) was shorter at 25 mm than the average minus 2 standard deviations of the others (27.9 mm). Also d(ss-c') was lower at 7 mm than the average minus 2 standard deviations of the others (7.6 mm). Two other cases led to difficult surgical procedures because of a low middle fossa dura. This too low middle fossa dura could be identified on preoperative coronal CT-scans in these two cases. Audiometric gains were remarkable, with an average of 39 +/- 16 dB. In case of severe sensorineural hearing loss the average gain was higher at 46 +/- 9 dB. Two revision-procedures were required, one for a device failure, the second because of skin alteration due to systemic inflammatory disease requiring corticosteroids. Mean follow-up was 50 +/- 22 months., Conclusion: The SIMOS is a powerful middle ear implant that can undoubtedly give a huge audiometric gain. The implantation procedure requires a precise microsurgical operation that can be hampered by anatomical conditions of the petrous bone. A thorough examination of preoperative CT-scan is highly recommended in order to obtain measurements of the mastoid in axial views, and the analysis of the position of the middle fossa dura in coronal views.

Objectives: First, to assess for the performance of the Carina placed on the round window at various European centers; second, to study the follow-up after 2 years and discuss limitations and technical issues; and finally, to further develop our understanding of the principles of acoustic transfer through the round window., Materials and Methods: Eleven patients were included in this retrospective study (7 women and 4 men) from 7 European tertiary referral hospitals (4 centers in France, 2 in Belgium, 1 in Spain). The mean age was 50.8 years (35-71 yr). All patients have multiple previous surgeries (>3 surgical procedures) for otosclerosis (3 patients) or chronic otitis media (8 patients), and in all cases, the stapes was not accessible due to obliteration by sclerotic tissue. Preoperative and postoperative air conduction, bone conduction, as well as aided and unaided thresholds and speech scores were measured., Results: No significant differences were observed between preoperative and postoperative air-conduction and bone-conduction pure-tone averages. The average free field functional gain obtained with the implant ranged from 22 to 42 dB at each individual frequency, with a mean of 29 +/- 5 dB across all audiometric frequencies. Word recognition scores demonstrated significant differences between unaided and implant-aided conditions. Complications included 2 cases of postoperative infection (including 1 anacusis) that required explantation, and 1 case reduced initial benefit, followed by a nonfunctioning device. In 10 patients, postoperative hearing was unchanged. The 8 other patients are using their implant daily., Conclusion: These results show that this option is valid for patients with a fixed footplate and unsuccessful previous surgeries or patients who cannot benefit from a stapedotomy for anatomic reasons. In some cases, access to the round window membrane could represent a limitation. However, these promising initial results establish the need for further works with regard to 3 issues: 1) clinical data studies are needed, including a greater number of patients to confirm these preliminary results; 2) a long-term follow-up must be performed to detect any possible cochlear adverse effects, in particular, on the basilar membrane; 3) the effect of fascia interposition and tip size has to be evaluated in experimental studies.

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. Retrospective analysis of cochlear implant patients. 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. 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). 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. [ABSTRACT FROM AUTHOR]