Comparative study of vestibular function preservation in manual versus robotic-assisted cochlear implantation.

OBJECTIVE: To compare vestibular outcomes in cochlear implant (CI) surgery, between robotic-assisted insertion of the electrodes versus manual insertion. METHODS: We performed a monocentric retrospective study. From March 2021, the robotic system RobOtol© was used for all CI cases. We compared this robotic-assisted insertion group with a manual insertion group of patients who received a CI between July 2020 and March 2021. Primary objective was vestibular outcome. We used objective vestibular function tests: caloric testing, Vestibular Evoked Myogenic Potential (VEMP), and Video Head Impulse Test (VHIT). Secondary objectives were postoperative complications including patient-reported postoperative vertigo. RESULTS: We found no statistically significant difference between the two groups in terms of caloric testing, VEMP or VHIT outcomes. In patient-reported outcomes, there was significantly more vertigo in the manual insertion group compared with robotic-assisted insertion. CONCLUSION: It is hypothesized that a non-traumatic insertion would cause less vestibular dysfunction postoperatively. Larger prospective studies are required to determine whether robotic-assisted CI insertion has a significant impact on vestibular outcomes in CI surgery.

A New Robotic Endoscope Holder for Ear and Sinus Surgery with an Integrated Safety Device.

In the field of sinus and ear surgery, and more generally in microsurgery, the surgeon is faced with several challenges. The operations are traditionally carried out under binocular loupes, which allows for the surgeon to use both hands for a microinstrument and an aspiration tool. More recently, the development of endoscopic otological surgery allowed for seeing areas that are difficult to access. However, the need to handle the endoscope reduces the surgeon's ability to use only one instrument at a time. Thus, despite anaesthesia, patient motions during surgery can be very risky and are not that rare. Because the insertion zone in the middle ear or in the sinus cavity is very small, the mobility of the endoscope is limited to a rotation around a virtual point and a translation for the insertion of the camera. A mechanism with remote center motion (RCM) is a good candidate to achieve this movement and allow for the surgeon to access the ear or sinus. Since only the translational motion along the main insertion axis is enabled, the ejection motion along the same axis is safe for the patient. A specific mechanism allows for inserting and ejecting the endoscope. In a sense, the position is controlled, and the velocity is limited. In the opposite sense, the energy stored in the spring allows for very quick ejection if the patient moves. A prototype robot is presented using these new concepts. Commercially available components are used to enable initial tests to be carried out on synthetic bones to validate the mobility of the robot and its safety functions.

Evaluation of vestibular function following endolymphatic sac surgery.

PURPOSE: To evaluate objective vestibular function after endolymphatic sac surgery (ELSS) for Menière's disease (MD), using comparative vestibular function tests: videonystagmography (VNG), vestibular evoked myogenic potentials (VEMP) and video head-impulse test (VHIT) METHODS: Patients with definite MD using the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) of 1995 criteria modified in 2015 and treated with ELSS (sac decompression or sac opening) were included. The primary outcome was the preservation of vestibular function, comparing pre- and postoperative vestibular function tests: VNG, VEMP, VHIT. Secondary outcomes were control of episodes of vertigo, hearing outcome using AAO-HNS criteria, and QoL using the Menière's disease outcome questionnaire. RESULTS: 73 patients were included in the study. We found a significant preservation of vestibular function as measured by VNG and VHIT. There was no statistical difference in the presence or absence of cervical and ocular (P13/N23 and N1/P1) waves on VEMP pre- and postoperatively. 67% of patients had good control of episodes of vertigo post-operatively, with significantly better results in the sac opening group (75%). There was no significant change in hearing postoperatively, and QoL scores were significantly improved after surgery (p < 0.0001). CONCLUSION: Endolymphatic sac surgery (ELSS) is a conservative surgical treatment, which does not negatively impact vestibular function. It was associated with improved control of episodes of vertigo, preservation of hearing, and a clear improvement in QoL scores. Despite its pathophysiology not being fully understood, it remains a first-line procedure preserving vestibular function, for MD refractory to medical management.

Geometric Atlas of the Middle Ear and Paranasal Sinuses for Robotic Applications.

In otolaryngologic surgery, more and more robots are being studied to meet the clinical needs of operating rooms. However, to help design and optimize these robots, the workspace must be precisely defined taking into account patient variability. The aim of this work is to define a geometric atlas of the middle ear and paranasal sinuses for endoscopic robotic applications. Scans of several patients of different ages and sexes were used to determine the average size of these workspaces, which are linked by the similar use of endoscopes in surgery.

A dominant vimentin variant causes a rare syndrome with premature aging.

Progeroid syndromes are a group of rare genetic disorders, which mimic natural aging. Unraveling the molecular defects in such conditions could impact our understanding of age-related syndromes such as Alzheimer's or cardiovascular diseases. Here we report a de novo heterozygous missense variant in the intermediate filament vimentin (c.1160 T > C; p.(Leu387Pro)) causing a multisystem disorder associated with frontonasal dysostosis and premature aging in a 39-year-old individual. Human vimentin p.(Leu387Pro) expression in zebrafish perturbed body fat distribution, and craniofacial and peripheral nervous system development. In addition, studies in patient-derived and transfected cells revealed that the variant affects vimentin turnover and its ability to form filaments in the absence of wild-type vimentin. Vimentin p.(Leu387Pro) expression diminished the amount of peripilin and reduced lipid accumulation in differentiating adipocytes, recapitulating key patient's features in vivo and in vitro. Our data highlight the function of vimentin during development and suggest its contribution to natural aging.

The Oticon Medical Neuro Zti cochlear implant and the Neuro 2 sound processor: multicentric evaluation of outcomes in adults and children.

Objective: This study evaluated the outcomes of the Oticon Medical Neuro Zti cochlear implant and the Neuro 2 sound processor.Design: Neuro One users were upgraded to Neuro 2. Monosyllabic word identification was evaluated in adults with Neuro One after ≥5 months, with Neuro 2 at upgrade, and with Neuro 2 after 3 months. Self-reported listening ability, satisfaction, and usability were measured in adults and children.Study sample: Participants were 44 adults and 26 children.Results: Speech identification scores in quiet and noise were 58% and 45% with Neuro One and 67% and 55% with Neuro 2 after 3 months, respectively. Hearing impairment duration and number of active electrodes significantly predicted speech identification in noise with Neuro 2. Significantly higher questionnaire ratings were obtained for Neuro 2 than Neuro One regarding listening ability in complex listening situations, comfort and music, as well as nine aspects of satisfaction and usability.Conclusion: This study demonstrates the clinical superiority of the Neuro 2 sound processor over Neuro One in terms of speech identification in quiet and in noise and reported patient benefit and satisfaction. Given the study design, sources of improvement may include factors unrelated to the sound processor itself.

Long-Term Cognitive Prognosis of Profoundly Deaf Older Adults After Hearing Rehabilitation Using Cochlear Implants.

OBJECTIVES: To analyze long-term cognitive status and function after cochlear implantation in profoundly deaf individuals. DESIGN: Prospective observational longitudinal study. SETTING: Ten academic medical centers referent for cochlear implantation. PARTICIPANTS: Individuals aged 65 and older who qualified for cochlear implantation (N=70). MEASUREMENTS: Cognitive tests were administered before cochlear implantation and 1 and 5 or more years after cochlear implantation. Evaluation consisted of 6 tests assessing attention, memory, orientation, executive function, mental flexibility, and fluency. Cognitive status was determined as normal, mild cognitive impairment (MCI), or dementia. Speech perception in quiet and noisy conditions was assessed using disyllabic words, and quality of life was assessed using the Nijmegen Cochlear Implant Questionnaire. RESULTS: Mean follow-up was 6.8 years (range 5.5-8.5 years). Speech perception scores and quality of life remained stable from 1 to 7 years after cochlear implantation. Of 31 participants (45%) with MCI before cochlear implantation, 2 (6%) developed dementia during follow-up, 19 (61%) remained stable, and 10 (32%) returned to normal cognition. None of the 38 with normal cognition developed dementia during follow-up, although 12 (32%) developed MCI. CONCLUSION: MCI is highly prevalent in older adults with profound hearing loss. Nevertheless, we observed a low rate of progression to dementia, and cognitive function improved in some individuals with MCI at baseline. These results highlight that cochlear implantation should be strongly considered in profoundly deaf individuals, even those with MCI, who may have a specific subtype of MCI, with a possible positive effect of hearing rehabilitation on neurocognitive functioning.

Improvement of cognitive function after cochlear implantation in elderly patients.

IMPORTANCE: The association between hearing impairment and cognitive decline has been established; however, the effect of cochlear implantation on cognition in profoundly deaf elderly patients is not known. OBJECTIVE: To analyze the relationship between cognitive function and hearing restoration with a cochlear implant in elderly patients. DESIGN, SETTING, AND PARTICIPANTS: Prospective longitudinal study performed in 10 tertiary referral centers between September 1, 2006, and June 30, 2009. The participants included 94 patients aged 65 to 85 years with profound, postlingual hearing loss who were evaluated before, 6 months after, and 12 months after cochlear implantation. INTERVENTIONS: Cochlear implantation and aural rehabilitation program. MAIN OUTCOMES AND MEASURES: Speech perception was measured using disyllabic word recognition tests in quiet and in noise settings. Cognitive function was assessed using a battery of 6 tests evaluating attention, memory, orientation, executive function, mental flexibility, and fluency (Mini-Mental State Examination, 5-word test, clock-drawing test, verbal fluency test, d2 test of attention, and Trail Making test parts A and B). Quality of life and depression were evaluated using the Nijmegen Cochlear Implant Questionnaire and the Geriatric Depression Scale-4. RESULTS: Cochlear implantation led to improvements in speech perception in quiet and in noise (at 6 months: in quiet, 42% score increase [95% CI, 35%-49%; P < .001]; in noise, at signal to noise ratio [SNR] +15 dB, 44% [95% CI, 36%-52%, P < .001], at SNR +10 dB, 37% [95% CI 30%-44%; P < .001], and at SNR +5 dB, 27% [95% CI, 20%-33%; P < .001]), quality of life, and Geriatric Depression Scale-4 scores (76% of patients gave responses indicating no depression at 12 months after implantation vs 59% before implantation; P = .02). Before cochlear implantation, 44% of the patients (40 of 91) had abnormal scores on 2 or 3 of 6 cognition tests. One year after implant, 81% of the subgroup (30 of 37) showed improved global cognitive function (no or 1 abnormal test score). Improved mean scores in all cognitive domains were observed as early as 6 months after cochlear implantation. Cognitive performance remained stable in the remaining 19% of the participants (7 of 37). Among patients with the best cognitive performance before implantation (ie, no or 1 abnormal cognitive test score), 24% (12 of 50) displayed a slight decline in cognitive performance. Multivariate analysis to examine the association between cognitive abilities before implantation and the variability in cochlear implant outcomes demonstrated a significant effect only between long-term memory and speech perception in noise at 12 months (SNR +15 dB, P = .01; SNR +10 dB, P < .001; and SNR +5 dB, P = .02). CONCLUSIONS AND RELEVANCE: Rehabilitation of hearing communication through cochlear implantation in elderly patients results in improvements in speech perception and cognitive abilities and positively influences their social activity and quality of life. Further research is needed to assess the long-term effect of cochlear implantation on cognitive decline.

The relationship between electrical auditory brainstem responses and perceptual thresholds in Digisonic® SP cochlear implant users.

Determining the electrical stimulation levels is often a difficult and time-consuming task because they are normally determined behaviorally - a particular challenge when dealing with pediatric patients. The evoked stapedius reflex threshold and the evoked compound action potential have already been shown to provide reasonable estimates of the C- and T-levels, although these estimates tend to overestimate the C- and T-levels. The aim of this study was to investigate whether the evoked auditory brainstem response (eABR) can also be used to reliably estimate a patient's C- and T-levels. The correlation between eABR detection thresholds and behaviorally measured perceptual thresholds was statistically significant (r = 0.71; P < 0.001). In addition, eABR Wave-V amplitude increased with increasing stimulation level for the three loudness levels tested. These results show that the eABR detection threshold can be used to estimate a patient's T-levels. In addition, Wave-V amplitude could provide a method for estimating C-levels in the future. The eABR objective measure may provide a useful cochlear implant fitting method - particularly for pediatric patients.

Clinical presentation of intralabyrinthine schwannomas: a multicenter study of 110 cases.

OBJECTIVE: To describe the presentation of intralabyrinthine schwannomas (ILSs). STUDY DESIGN AND SETTING: Retrospective multicenter study involving 12 European skull base surgery tertiary referral centers. PATIENTS: One hundred ten patients with the diagnosis of ILS, either labyrinth confined or extending into the internal auditory meatus for less than 50% of their volume. MAIN OUTCOME MEASURES: Data collected were age, sex, nature and timing of presenting symptoms, hearing (according to the AAO-HNS grading system), results of vestibular tests (caloric tests and cervical vestibular-evoked myogenic potentials [c-VEMPs]), and tumor localization. Presenting symptoms and laboratory test results were studied according to the extension of the lesion into the cochlea (C) and vestibule (V), on one hand, and according to unifocal (L1) or plurifocal (L2) extension into the labyrinth, on the other. RESULTS: Intracochlear type was more common (50%) than vestibular (19.1%) and more diffuse forms (30.9%). The mean delay for diagnosis was long (72.5 mo; SD, 76.6). Mean age was 53.9 years (SD, 13.2). Deafness was the most common symptom (77.8 dB HL [SD, 33.6], with only 24.6% of patients keeping viable hearing. Caloric tests (65.5% of patients) were abnormal in 77.8% of cases. c-VEMPs were abnormal in 65.7% of the 36 cases analyzed. In V forms, hearing was significantly better (class A + B in 21.1% in C and 45.8% in V forms) (p = 0.03), and vestibular function was more altered (C: 57%, V: 100%, p = 0.0009*). L2 forms were diagnosed later (L1: 59.1 mo, L2: 104.5 mo; p = 0.004*) and were associated more frequently with a dead ear (L1: 13.1%, L2: 41.2%, p = 0.002*) than L1 forms. CONCLUSIONS: This series, which is the largest in the literature, demonstrates that even very small and localized ILSs heavily compromise labyrinthine functions.

Tolerance and osteointegration of TricOs(TM)/MBCP(®) in association with fibrin sealant in mastoid obliteration after canal wall-down technique for cholesteatoma.

CONCLUSION: The TricOs™/MBCP(®) and fibrin sealant composite was a convenient, effective, and well-tolerated material for mastoid cavity filling and immediate reconstruction of the external auditory meatus after cholesteatoma surgery with canal wall down (CWD). OBJECTIVE: To assess the tolerance and osteointegration of a bone graft substitute, TricOs™/MBCP(®), in association with fibrin sealant for filling the mastoid cavity after cholesteatoma surgery using the CWD technique. METHODS: In this prospective observational study 57 patients with cholesteatoma suitable for CWD were recruited from April 2006 to April 2008 and followed up for 1 year. The mastoid cavity was filled with TricOs™/MBCP(®) followed by immediate reconstruction of the external auditory meatus covered with fascia temporalis and/or cartilage. The main outcome was skin tolerance assessed by a novel weighted score emphasizing long-term results. The typical weighted reference score was 1.67; skin tolerance was considered acceptable if 75% of patients had a score ≤ 1.67. Secondary outcomes were otorrhea and/or otalgia, hearing, and osteointegration assessed through computed tomography scanning at 12 months. RESULTS: Forty-one patients had a complete follow-up; 34 (82.3%) patients achieved the main end point with scores ≤ 1.67. Otorrhea decreased postoperatively. No otalgia interfering with daily tasks was reported. Ossicular reconstruction was carried out in 29 patients. Absence of cochlear toxicity was confirmed by unimpaired bone conduction. Preoperative and postoperative speech audiometry results were similar. No serious adverse events were observed. Osteointegration was satisfactory with hyperdensity or intermediate density in 95% of patients at 12 months.

Predictive factors of cochlear implant outcomes in the elderly.

OBJECTIVE: To analyze predictive factors of cochlear implant outcomes and postoperative complications in the elderly. STUDY DESIGN: Prospective, longitudinal study performed in 10 tertiary referral centers. METHODS: Ninety-four patients aged 65-85 years with a profound, postlingual hearing loss were evaluated before implantation, at time of activation, and 6 and 12 months after cochlear implantation. Speech perception and lipreading were measured using disyllabic word recognition in quiet and noise, and lipreading using disyllabic words and sentences. The influence of preoperative factors on speech perception in quiet and noise at 12 months was tested in a multivariate analysis. Complications, presence of tinnitus and of vestibular symptoms were collected at each evaluation. RESULTS: The effect of age was observed only in difficult noisy conditions at SNR 0 dB. Lipreading ability for words and sentences was negatively correlated with speech perception in quiet and noise. Better speech perception scores were observed in patients with shorter duration of hearing deprivation, persistence of residual hearing for the low frequencies, the use of a hearing aid before implantation, the absence of cardiovascular risk factors, and in those with implantation in the right ear. General and surgical complications were very rare, and the percentage of vestibular symptoms remained stable over time. CONCLUSION: This study demonstrates that cochlear implantation in the elderly is a well-tolerated procedure and an effective method to improve communication ability. Advanced age has a low effect on cochlear implant outcome. Analyses of predictive factors in this population provide a convincing argument to recommend treatment with cochlear implantation as early as possible in elderly patients with confirmed diagnosis of a severe-to-profound hearing loss and with only limited benefit from hearing aid use in one ear.

Multicenter evaluation of Neurelec Digisonic® SP cochlear implant reliability.

Over the past decade, the adoption of universal hearing screening in newborns has led to earlier detection of hearing problems and significant lowering of the age of first cochlear implantation. As a consequence, recipients are now expected to keep their cochlear implants (CIs) for a longer period of time. Comprehensive longitudinal information on CI reliability is essential for device choice. The aim of this study was to assess the reliability (in children and adults) of the latest generation of the Digisonic(®) SP CI launched in 2006 by Neurelec. Failure rate (FR) and cumulative survival rate (CSR) for a 5-year period were calculated. This survey is a multicenter retrospective study. A questionnaire was sent to nine CI centers requesting information about patients implanted with Neurelec Digisonic(®) SP CIs. FR and CSR over a 5-year period were calculated on this group. Collaborating centers collected data on 672 patients (362 children and 310 adults) implanted between March 2006 and March 2011. The overall rate of explantation was 2.23 % (15 cases): six devices were explanted due to device failure (0.89 %) and nine were explanted for medical reasons (1.34 %). Four patients were lost to follow-up. The CSR at 5 years was 98.51 % on all patients, 98.48 % for children and 98.57 % for adults. FR was 0.97 % for adults and 0.83 % for children. This first independent study that assesses FR and CSR on the current generation of Digisonic(®) SP CI represents an important resource that can help clinicians and patients during their device choice.

Bilateral cochlear implantation in children: localization and hearing in noise benefits.

OBJECTIVE: The aim of this study was to report speech performance in quiet and in noise, sound localization with cochlear implanted children bilaterally. Their performances were compared also in unilateral conditions. In addition, speech and language evaluation was analyzed. METHODS: Twenty-three children implanted with Neurelec Digisonic SP devices in 3 tertiary centres were tested on a battery of speech perception tests in quiet and in noise. Localization was assessed by lateralization tasks (90° and 30°). Progress in speech and language development and subjective assessment of benefit were assessed using several rating scales and questionnaires (categories of auditory perception, speech intelligibility rating, family participating rating scale). RESULTS: Children scored better when tested in bilateral conditions rather than in unilateral conditions. In quiet, the mean scores for the poorer and better side were 52% and 73%, respectively. In the bilateral condition, the mean score increased to 83%. In noise, the mean scores were 39% and 57% respectively, which increased to a mean of 70% in the bilateral condition. Nine children (<9 years) completed the ±90° lateralization task. For both unilateral conditions performance was not significantly different from chance level. In the bilateral condition, the mean score was 86%. The ±30° lateralization score was completed by eight of the older children (>9 years). The scores in the unilateral conditions were closed to chance level, but significantly better in the bilateral condition (mean of 86%). CONCLUSIONS: Performances in bilateral conditions were significantly better than in unilateral conditions on speech perception in quiet and in noise. Localization was significantly better when tested in the bilateral condition for ±90° lateralization task for the younger children and the ±30° task for the older children. All these results supported the hypothesis than bilateral cochlear implantation is more beneficial than unilateral implantation in children.

Speech perception performance for 100 post-lingually deaf adults fitted with Neurelec cochlear implants: Comparison between Digisonic® Convex and Digisonic® SP devices after a 1-year follow-up.

CONCLUSION: Patients implanted with the Digisonic® SP device showed better identification scores than those implanted with the Convex device, with skills continuing to improve over a longer time period. Technological improvements were beneficial in terms of speech perception in quiet. OBJECTIVE: To compare speech perception skills for post-lingually deaf patients implanted with a previous Neurelec device, the Digisonic® Convex, with those implanted with a more recent one, the Digisonic® SP, which provides more electrodes and a faster stimulation rate. METHODS: This was a retrospective study of 100 implanted patients, 45 with the Digisonic® Convex implant and 55 with the Digisonic® SP. Speech perception (dissyllabic words and sentences, in open set) was evaluated until 1 year after implantation. RESULTS: Patients fitted with the Digisonic® SP implant showed significantly better scores after 3, 6, and 12 months (mean scores: 53%, 62%, and 68% for words; 58%, 69%, and 75% for sentences) than those fitted with the Convex implant (34%, 42%, and 43% for words; 38%, 59%, and 51% for sentences). The improvement in speech perception after implantation for SP patients continued throughout the 12 months for words and 6 months for sentences, versus 6 months for words and 3 months for sentences for Convex patients.

Systematic screening for nonspecific autoantibodies in idiopathic sensorineural hearing loss: no association with steroid response.

OBJECTIVE: An autoimmune pathogenesis has been suggested for idiopathic sensorineural hearing loss (iSHL). Specific tests have been developed to detect inner ear autoantibodies and have been shown to correlate with treatment outcome. However, the disease is rare, and specific tests are not easily available. We aimed to analyze the correlation between positive systemic autoimmune test results and steroid treatment outcome in patients with iSHL. STUDY DESIGN: Prospective, single-center, open trial. SETTING: All patients younger than 60 years seen in the ENT department from 1999 to 2007 and fulfilling the criteria for iSHL were tested for systemic autoimmunity. PATIENTS: Patients were classified into 2 groups, according to the presence or absence of autoimmunity. INTERVENTION: : Clinical evaluation and audiologic tests. MAIN OUTCOME MEASURES: The outcomes of steroid treatment were compared between these 2 groups. RESULTS: Forty-nine patients were included; the mean age at iSHL onset was 36.1 years. Hearing loss was often bilateral (89.8%). Tinnitus and vertigo were present in 75.5% and 51%, respectively. On audiograms, disease severity was correlated with disease duration. Nine patients (18.4%) had positive autoimmune tests: anti-neutrophil cytoplasmic antibody (n = 1), antinuclear antibody (n = 3), rheumatoid factor (n = 3), and antiphospholipid (n = 2). Twenty-five courses of oral steroids were evaluated after 1 month: 52% of cases experienced some improvement. There were no differences in outcome associated with autoimmune status (p = 0.85). CONCLUSION: The results of this study suggest that positive autoimmune tests in patients with iSHL are not predictive of improvement after a 1-month steroid course. Therefore, systematic screening does not seem to be useful, and specific inner ear autoantibody tests need to be developed.

Cholesteatoma secondary to temporal bone involvement by Langerhans cell histiocytosis: a complication amenable to curative surgery.

OBJECTIVES: To describe secondary acquired cholesteatoma in patients previously treated for Langerhans cell histiocytosis (LCH). To focus on misleading symptoms suggesting LCH relapse. PATIENTS: This study involved 3 patients aged 12, 20, and 58 months whose conditions were diagnosed with LCH. All 3 had involvement of the mastoid and of the skin of the external ear canal (EAC) at diagnosis. They were treated with steroids and vinblastine. INTERVENTIONS: Serial computed tomographic (CT) scans and clinical follow-up. MAIN OUTCOME MEASURE: Exploratory surgery of the mastoid. RESULTS: Otorrhea recurred in all 3 patients at 24, 17, and 26 months, respectively, with difficulties to clinically identify a hole in the posterior part of the EAC. The otorrhea was considered a sign of a new occurrence of LCH, leading to systemic chemotherapy in 2 cases. A CT scan showed a defect in the posterior wall of the EAC and suggested cholesteatomatous invasion of the mastoid (2 true cholesteatomas and 1 precholesteatomatous case).Surgery (canal wall up mastoidectomies) successfully removed the cholesteatoma (bilateral in 2 cases) and reconstructed the bony defect using cartilage. Biopsies ruled out LCH recurrence. CONCLUSION: Secondary acquired cholesteatoma (through a bony defect of the EAC) may occur in patients previously treated for LCH. Recurrence of symptoms and bone destruction on CT may wrongly suggest LCH recurrence. Surgery allows removal of the cholesteatoma as well as EAC reconstruction and control biopsy.

Speech performance and sound localization in a complex noisy environment in bilaterally implanted adult patients.

OBJECTIVE: To evaluate speech performance, in quiet and noise, and localization ability in adult patients who had undergone bilateral and simultaneous implantation. STUDY DESIGN: Prospective multi-center study. METHODS: Twenty-seven adult patients with profound or total hearing loss were bilaterally implanted in a single-stage procedure, and simultaneously activated (Med-El, Combi 40/40+). Subjects were assessed before implantation and at 3, 6 and 12 months after switch-on. Speech perception tests in monaural and binaural conditions were performed in quiet and in noise using disyllabic words, with speech coming from the front and a cocktail party background noise coming from 5 loudspeakers. Sound localization measurements were also performed in background noise coming from 5 loudspeakers positioned from -90 degrees to +90 degrees azimuth in the horizontal plane, and using a speech stimulus. RESULTS: There was a bilateral advantage at 12 months in quiet (77 +/- 5.0% in bilateral condition, 67 +/- 5.3% for the better ear, p < 0.005) and in noise (signal-to-noise ratio +15 dB: 63 +/- 5.9% in bilateral condition, 55 +/- 6.9% for the better ear, p < 0.05). Considering unilateral speech scores recorded in quiet at 12 months, subjects were categorized as 'good performers' (speech comprehension score > or =60% for the better ear, n = 19) and 'poor performers' (n = 8). Subjects were also categorized as 'asymmetrical' (difference between their 2 unilateral speech scores > or =20%, n = 11) or 'symmetrical' (n = 16). The largest advantage (bilateral compared to the better ear) was obtained in poor performers: +19% compared to +7% in good performers (p < 0.05). In the group of good performers, there was a bilateral advantage only in cases of symmetrical results between the 2 ears (n = 10). In the group of poor performers, the bilateral advantage was shown in both patients with symmetrical (n = 6) and asymmetrical results (n = 2). In bilateral conditions, the sound localization ability in noise was improved compared to monaural conditions in patients with symmetrical and asymmetrical performance between the 2 ears. No preoperative factor (age, duration of deafness, use of hearing aids, etiology, etc.) could predict the asymmetrical performance, nor which ear would be the best. CONCLUSION: This study demonstrates a bilateral advantage (at 12 months after the implantation) in speech intelligibility and sound localization in a complex noisy environment. In quiet, this bilateral advantage is shown in cases of poor performance of both ears, and in cases of good performance with symmetrical results between the 2 ears. No preoperative factor can predict the best candidates for a simultaneous bilateral implantation.

Benefit of the Vibrant Soundbridge device in patients implanted for 5 to 8 years.

OBJECTIVES: To assess audiological performance, satisfaction rate, and side effects of 100 patients who have been using the middle ear implant Vibrant Soundbridge (VSB) for 5 to 8 yr when compared with data collected from 3 to 18 mo postsurgery. DESIGN: Audiological testing and subjective evaluation using self-assessment scales were performed in 77 out of the 100 patients using the VSB for 5 to 8 years. The results were compared to data collected 3 months (audiological testing) and 18 months (self-assessment scales) after surgery. Twenty-three patients have not been evaluated for different reported reasons. RESULTS: Pure-tone hearing thresholds decreased similarly in both implanted and contralateral ears. The satisfaction ratings and the functional gain provided by the VSB remained stable. Speech comprehension in quiet conditions without the VSB decreased from 56 to 37% in 5 to 8 yr, but an 81% score was achieved with the VSB. CONCLUSIONS: This study demonstrates that the performance of the VSB does not deteriorate for more than 5 yr, without adverse effect. These results confirm the safety and the effectiveness of the VSB with a long-term follow-up.

Biomaterials for tissue reconstruction and bone substitution of the ear, nose and throat, face and neck.

The role of biomaterials has become more important in the last 30 years in otorhinolaryngology. Legal directives for their use and, more importantly, indications have been specified. Biomaterials are medical devices, designed for tissue substitution or reconstruction. Approval labeling is issued in the form of European Community certification and postmarketing medical device safety in Europe - completely independent from the US FDA's certification. The indications for biomaterials are generally similar to those of autografts. Their main advantage is that they limit the morbidity caused by autograft harvesting. The benefits are aesthetic, functional or both. The main indications are in otology, sinus surgery, cranio-maxillo-facial traumatology, osteosynthesis and orthognatic surgery, skeletal augmentation and anti-aging surgery, facial prosthetic rehabilitation and laryngology. The research fields are extremely varied (e.g., increased therapeutic properties, drug-delivery systems or tissue engineering). Increasingly, biomaterials are implanted and the surgical success of their use is dependent upon strict legal labeling and well-defined indications.