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1.
Otolaryngol Head Neck Surg ; 171(2): 521-529, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38532540

RESUMO

OBJECTIVE: To assess trauma patterns associated with the insertion of lateral wall electrode arrays. The study focused on 3 categories-scala tympani (ST), intermediate, and scala vestibuli (SV)-to identify traumatic patterns and contributing factors. STUDY DESIGN: Retrospective study. SETTING: Data from 106 cochlear implant recipients at a tertiary otologic center. METHODS: Demographic and surgical data were collected from recipients who underwent cochlear implantation manually and with RobOtol®. Measurements included cochlear dimensions, angular depth of insertion, and position of the first electrode. Three-dimensional reconstructions were used to analyze the electrode array location relative to the basilar membrane, categorized into ST, intermediate, and SV electrodes. Nontraumatic insertion was defined as all electrodes in the ST, while traumatic insertions had 1 or more electrodes in intermediate or SV locations. RESULTS: Out of 106 cases, 44% had nontraumatic and 56% had traumatic insertions. Demographic and surgical characteristics showed no association with traumatic insertions. A deeper position of the first electrode, relative to the round window, was associated with traumatic insertions (P = .03). Three trauma patterns were observed: distal (facing the apical electrodes), proximal (facing the middle electrodes around 180°), and distal/proximal. CONCLUSION: This study considers the intermediate position which could be associated with basilar membrane lesions. Risk zones for intracochlear trauma with lateral wall arrays were identified distally and proximally. Traumatic insertions were independently linked to deeper array placement. Future studies should explore whether gentler insertion, without insisting on further electrode array insertion depth, could reduce the trauma during cochlear implantation.


Assuntos
Implante Coclear , Implantes Cocleares , Humanos , Estudos Retrospectivos , Implante Coclear/efeitos adversos , Implante Coclear/métodos , Masculino , Feminino , Implantes Cocleares/efeitos adversos , Pessoa de Meia-Idade , Adulto , Criança , Pré-Escolar , Adolescente , Idoso , Rampa do Tímpano/cirurgia , Eletrodos Implantados/efeitos adversos , Lactente , Adulto Jovem , Cóclea/lesões
2.
Otolaryngol Head Neck Surg ; 171(1): 218-230, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38482961

RESUMO

OBJECTIVE: To evaluate long-term hearing outcomes following cochlear implantation in patients with neurofibromatosis type 2 and ipsilateral vestibular schwannoma. STUDY DESIGN: Retrospective study. SETTING: Tertiary general hospital. METHODS: Twenty-two patients undergoing cochlear implantation between 2004 and 2018 with at least 1 year of follow-up were included. Patients were categorized as "users" or "nonusers" of their cochlear implant (CI). For users, speech perception (disyllabic words) without lip-reading was assessed in quiet conditions 1-year postimplantation, and annually thereafter. CI users were classified into 2 groups on the basis of speech intelligibility (≥40% or <40%). Demographic data, treatment options, and tumor size were also recorded. RESULTS: One year after implantation, 16 (73%) patients used their CI daily. Twelve of these patients had a speech intelligibility ≥40% (mean: 74 ± 21.9%). Three had a Koos stage IV tumor. At the last visit (mean duration of follow-up: 6 ± 5 years), 12 of these 16 patients were still using their implant daily, and 6 had a speech intelligibility ≥40%. No predictive factors for good performance at 1 year or performance stability were identified. CONCLUSION: Neurofibromatosis type 2 is a complex disease profoundly affecting patient quality of life, and cochlear implantation should always be considered on a case-by-case basis. In some individuals, cochlear implantation can provide good speech intelligibility for extended periods, even posttreatment or in cases of large tumors.


Assuntos
Implante Coclear , Neurofibromatoses , Neurofibromatose 2 , Humanos , Neurofibromatose 2/complicações , Neurofibromatose 2/cirurgia , Masculino , Estudos Retrospectivos , Feminino , Pessoa de Meia-Idade , Adulto , Neurofibromatoses/complicações , Neurofibromatoses/cirurgia , Percepção da Fala , Resultado do Tratamento , Neoplasias Cutâneas/cirurgia , Neoplasias Cutâneas/complicações , Idoso , Neurilemoma/cirurgia , Neurilemoma/complicações , Neuroma Acústico/cirurgia , Neuroma Acústico/complicações , Inteligibilidade da Fala , Seguimentos
3.
Audiol Neurootol ; 2024 Mar 25.
Artigo em Inglês | MEDLINE | ID: mdl-38527427

RESUMO

INTRODUCTION: Auditory performance in noise of cochlear implant recipients can be assessed with the adaptive Matrix test (MT); however, when the speech-to-noise ratio (SNR) exceeds 15 dB, the background noise has any negative impact on the speech recognition. Here, we aim to evaluate the predictive power of aided pure-tone audiometry and speech recognition in quiet, and establish cut-off values for both tests that indicate whether auditory performance in noise can be assessed using the Matrix sentence test in a diffuse noise environment. METHODS: Here, we assessed the power of pure-tone audiometry and speech recognition in quiet to predict the response to the MT. Ninety-eight cochlear implant recipients were assessed using different sound processors from Advanced Bionics (n=56) and Cochlear (n=42). Auditory tests were performed at least 1-year after cochlear implantation or upgrading the sound processor to ensure the best benefit of the implant. Auditory assessment of the implanted ear in free-field conditions included: pure-tone average (PTA), speech discrimination score (SDS) in quiet at 65 dB, and speech recognition threshold (SRT) in noise that is the SNR at which the patient can correctly recognize 50% of the words using the MT in a diffuse sound field. RESULTS: The SRT in noise was determined in sixty patients (61%) and undetermined in 38 (39%) using the MT. When cut-off values for PTA <36 dB and SDS >41% were used separately, they were able to predict a positive response to the MT in 83% of recipients; using both cut-off values together, the predictive value reached 92%. DISCUSSION/CONCLUSION: As the pure-tone audiometry is standardized universally and the speech recognition in quiet could vary depending on the language used; we propose that the MT should be performed in recipients with PTA <36 dB, and in recipients with PTA >36 dB, a list of Matrix sentences at a fixed SNR should be presented to determine the percentage of words understood. This approach should enable clinicians to obtain information about auditory performance in noise whenever possible.

4.
Eur Arch Otorhinolaryngol ; 281(1): 155-162, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37516989

RESUMO

PURPOSE: In cochlear implantation, a scala vestibuli (SV) insertion of an electrode array is a rare occurrence and is reported to be linked to poor hearing outcomes. Using the same electrode array, the auditory performance of patients with a complete SV location was compared with that of patients having a complete scala tympani (ST) location 1 year after implantation. METHODS: Thirty-three patients were included in this retrospective case-control study (SV, n = 12; ST, n = 21). The matching criteria were electrode array type, age at implantation, and duration of severe or profound deafness. The array location was analyzed using 3D reconstruction of postoperative CT scans. Postoperative audiological evaluation of the implanted ear was performed using pure-tone audiometry, speech recognition of monosyllabic words in quiet, and words and sentences in noise. RESULTS: On the preoperative CT scan, six patients in the SV group presented with both round window (RW) and ST ossification, three with RW ossification alone, and three with no RW ossification. Auditory performance did not differ between SV and ST groups 1 year after cochlear implantation. Speech recognition of words was 49 ± 7.6% and 56 ± 5.0% in quiet and 75 ± 9.5% and 66 ± 6.0% in noise in SV and ST groups, respectively. CONCLUSION: ST insertion is the gold standard that allows the three cochlear scalae to preserve scalar cochlear integrity. However, 1 year after implantation, a planned or unexpected SV insertion is not detrimental to hearing outcomes, providing similar auditory performance in quiet and noise to ST insertion.


Assuntos
Implante Coclear , Implantes Cocleares , Humanos , Rampa do Vestíbulo/cirurgia , Rampa do Tímpano/diagnóstico por imagem , Rampa do Tímpano/cirurgia , Estudos Retrospectivos , Estudos de Casos e Controles , Audiometria de Tons Puros
5.
Laryngoscope Investig Otolaryngol ; 8(1): 220-229, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36846428

RESUMO

Objectives: The objective of this study was to predict occurrence of facial nerve stimulation (FNS) in cochlear implanted patients for far-advanced otosclerosis (FAO) by correlating preoperative computed tomography (CT)-scan data to FNS and to evaluate FNS impact on hearing outcomes. Methods: Retrospective analysis on 91 ears (76 patients) implanted for FAO. Electrodes were straight (50%) or perimodiolar (50%). Demographic data, extension of otosclerosis on preoperative CT scan, occurrence of FNS, and speech performance were analyzed. Results: Prevalence of FNS was 21% (19 ears). FNS appeared during the first month (21%), 1-6 months (26%), 6-12 months (21%), and over 1 year (32%) postimplantation. Cumulative incidence of FNS at 15 years was 33% (95% CI = [14-47%]). Extension of otosclerotic lesions on preimplantation CT-scan was more severe in FNS ears compared to No-FNS (p < .05): for Stage III, 13/19 (68%) and 18/72 (25%) ears for FNS and No-FNS groups, respectively (p < .05). Location of otosclerotic lesions relative to the facial nerve canal was similar whatever the presence or not of FNS. Electrode array had no impact on FNS occurrence. At 1 year post-implantation, duration of profound hearing loss (≥5 years) and previous stapedotomy were negatively associated with speech performance. FNS did not impact hearing outcomes, despite a lower percentage of activated electrodes (p < .01) in the FNS group. Nevertheless, FNS were associated with a decrease of speech performance both in quiet (p < .001) and in noise (p < .05). Conclusion: Cochlear implanted patients for FAO are at greater risk of developing FNS affecting speech performance over time, probably due to a higher percentage of deactivated electrodes. High resolution CT-scan is an essential tool allowing FNS prediction but not time of onset. Level of evidence: 2b, Laryngoscope Investigative Otolaryngology, 2022.

6.
J Clin Med ; 11(8)2022 Apr 07.
Artigo em Inglês | MEDLINE | ID: mdl-35456169

RESUMO

The scalar position of the electrode array is assumed to be associated with auditory performance after cochlear implantation. We propose a new method that can be routinely applied in clinical practice to assess the position of an electrode array. Ten basilar membrane templates were generated using micro-computed tomography (micro-CT), based on the dimensions of 100 cochleae. Five surgeons were blinded to determine the position of the electrode array in 30 cadaveric cochleae. The procedure consisted of selecting the appropriate template based on cochlear dimensions, merging the electrode array reconstruction with the template using four landmarks, determining the position of the array according to the template position, and comparing the results obtained to histology data. The time taken to analyze each implanted cochlea was approximately 12 min. We found that, according to histology, surgeons were in almost perfect agreement when determining an electrode translocated to the scala vestibuli with the perimodiolar MidScala array (Fleiss' kappa (κ) = 0.82), and in moderate agreement when using the lateral wall EVO array (κ = 0.42). Our data indicate that an adapted basilar membrane template can be used as a rapid and reproducible method to assess the position of the electrode array after cochlear implantation.

7.
J Clin Med ; 11(7)2022 Mar 28.
Artigo em Inglês | MEDLINE | ID: mdl-35407482

RESUMO

Cochlear implantation is usually not recommended for prelingual profoundly deaf adults, although some of these patients might benefit from it. This study aims to define the candidates for cochlear implantation in this population. This retrospective study reviewed 34 prelingual profoundly deaf patients who had received a cochlear implant at 32 ± 1.7 years old (16−55), with at least 1 year of follow-up. Speech perception and quality of life were assessed before and 3, 6, and 12 months after cochlear implantation, then every year thereafter. According to the word speech intelligibility in quiet (WSI) 1 year after implantation, two groups were identified: good performer (GP) with WSI ≥ 50% (n = 15), and poor performer (PP) with WSI ≤ 40% (n = 19). At the 1 year mark, mean WSI improved by 28 ± 4.6% (−20−100) (p < 0.0001). In GP, the intelligibility for words and sentences, communication and quality of life scales improved. In PP, the communication scale improved, but not auditory performance or quality of life. GP and PP differed pre-operatively in speech production, communication abilities, and WSI in best-aided conditions. In prelingual profoundly deaf adults, a dramatic auditory performance benefit could be expected after cochlear implantation if the patients have some degree of speech intelligibility in aided conditions and have developed oral communication and speech production.

8.
Hear Res ; 414: 108425, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34979455

RESUMO

In the last two decades, cochlear implant surgery has evolved into a minimally invasive, hearing preservation surgical technique. The devices used during surgery have benefited from technological advances that have allowed modification and possible improvement of the surgical technique. Robotics has recently gained popularity in otology as an effective tool to overcome the surgeon's limitations such as tremor, drift and accurate force control feedback in laboratory testing. Cochlear implantation benefits from robotic assistance in several steps during the surgical procedure: (i) during the approach to the middle ear by automated mastoidectomy and posterior tympanotomy or through a tunnel from the postauricular skin to the middle ear (i.e. direct cochlear access); (ii) a minimally invasive cochleostomy by a robot-assisted drilling tool; (iii) alignment of the correct insertion axis on the basal cochlear turn; (iv) insertion of the electrode array with a motorized insertion tool. In recent years, the development of bone-attached parallel robots and image-guided surgical robotic systems has allowed the first successful cochlear implantation procedures in patients via a single hole drilled tunnel. Several other robotic systems, new materials, sensing technologies applied to the electrodes, and smart devices have been developed, tested in experimental models and finally some have been used in patients with the aim of reducing trauma in cochleostomy, and permitting slow and more accurate insertion of the electrodes. Despite the promising results in laboratory tests in terms of minimal invasiveness, reduced trauma and better hearing preservation, so far, no clinical benefits on residual hearing preservation or better speech performance have been demonstrated. Before these devices can become the standard approach for cochlear implantation, several points still need to be addressed, primarily cost and duration of the procedure. One can hope that improvement in the cost/benefit ratio will expand the technology to every cochlear implantation procedure. Laboratory research and clinical studies on patients should continue with the aim of making intracochlear implant insertion an atraumatic and reversible gesture for total preservation of the inner ear structure and physiology.


Assuntos
Implante Coclear , Implantes Cocleares , Robótica , Cóclea/cirurgia , Implante Coclear/métodos , Audição , Humanos
9.
Audiol Neurootol ; 27(2): 148-155, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-34284383

RESUMO

INTRODUCTION: Electrode array translocation is an unpredictable event with all types of arrays, even using a teleoperated robot in a clinical scenario. We aimed to compare the intracochlear trauma produced by the HiFocus™ Mid-Scala (MS) electrode array (Advanced Bionics, Valencia, CA, USA) using a teleoperated robot, with an automated robot connected to a navigation system to align the pre-curved tip of the electrode array with the coiling direction of the scala tympani (ST). METHODS: Fifteen freshly frozen temporal bones were implanted with the MS array using the RobOtol® (Collin, Bagneux, France). In the first group (n = 10), the robot was teleoperated to insert the electrode array into the basal turn of the ST under stereomicroscopic vision, and then the array was driven by a slow-speed hydraulic insertion technique with an estimated placement of the pre-curved electrode tip. In the second group (n = 5), 3 points were obtained from the preoperative cone-beam computed tomography: the 2 first defining the ST insertion axis of the basal turn and a third one at the center of the ST at 270°. They provided the information to the automated system (RobOtol® connected with a navigation system) to automatically align the electrode array with the ST insertion axis and to aim the pre-curved tip toward the subsequent coiling of the ST. After this, the electrode array was manually advanced. Finally, the cochleae were obtained and fixed in a crystal resin, and the position of each electrode was determined by a micro-grinding technique. RESULTS: In all cases, the electrode array was fully inserted into the cochlea and the depth of insertion was similar using both techniques. With the teleoperated robotic technique, translocations of the array were observed in 7/10 insertions (70%), but neither trauma nor array translocation occurred with automated robotic insertion. CONCLUSION: We have successfully tested an automated insertion system (robot + navigation) that could accurately align a pre-curved electrode array to the axis of the basal turn of the ST and its subsequent coiling, which reduced intracochlear insertion trauma and translocation.


Assuntos
Implante Coclear , Implantes Cocleares , Robótica , Cóclea/diagnóstico por imagem , Cóclea/cirurgia , Implante Coclear/métodos , Eletrodos Implantados , Rampa do Tímpano/diagnóstico por imagem , Rampa do Tímpano/cirurgia , Osso Temporal/cirurgia
10.
Front Neurosci ; 15: 718416, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34899153

RESUMO

This manuscript summarizes available evidence-based best practices in the development, translation, and cultural adaptation of one type of outcome measure for adults with hearing impairment, patient-reported outcome measures (PROMs). It presents the development of the Cochlear Implant Quality of Life (CIQOL) instruments and the ongoing translation and cultural adaptation of the CIQOL-35 Profile from English to French as case studies and discusses useful lessons for selecting, developing, translating, culturally adapting, and using PROMs. Relevant best practice guides are introduced, described and their steps are illustrated with examples. Future trends in hearing-related PROMs, including computerized adaptive testing, patient-reported experience measures (PREMs), economic evaluation and allocation of scarce resources, and PROMs in low-resource settings, are discussed. The manuscript concludes on the lessons that can be learned from implementation science for the successful and sustainable integration of PROMs in clinical practice.

11.
Front Surg ; 8: 740935, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34692763

RESUMO

Background: Endoscopy during middle ear surgery is advantageous for better exploration of middle ear structures. However, using an endoscope has some weaknesses as surgical gestures are performed with one hand. This may trouble surgeons accustomed to using two-handed surgery, and may affect accuracy. A robot-based holder may combine the benefits from endoscopic exposure with a two-handed technique. The purpose of this study was to assess the safety and value of an endoscope held by a teleoperated system. Patients and Methods: A case series of 37 consecutive patients operated using endoscopic exposure with robot-based assistance was analyzed retrospectively. The RobOtol® system (Collin, France) was teleoperated as an endoscope holder in combination with a microscope. The following data were collected: patient characteristics, etiology, procedure type, complications, mean air and bone conduction thresholds, and speech performance at 3 months postoperatively. Patients had type I (myringoplasty), II (partial ossiculoplasty), and III (total ossiculoplasty) tympanoplasties in 15, 14, and 4 cases, respectively. Three patients had partial petrosectomies for cholesteatomas extending to the petrous apex. Finally, one case underwent resection of a tympanic paraganglioma. Ambulatory procedures were performed in 25 of the 37 patients (68%). Results: Complete healing with no perforation of the tympanic membrane was noted postoperatively in all patients. No complications relating to robotic manipulation occurred during surgery or postoperatively. The mean air conduction gain was 3.8 ± 12.6 dB for type I (n = 15), 7.9 ± 11.4 dB for type II (n = 14), and -0.9 ± 10.8 for type III tympanoplasties (n = 4), and the postoperative air-bone conduction gap was 13.8 ± 13.3 dB for type I, 19.7 ± 11.7 dB for type II and 31.6 ± 13.0 dB for type III tympanoplasty. They was no relapse of cholesteatoma or paraganglioma during the short follow-up period (<1 year). Conclusion: This study indicates that robot-assisted endoscopy is a safe and trustworthy tool for several categories of middle ear procedures. It combines the benefits of endoscopic exposure with a two-handed technique in middle ear surgery. It can be used as a standalone tool for pathology limited to the middle ear cleft or in combination with a microscope in lesions extending to the mastoid or petrous apex.

12.
Front Surg ; 8: 729736, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34568420

RESUMO

Background and Purpose: Robot-assisted cochlear implantation has recently been implemented in clinical practice; however, its effect on hearing outcomes is unknown. The aim of this preliminary study was to evaluate hearing performance 1 year post-implantation whether the electrode array was inserted manually or assisted by a robot. Methods: Forty-two profoundly deaf adults were implanted either manually (n = 21) or assisted by a robot (RobOtol®, Collin, Bagneux, France) with three different electrode array types. Participants were paired by age, and electrode array type. The scalar position of the electrode array in the cochlea was assessed by 3D reconstruction from the pre- and post-implantation computed tomography. Pure-tone audiometry and speech perception in silence (percentage of disyllabic words at 60 dB) were tested on the implanted ear 1 year post-implantation in free-field conditions. The pure-tone average was calculated at 250-500-750 Hz, 500-1,000-2,000-3,000 Hz, and 3,000-4,000-8,000 Hz for low, mid, and high frequencies, respectively. Results: One year after cochlear implantation, restoration of the high-frequency thresholds was associated with better speech perception in silence, but not with low or mid frequencies (p < 0.0001; Adjusted R 2 = 0.64, polynomial non-linear regression). Although array translocation was similar using either technique, the number of translocated electrodes was lower when the electrode arrays had been inserted with the assistance of the robot compared with manual insertion (p = 0.018; Fisher's exact test). Conclusion: The restoration of high-frequency thresholds (3,000-4,000-8,000 Hz) by cochlear implantation was associated with good speech perception in silence. The numbers of translocated electrodes were reduced after a robot-assisted insertion.

13.
Int J Pharm ; 604: 120757, 2021 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-34058306

RESUMO

Patients with residual hearing can benefit from cochlear implantation. However, insertion can damage cochlear structures and generate oxidative stress harmful to auditory cells. The antioxidant N-acetyl-L-cysteine (NAC) is a precursor of glutathione (GSH), a powerful endogenous antioxidant. NAC local delivery to the inner ear appeared promising to prevent damage after cochlear implantation in animals. NAC-loaded liposomal gel was specifically designed for transtympanic injection, performed both 3 days before and on the day of surgery. Hearing thresholds were recorded over 30 days in implanted guinea pigs with and without NAC. NAC, GSH, and their degradation products, N,N'-diacetyl-L-cystine (DiNAC) and oxidized glutathione (GSSG) were simultaneously quantified in the perilymph over 15 days in non-implanted guinea pigs. For the first time, endogenous concentrations of GSH and GSSG were determined in the perilymph. Although NAC-loaded liposomal gel sustained NAC release in the perilymph over 15 days, it induced hearing loss in both implanted and non-implanted groups with no perilymphatic GSH increase. Under physiological conditions, NAC appeared poorly stable within liposomes. As DiNAC was quantified at concentrations which were twice as high as NAC in the perilymph, it was hypothesized that DiNAC could be responsible for the adverse effects on hearing.


Assuntos
Implante Coclear , Acetilcisteína , Animais , Cóclea , Cobaias , Humanos , Lipossomos , Perilinfa
14.
Audiol Neurootol ; 26(6): 454-460, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33823505

RESUMO

INTRODUCTION: Audiovestibular symptoms are rare in sarcoidosis, but they may also be the first manifestation of the disease. Sudden or progressive bilateral hearing loss is usually associated with vestibular impairment. The mechanism of hearing loss remains unclear, but clinical presentation and magnetic resonance imaging suggest a retrocochlear site for the lesion in most patients. Several cases of hearing recovery after corticosteroid treatment have been reported. In patients with severe or profound hearing loss, the benefit of cochlear implantation is challenging to predict in the case of auditory neuropathy and is rarely described. We present a case series of cochlear implantation in patients with documented neurosarcoidosis. RESULTS: Seven cases of cochlear implantation in 4 patients with neurosarcoidosis are reported. All of the patients showed a great improvement very quickly in both quiet and noise. Speech performance remained stable over time with a follow-up ranging from 4 to 11 years, even in patients who had disease exacerbation. CONCLUSION: Cochlear implantation is possible in deaf patients with neurosarcoidosis. The excellent benefit obtained in our patients suggests a particular type of neuropathy, but endocochlear involvement cannot be entirely ruled out.


Assuntos
Implante Coclear , Implantes Cocleares , Perda Auditiva Neurossensorial , Sarcoidose , Percepção da Fala , Doenças do Sistema Nervoso Central , Perda Auditiva Neurossensorial/cirurgia , Humanos , Sarcoidose/complicações , Sarcoidose/diagnóstico por imagem , Resultado do Tratamento
15.
Eur Arch Otorhinolaryngol ; 278(11): 4269-4277, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33388980

RESUMO

PURPOSE: To evaluate the forces involved in different manipulations, manual or robot-assisted, applied to the ossicular chain, on normal temporal bones and on an anatomical model of otosclerosis. METHODS: Thirteen cadaveric temporal bones, with mobile footplates or with footplates that were fixed using hydroxyapatite cement, were manipulated, manually or using a robotic arm (RobOtol®). "Short contact" of a mobile footplate was the weakest interaction on the incus. "Long contact" was the same manipulation held for 10 s. "Mobilization" was the smallest visualized movement of the mobile footplate, or the movement necessary to regain mobility of the fixed footplate. A six-axis force sensor (Nano17, ATI) measured the maximal peak of forces, summation of forces applied, and yank. RESULTS: Maximal forces during short (~4 mN) and long contact (~15 mN) were similar for manual and robot-assisted manipulations. For manual manipulation, yank measured during long contact was twice as high compared to robot-assisted manipulation: 6 ± 2.4 (n = 5) and 3 ± 1.3 mN/s (n = 5), respectively (mean ± SD, p < 0.02). For mobilization of the mobile footplate, maximal forces during mobilization were similar during manual and robot-assisted manipulations, respectively: 12 ± 2.5 (n = 6) and 19 ± 7.6 mN (n = 7). Compared with mobilization of a mobile footplate, mobilization of a fixed footplate required ~ 60 and ~ 27 times higher maximal forces for manual and robot-assisted manipulations, respectively: 724 ± 366.4 and 507 ± 283.2 mN. Yank was twice as high during manual manipulation compared to robot-assisted manipulation (p < 0.05). CONCLUSION: Robot-assisted manipulation of the ossicular chain was reliable. Our anatomical model of otosclerosis was successfully developed requiring higher forces for stapes mobilization.


Assuntos
Prótese Ossicular , Otosclerose , Robótica , Cirurgia do Estribo , Humanos , Otosclerose/cirurgia , Estribo , Osso Temporal
16.
Eur Arch Otorhinolaryngol ; 278(1): 77-85, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32458123

RESUMO

PURPOSE: Middle ear surgery may benefit from robot-based assistance to hold micro-instruments or an endoscope. However, the surgical gesture performed by one hand may perturb surgeons accustomed to two-handed surgery. A robot-based holder may combine the benefits from endoscopic exposure and a two-handed technique. Furthermore, tremor suppression and accurate tool control might help the surgeon during critical surgical steps. The goal of this work was to study the safety of an otological robot-based assistant under clinical conditions in a limited series of patients. METHODS: The RobOtol system has been used as an endoscope or a micro instrument holder for this series. Eleven cases were operated on with the robot as an endoscope holder for chronic otitis. Twenty-one cases were operated on with the robot as a micro-instrument holder for otosclerosis (9 cases), transtympanic tube placement (2 cases), or cochlear implantation (10 cases). RESULTS: No complications related to the robot manipulation occurred during surgery nor in postoperative. In the chronic otitis group, all perforations were sealed and 3-month postoperative pure-tone average air-bone gap (PTA ABG) was 15 ± 2.6 dB. In the otosclerosis group, 1-month post-op PTA ABG was 10 ± 1 dB. For cochlear implantation cases, a scala tympani insertion, a vestibular scala translocation occurred and a full scala vestibuli insertion was observed in 7, 2 and 1 case, respectively. CONCLUSION: The RobOtol system has reached the clinical stage. It could be used safely and with accurate control as an endoscope holder or a micro instrument holder in 32 cases.


Assuntos
Implante Coclear , Endoscopia/métodos , Otosclerose/cirurgia , Robótica/instrumentação , Adulto , Orelha Média/cirurgia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Rampa do Tímpano/cirurgia , Resultado do Tratamento
17.
Otol Neurotol ; 42(4): e438-e444, 2021 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-33306661

RESUMO

OBJECTIVE: To describe the first cochlear array insertions using a robot-assisted technique, with different types of straight or precurved electrode arrays, compared with arrays manually inserted into the cochlea. STUDY DESIGN: Retrospective review. SETTING: Tertiary otologic center. PATIENTS: Twenty cochlear implantations in the robot-assisted group and 40 in the manually inserted group. INTERVENTIONS: Cochlear implantations using a robot-assisted technique (RobOtol) with straight (eight Cochlear CI522/622, and eight Advanced Bionics Hifocus Slim J) or precurved (four Advanced Bionics Hifocus Mid-Scala) matched to manual cochlear implantations. Three-dimensional reconstruction images of the basilar membrane and the electrode array were obtained from pre- and postimplantation computed tomography. MAIN OUTCOME MEASURES: Rate and localization of scalar translocations. RESULTS: For straight electrode arrays, scalar translocations occurred in 19% (3/16) of the robot-assisted group and 31% (10/32) of the manually inserted group. Considering the number of translocated electrodes, this was lower in the robot-assisted group (7%) than in the manually inserted group (16%) (p < 0.0001, χ2 test). For precurved electrode arrays, scalar translocations occurred in 50% (2/4) of the robot-assisted group and 38% (3/8) of the manually inserted group. CONCLUSION: This study showed a safe and reliable insertion of different electrode array types with a robot-assisted technique, with a less traumatic robotic insertion of straight electrode arrays when compared with manual insertion.


Assuntos
Implante Coclear , Implantes Cocleares , Robótica , Adulto , Cóclea/diagnóstico por imagem , Cóclea/cirurgia , Eletrodos Implantados , Humanos , Estudos Retrospectivos
18.
Int J Pharm ; 592: 120038, 2021 Jan 05.
Artigo em Inglês | MEDLINE | ID: mdl-33159985

RESUMO

Despite the high incidence of inner ear disorders, there are still no dedicated medications on the market. Drugs are currently administered by the intratympanic route, the safest way to maximize drug concentration in the inner ear. Nevertheless, therapeutic doses are ensured for only a few minutes/hours using drug solutions or suspensions. The passage through the middle ear barrier strongly depends on drug physicochemical characteristics. For the past 15 years, drug encapsulation into nanocarriers has been developed to overcome this drawback. Nanocarriers are well known to sustain drug release and protect it from degradation. In this review, in vivo studies are detailed concerning nanocarrier biodistribution, their pathway mechanisms in the inner ear and the resulting drug pharmacokinetics. Key parameters influencing nanocarrier biodistribution are identified and discussed: nanocarrier size, concentration, surface composition and shape. Recent advanced strategies that combine nanocarriers with hydrogels, specific tissue targeting or modification of the round window permeability (cell-penetrating peptide, magnetic delivery) are explored. Most of the nanocarriers appear to be safe for the inner ear and provide a significant efficacy over classic formulations in animal models. However, many challenges remain to be overcome for future clinical applications.


Assuntos
Orelha Interna , Animais , Sistemas de Liberação de Medicamentos , Liberação Controlada de Fármacos , Janela da Cóclea , Distribuição Tecidual
19.
Eur Arch Otorhinolaryngol ; 277(3): 705-713, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31802226

RESUMO

PURPOSE: To evaluate the long-term hearing outcomes in cochlear implanted adults with residual hearing at low frequencies, and the proportion of patients using electro-acoustic stimulation (EAS). METHODS: A monocentric retrospective cohort study was performed in a tertiary referral center. Population demographics, surgical approach, pre- and postoperative hearing at low frequencies, in the implanted and contralateral ear, were recorded as well as duration of EAS use. The percentage hearing preservation was calculated according to the formula S (HEARRING group). RESULTS: In total, 63 adults (81 ears) with residual hearing underwent cochlear implantation with intent to use EAS processors. Six different types of electrode array were implanted. The mean pure tone audiometry (PTA) shift after cochlear implantation was 16 ± 15 dB HL (range 0-59 dB HL). Half of the implanted ears had minimal hearing preservation or total hearing loss (HL) at 5.5 years and the cumulative risk of total HL was 50% at 7 years. During the follow-up, total HL occurred in 22 ears. The decrease in hearing levels was similar in both implanted and contralateral ear during follow-up (ns, F = 2.46 ± 3, Linear Mixed Model (LMM)). Only 44 patients found a benefit from EAS at the first fitting. At the last visit, EAS processors were fitted in 30% of the cases. The pre- and postoperative mean PTA thresholds were not predictive of EAS use (Cox's proportional hazards analysis). CONCLUSIONS: Postoperative residual hearing was observed in 93% of implanted ears, but only half of them had an initial benefit from EAS. No predictive factors were found to influence the use of EAS processors.


Assuntos
Estimulação Acústica , Percepção Auditiva , Implante Coclear , Perda Auditiva/terapia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Audiometria de Tons Puros , Limiar Auditivo , Implantes Cocleares , Progressão da Doença , Feminino , Audição , Perda Auditiva/diagnóstico , Perda Auditiva/etiologia , Perda Auditiva/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Percepção da Fala , Resultado do Tratamento , Adulto Jovem
20.
Eur Arch Otorhinolaryngol ; 276(8): 2205-2213, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31102018

RESUMO

PURPOSE: Many bilaterally deaf adults are only able to receive one cochlear implant (CI), resulting in suboptimal listening performance, especially in challenging listening environments. Adding a contralateral routing of signal (CROS) device to a unilateral CI is one possibility to alleviate these challenges. This study examined the benefit of such a CROS device. METHODS: Thirteen adult subjects with at least 6 months of CI use, and no or limited benefit of a hearing instrument in the contralateral ear were included in the study. The perceived benefit of a CROS device in everyday listening environments was evaluated up to 1 year after initial fitting using several questionnaires. Speech intelligibility performance was determined using the French matrix sentence test in quiet and in two speech-in-noise setups and was followed for 3 months after CROS fitting. RESULTS: Subjects indicated high satisfaction with the practical usability of the CROS device and long-term device retention was high. Perceived benefits in everyday listening environments were reported. Formal speech intelligibility tests revealed statistically significant median improvements of 6.93 dB SPL (Wilcoxon Z = 2.380, p = 0.017) in quiet and up to 8.00 dB SNR (Wilcoxon Z = 2.366, p = 0.018) in noise. These benefits were accessible immediately without a need for prolonged acclimatization. CONCLUSIONS: Subjective satisfaction and device retention as well as speech intelligibility benefits in quiet and in noise prove the CROS device to be a valuable addition to a unilateral CI in cases of bilateral deafness where bilateral implantation is not an option.


Assuntos
Implante Coclear , Implantes Cocleares , Surdez , Retenção da Prótese , Inteligibilidade da Fala , Idoso , Implante Coclear/efeitos adversos , Implante Coclear/métodos , Implante Coclear/psicologia , Surdez/psicologia , Surdez/reabilitação , Feminino , França , Testes Auditivos/métodos , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Localização de Som
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