Objectives The method of drug delivery directly into the cochlea with an implantable pump connected to a CI electrode array ensures long-term delivery and effective dose control, and also provides the possibility to use different drugs. The objective is to develop a model of inner ear pharmacokinetics of an implanted cochlea, with the delivery of FITC-Dextran, in the non-human primate model. Design A preclinical cochlear electrode array (CI Electrode Array HL14DD, manufactured by Cochlear Ltd.) attached to an implantable peristaltic pump filled with FITC-Dextran was implanted unilaterally in a total of 15 Macaca fascicularis (Mf). Three groups were created (5 Mf in each group), according to three different drug delivery times: 2 hours, 24 hours and 7 days. Perilymph (10 samples, 1¿L each) was sampled from the apex of the cochlea and measured immediately after extraction with a spectrofluorometer. After scarifying the specimens, x-Rays and histological analysis were performed. Results Surgery, sampling and histological analysis were performed successfully in all specimens. FITC-Dextran quantification showed different patterns, depending on the delivery group. In the 2 hours injection experiment, an increase in FITC-Dextran concentrations over the sample collection time was seen, reaching maximum concentration peaks (420-964µM) between samples 5 and 7, decreasing in successive samples, without returning to baseline...

Background: Technological developments to treat hearing loss with different types of hearing aids and auditory implants have improved the auditory perception of patients, particularly in highly complex listening conditions. These devices can be fitted and adapted to enhance speech perception. Audiological tests that assess hearing with and without auditory devices have traditionally taken place in sound-attenuated audiometric booths. Although the insights gained from these tests are extremely useful, they do not accurately reflect everyday listening situations, and accurate information about the potential benefits of the hearing device in real acoustic scenarios cannot be established. Consequently, it is difficult to optimize this technology since fitting cannot be customized. Objectives: The aim of this study was to validate an audiological testing method using a new development, the Realistic Environment Audiometric Booth (REAB), in clinical practice. Materials: We used specifically designed software to perform audiological tests in an 8 m(2) sound-attenuated booth. The REAB was designed to conduct audiological tests in standard testing conditions and in new hearing scenarios that simulate real-life situations since sound can be emitted simultaneously or alternately 360 degrees around the patient, along with 3D images. Methods: Prospective study in which subjects were tested randomly in the REAB and the conventional booth (CB) in free field. Results: 150 subjects were recruited, mean age 56 +/- 20.7 years. Auditory outcomes for pure-tone audiometry showed a high correlation; this was also the case for speech audiometries in quiet and in noise. The outcome of the new scenarios with real-life noise was plotted, including the mean values and their confidence intervals. A decreasing trend was observed in the results obtained by the different groups, according to their hearing levels. Conclusions: We have developed and validated a new audiological testing method that enables hearing ability to be assessed in listening conditions similar to those found in real life. The REAB complements the tests performed in CBs, thereby aiding the diagnostic process by reproducing acoustic and visual scenarios that conventional tests do not offer.

Introduction: Cochlear implants have been able to treat some types of hearing loss, but those related to cochlear nerve impairment made it necessary to find new ways to manage these deficits; leading to auditory brainstem implants (ABI). Aim: Our objective is to present the clinical profile of patients treated through an ABI and the results obtained from 1997 to 2017. Material and methods: On the one hand, patients with statoacoustic nerve tumours (VIIIcranial nerve) were selected, and on the other hand, patients withoutVIII tumours with congenital malformations of the inner ear. Before and after the placement of the ABI, hearing was assessed through tonal audiometry, from which the PTA (Pure Tone Average) and the CAP (Categories of Auditory Performance) scale were obtained. Results: A total of 20 patients undergoing ABI surgery were included. Eight were of tumour cause (40%) and 12 non-tumour (60%). In 15 subjects (75%) a suboccipital approach was performed and in 5 (25%) translabyrinthine. The mean of active electrodes before the implantation of Cochlear® (Nucleus ABI24) was 13/21 (61.90%) versus 8.5/12 (70.83%) of the Med-el® (ABI Med-el). An improvement in the mean PTA of 118.49dB was found against 46.55dB at 2years. On the CAP scale, values of1 were obtained in the preimplantation and of 2.57 (1-5) in the 2-year revision. Conclusion: The ABI is a safe option, and with good hearing results when the indication is made correctly.

Objectives: The aim of this study was to determine whether the dexamethasone-eluting electrode (DEXEL) has a protective anti-inflammatory effect in a normal hearing implanted cochlea, as well as its performance and safety. Design: Ten healthy and normal hearing cynomolgus macaques (Mf) were divided into two cohorts: DEXEL group (DG) (CONCERTO CI device containing a DEXEL) and conventional CI group (CG) (unmodified CONCERTO CI device). The electrode was inserted into the scala tympani via the round window with an angle of insertion of 270 degrees. Auditory, impedance, electrically evoked compound action potential (eCAP), and recovery of function measurements were recorded monthly until sacrifice at 6 months post-implantation. A histologic analysis was also performed. Results: At 6 months, measurement of auditory brainstem responses revealed a mean threshold shift, as well as a mean impedance value, lower in the DEXEL group. The minimum eCAP for the remaining active contacts in the DEXEL group was 68% of that in the conventional CI group. Also at 6 months, the eCAP amplitude produced by a stimulating current of 800 cu (eCAP800) was almost 2.5-fold higher in the DEXEL group than in the conventional CI group (1338.86 +/- 637.87 mu V versus 545.00 +/- 137.37 mu V; p = 0.049). Tissue reactions, in particular fibrosis and ossification, were more common in the conventional CI group. Conclusions: The CI electrode array equipped with a dexamethasone-eluting component tested in ...

Purpose To compare the surgical and audiological outcomes with two perimodiolar electrode arrays (Nucleus 512-Contour Advance (R) y Nucleus 532-Slim Perimodiolar (R)) and a straight electrode array (Nucleus 422/522). Methods Patients were retrospectively selected from our cochlear implant program database. Only patients with a history of bilateral, sensorineural postlingually profound hearing loss who underwent cochlear implant surgery with either a N512, a N532 or a N422 were included. Throughout a year of follow-up, pure tone audiometry (PTA), speech perception, Impedances and T-C Thresholds levels were analyzed. Surgical data were also analyzed. Results 66 patients were included (19-CI532, 20-CI512 and 27-CI422). The most common type of cochlea access with the N532, N512 and N422 was through an extended round window, a promontorial cochleostomy and a pure round window, respectively. No significant differences were observed after 12 months in Mean PTA and Speech recognition. No significant differences were seen in the levels of hearing preservation at frequencies of 250 and 500. The average values of the impedances were significantly higher in the CI group N532 and N422 than in the N512. The mean values of the T and C levels were significantly lower in the CI groups N532 and N422 compared with the N512. Conclusions No significant differences were observed after 12 months in Mean PTA and Speech recognition; however, a faster acquisition of auditory results were observed in the group of patients treated with the CI N532. The type of electrode array influences in the type of cochleostomy.

Purpose Since the beginning of cochlear implant (CI) surgery, several techniques to fixate the electrode array at the cochleostomy and stabilize it have been described; however, most techniques use autologous tissues such as fascia, muscle, fat or fibrin glue. We describe a new surgical technique aimed to stabilize the electrode array of a CI without using autologous tissues or artificial materials. Materials and methods The surgical technique described consists in creating three stabilizing channels in the temporal bone for the electrode array. The first one in a partially opened aditus, the second one in a partially preserved Koerner's septum (KS) and the last one in the sinodural angle. The procedure was performed in five human temporal bones using a straight array; a radiography was made to confirm the correct placement of the electrode array and afterwards all temporal bones were shaken using a Titramax 1000 platform. The correct placement of the array post-shaking was then confirmed using the microscope and another radiography. Results No migration of the electrodes outside the cochlea was observed. The CI cable remained in the same position at the aditus and the KS in all the temporal bones. In three cases (60%), the electrode array moved away from the groove carved in the sinodural angle. Conclusions The new surgical technique described stabilizes the electrode array using the temporal bone's normal anatomy, preserving the middle ear spaces, facilitating the ulterior explantation and reimplantation if necessary, and may reduce cost and surgery time.

In the last decade numerous hospitals have started to work with patients who are candidates for a cochlear implant (CI) and there have been numerous and relevant advances in the treatment of sensorineural hearing loss that extended the indications for cochlear implants. OBJECTIVES: To provide a guideline on cochlear implants to specialists in otorhinolaryngology, other medical specialities, health authorities and society in general. METHODS: The Scientific Committees of Otology, Otoneurology and Audiology from the Spanish Society of Otolaryngology and Head and Neck Surgery (SEORL-CCC), in a coordinated and agreed way, performed a review of the current state of CI based on the existing regulations and in the scientific publications referenced in the bibliography of the document drafted. RESULTS: The clinical guideline on cochlear implants provides information on: a) Definition and description of Cochlear Implant; b) Indications for cochlear implants; c) Organizational requirements for a cochlear implant programme. CONCLUSIONS: A clinical guideline on cochlear implants has been developed by a Committee of Experts of the SEORL-CCC, to help and guide all the health professionals involved in this field of CI in decision-making to treathearing impairment.

Introduction and goals: During the last decade there have been multiple and relevant advances in conduction and mixed hearing loss treatment. These advances and the appearance of new devices have extended the indications for bone-conduction implants. The Scientific Committee of Audiology of the Sociedad Espanola de Otorrinolaringologia y Cirugia de Cabeza y Cuello SEORL-CCC (Spanish Society of Otolaryngology and Head and Neck Surgery), together with the Otology and Otoneurology Committees, have undertaken a review of the current state of bone-conduction devices with updated information, to provide a clinical guideline on bone-conduction implants for otorhinolaryngology specialists, health professionals, health authorities and society in general. Methods: This clinical guideline on bone-conduction implants contains information on the following: 1) Definition and description of bone-conduction devices; 2) Current and upcoming indications for bone conduction devices: Magnetic resonance compatibility; 3) Organization requirements for a bone-conduction implant programme. Results and conclusions: The purpose of this guideline is to describe the different bone-conduction implants, their characteristics and their indications, and to provide coordinated instructions for all the above-mentioned agents for decision making within their specific work areas.

OBJECTIVES: Bimodal stimulation for asymmetric hearing loss is an emerging treatment with proven audiometric outcomes. Our objectives are to assess the changes of the hearing impairment and the quality of life of patients treated with this type of stimulation, when compared to a unilateral Cochlear Implant (CI) stimulated condition. MATERIALS and METHODS: 31 patients with asymmetric hearing loss (Group 1) were recruited for the study. They were divided into three groups, based on their hearing loss in the ear treated with the hearing aid: Group 1A (Pure Tone Audiometry (PTA) between 41 and 70 decibels (dB)); Group 1B, (PTA between 71 and 80 dB) and Group 1C (PTA between 81 and 90 dB). 30 patients had profound, bilateral hearing loss. Then, users of a unilateral cochlear implant were recruited for the control group. Their hearing impairment and quality of life were analyzed with questionnaires Abbreviated Profile of Hearing Aid Benefit (APHAB), Speech, Spatial and Qualities of Hearing Scale (SSQ) and the Health Utilities Index (HUI). They were followed up for at least 2 years. RESULTS: The group with the asymmetric hearing loss obtains a statistically significant clinical improvement in the APHAB under category "with hearing aid" compared to "without hearing aid". The group with the asymmetric hearing loss benefits more across basically all variables compared with the control group in the SSQ. Group 1A obtains the best outcome of the sample in the HUI. CONCLUSION: Bimodal stimulation and better hearing in the ear treated with the hearing aid reduce hearing impairment and improve the quality of life.

OBJECTIVES: To determine the feasibility of progressive insertion (two sequential surgeries: partial to full insertion) of an electrode array and to compare functional outcomes. MATERIAL AND METHODS: 8 normal-hearing animals (Macaca fascicularis (MF)) were included. A 14 contact electrode array, which is suitably sized for the MF cochlea was partially inserted (PI) in 16 ears. After 3 months of follow-up revision surgery the electrode was advanced to a full insertion (FI) in 8 ears. Radiological examination and auditory testing was performed monthly for 6 months. In order to compare the values a two way repeated measures ANOVA was used. A p-value below 0.05 was considered as statistically significant. IBM SPSS Statistics V20 was used. RESULTS: Surgical procedure was completed in all cases with no complications. Mean auditory threshold shift (ABR click tones) after 6 months follow-up is 19 dB and 27 dB for PI and FI group. For frequencies 4, 6, 8, 12, and 16 kHz in the FI group, tone burst auditory thresholds increased after the revision surgery showing no recovery thereafter. Mean threshold shift at 6 months of follow- up is 19.8 dB ranging from 2 to 36dB for PI group and 33.14dB ranging from 8 to 48dB for FI group. Statistical analysis yields no significant differences between groups. CONCLUSION: It is feasible to perform a partial insertion of an electrode array and progress on a second surgical time to a full insertion (up to 270º). Hearing preservation is feasible for both procedures. Note that a minimal threshold deterioration is depicted among full insertion group, especially among high frequencies, with no statistical differences.

Different types of otic capsule dehiscence restricted to the cochlea have been described. Here we describe the case of a patient with a cochlear-internal auditory canal dehiscence associated with a cochlear-facial dehiscence not reported before. A 53-year-old patient with severe to profound sensor ineural hearing loss due to bilateral Meniere's disease under went a cochlear implant surgery on the right ear. Preoperative brain magnetic resonance imaging findings were reported to be normal; dur ing surgery, a cerebrospinal fluid gusher occur red at the time of round window opening. Postoperative computed tomography imaging showed a bony dehiscence at two levels of the otic capsule.

INTRODUCTION: This study aims to analyse the knowledge of cochlear implant (CI) candidacy criteria of otorhinolaryngology specialists in Spain, and from the results, consider whether it is necessary to implement training measures aimed at improving knowledge in this area. MATERIAL AND METHODS: A questionnaire was designed for measuring the level of knowledge of cochlear implant candidacy criteria (CI) in people with hearing loss. The questionnaire collected the demographic data of the respondents and their knowledge on the conventional and emergency indications for CI, technical characteristics of CI and results in the implanted population. RESULTS: A total of 222 Spanish specialists in otorhinolaryngology answered the questionnaire (10.29% of the sample surveyed). CONCLUSIONS: The 50% of all respondents showed a medium-high knowledge about CI. Epidemiological data suggest that a high percentage of adults with postlocutive deafness and candidates for a CI are not referred for treatment. The lack of knowledge about the criteria for the indication of CI by otorhinolaryngology specialists may contribute to inadequate guidance of patients who are potential candidates for CI. The greatest shortcomings are found in the most emergency indications for a CI. Among otorhinolaryngology professionals, the greatest knowledge about CI is found in those who work in tertiary hospitals in the areas of otology and otoneurology, either in the public or private sector. This study suggests that training on CI should be increased for otorhinolaryngology professionals, especially for general otorhinolaryngologists.

Active middle ear implants are surgically implanted prosthesis, which intend to stimulate the ossicular chain or the inner ear fluids through the oval or round windows. These implants may be useful for the treatment of certain patients with sensorineural hearing loss as well as for conductive or mixed hearing loss. This clinical guide attempts to summarize the current knowledge concerning the basic characteristics and indications of the most commonly used middle ear implants, including Vibrant Soundbrige (Med-el, Innsbruck), Carina (Cochlear, Australia), and CodacsTM. (Cochlear, Australia).

Objective: To show that patients with unilateral hearing loss (UHL), with one ear fulfilling cochlear implant (CI) indication criteria, and an additional severe tinnitus handicap can be treated effectively with a Cl. Method: A prospective multi-centre study was conducted in five Spanish centres. Sixteen adult patients with UHL and a mean Tinnitus Handicap Inventory (THI) score of at least 58 were implanted. The study design included repeated within-subject measures of quality of life (Health Utility Index Mark 3 [HUI3]), tinnitus (THI, Visual Analogue Scale [VAS] on tinnitus loudness), hearing (Speech, Spatial, and Qualities of Hearing Scale- [SSQ]), and hyperacusis (Test de Hipersensibilidad al Sonido [THS]) up to 12 months after the initial CI fitting. Results: Group data showed significant subjective benefit from CI treatment: the preoperative HUI3 total utility score of 0.45 went up to 0.57 at 6 months and 0.63 at 12 months; the preoperative THI total score of 75 decreased to 40 at 6 months and 35 at 12 months. The preoperative tinnitus loudness VAS score of 8.2 decreased to 2.4 at 6 months and 2.2 at 12 months with the implant "On" and to 6.7 at 6 months and 6.5 at 12 months with the implant "Off." The preoperative THS total score of 26 decreased to 17 at 12 months. The preoperative SSQ total score of 4.2 increased to 5.1 at 6 months and 6.3 at 12 months. No unanticipated adverse events were reported during the study period. At 12 months after CI activation all subjects (except 1 subject who used the device 6 days a week) wore their devices all day and every day. The primary reason for CI use was split evenly between tinnitus suppression (n =6) and both hearing and tinnitus (n = 6). Conclusion: A CI should be considered as a treatment option in patients with UHL and a concomitant severe tinnitus handicap. However, appropriate counselling of candidates on the anticipated risks, benefits, and limitations that are inherent to cochlear implantation is imperative. (C) 2018 The Author(s) Published by S. Karger AG, Basel

OBJECTIVES: To measure the auditory (pure tone audiometry and word recognition scores) and vestibular (video head impulse test and vestibular myogenic potentials) outcomes in patients diagnosed with Meniere¿s disease (MD) who underwent cochlear implantation. MATERIAL AND METHODS: This prospective study included 23 cochlear implant users with MD and 29 patients diagnosed with far-advanced oto - sclerosis (the control group). RESULTS: The preoperative mean pure tone average thresholds were 99 and 122.5 dB for the Meniere¿s and control groups, respectively. Word recog- nition scores after cochlear implant yielded a median of 80% and 72% for the Meniere¿s and control groups, respectively. Semicircular canal gain was not observed to vary post implantation (mean variation for lateral, posterior, and anterior plane was 0, 0.03, and 0, respectively). The mean ocular and cervical myogenic potentials asymmetry varied as 9.65% and 18.39%, respectively. CONCLUSIONS: The auditory performance improved in patients with MD similar to the general cochlear implant population. No major dysfunction of otolithic or semicircular canal function was demonstrated after the implantation surgery

OBJECTIVES:: The objectives of this study were to evaluate the effect of reimplanting a cochlear implant electrode in animal normal-hearing cochlea to propose measures that may prevent cochlear injury and, given its close phylogenetic proximity to humans, to evaluate the macaque as a model for electroacoustic stimulation. DESIGN:: Simultaneous, bilateral surgical procedures in a group of 5 normal-hearing specimens (Macaca fascicularis) took place in a total of 10 ears. Periodic bilateral auditory testing (distortion product otoacoustic emissions and auditory brainstem evoked responses [ABR]) took place during a 6-month follow-up period. Subsequently, unilateral explantation and reimplantation was performed. Auditory follow-up continued up to 12 months, after which animals were sacrificed and both temporal bones extracted for histological analysis. RESULTS:: Implantation and reimplantation surgeries were performed without complications in 9 of 10 cases. Full insertion depth was achieved at reimplantation in four of five ears. Auditory evaluation: Statistically significant differences between implanted and reimplanted were observed for the frequencies 2000 and 11,000 Hz, the remaining frequencies showed no differences for distortion product otoacoustic emission. Before the procedure, average thresholds with click-stimuli ABR of the five animals were 40 dB SPL (implanted group) and 40 dB SPL (reimplanted group). One week after first implantation, average thresholds were 55 dB SPL and 60 dB, respectively. After 12 months of follow-up, the average thresholds were 72.5 dB SPL (implanted group) and 65 dB SPL (reimplanted group). Hearing loss appeared during the first weeks after the first implantation and no deterioration was observed thereafter. Differences for ABR under click stimulus were not significant between the two ear groups. Similar results were observed with tone-burst ABR. A 15 dB shift was observed for the implanted group preoperatively versus 1-week post surgery and an additional 17.5 dB shift was seen after 12-month follow-up. For the reimplanted group, a 20 dB shift was observed within the first week post reimplantation surgery and an additional 5 dB after 6 months follow-up. Statistical analysis revealed significant differences between the implanted and reimplanted ear groups for frequencies 4000 Hz (p = 0.034), 12000 Hz (p = 0.031), and 16,000 Hz (p = 0.031). The histological analysis revealed that the electrode insertion was minimally traumatic for the cochlea, mainly indicating rupture of the basilar membrane in the transition area between the basal turn and the first cochlear turn only in Mf1 left ear. CONCLUSIONS:: With application of minimally traumatic surgical techniques, it is possible to maintain high rates of hearing preservation after implantation and even after reimplantation. Partial impairment of auditory thresholds may occur during the first weeks after surgery, which remains stable. Considering the tonotopic distribution of the cochlea, we found a correlation between the histological lesions sites and the auditory findings, suggesting that a rupture of the basilar membrane may impact hearing levels. The macaque was observed to be a functionally and anatomically an excellent animal model for cochlear implantation

Introducción El objetivo de este trabajo es conocer el impacto que el implante coclear (IC) tiene en la vida laboral de las personas implantadas, a través de una primera versión de un cuestionario elaborado en el programa de implantes cocleares de la Clínica Universidad de Navarra. Se pretende demostrar que el IC está teniendo un impacto significativo en la vida laboral de estos pacientes. Material y métodos Se estudia una población de 60 pacientes de 48 años de edad media, con hipoacusia neurosensorial profunda bilateral tratada con un IC, a la que se le presenta un cuestionario elaborado para evaluar su calidad de vida laboral con carácter retrospectivo. Resultados El 94,23% de los pacientes que completaron el cuestionario están actualmente satisfechos con su trabajo. El 93,05% se sienten más motivados para ir a trabajar tras su IC. Un 79,31% se consideran más competentes tras la cirugía y activación del dispositivo. Un 67,23% de los pacientes han mejorado sus relaciones interpersonales en el ámbito de trabajo tras la implantación coclear. Conclusiones El IC proporciona una ayuda positiva en la esfera profesional al igual que en las destrezas sociales al beneficiar la capacidad de comunicación de los pacientes implantados. El desarrollo de herramientas para evaluar el grado de satisfacción laboral de los pacientes tratados con un IC es de gran interés.

Bimodal stimulation provides better results than any monaural hearing mode, regardless of whether it involves the use of a hearing aid alone or a cochlear implant alone.

The objective of this study was to review cochlear reimplantation outcomes in the tertiary hospital and analyze whether facts such as type of failure, surgical findings, or etiology of deafness have an influence. A retrospective study including 38 patients who underwent cochlear implant revision surgery in a tertiary center is performed. Auditory outcomes (pure tone audiometry, % disyllabic words) along with etiology of deafness, type of complication, issues with insertion, and cochlear findings are included. Complication rate is 2.7 %. Technical failure rate is 57.9 % (50 % hard failure and 50 % soft failure), and medical failure (device infection or extrusion, migration, wound, or flap complication) is seen in 42.1 % of the cases. Management of cochlear implant complications and revision surgery is increasing due to a growing number of implantees. Cases that require explantation and reimplantation of the cochlear implant are safe procedures, where the depth of insertion and speech perception results are equal or higher in most cases. Nevertheless, there must be an increasing effort on using minimally traumatic electrode arrays and surgical techniques to improve currently obtained results.

Se entiende por telemedicina la prestación de servicios de medicina a distancia. En áreas rurales o remotas donde no llegan muchos de los servicios médicos especializados requeridos por la comunidad, la telemedicina puede ser una alternativa viable y fiable para facilitar el acceso a dichos servicios. En el caso de la tele-audiología, se ha mostrado que los resultados obtenidos mediante pruebas remotas son equivalentes a los de las mismas pruebas presenciales. Aunque todavía se ha investigado poco en este campo, es un área de gran importancia debido a los problemas en el desarrollo y la calidad de vida que implica la pérdida de audición y a que la mayor parte de la población mundial no tiene fácil acceso a los servicios de salud auditiva. Se revisan las potenciales aplicaciones de la telemedicina, sus ventajas y sus inconvenientes.

The study aim was to determine the benefit of cochlear implantation and hearing aids in older adults diagnosed with hearing loss and to evaluate the index of depression, anxiety and quality of life after such treatments. A retrospective cohort comprised 117 patients older than 65 years and diagnosed with moderate to profound hearing loss who were included and classified into 2 groups (treated vs. non-treated). A battery of tests including auditory (pure-tone average, disyllabic words in quiet at 65 dB SPL) and findings from a series of questions relevant to quality of life were compared between both groups. Auditory outcomes for disyllabic words were 58.21% for the cochlear implant-treated group and 82.8% for the hearing aid-treated group. There was a positive effect on anxiety, depression, health status and quality of life in the cochlear implant group versus the profound hearing loss control group. We conclude that older adults with moderate to profound hearing loss gain benefit from hearing aids or cochlear implants not only in terms of improved hearing function, but also in terms of positive effects on anxiety, depression, health status and quality of life.

Tinnitus is an incapacitating condition commonly affecting cochlear implant (CI) candidates. The aim of this clinical study is to assess the long-term effects of CI treatment in patients with severe-to-profound, sensorineural, unilateral hearing loss (UHL) and incapacitating tinnitus. We performed a prospective Cochlear¿ company-sponsored multicentre study in five Spanish centres. Sixteen patients with UHL and incapacitating tinnitus, which was indicated by a Tinnitus Handicap Inventory (THI) score >58%, received a Nucleus® CI in their deaf ear. The study design includes repeated within-subject measures on hearing, tinnitus, hyperacusis and quality of life up to 12 months after initial CI fitting. In addition to hearing loss and tinnitus, all patients suffered from hyperacusis. Most patients had a sudden hearing loss and received a CI within 2 years after their hearing loss. Preliminary 6-month, post-CI activation data of 13 subjects showed that the majority of patients perceived a subjective benefit from CI treatment, which was assessed using the THI, a Visual Analogue Scale of tinnitus loudness/annoyance and the Speech, Spatial and Qualities of Hearing Scale. Preliminary 12-month data of 7 subjects showed that most patients also perceived a degree of relief from their hyperacusis. One patient showed no improvements in any of the applied scales, which could be explained by partial insertion of the electrode due to obstruction of the cochlea by otosclerosis. In conclusion, CI can successfully be used in the treatment of UHL patients with accompanying severe tinnitus and hyperacusis. Implantation resulted in hearing benefits and a durable relief from tinnitus and hyperacusis in the majority of patients. These findings support the hypothesis that pathophysiological mechanisms after peripheral sensorineural hearing loss are at least partly reversible when hearing is restored with a CI.

This article presents an analysis of the impact of functional neuroimaging studies (positron emission tomography, PET) in asymmetric hearing loss based on the clinical expertise obtained from a group of 21 patients. In these patients, PET studies are performed at rest and after auditory stimulation in order to measure the increase in brain activity in the ipsi- and contralateral cortex, providing supporting evidence to recommend a specific treatment and the side to implant. In conclusion, PET is a useful tool for selected cases in which information on the metabolic status of the auditory pathway can drive the decision regarding the treatment of the most appropriate ear. However, in view of our small sample, further research is needed to confirm our results in this topic

Cochlear implants are indicated in severe to profound hearing loss with no benefit with hearing aids. Since the beginning of cochlear implants 30 years ago, auditory outcomes have been improving due to changes introduced in differ-ent areas: electrode design, strategy, surgical technique... Given good results within this period of time, cochlear implant indication has varied too. The aim of this paper is to show an update on indication criteria for cochlear implantation in Navarre, for application in daily practice. The indications are established by consensus amongst the hospitals of the region.

CONCLUSION: Patients with cochlear implants should be treated no differently than non-implanted patients with similar symptomatology. OBJECTIVES: To describe the spectrum of symptomatology, treatment, and long-term follow-up of patients with cochlear implant and vestibular complaints. METHODS: This retrospective study included 25 patients with late onset vestibular complaints (more than 1 month post-implantation). Each patient underwent an extensive interrogatory and physical exam with ancillary test to complete a diagnosis. Treatment was given according to this and all patients followed a vestibular rehabilitation program. RESULTS: The total population was 72% male and 28% female, median age was 58 years; minimal follow-up was 9 months (mean = 51, median = 34). Cochleostomy was performed in eight cases and round window insertion was performed in 19 (two patients were removed from each group in the analysis due to their bilateral implantation under a different approach). The mean time from implant to vestibular symptoms was 53 months, median = 32; a Kaplan Meier graphic showed the round window approach has faster onset of symptoms with statistical significance (p = 0.020). The most common complaint was instability in all patients and after both surgical approaches. No difference in symptoms was found with a Kruskall Wallis test except for vertigo spells (more common in the round window approach). In 12 patients the symptomatology was attributed to the implanted side. In the long-term follow-up a relatively high number of patients (20/25) recovered with standard treatment, suggesting the presence of the implant is not associated with poor recovery prognosis.

Objectives: To determine whether individuals older than 60 years of age suffering from profound, bilateral, sensorineural hearing loss and unable to use hearing aids can benefit from a cochlear implant in order to improve hearing performance. Additionally, to evaluate how they manage the external components of their implanted system. Materials and Methods: The records of 68 cochlear implant users over 60 years of age were reviewed. They had undergone tonal and speech audiometry evaluations of hearing before and after implantation. A subset of 27 elderly patients were asked to respond to a specially designed questionnaire regarding the use of the external components of the implanted system. Results: Patients over 60 years of age benefit from cochlear implants. The earlier the implantation, the better the results tend to be. Certain limitations when using the external components of the implanted system were evident among the elderly. Conclusions: People >60 years of age suffering from profound, bilateral, sensorineural hearing loss show improved hearing performance following cochlear implantation. Using the implanted system includes some limitations that should be studied and overcome.

OBJECTIVE: To describe the surgical technique under local or general anesthesia of 5 cases that have undergone this procedure and the audiologic results obtained with this new device. PATIENTS: Four patients with mixed hearing loss and 1 patient with single-sided deafness. INTERVENTION: Therapeutic. MAIN OUTCOME MEASURES: The surgery was planned beforehand with a 3D reconstruction of a CT scan. The procedure was documented and timed in every case. Air and bone conductive pure tone audiometry and disyllabic words discrimination were tested after and before the procedure. Results were statistically analyzed. RESULTS: All patients tolerated well the procedure. Four patients were intervened under local anesthesia and 1 under general anesthesia because of an associated procedure. All patients showed statistically significant difference between the presurgery and postsurgery audiologic tests. CONCLUSION: Implantation of the Bonebridge with local or general anesthesia is a safe and feasible procedure, with audiometric results that can come close with the ones provided by BAHD users.

Hypothesis: Evaluate, based on morphologic and histologic parameters, the atraumaticity of 2 electrode arrays implanted in 10 human temporal bones. Background: Atraumatic surgery and electrode arrays are current topics in otologic surgery. The preservation of cochlear anatomy and its functions is a priority and morphologic evaluation of the surgical trauma is essential to continue improving in this field. Methods: Ten preserved human temporal bones (TB) without anatomic alterations were used in this study. They were divided into 2 groups of 5, and atraumatic surgery was performed to insert HiFocus 1J (group A) and HiFocus Helix (group B) electrode arrays. Anatomic comparisons were performed using computed tomography and histologic analysis. Results: Group A: the mean length for the cochlear longitudinal axis was 10.30 mm, and the cochlear transversal axis was 7.2 mm. Scala tympani insertion was achieved in 4/5 TB studied, with a mean depth and angle of insertion of 19.2 mm and 325.5°, respectively. Lateral location of the electrode array was achieved in all specimens. No significant correlation was observed between these dimensions and depth of insertion. Group B: the mean length for the cochlear longitudinal axis was 9.52 mm, and cochlear transversal axis was 6.38 mm. Scala tympani insertion was achieved in 4/5 TB studied, with a mean depth and angle of insertion of 17.5 mm and 352°, respectively. Modiolar location of the electrode array was achieved in all specimens. A positive correlation was established between the linear and angular insertion depths (p = 0.044). Conclusion: In summary, it is safe to state that neither electrode array shows significant insertion trauma.

Introducción La aticoexposición-antroexclusión (AE-AE) simple o ampliada, es una técnica a la demanda para el tratamiento del colesteatoma. Las tasas de recurrencia/recidiva descritas con diferentes técnicas quirúrgicas son variables. El objetivo de este estudio es describir la técnica quirúrgica, sus indicaciones y analizar los resultados a largo plazo. Material y métodos Se incluyen 42 pacientes intervenidos de AE-AE en un centro terciario con un seguimiento de 6 meses-7 años. Esta técnica expone completamente el ático fresando la pared superior del conducto auditivo externo y excluye el antro y mastoides cerrando el additus con injertos de cartílago. Se indica en pacientes con colesteatoma localizado en la caja timpánica sin sobrepasar el additus o en caso de hacerlo estar encapsulado sin erosionar la cápsula laberíntica. El seguimiento es clínico y radiológico (TC de peñascos y RM con secuencias de difusión desde 2009). Resultados El 4,8% de los casos presentó una recidiva, los cuales fueron rescatados en un segundo tiempo quirúrgico. En el seguimiento la tasa de otorrea (2/42), otitis serosa (2/42) u otras complicaciones fue baja, no contraindicando las actividades acuáticas. La AE-AE no modificó el tipo de reconstrucción osicular respecto a otras técnicas. Conclusiones La AE-AE es una técnica abierta. Pretende eliminar totalmente la lesión y reducir la recidiva de colesteatoma, facilitando una normalización en los baños y una disminución de revisiones posquirúrgicas. La RM en secuencias de difusión es una técnica fiable en el despistaje y seguimiento, especialmente para el control de los espacios mastoideos tras la AE-AE.

Objectives: To investigate the preservation of residual hearing in subjects who received the Nucleus Hybrid L24 cochlear implant. To investigate the performance benefits up to one year post-implantation in terms of speech recognition, sound quality, and quality of life. Design: Prospective, with sequential enrolment and within-subject comparisons. Post-operative performance using a Freedom Hybrid sound processor was compared with that of pre-operative hearing aids. Study sample: Sixty-six adult hearing-impaired subjects with bilateral severe-to-profound high frequency hearing loss. Results: Group median increase in air-conduction thresholds in the implanted ear for test frequencies 125¿1000 Hz was < 15 dB across the population; both immediately and one year post-operatively. Eighty-eight percent of subjects used the Hybrid processor at one year post-op. Sixty-five percent of subjects had significant gain in speech recognition in quiet, and 73% in noise (¿ 20 percentage points/2 dB SNR). Mean SSQ subscale scores were significantly improved (+ 1.2, + 1.3, + 1.8 points, p < 0.001), as was mean HUI3 score (+ 0.117, p < 0.01). Combining residual hearing with CI gave 22¿26 %age points mean benefit in speech recognition scores over CI alone (p < 0.01). Conclusions: Useful residual hearing was conserved in 88% of subjects. Speech perception was significantly improved over preoperative hearing aids, as was sound quality and quality of life.

Objective: Quantify the improvement and impact of the active middle ear implants (AMEIs) on a moderate-to-severe mixed hearing loss population. Study Design: Retrospective study on the indications and results obtained by individuals implanted with the AMEI. SettingS: Tertiary referral center. Patients: Thirteen adult patients with moderate-to-severe hearing loss were evaluated. Air and bone conductive pure tone audiometry and disyllabic word discrimination was performed before and after surgery. The follow-up period was from 5 to 64 months. INTERVENTION: Surgical implantation of the AMEI. MAIN OUTCOME MEASUREMENT: Auditory performance analyzed using pure tone and speech audiometry with AMEI off and on. Results: The average auditory gain in the frequency range 0.5 of 6 kHz was 44.07 dB. The average AC audiometric performance after activating the device is significantly better than the preoperative BC performance in 10 of 13 patients, with an average gain of 11.3 dB. Speech audiometry performance using disyllabic words showed a significant improvement. The detection threshold reduced significantly, from 65 to 24 dB (p = 0.012) with the AMEI. The speech recognition score at 65 dB SPL also showed a significant improvement from 28% to 90% post surgery (p = 0.004). The maximum speech recognition score also improved post surgery, from 56% to 93% with the AMEI (p = 0.023). Conclusion: The AMEI is considered an appropriate device to be used by patients with BC losses up to 70 dB, provided that hearing levels are present in all frequencies between 0.5 and 4 KHz, and the speech recognition percentage is above 60% in the ear chosen for implantation.

The purpose of this study is to determine if surgical approach to the inner ear is feasible without generating a hearing loss in an animal model. Five Macaca fascicularis were used as experimental animals and followed up for 27 months. Mastoidectomy, posterior tympanotomy and promontorial cochleostomy were performed on four specimens and one specimen was kept as control animal. Before and after drilling and exposing the endosteal layer and the membranous labyrinth, otoacustic emissions (dPOAE) and auditory brainstem responses (ABR) were used to test hearing. In vivo experimental studies prove it is reliable to expose the membranous labyrinth without causing hearing loss. dPOAE were present after 3, 6, 12, 24 and 26 months of follow-up. Regarding the ABR results from the four M. fascicularis in which a cochleostomy has been carried out, auditory thresholds are within the 20-30 dB interval at 27 months of follow-up. Experimental studies support clinical experiences indicating it is feasible to surgically approach the membranous labyrinth of the cochlea without damaging its hearing function.

Conclusion: The use of a hearing aid (HA) in combination with a cochlear implant (CI) significantly improved performance for speech perception in quiet, in noise, and for localization compared with monaural conditions. No significant differences in functional performance were observed following optimization of HA fitting. Objectives: To evaluate the binaural benefits derived from using a contralateral HA in conjunction with a CI in subjects with significant functional hearing in the nonimplanted ear and the effects of HA fitting optimization. Methods: Fifteen adult CI users, intra-subject controls, were enrolled in a prospective repeated-measure multicenter study. Evaluation of performance for speech understanding, localization, and subjective impressions was conducted before and following HA fitting optimization for CI alone, HA alone, and CI + HA. Results: For speech testing in quiet, bimodal scores were significantly better than for HA alone and CI alone conditions (p < 0.01). For speech and noise (S0N0) at 0 degrees azimuth the scores were significantly better in the bimodal condition than for CI alone (p = 0.01), indicating binaural summation. When noise was presented to the HA side (S0NHA) bimodal scores were significantly better than for CI alone (p < 0.01 and p < 0.05, respectively), suggesting a significant binaural squelch effect. Sound localization ability was significantly improved in the bimodal condition compared with the CI alone condition (p = 0.002).

This is a consensus statement on pediatric cochlear implantation by the European Bilateral Pediatric Cochlear Implant Forum.The consensus statement was determined by review of current scientific literature to identify areas of scientific and clinical agreement of current understanding of bilateral cochlear implantation.The statement is "Currently we feel that the infant or child with unambiguous cochlear implant candidacy should receive bilateral cochlear implants simultaneously as soon as possible after definitive diagnosis of deafness to permit optimal auditory development; an atraumatic surgical technique designed to preserve cochlear function, minimize cochlear damage, and allow easy, possibly repeated re-implantation is recommended."

Objective: The objective of this study was to identify patients with otosclerosis and to characterize its clinical presentation among patients examined at our hospital with vertigo as the primary and most distressing symptom. Study Design: Retrospective chart review. Setting: Tertiary medical center. Patients: This study involved 40 patients suffering from dizziness and diagnosed with otosclerosis. Methods: At inclusion, the clinical status, as well as auditory (pure tone hearing level and speech audiometry, impedancemetry) and vestibular function (bedside, nystagmography, caloric test and rotator chair testing) were assessed. The results were analyzed using parametric and non-parametric tests, and the chi2 test. Results: The clinical presentation was diverse: 12 patients with Menière's syndrome (30%); 11 patients with spontaneous recurrent vertigo without hearing fluctuation (27.5%); 13 patients with positional vertigo (32.5%); 3 patients with chronic unrelapsing imbalance (7.5%); and 1 patient with acute unilateral vestibulopathy (2.5%). There was a lag between the detection of hearing loss and the beginning of vertigo attacks or imbalance in all patients. When measured through bone conduction, hearing loss was significantly different in patients with Menière's disease, spontaneous recurrent vertigo and positional vertigo. Conclusions: Dizziness, although frequent in patients with otosclerosis is rarely a cause for specific clinical assessment. There is a lag between the patient's perception of hearing loss and the initiation of vestibular symptoms, and it is not associated with any specific clinical disorder Otosclerosis can be found as any one of the most common vestibular disorders and in general, vestibular function tests reveal a more severe vestibular dysfunction than in the idiopathic forms. Level Of Evidence: 2A.

Current cochlear implants can operate at high pulse rates. The effect of increasing pulse rate on speech performance is not yet clear. Habituation to low rates may affect the outcome. This paper presents the results of three subsequent studies using different experimental paradigms, applying the Nucleus CI24RE device, and conducted by ten European implant teams. Pulse rate per channel varied from 500 to 3500 pulses per second with ACE and from 1200 to 3500 pps with CIS strategy. The results showed that the first rate presented had little effect on the finally preferred rate. Lower rates were preferred. The effect of pulse rate on word scores of post-linguistic implantees was small; high rates tended to give lower scores. However, there were no significant differences between the word scores across subjects if collected at the individually preferred pulse rate. High pulse rates were preferred when the post-implantation threshold was low.

Objectives/Hypothesis: The goal of this study is to ascertain worldwide experience with bilateral cochlear implantation (BCI) with regard to patient demographics, trends in provision of BCI to adult and child patient populations, differences and similarities in BCI candidacy criteria, diagnostic requirements, and treatment approaches among clinicians in high-volume cochlear implant centers. Study Design: Retrospective/prospective. Methods: An electronic survey consisting of 59 mainly multiple-choice questions was developed for online completion. It examined the implant experience and clinical opinion of expert cochlear implant (CI) centers worldwide on the indications, motivations, and contraindications for adult and pediatric, simultaneous and sequential BCI candidacy. Centers were chosen to complete the survey based on their known reputation as a center of excellence. Patient demographics were queried for two time periods to elucidate trends: 2006 and prior, and for the year 2007. Results: Seventy-one percent (25/35) of the CI clinics approached completed the survey. Collectively, these 25 clinics represent experience with approximately 23,200 CI users globally, representing 15% of the total estimated CI population worldwide. The total number of BCI surgeries reflected in their experience (2,880) represents 36% of the estimated number worldwide as of December 2007. Cumulatively to the end of 2007, 70% of all BCI surgeries have occurred in children, with the 3- to 10-year-old age group having the highest representation (33% of all BCIs), followed in order by adults (30%), children under 3 years of age (26%), and children between 11 and 18 years of age (11%). Seventy-two percent of all BCI surgeries were performed sequentially (70% of children, 76% of adults). Children <3 years of age represent the only age group of all patients in which simultaneous surgeries predominate (58% simultaneous). For all other age groups, sequential surgeries far outnumber simultaneous (3¿10 years, 84% sequential; 11¿18 years, 94% sequential; adults, 76% sequential). Prior to January 2007, 68% of BCIs were performed in children. This increased to 79% for the year 2007 (P < .001). With regard to children only, a change is apparent over time in terms of the age group making up the majority of pediatric BCI surgeries performed. Prior to 2007, children 3 to 10 years of age made up 50% of the children undergoing BCI, whereas those <3 years made up only 33%. In 2007 this shifted more toward the younger age group (47% for those <3 years and 40% for 3¿10-year-olds; P < .001). United States clinics had a higher proportion of adult BCI patients (59% children, 41% adults) than the non-United States clinics (78% children, 22% adults; P < .001). The majority of responders do not hold to a minimum or maximum age by which they limit BCI. Conclusions: Worldwide experience with BCI is now quite extensive and provides a useful base for evaluating clinical outcomes across patient categories and for providing further support during the patient/parent counseling process.