The impact of round window reinforcement on middle and inner ear mechanics with air and bone conduction stimulation.

The round window (RW) membrane plays an important role in normal inner ear mechanics. Occlusion or reinforcement of the RW has been described in the context of congenital anomalies or after cochlear implantation and is applied as a surgical treatment for hyperacusis. Multiple lumped and finite element models predict a low-frequency hearing loss with air conduction of up to 20 dB after RW reinforcement and limited to no effect on hearing with bone conduction stimulation. Experimental verification of these results, however, remains limited. Here, we present an experimental study measuring the impact of RW reinforcement on the middle and inner ear mechanics with air and bone conduction stimulation. In a within-specimen repeated measures design with human cadaveric specimens (n = 6), we compared the intracochlear pressures in scala vestibuli (PSV) and scala tympani (PST) before and after RW reinforcement with soft tissue, cartilage, and bone cement. The differential pressure (PDIFF) across the basilar membrane - known to be closely related to the hearing sensation - was calculated as the complex difference between PSV and PST. With air conduction stimulation, both PSV and PSTincreased on average up to 22 dB at frequencies below 1500 Hz with larger effect sizes for PST compared to PSV. The PDIFF, in contrast, decreased up to 11 dB at frequencies between 700 and 800 Hz after reinforcement with bone cement. With bone conduction, the average within-specimen effects were less than 5 dB for either PSV, PST, or PDIFF. The inter-specimen variability with bone conduction, however, was considerably larger than with air conduction. This experimental study shows that RW reinforcement impacts air conduction stimulation at low frequencies. Bone conduction stimulation seems to be largely unaffected. From a clinical point of view, these results support the hypothesis that delayed loss of air conduction hearing after cochlear implantation could be partially explained by the impact of RW reinforcement.

Hampshire Sheep as a Large-Animal Model for Cochlear Implantation.

BACKGROUND: Sheep have been proposed as a large-animal model for studying cochlear implantation. However, prior sheep studies report that the facial nerve (FN) obscures the round window membrane (RWM), requiring FN sacrifice or a retrofacial opening to access the middle-ear cavity posterior to the FN for cochlear implantation. We investigated surgical access to the RWM in Hampshire sheep compared to Suffolk-Dorset sheep and the feasibility of Hampshire sheep for cochlear implantation via a facial recess approach. METHODS: Sixteen temporal bones from cadaveric sheep heads (ten Hampshire and six Suffolk-Dorset) were dissected to gain surgical access to the RWM via an extended facial recess approach. RWM visibility was graded using St. Thomas' Hospital (STH) classification. Cochlear implant (CI) electrode array insertion was performed in two Hampshire specimens. Micro-CT scans were obtained for each temporal bone, with confirmation of appropriate electrode array placement and segmentation of the inner ear structures. RESULTS: Visibility of the RWM on average was 83% in Hampshire specimens and 59% in Suffolk-Dorset specimens (p = 0.0262). Hampshire RWM visibility was Type I (100% visibility) for three specimens and Type IIa (> 50% visibility) for seven specimens. Suffolk-Dorset RWM visibility was Type IIa for four specimens and Type IIb (< 50% visibility) for two specimens. FN appeared to course more anterolaterally in Suffolk-Dorset specimens. Micro-CT confirmed appropriate CI electrode array placement in the scala tympani without apparent basilar membrane rupture. CONCLUSIONS: Hampshire sheep appear to be a suitable large-animal model for CI electrode insertion via an extended facial recess approach without sacrificing the FN. In this small sample, Hampshire specimens had improved RWM visibility compared to Suffolk-Dorset. Thus, Hampshire sheep may be superior to other breeds for ease of cochlear implantation, with FN and facial recess anatomy more similar to humans.

Oval and round window reinforcement surgery leads to improvements in sound tolerance and quality of life for hyperacusis patients.

PURPOSE: Hyperacusis is an audiological disorder in which patients become persistently sensitive and intolerant to everyday environmental sounds. For those patients that fail conservative options, a minimally invasive surgical procedure has been developed. MATERIALS & METHODS: Retrospective case series of 73 adult patients with hyperacusis who underwent oval and round window reinforcement surgery between 1/2017-6/2023. Small pieces of temporalis fascia were used to reinforce the round and oval windows. Patients were separated into two groups based on their preoperative speech Loudness Discomfort Level (LDL). Patients with a preoperative speech LDL ≤ 70 dB were placed in the "low LDL group" whereas patients with a preoperative speech LDL >70 dB were placed in the "high LDL group." Preoperative and one-week postoperative audiogram and speech LDLs were compared. Quality of life was assessed using the Glasgow Benefit Inventory (GBI) survey. RESULTS: 73 patients met inclusion criteria - 21 patients in the low LDL group and 52 in the high LDL group. Patients in the high LDL group significantly improved their LDLs by an average of 3.5 dB (P < 0.0001). 42 patients (80.8 %) in the high LDL group had improvement and would recommend the surgery for hyperacusis. Patients in the low LDL group significantly improved their LDL by an average of 12.9 dB (P = 0.032). Ten patients (47.6 %) from the low LDL group experienced improvement and would recommend hyperacusis surgery. CONCLUSION: Many patients with hyperacusis who undergo oval and round window reinforcement can receive significant improvement in sound tolerance and quality of life. Patients with a pre-op speech LDL > 70 dB have the greatest potential for improvement with surgery (80.8 %), probably because their hyperacusis was less severe. In the high LDL group(>70dB) the improvement in 1-10 scale went from 8.6 pre-op to 2.4 post op. In the low LDL group(<70dB) went from 9.2 pre-op to 6.8 post-op. These findings were consistent with the GBI results.

Localization of the Vertical Part of the Facial Nerve in the High-Resolution Computed Tomography During Pediatric Cochlear Implantation.

BACKGROUND: This study proposed a classification of the vertical portion of the facial nerve (VPFN) location, incorporating the previous classifications regarding the posterior-to-anterior and medial-to-lateral dimensions. We also evaluated the implication of this proposed classification on the round window visibility during pediatric cochlear implantation (CI). METHODS: It was a retrospective multicenter observational cohort study. This study included 334 cases that underwent CI between 2015 and 2022 at multiple referral institutes. Two physicians evaluated the preoperative computed tomography images of 334 patients and determined the radiological type of the VPFN. These types were matched with intraoperative round window accessibility. RESULTS: The Spearman's correlation coefficient showed a strong correlation between the proposed VPFN type and the intraoperative round window visibility, as the P-value was <.001. CONCLUSION: This classification could provide the surgeon preoperatively with the precise location of the VPFN in the lateral-to-medial and posterior-to-anterior dimensions. Furthermore, this location classification of the VPFN was significantly correlated with intraoperative round window accessibility, with an accuracy of 90.42%. Therefore, types C and D were expected to have difficult accessibility into the round window, and more surgical interventions were needed to modify the posterior tympanotomy or use other approaches.

Guinea Pig Round Window Membrane Explantation for Ex Vivo Studies.

Efficient and minimally invasive drug delivery to the inner ear is a significant challenge. The round window membrane (RWM), being one of the few entry points to the inner ear, has become a vital focus of investigation. However, due to the complexities of isolating the RWM, our understanding of its pharmacokinetics remains limited. The RWM comprises three distinct layers: the outer epithelium, the middle connective tissue layer, and the inner epithelial layer, each potentially possessing unique delivery properties. Current models for investigating transport across the RWM utilize in vivo animal models or ex vivo RWM models which rely on cell cultures or membrane fragments. Guinea pigs serve as a validated preclinical model for the investigation of drug pharmacokinetics within the inner ear and are an important animal model for the translational development of delivery vehicles to the cochlea. In this study, we describe an approach for explantation of a guinea pig RWM with surrounding cochlear bone for benchtop drug delivery experiments. This method allows for preservation of native RWM architecture and may provide a more realistic representation of barriers to transport than current benchtop models.

Uncovering Vulnerable Phases in Cochlear Implant Electrode Array Insertion: Insights from an In Vitro Model.

OBJECTIVES: The aim of this study is to improve our understanding of the mechanics involved in the insertion of lateral wall cochlear implant electrode arrays. DESIGN: A series of 30 insertion experiments were conducted by three experienced surgeons. The experiments were carried out in a previously validated artificial temporal bone model according to established soft surgery guidelines. The use of an in vitro setup enabled us to comprehensively evaluate relevant parameters, such as insertion force, intracochlear pressure, and exact electrode array position in a controlled and repeatable environment. RESULTS: Our findings reveal that strong intracochlear pressure transients are more frequently caused during the second half of the insertion, and that regrasping the electrode array is a significant factor in this phenomenon. For choosing an optimal insertion speed, we show that it is crucial to balance slow movement to limit intracochlear stress with short duration to limit tremor-induced pressure spikes, challenging the common assumption that a slower insertion is inherently better. Furthermore, we found that intracochlear stress is affected by the order of execution of postinsertion steps, namely sealing the round window and posterior tympanotomy with autologous tissue and routing of the excess cable into the mastoid cavity. Finally, surgeons' subjective estimates of physical parameters such as speed, smoothness, and resistance did not correlate with objectively assessed measures, highlighting that a thorough understanding of intracochlear mechanics is essential for an atraumatic implantation. CONCLUSION: The results presented in this article allow us to formulate evidence-based surgical recommendations that may ultimately help to improve surgical outcome and hearing preservation in cochlear implant patients.

Comparison of depth of electrode insertion between cochleostomy and round window approach: a cadaveric study.

INTRODUCTION: Round window approach and cochleostomy approach can have different depth of electrode insertion during cochlear implantation which itself can alter the audiological outcomes in cochlear implant. OBJECTIVE: The current study was conducted to determine the difference in the depth of electrode insertion via cochleostomy and round widow approach when done serially in same temporal bone. METHODOLOGY: This is a cross-sectional study conducted in the Department of Otorhinolaryngology in conjunction with Department of Anatomy and Department of Diagnostic and Interventional Radiology over a period of 1 year. 12-electrode array insertion was performed via either approach (cochleostomy or round window) in the cadaveric temporal bone. HRCT temporal bone scan of the implanted temporal bone was done and depth of insertion and various cochlear parameters were calculated. RESULT: A total of 12 temporal bones were included for imaging analysis. The mean cochlear duct length was 32.892 mm; the alpha and beta angles were 58.175° and 8.350°, respectively. The mean angular depth of electrode insertion via round window was found to be 325.2° (SD = 150.5842) and via cochleostomy 327.350 (SD = 112.79) degree and the mean linear depth of electrode insertion via round window was found to be 18.80 (SD = 4.4962) mm via cochleostomy 19.650 (SD = 3.8087) mm, which was calculated using OTOPLAN 1.5.0 software. There was a statically significant difference in linear depth of insertion between round window and cochleostomy. Although the angular depth of insertion was higher in CS group, there was no statistically significant difference with round window type of insertion. CONCLUSION: The depth of electrode insertion is one of the parameters that influences the hearing outcome. Linear depth of electrode insertion was found to be more in case of cochleostomy compared to round window approach (p = 0.075) and difference in case of angular depth of electrode insertion existed but not significant (p = 0.529).

Surgical anatomy of posterior tympanotomy: influence of the retrotympanum on round window exposure.

OBJECTIVES: To describe how the retrotympanic structures could influence the visibility of the round window niche and the round window membrane during cochlear implant surgery, and to investigate if a round window approach is possible even in cases with unfavourable anatomy. METHODS: Video recordings from 37 patients who underwent cochlear implantation were reviewed. The visibility of the round window niche and round window membrane at different timepoints was assessed according to a modified version of the Saint Thomas Hospital classification. The structures that concealed the round window niche and round window membrane were evaluated. RESULTS: After posterior tympanotomy, 54 per cent of cases had limited exposure (classes IIa, IIb and III) of the round window niche. After remodelling the retrotympanum, round window niche visibility significantly increased, with 100 per cent class I and IIa cases. Following remodelling of the round window niche, visibility of more than 50 per cent of the round window membrane surface was achieved in 100 per cent of cases. CONCLUSION: Remodelling the retrotympanum and the round window niche significantly increased exposure of the round window niche and round window membrane respectively, allowing round window insertion in all cases.

Round Window Niche Veil is Visible on High-Resolution Computed Tomography and a Predictor of Local Drug Efficacy to Inner Ear.

OBJECTIVES: To determine the morphologies and effect of the round window niche veil (RWNV) on local drug delivery efficacy and develop diagnostic criteria on high-resolution computed tomography (HRCT). METHODS: Patients diagnosed with otosclerosis, bilateral profound sensorineural hearing loss or vestibular schwannoma were enrolled from 2019 to 2022, receiving temporal bone HRCT scanning, and anatomic variations of RWMV were summarized intraoperative. For patients with vestibular schwannoma, 1 mL of dexamethasone solution (4 mg/mL) was administered via facial recess during operation, and samples of perilymph were collected to analyze. The diagnostic criteria of RWNV on HRCT were developed and verified. RESULTS: A total of 85 patients were enrolled. RWNV was observed in 54 cases intraoperatively with an incidence of 63.5% (95% CI, 52.9%-73.0%). The median perilymph concentrations were 4.86-fold higher in the group without RWNV than with RWNV (p < 0.0001). RWNV could be visualized on HRCT with a window width of 3500-4500 HU and a window level of 300-500 HU. The characteristic features were as follows: (1) a thin soft tissue shadow could be seen at the entrance of the round window niche (RWN); (2) it was visible in at least 2 consecutive layers along the upper margin of RWN from top to bottom; (3) it was discontinuous with the adjacent bone margin. The sensitivity and specificity of the diagnostic criteria were 77.8% and 93.6%, respectively. CONCLUSION: RWNV could reduce local dexamethasone diffusion efficacy to the inner ear, which could be diagnosed on HRCT and used as a predictor of local drug delivery efficacy to the inner ear. LEVEL OF EVIDENCE: 3 Laryngoscope, 134:1396-1402, 2024.

Human Histology after Structure Preservation Cochlear Implantation via Round Window Insertion.

OBJECTIVES: Current surgical techniques aim to preserve intracochlear structures during cochlear implant (CI) insertion to maintain residual cochlear function. The optimal technique to minimize damage, however, is still under debate. The aim of this study is to histologically compare insertional trauma and intracochlear tissue formation in humans with a CI implanted via different insertion techniques. METHODS: One recent temporal bone from a donor who underwent implantation of a full-length CI (576°) via round window (RW) insertion was compared with nine cases implanted via cochleostomy (CO) or extended round window (ERW) approach. Insertional trauma was assessed on H&E-stained histological sections. 3D reconstructions were generated and virtually re-sectioned to measure intracochlear volumes of fibrosis and neo-ossification. RESULTS: The RW insertion case showed electrode translocation via the spiral ligament. 2/9 CO/ERW cases showed no insertional trauma. The total volume of the cochlea occupied by fibro-osseous tissue was 10.8% in the RW case compared with a mean of 30.6% (range 8.7%-44.8%, N = 9) in the CO/ERW cases. The difference in tissue formation in the basal 5 mm of scala tympani, however, was even more pronounced when the RW case (12.3%) was compared with the cases with a CO/ERW approach (mean of 93.8%, range 81% to 100%, N = 9). CONCLUSIONS: Full-length CI insertions via the RW can be minimally traumatic at the cochlear base without inducing extensive fibro-osseous tissue formation locally. The current study further supports the hypothesis that drilling of the cochleostomy with damage to the endosteum incites a local tissue reaction. LEVEL OF EVIDENCE: 4: Case-control study Laryngoscope, 134:945-953, 2024.

Hearing rehabilitation in children with malformed ears: The endoscopic-assisted approach for cochlear implantation.

BACKGROUND: Cochlear implantation (CI) in children with malformed ears can be challenging through the standard surgical technique. Several alternative approaches have been described. The endoscopic-assisted approach can be chosen as an effective and safe surgical technique, overcoming the drawbacks of the traditional approach. MATERIAL: We further describe a combined technique based on a limited mastoidectomy with no posterior tympanotomy and an endoscopic transmeatal approach to the round window (RW): the electrode is driven from the mastoid to the middle ear through the attic. RESULTS: The concomitant endoscopic assistance allows for improved surgical vision, reducing the risk of major complications. The main advantages of this technique are related to better visualization of the RW for safe insertion of the electrode; avoidance of damage to the facial nerve (FN), due to direct visualization, and sparing the posterior tympanotomy; avoidance of subtotal petrosectomy, if not necessary. CONCLUSION: The purpose of this article, supported with a video file, is to describe step by step this endoscopic-assisted procedure in a patient with middle ear malformation.

Effectiveness of endoscopy in cochlear implantation.

OBJECTIVE: Determine the effectiveness of endoscopy in cochlear implantation as compared to microscopy. METHOD: Study comparing microscopy and endoscopy in cochlear implant placement in 34 patients (23 endoscopic implants and 20 implants via microscopy), between 2014 and 2019, at the Centro Medico Naval, Mexico City. The study was performed under informed consent and according to the Council for International Organizations of Medical Sciences (CIOMS). RESULTS: Of the 34 patients, 12 were children or adolescents and 22 were adults. The visualization of the round window classified via microscopy per St. Thomas Hospital's classification showed that type IIB prevailed in 30.2% of patients, and type III in 41.9%, and when using the endoscope, the round window was observed in full in 82.6% of patients (type I), and type IIA was only observed in 17.4% (four patients). The number of attempts made to place the cochlear implant was greater with the microscope. The time to insertion of the electrode was 1.6 minutes. No differences were observed (p > 0.05) in the number of inpatient days. Cochleostomy was more frequent when using the microscope. CONCLUSIONS: Endoscopy is an effective resource in cochlear implantation for posterior tympanotomy, with no complications observed, offering greater safety in inserting the electrode through the round window.

OBJETIVO: Determinar la efectividad de la endoscopía en la implantación coclear en comparación con la técnica microscópica. MÉTODO: Se comparó la microscopía frente a la endoscopía en la colocación de implante coclear en 34 pacientes (23 endoscópicos y 20 microscópicos), del año 2014 al año 2019, en el Centro Médico Naval de la Ciudad de México. El estudio se realizó bajo consentimiento informado y apegado a las normas del Council for International Organizations of Medical Sciences. RESULTADOS: De los 34 pacientes, 12 eran niños o adolescentes y 22 eran adultos. La visualización de la ventana redonda fue clasificada con microscopio según la clasificación del St. Thomas Hospital, predominando la tipo IIB (30.2%) y la III (41.9%), y al utilizar el endoscopio se observó completa en el 82.6% (tipo I) y tipo IIA en tan solo el 17.4% (cuatro pacientes). El número de intentos en la colocación del implante coclear fue mayor con el microscopio. El tiempo en el que se insertó el electrodo fue de 1.6 minutos. No hubo diferencias (p > 0.05) en la estancia hospitalaria. Fue más frecuente la cocleostomía cuando se uso el microscopio. CONCLUSIONES: La endoscopía es un instrumento efectivo en la implantación coclear por timpanotomía posterior, sin presentarse complicaciones y dando mayor seguridad para insertar el electrodo por la ventana redonda.

Developing the supraparticle technology for round window-mediated drug administration into the cochlea.

The semi-permeable round window membrane (RWM) is the gateway to the cochlea. Although the RWM is considered a minimally invasive and clinically accepted route for localised drug delivery to the cochlea, overcoming this barrier is challenging, hindering development of effective therapies for hearing loss. Neurotrophin 3 (NT3) is an emerging treatment option for hearing loss, but its therapeutic effect relies on sustained delivery across the RWM into the cochlea. Silica supraparticles (SPs) are drug delivery carriers capable of providing long-term NT3 delivery, when injected directly into the guinea pig cochlea. However, for clinical translation, a RWM delivery approach is desirable. Here, we aimed to test approaches to improve the longevity and biodistribution of NT3 inside the cochlea after RWM implantation of SPs in guinea pigs and cats. Three approaches were tested (i) coating the SPs to slow drug release (ii) improving the retention of SPs on the RWM using a clinically approved gel formulation and (iii) permeabilising the RWM with hyaluronic acid. A radioactive tracer (iodine 125: 125I) tagged to NT3 (125I NT3) was loaded into the SPs to characterise drug pharmacokinetics in vitro and in vivo. The neurotrophin-loaded SPs were coated using a chitosan and alginate layer-by-layer coating strategy, named as '(Chi/Alg)SPs', to promote long term drug release. The guinea pigs were implanted with 5× 125I NT3 loaded (Chi/Alg) SPs on the RWM, while cats were implanted with 30× (Chi/Alg) SPs. A cohort of animals were also implanted with SPs (controls). We found that the NT3 loaded (Chi/Alg)SPs exhibited a more linear release profile compared to NT3 loaded SPs alone. The 125I NT3 loaded (Chi/Alg)SPs in fibrin sealant had efficient drug loading (~5 µg of NT3 loaded per SP that weights ~50 µg) and elution capacities (~49% over one month) in vitro. Compared to the SPs in fibrin sealant, the (Chi/Alg)SPs in fibrin sealant had a significantly slower 125I NT3 drug release profile over the first 7 days in vitro (~12% for (Chi/Alg) SPs in fibrin sealant vs ~43% for SPs in fibrin sealant). One-month post-implantation of (Chi/Alg) SPs, gamma count measurements revealed an average of 0.3 µg NT3 remained in the guinea pig cochlea, while for the cat, 1.3 µg remained. Histological analysis of cochlear tissue revealed presence of a 125I NT3 signal localised in the basilar membrane of the lower basal turn in some cochleae after 4 weeks in guinea pigs and 8 weeks in cats. Comparatively, and in contrast to the in vitro release data, implantation of the SPs presented better NT3 retention and distribution inside the cochlea in both the guinea pigs and cats. No significant difference in drug entry was observed upon acute treatment of the RWM with hyaluronic acid. Collectively, our findings indicate that SPs and (Chi/Alg)SPs can facilitate drug transfer across the RWM, with detectable levels inside the cat cochlea even after 8 weeks with the intracochlear approach. This is the first study to examine neurotrophin pharmacokinetics in the cochlea for such an extended period of times in these two animal species. Whilst promising, we note that outcomes between animals were variable, and opposing results were found between in vitro and in vivo release studies. These findings have important clinical ramifications, emphasising the need to understand the physical properties and mechanics of this complex barrier in parallel with the development of therapies for hearing loss.

Round-Window Vibroplasty: Systematic Review and Meta-Analysis of Audiological Effectiveness With Different Round-Window Coupling Techniques.

OBJECTIVE: Active middle ear implants can be directly coupled to the round-window (RW) membrane via RW Vibroplasty. The objectives of this systematic review were to summarize data on different RW coupling techniques and to investigate their effect on audiological and safety outcomes using meta-analyses. DATABASES REVIEWED: PubMed (MEDLINE), Cochrane Library, and Embase (DIMDI). METHODS: All publications reporting on audiological outcomes in human patients after RW Vibroplasty were included. Two independent reviewers carried out screening and data extraction. Meta-analyses and meta-regression were used to evaluate the potential effects of surgical and demographic parameters on primary audiological outcomes. Adverse events were extracted and tabulated for qualitative analysis. RESULTS: Fourteen different combinations of surgical coupling parameters were identified in 61 included publications. Overall, data from 23 publications could be used for meta-analyses. Significantly better aided sound-field thresholds were reported for RW Vibroplasty performed without a dedicated coupler and using fascia as interponate, compared with RW Vibroplasty with an RW coupler or without an interponate. These effects were not found in other outcomes (i.e., functional gain, word recognition score). Reporting of adverse events was relatively heterogeneous, with 32 explicit mentions of revision surgery after the loss of coupling efficacy. CONCLUSION: There are numerous publications investigating the effectiveness of coupling active middle ear implants to the RW membrane. However, studies are typically undersampled and of low evidence level. Using meta-analyses, weighted means, and qualitative analyses enabled a summary of the existing literature on audiological and safety outcomes after RW Vibroplasty. Individual selection of the most appropriate coupling modality with standardized intraoperative measurement and careful patient follow-up may be considered key factors for achieving effective RW coupling.

The growth of the mastoid volume in children with a cochlear implant.

The aim of this study was to understand the mastoid volume development in children who undergo cochlear implantation surgery. Cochlear implant (CI) database of our clinic (Kuopio University Hospital) was reviewed for computed tomography (CT) images of CI patients (age under 12 years at the time of implantation) with a minimum time interval of twelve months between their pre- and postoperative CT. Eight patients (nine ears) were found eligible for inclusion. Three linear measurements were taken by using picture archiving and communication systems (PACS) software and the volume of the MACS was measured with Seg 3D software. The mastoid volume increased on average 817.5 mm3 between the pre- and the postoperative imaging time point. The linear distances measured between anatomical points like the round window (RW)- bony ear canal (BEC), the RW-sigmoid sinus (SS), the BEC-SS, and the mastoid tip (MT)-superior semicircular canal (SSC) increased significantly with the age of the patient at both the pre-op and post-op time points. The linear measurements between key anatomical points and mastoid volume showed a positive linear correlation. The correlation between linear measurement and volume were significant between the MT-SSC (r = 0.706, p = 0.002), RW-SS (r = 0.646, p = 0.005) and RW-BEC (r = 0.646, p = 0.005). Based on our findings from the CI implanted patients and comparing it with the previous literature findings from non-CI implanted patients, we could say that the CI surgery seem to have no effect on the development of mastoid volume in children.

FLUCTUATING HEARING LOSS AS A SYMPTOM OF ACQUIRED PERILYMPHATIC FISTULA (PLF) UNDER EXTERNAL INJURIES FACTOR.

OBJECTIVE: The aim: To evaluate the effectiveness of treatment patients with spontaneous PLF and labyrinthine window ruptures by studying the clinical and audiological results. PATIENTS AND METHODS: Materials and methods: 52 patients after exposure to traumatic factors in the anamnesis were evaluated. The perilymphatic fistula was diagnosed in 18 patients after the complex examination. All patients with PLF underwent surgical treatment. RESULTS: Results: Vestibular disorders and hearing loss were the predominant symptoms. The fistula test was positive in 11 (61%) patients. Fluctuating hearing loss was determined in 9 (50%) patients. Labyrinthine window ruptures were detected in 16 (88%) patients: oval window membrane rupture was identified in 6 patients, and in another 10 patients round window membrane rupture was found and was detected on CT scan. The surgical treatment included minimally invasive tympanotomy with combined microscopic and endoscopic visualization and sealing techniques. Results were evaluated in 6 months after surgical treatment, patients had a decrease in bone and air conduction thresholds at all evaluated frequencies and a significant decrease in the level of the air-bone interval. CONCLUSION: Conclusions: Fluctuating hearing loss is considered one of the key symptoms, which suggests the presence of PLF. Determination of PLF and its surgical treatment, by using minimally invasive tympanotomy with sealing technique using optimal combined visualization, allows obtaining a stable functional result, with hearing improvement and vestibular symptoms reducing.

True keyhole cochlear implant surgery.

INTRODUCTION: Minimal invasive Robotic Assisted Cochlear Implant Surgery (RACIS) is a keyhole surgery by definition. It is therefore not possible to visualize the electrode array during insertion in the scala tympani. Hitherto, surgeons visualised the round window via the external auditory canal by folding over the tympanic membrane. However, the opening of a tympanomeatal flap is not minimal invasive and is especially in conventional cochlear implantation surgery not even necessary. Here we prove that image guided and robot assisted surgery can also allow correct electrode array insertion without opening the tympanomeatal flap. AIM: The aim is to report the first experience of robotic cochlear implantation surgery fully based on image guided surgery and without the opening of a tympanomeatal flap for electrode array insertion. INTERVENTION: RACIS with a straight flexible lateral wall electrode. PRIMARY OUTCOME MEASUREMENTS: Electrode cochlear insertion depth with RACIS and autonomous inner ear access with full electrode insertion of a flexible lateral wall electrode array. SECONDARY OUTCOME MEASUREMENTS: The audiological outcome in terms of mean hearing thresholds. CONCLUSION: After a series of 33 cases and after fine-tuning the insertion angles and yet another new version of planning software to depict the round window approach, a new clinical routine for inserting electrodes fully based on image guided surgery without opening a tympanomeatal flap was developed in robotic-assisted cochlear implant surgery.

Histopathological reaction in the vestibule after cochlear implantation in Macaca fascicularis.

Cochlear implantation surgery (CI) is considered a safe procedure and is the standard treatment for the auditory rehabilitation in patients with severe-to-profound sensorineural hearing loss. Although the development of minimally traumatic surgical concepts (MTSC) have enabled the preservation of residual hearing after the implantation, there is scarce literature regarding the vestibular affection following MTCS. The aim of the study is to analyze histopathologic changes in the vestibule after CI in an animal model (Macaca fascicularis). Cochlear implantation was performed successfully in 14 ears following MTCS. They were classified in two groups upon type of electrode array used. Group A (n = 6) with a FLEX 28 electrode array and Group B (n = 8) with HL14 array. A 6-month follow-up was carried out with periodic objective auditory testing. After their sacrifice, histological processing and subsequent analysis was carried out. Intracochlear findings, vestibular presence of fibrosis, obliteration or collapse is analyzed. Saccule and utricle dimensions and neuroepithelium width is measured. Cochlear implantation was performed successfully in all 14 ears through a round window approach. Mean angle of insertion was >270° for group A and 180-270° for group B. In group A auditory deterioration was observed in Mf 1A, Mf2A and Mf5A with histopathological signs of scala tympani ossification, saccule collapse (Mf1A and Mf2A) and cochlear aqueduct obliteration (Mf5A). Besides, signs of endolymphatic sinus dilatation was seen for Mf2B and Mf5A. Regarding group B, no auditory deterioration was observed. Histopathological signs of endolymphatic sinus dilatation were seen in Mf 2B and Mf 8B. In conclusion, the risk of histological damage of the vestibular organs following minimally traumatic surgical concepts and the soft surgery principles is very low. CI surgery is a safe procedure and it can be done preserving the vestibular structures.

Using Stapes Velocity to Estimate the Efficacy of Mechanical Stimulation of the Round Window With an Active Middle Ear Implant.

OBJECTIVE: To test a method to measure the efficacy of active middle ear implants when coupled to the round window. METHODS: Data previously published in Koka et al. ( Hear Res 2010;263:128-137) were used in this study. Simultaneous measurements of cochlear microphonics (CM) and stapes velocity in response to both acoustic stimulation (forward direction) and round window (RW) stimulation (reverse direction) with an active middle ear implant (AMEI) were made in seven ears in five chinchillas. For each stimulus frequency, the amplitude of the CM was measured separately as a function of intensity (dB SPL or dB mV). Equivalent vibrational input to the cochlea was determined by equating the acoustic and AMEI-generated CM amplitudes for a given intensity. In the condition of equivalent CM amplitude between acoustic and RW stimulation-generated output, we assume that the same vibrational input to the cochlea was present regardless of the route of stimulation. RESULTS: The measured stapes velocities for equivalent CM output from the two types of input were not significantly different for low and medium frequencies (0.25-4 kHz); however, the velocities for AMEI-RW drive were significantly lower for higher frequencies (4-14 kHz). Thus, for RM stimulation with an AMEI, stapes velocities can underestimate the mechanical input to the cochlea by ~20 dB for frequencies greater than ~4 kHz. CONCLUSIONS: This study confirms that stapes velocity (with the assumption of equivalent stapes velocity for forward and reverse stimulation) cannot be used as a proxy for effective input to the cochlea when it is stimulated in the reverse direction. Future research on application of intraoperative electrophysiological measurements during surgery (CM, compound action potential, or auditory brainstem response) for estimating efficacy and optimizing device coupling and performance is warranted.