On the battery life of a totally implantable active middle ear device: a retrospective study in a single implanting center.

BACKGROUND: Totally-implantable active middle ear devices (AMED) rely on a non-rechargeable battery encased with the implantable sound processor that needs to be replaced with a minor surgical procedure after its depletion. OBJECTIVES: This study aimed to investigate the most significant factors affecting the implant's battery life. MATERIALS AND METHODS: The implanted subjects (29 patients) were divided into three groups; group A with 17 patients who underwent one battery change surgery; group B with ten patients who underwent two battery changes; and group C with two patients and three surgeries. The battery life was put in correlation with several variables, including daily use and the auditory threshold. RESULTS: The battery life ranged from 26 to 67 months, with a mean of 48.93 ± 13.47. Pearson's correlation coefficient revealed that the battery life was statistically correlated only with the mean post-implantation bone conduction thresholds (p-value <.0001). CONCLUSIONS: Although the non-rechargeable battery system of the AMED under study overcomes the drawbacks of daily charging, it needs to be surgically changed after its depletion. The different rates of battery life were shown to mainly depend on the post-implantation BC thresholds, which in some cases showed a deterioration concerning the pre-implanting values.

Evaluation of prednisolone and prednisolone sodium succinate concentrations in human plasma and inner ear perilymph during cochlear implantation 24 h after intratympanic injection.

BACKGROUND: The use of intratympanic (IT) steroids has drastically increased over the past 10-15 years to manage many otological pathologies. OBJECTIVES: This study aimed to compare the concentrations of prednisolone and prednisolone sodium succinate (SS) in the plasma and inner ear perilymph of participants who underwent cochlear implantation 24 h after IT injection. MATERIALS AND METHODS: It was a prospective comparative randomized study. Twenty participants received an IT injection of prednisolone SS ∼24 h before the cochlear implantation. The other five participants received an IT saline injection and represented the control group. Perilymph and blood were sampled during the cochlear implantation surgery. RESULTS: Both prednisolone and prednisolone SS were still present in perilymph ∼24 h after the IT administration. Only prednisolone was present in the blood plasma of seven participants (35%). CONCLUSION: IT injection of prednisolone SS resulted in high perilymph concentrations of prednisolone and prednisolone SS, which could stay in the perilymph for at least 24 h. Using a mini-endoscope during the IT injection may effectively detect barriers infront of the round window membrane, increasing the drug concentration in the inner ear. SIGNIFICANCE: IT injection is an effective method for delivering prednisolone to the inner ear.

The Use of Nanoparticles in Otoprotection.

The inner ear can be insulted by various noxious stimuli, including drugs (cisplatin and aminoglycosides) and over-acoustic stimulation. These stimuli damage the hair cells giving rise to progressive hearing loss. Systemic drugs have attempted protection from ototoxicity. Most of these drugs poorly reach the inner ear with consequent ineffective action on hearing. The reason for these failures resides in the poor inner ear blood supply, the presence of the blood-labyrinthine barrier, and the low permeability of the round window membrane (RWM). This article presents a review of the use of nanoparticles (NPs) in otoprotection. NPs were recently used in many fields of medicine because of their ability to deliver drugs to the target organs or cells. The studies included in the review regarded the biocompatibility of the used NPs by in vitro and in vivo experiments. In most studies, NPs proved safe without a significant decrease in cell viability or signs of ototoxicity. Many nano-techniques were used to improve the drugs' kinetics and efficiency. These techniques included encapsulation, polymerization, surface functionalization, and enhanced drug release. In such a way, it improved drug transmission through the RWM with increased and prolonged intra-cochlear drug concentrations. In all studies, the fabricated drug-NPs effectively preserved the hair cells and the functioning hearing from exposure to different ototoxic stimuli, simulating the actual clinical circumstances. Most of these studies regarded cisplatin ototoxicity due to the wide use of this drug in clinical oncology. Dexamethasone (DEX) and antioxidants represent the most used drugs in most studies. These drugs effectively prevented apoptosis and reactive oxygen species (ROS) production caused by ototoxic stimuli. These various successful experiments confirmed the biocompatibility of different NPs and made it successfully to human clinical trials.

Proposal of a magnetic resonance imaging follow-up protocol after cholesteatoma surgery: a prospective study.

BACKGROUND: Non-echo planar (EPI) diffusion-weighted (DW) MRI has become an effective tool for the follow-up after cholesteatoma surgery and decreased the rate of second-look surgeries. OBJECTIVES: To shed light on the optimal imaging follow-up protocol to detect postoperative residual or recurrent cholesteatoma. MATERIALS AND METHODS: 64 patients were included in this prospective study. Three different surgical procedures were considered: canal-wall-up (26 patients), canal-wall-down (20 patients), and obliterative (18 patients). The imaging follow-up protocol included non-EPI DW MRI during the following postoperative periods: 1 month, 6 months, and 1, 3, 5, and 7 years after the primary surgery. RESULTS: MRI-positive lesions were present in 18.75% of patients. 50% of the MRI-positive findings occurred at the 1-month follow-up. The other peak of MRI positivity occurred at the 3-year follow-up. The last MRI-positive finding appeared at the 5-year follow-up. CONCLUSIONS: The timing for the imaging protocol proposed by this prospective study to detect recidivism after cholesteatoma surgery stressed the importance of performing non-EPI DW MRI for detecting residual, though rare, disease. Likewise, extending the follow-up to a least 5 years after primary surgery was also recommended to detect any recurrent cholesteatoma that would appear unlikely to be present beyond this time set.

Thulium laser in stapedotomy surgery.

BACKGROUND: Thulium laser use in stapedotomy surgery is usually associated with many doubts regarding the thermal effect on the vestibular area and the production of acoustic shock waves, which may result in permanent complications. OBJECTIVES: We aimed to evaluate the efficacy and safety of the Thulium laser use in stapedotomy and its long-term effects on the clinical and audiological results. MATERIAL AND METHODS: It was a retrospective randomized case-series study. We included 148 otosclerosis patients. They were divided randomly into two groups; group A (multiple shots) included 62 patients and group B (one shot with a manual perforator) included 86 patients. RESULTS: There was a statistically significant improvement of the ABG in both groups. ABG closure (<10 dB) occurred in 87.1% of patients in group A, and 89.5% of patients in group B. Intraoperative complications were more in group B (p-value = 0.038). The postoperative complications were more in group A (p-value = .017). CONCLUSIONS: According to our experience on a relatively large number of cases, the Thulium laser is a safe tool to be used in stapedotomy either in multiple shots or one shot with a manual perforator. It improved functional hearing efficiently without showing signs of inner ear impairment.

A Challenging Nodular Lesion of the Ear.

Skin nodular lesion are really frequent, but rapidly growing ones needs to be quickly removed since they can hide really aggressive skin tumor. Among malignant lesion Merkel cell carcinoma arise. It is a rare neuroendocrine skin tumor highly aggressive, not easy to diagnose at first stage, since at first diagnosis it is already widespreading all over the body. In order to renew interest in this letal skin tumori is mandatory to remind high risk population which include elderly people, white skin, chronically exposed to UV immunocompromised. Our unhappy case was described to increase awareness on this kind of skin tumor, since new drug appeared in the market can give an hope to these patients.

Early non-EPI DW-MRI after cholesteatoma surgery.

OBJECTIVE: Middle ear cholesteatoma may lead to the erosion of the bony structures of the temporal bone, possibly causing intra- and extracranial complications. Surgical treatment is mandatory, and due to possible residual/recurrent disease, the use of reliable diagnostic methods is essential. Our study aimed to evaluate the reliability of non-EPI DW-MRI for the follow-up of cholesteatoma after surgery. METHODS: In a study group including 53 consecutive patients who underwent surgery for cholesteatoma at a tertiary university hospital, an imaging protocol was applied, including non-echo planar diffusion-weighted imaging magnetic resonance (MR) at 1 month after surgery and then at 6 and 12 months after surgery. Based on the combination of preoperative assessment and intraoperative findings, the study group was divided into 3 subgroups: petrous bone (PB) cholesteatoma, complicated cholesteatoma and uncomplicated cholesteatoma. PB cholesteatoma patients were treated by a subtotal petrosectomy, whereas complicated and uncomplicated cholesteatoma patients were treated either by a canal wall up procedure or a retrograde (inside-out) canal wall down technique with bone obliteration technique (BOT). RESULTS: The results show that patients who had positive findings on non-EPI DW-MRI scans 1 month after surgery consequently underwent revision surgery during which residual cholesteatoma was noted. All the patients who displayed negative findings on non-EPI DWI-MRI scan at 1 month after surgery did not show the presence of a lesion at the 6- and 12-month evaluations. The 6 patients who displayed residual cholesteatoma at the 1-month follow-up presented dehiscence/exposure of the facial nerve canal at the primary surgery, mostly at the level of the labyrinthine segment. CONCLUSION: Non-EPI DW-MRI is a useful and reliable tool for follow-up cholesteatoma surgery, and when applied early, as was done in the protocol proposed in the present study, this tool may be used to detect the presence of residual cholesteatoma in some patients, prompting the planning of early revision surgery.

Rehabilitation of severe-to-profound sensorineural hearing loss with an active middle ear implant.

Background: Severe-to-profound sensorineural hearing loss (spSNHL) is mostly relying on the use of a cochlear implant (CI).Aims: The present study reports on the auditory outcome from a group of subjects affected by spSNHL who received an AMEI application.Materials and methods: Nine out of 43 subjects who received a fully-implantable AMEI were initially candidated as off-label (primary off-label group or POLG). Twelve subjects showed over time a decrease in bone conduction threshold (BCT) in the operated ear (Secondary Off-Label Group or SOLG): SOLGa with no detectable BCT (9 subjects), SOLGb with residual low-frequency BCT (3 subjects). The auditory assessment included pure tone audiometry and speech audiometry in quiet and noise.Results: A significant PTA5 difference was found at activation in SOLGb group and at the last fitting in SOLGa Group in respect to the label control group. No significant difference was found between POLG group and control group. Speech audiometry in noise revealed a significant lower gain in all three groups in comparison to the control group.Conclusions: The adoption of an AMEI in unconventional indications could be beneficial also for subjects with spSNHL, although this solution can in some cases only be transient before performing CI surgery.

Early Assessment of Vestibular Function after Unilateral Cochlear Implant Surgery.

INTRODUCTION: Cochlear implantation (CI) has been reported to negatively affect vestibular function. The study of vestibular function has variably been conducted using different types of diagnostic tools. The combined use of modern, rapidly performing diagnostic tools could prove useful for standardization of the evaluation protocol. METHODS: In a group of 28 subjects undergoing CI, the video head impulse test (vHIT), the cervical vestibular evoked myogenic potentials (cVEMP) and the short form of the Dizziness Handicap Inventory (DHI) questionnaire were investigated preoperatively and postoperatively (implant on and off) in both the implanted and the contralateral, nonimplanted ear. All surgeries were performed with a round window approach (RWA), except for 3 otosclerosis cases in which the extended RWA (eRWA) was used. RESULTS: The vHIT of the lateral semicircular canal showed preoperative vestibular involvement in nearly 50% of the cases, while the 3 canals were contemporarily affected in only 14% of the cases. In all the hypofunctional subjects, cVEMP were absent. A low VOR gain in all of the investigated superior semicircular canals was found in 4 subjects (14%). In those subjects (21.7%) in whom cVEMP were preoperatively present and normal on the operated side, the absence of a response was postoperatively recorded. DISCUSSION/CONCLUSION: The vestibular protocol applied in this study was found to be appropriate for distinguishing between the CI-operated ear and the nonoperated ear. In this regard, cVEMP was found to be more sensitive than vHIT for revealing a vestibular sufferance after CI, though without statistical significance. Finally, the use of RWA surgery apparently did not reduce the occurrence of signs of vestibular impairment.

Video Head Impulse Test in Labyrinthine Fistula due to Middle Ear Cholesteatoma.

OBJECTIVES: To assess and monitor lateral semicircular canal (LSC) function over time in patients affected by chronic otitis media with cholesteatoma (CHO) complicated by fistula of LSC (LSC-F) before and after surgery using video Head Impulse Test (vHIT). MATERIALS AND METHODS: Eight patients aged 18-67 years affected by CHO with imaging-ascertained LSC-F were included in this preliminary prospective study. The following protocol has been applied: oto-microscopic diagnosis with patient's history; computed tomography scan of the temporal bone; surgery with concomitant resurfacing of LSF-F; audiological and vestibular evaluation before surgery (T0) and at 30 days (T1), 6 months (T2), and 1 year after surgery (T3). vHIT was used to assess vestibulo-ocular reflex (VOR) in LSC. RESULTS: None of the patients showed deterioration of bone conduction hearing levels during the different time of evaluation. Three patients showed a reduced VOR gain and catch-up saccades at T0, with VOR gain normalization at T2. This finding remained stable at the 1-year follow-up. The VOR gain in the nonaffected side generally experienced an increase, paralleled by the normalization on the affected side, with statistically significant correlation. The subjects with normal vHIT before surgery did not show any variation following surgery. CONCLUSION: vHIT allows the assessment of LSC function in case of fistula. The adopted surgical fistula repair did not induce deterioration of the auditory or LSC function, but indeed, it could prevent worsening and help promoting recovery to the normal function.

Transitions in auditory rehabilitation with bone conduction implants (BCI).

BACKGROUND: The bone conductive implants (BCI) are nowadays a reliable alternative for rehabilitation of specific forms of hearing loss, i.e. conductive, mixed or single sided deafness (SSD). Aims/Objective: To analyse the various factors in play when considering an auditory rehabilitation with a bone-conductive device (BCI). MATERIALS AND METHODS: The clinical charts of subjects who underwent BCI application at the same Implanting Center from 2005 to 2018 were retrieved analysing also the reason for eventual explantation and the alternative option (transition) for hearing rehabilitation. RESULTS: Nine BAHA Compact, 4 BAHA Intenso, 21 BAHA Divino, 3 BAHA BP100, 4 Ponto, 2 Sophono, 5 Bonebridge, 5 BAHA5 Attract; 11 BAHA5 Connect were used in 12 unilateral COM; 16 bilateral COM; 3 unilateral cholesteatoma; 6 bilateral cholesteatoma; 2 unilateral otosclerosis; 5 bilateral otosclerosis; 9 congenital malformations; 6 major otoneurosurgical procedures; 5 sudden deafness. Explantation was necessary for five subjects. CONCLUSIONS: Middle ear pathology and sequels from surgery represent the most common reason for BCI implantation, both in unilateral and in bilateral cases. Transition from one implantable device to another one can be predictable, mostly when explantation is necessary. SIGNIFICANCE: The role of BCI for rehabilitation in middle ear pathology may be extremely important.

Complications after round window vibroplasty.

PURPOSE: To evaluate the complication rate in adult subjects with open cavities that were implanted with the Vibrant Soundbridge implant, using the round window (RW) vibroplasty procedure. METHODS: From 2009 to 2014, 21 adult subjects with mixed hearing loss, all with sequel from open tympanoplasty surgery, underwent RW vibroplasty (RW-VPL). Surgical complications were recorded and a standard minimal approach was used as a basis for all the cases that needed revision. RESULTS: The mean follow-up was 42 months (range 12-76). Complications occurred in nearly half of the cases and included: cable extrusion (23.8%), hardware failure (14.3%), profound hearing loss (9.5%), and inadequate RW coupling (9.5%). A minimal endaural approach (MEA) was used in the majority of the cases (86.7%), while the extended endaural approach was adopted for those patients requiring explantation with or without replacement (14.3%). CONCLUSIONS: RW-VPL can be considered a possible option for the rehabilitation of auditory impairment derived from an open tympanoplasty procedure due to cholesteatoma. The procedure may lead to minor/major complications that may require a surgical revision. By adopting an MEA, it has been possible to manage all the situations in which functionality of the device is worth being preserved.

Intralabyrinthine Vestibular Schwannoma Responsive to Intratympanic Gentamicin Treatment.

Intralabyrinthine schwannoma (ILS) is a rare benign tumor that affects the ends of cochlear and vestibular nerves. In a majority of the cases, it occurs with unilateral progressive sensorineural hearing loss. Less frequent symptoms include tinnitus, imbalance, vertigo, or fullness. The advent of magnetic resonance imaging allows early diagnosis and enables an appropriate therapeutic protocol. This report describes a case of intravestibular schwannoma, with fluctuating hearing loss and intractable vertigo, treated with intratympanic gentamicin. The patient was a 28-year-old woman with intractable vertigo and fluctuating left-side hearing loss caused by left intravestibular schwannoma. Because surgery was temporarily rejected by the patient, a single dose of intratympanic gentamicin was administered. Following this, the patient showed a significant improvement in the symptoms. However, moderate to flat sensorineural hearing loss was also observed. Intratympanic gentamicin infiltration is a valid therapeutic option for patients with ILS, affected by intractable vertigo, when the patient refuses surgery.

Simultaneous Contralateral Vestibular Schwannoma and Middle Ear Paraganglioma Tumor.

To the best of our knowledge, only 2 cases of a simultaneous contralateral vestibular schwannoma (VS) and middle ear paraganglioma (MEP) have previously been reported in literature. We report the third case observed in a 43-year-old male, who presented with an 11-year history of right-sided hearing loss and a 1-year history of left-sided pulsatile tinnitus. A magnetic resonance imaging (MRI) showed a VS on the right side and computer tomography (CT) identified a Fisch type A1 paraganglioma on the left side. The VS was treated using a translabyrinthine approach and the MEP was kept under radiological observation for 1 year. Due to the growth of the MEP (Fisch type A2), it was treated with excision via a retroauricular approach. Our case was very challenging because there was a different and important pathology on each side, both carrying a risk of deafness as a consequence of the disease and/or the treatments.

Patient satisfaction after auditory implant surgery: ten-year experience from a single implanting unit center.

CONCLUSIONS: The satisfaction rate of the subjects with an auditory implant appears strictly related to the resulting auditory improvement, and the surgical variables would play a prevailing role in respect to the esthetic factors. OBJECTIVES: To assess the rate of satisfaction in subjects who underwent the surgical application of an auditory device at a single Implanting Center Unit. METHOD: A series of validated questionnaires has been administered to subjects who underwent the surgical application of different auditory devices. The Glasgow Benefit Inventory (GBI), the Visual Analog Scale (VAS), and the Abbreviated Profile of Hearing Aid Benefit (APHAB) have been used to compare the implanted situation with the hearing-aided one; a percutaneous bone conductive implant (pBCI) with an active middle ear implant (AMEI) on the round window in mixed hearing loss; and an invisible, fully-implantable device with a frankly and bulky semi-implantable device. RESULTS: The mean GBI scores were higher in Vibrant Soundbridge (VSB)® and Bonebridge® subjects, without significant differences among the various devices. The mean VAS score increased for all the devices in comparison with the conventional hearing aid. The mean APHAB score was similarly better in the implanted condition as total and partial scores.

Inner Ear Active Hearing Device in Non-Otosclerotic, Severe, Mixed Hearing Loss.

OBJECTIVE: To verify the efficacy of a powerful active hearing device in a patient different from far-advanced otosclerosis, specifically when the stapes footplate is mobile. PATIENT: A patient with severe-to-profound mixed hearing loss, who was not benefiting from the use of a conventional hearing aid, was selected for an inner ear active implant. This was justified by a bone conductive threshold above 60 dB, which had discouraged any other rehabilitative solutions such as a bone conductive implant, or an active middle ear implant (AMEI). INTERVENTION: The hearing device was surgically applied using a combined transmastoid/transcanal approach. During surgery, a mobile stapes were found and was perforated for the insertion of a piston prosthesis, crimped on the new-incus of the device. MAIN OUTCOME MEASURE: The bone conduction threshold was assessed postoperatively to identify any possible surgery-related hearing deterioration. Pure tone audiometry was conducted in a sound field, and a speech reception threshold test was performed with the contralateral ear masked. The hearing outcome was assessed soon after the implant activation (6 weeks after surgery), and 6 months after surgery. RESULTS: Upon activation of the device, a PTA of 45 dB was obtained (at 0.5, 1, 2 and 4 kHz). At 6 months after surgery, the speech discrimination score reached 90% at 80 dB SPL. CONCLUSION: The application of the Codacs device has shown to be compatible with a mobile stapes footplate, as demonstrated in this report. The footplate perforation did not cause any further hearing deterioration, and has allowed to achieve a favorable auditory outcome.