Magnetic Resonance Imaging Compatibility of a New Generation of Active Middle Ear Implant: A Clinically Relevant Temporal Bone Laboratory Study.

OBJECTIVE: Magnetic resonance imaging (MRI) has become an essential tool of modern medical imaging and disease diagnosis. In November 2014, a new MRI-conditional (up to 1.5 T) generation of an active middle ear implant (AMEI) was released to the market.The aim of the study was to test the MRI compatibility of the new implant system in a clinical-anatomical study. DESIGN: Experimental cadaver head model. SETTING: Temporal bone laboratory. PARTICIPANTS: AMEIs were implanted in 28 fixed temporal bones at three different floating mass transducer (FMT)-coupling positions (N = 8 short process of the incus, N = 16 long process of the incus, N = 4 round window). MAIN OUTCOME MEASURES: The position of the FMT and the integrity of the ossicular chain was monitored through microscopy, microendoscopy, and computed tomography (CT) scans before and after the MRI (1.5 T) was conducted. Proper function of the implant was tested with reverse transfer function (RTF) measurements. RESULTS: Neither positional nor functional changes after MRI were observed. CONCLUSION: The new generation of the AMEI is a MRI-compatible system, which features an easier and quicker implant fixation method. The option of MRI in patients with AMEI should be taken into consideration during the preoperative discussion with potential candidates.

Improvement of sound source localization abilities in patients bilaterally supplied with active middle ear implants.

CONCLUSIONS: Patients, who are bilaterally supplied with active middle ear implants, perform slightly better in sound localization tasks than when unilaterally aided or unaided. OBJECTIVES: To investigate the impact of bilateral use of active middle ear implants on sound source localization in the horizontal plane in patients with a sloping moderate-to-severe hearing loss. METHODS: Ten adults supplied with Med-EL Vibrant Soundbridge systems (VSB) in both ears participated in the study. Four listening conditions were tested: unaided, aided with VSB on left or right ear and on both sides. In each condition the subjects had to judge the direction of broadband noises delivered randomly across a semicircular array of 11 loudspeakers arranged in an anechoic chamber. RESULTS: When unaided or bilaterally aided, the subjects localized on average 40% of the stimuli correct; when unilaterally aided (left or right), this rate dropped to 20-30% in either condition. Precision of sound localization was highest when bilaterally aided, i.e. the mean RMS angular error was 10°, and lowest when unilaterally aided, i.e. 15°. This is in line with bilateral hearing aid users, who show similar performance in sound localization tasks.

A New Transcutaneous Bone Conduction Hearing Implant: Short-term Safety and Efficacy in Children.

OBJECTIVE: To investigate the safety and efficacy of a new bone conduction hearing implant in children, during a 3-month follow-up period. STUDY DESIGN: Prospective, single-subject repeated-measures design in which each subject serves as his/her own control. SETTING: Otolaryngology departments of four Austrian hospitals. PATIENTS: Twelve German-speaking children aged 5 to 17 suffering from conductive or mixed hearing loss, with an upper bone conduction threshold limit of 45 dB HL at frequencies between 500 and 4000 Hz. INTERVENTION: Implantation of the Bonebridge transcutaneous bone conduction hearing implant (tBCI). MAIN OUTCOME MEASURES: The subjects' audiometric thresholds (air conduction, bone conduction, and sound field at frequencies 500 Hz to 8 kHz) and speech perception (word recognition scores [WRS] and 50% word intelligibility in sentences [SRT50%]) were tested preoperatively and at 1 and 3 months postoperatively. The patients were also monitored for adverse events and they or their parents filled out questionnaires to analyze satisfaction levels. RESULTS: Speech perception as measured by WRS and SRT50% improved on average approximately 67.6% and 27.5 dB, respectively, 3 months after implantation. Aided thresholds also improved postoperatively, showing statistical significance at all tested frequencies. Air conduction and bone conduction thresholds showed no significant changes, confirming that subjects' residual unaided hearing was not damaged by the treatment. Only minor adverse events were reported and resolved by the end of the study. CONCLUSION: Safety and efficacy of the new bone conduction implant was demonstrated in children followed up to 3 months postoperatively.

Acute dyspnea caused by a giant spindle cell lipoma of the larynx.

BACKGROUND: The spindle cell lipoma (SCL) is a special type of lipoma and this is very rare in the head and neck regions. There are only five reported cases exist, which describes the occurrence of a SCL in the hypopharynx. METHODS: Our case report presents a case of a very large SCL in the larynx. We want to describe that how we treated the patients and compared the situation with other reported cases. RESULTS: Intraoperatively, we found a tumor mass of 7 × 5 cm. It was successfully removed with the carbon dioxide laser. No postoperative complications occurred. CONCLUSIONS: Although SCL is a very rare diagnosis in the larynx/hypopharynx, it should be included in the differential diagnosis of larynx/hypopharynx tumors. Our case is the first report of such a large SCL in the larynx. The clinical symptoms occurred relatively late and ended up in an acute situation of stridor and dyspnea.

Bilateral use of active middle ear implants: speech discrimination results in noise.

Binaural sound reception has advantages over unilateral perception, including better localization and sound quality as well as speech and tone reception in both quiet and noisy environments. Up to now, most active middle ear implant (AMEI) users have been unilaterally implanted, but patient demand for an implant on the other side is increasing. Ten bilaterally-AMEI implanted native German-speaking adults were included in the study. The Oldenburg sentence test was used to measure speech reception thresholds in noise. The subject's signal-to-noise ratio (SNR) at a speech reception score of 50 % was calculated for different noise conditions. SRT was measured as a function of noise condition (nc) and listening condition (lc)-for example, SRT (lc, nc), with nc from S0N0, S0N-90, or S0N90 and lc from left, right or both. For each noise condition, the squelch effect and the binaural summation effect were calculated. Patients in this study demonstrated improvement with bilateral AMEIs compared to right or left AMEI only in all three tested listening conditions. Statistical significance was found in the S0N0 condition to favor usage of bilateral AMI versus either the right or left side only. The benefits of binaural hearing are well known, also in normal-hearing individuals. In the future every bilateral implantation should be a part of the clinical routine. Bilateral implantation can help to reduce problems in background noise and restore directional hearing.

Towards a Unified Testing Framework for Single-Sided Deafness Studies: A Consensus Paper.

BACKGROUND: While hearing aids for a contralateral routing of signals (CROS-HA) and bone conduction devices have been the traditional treatment for single-sided deafness (SSD) and asymmetric hearing loss (AHL), in recent years, cochlear implants (CIs) have increasingly become a viable treatment choice, particularly in countries where regulatory approval and reimbursement schemes are in place. Part of the reason for this shift is that the CI is the only device capable of restoring bilateral input to the auditory system and hence of possibly reinstating binaural hearing. Although several studies have independently shown that the CI is a safe and effective treatment for SSD and AHL, clinical outcome measures in those studies and across CI centers vary greatly. Only with a consistent use of defined and agreed-upon outcome measures across centers can high-level evidence be generated to assess the safety and efficacy of CIs and alternative treatments in recipients with SSD and AHL. METHODS: This paper presents a comparative study design and minimum outcome measures for the assessment of current treatment options in patients with SSD/AHL. The protocol was developed, discussed, and eventually agreed upon by expert panels that convened at the 2015 APSCI conference in Beijing, China, and at the CI 2016 conference in Toronto, Canada. RESULTS: A longitudinal study design comparing CROS-HA, BCD, and CI treatments is proposed. The recommended outcome measures include (1) speech in noise testing, using the same set of 3 spatial configurations to compare binaural benefits such as summation, squelch, and head shadow across devices; (2) localization testing, using stimuli that rove in both level and spectral content; (3) questionnaires to collect quality of life measures and the frequency of device use; and (4) questionnaires for assessing the impact of tinnitus before and after treatment, if applicable. CONCLUSION: A protocol for the assessment of treatment options and outcomes in recipients with SSD and AHL is presented. The proposed set of minimum outcome measures aims at harmonizing assessment methods across centers and thus at generating a growing body of high-level evidence for those treatment options.

The Vibrant Soundbridge in Children and Adolescents: Preliminary European Multicenter Results.

OBJECTIVE: Evaluation of safety and efficacy of the Vibrant Soundbridge in the treatment of hearing loss in children and adolescents with primary focus on improvement in speech discrimination. STUDY DESIGN: Prospective, single-subject repeated-measures design in which each subject serves as his/her own control. SETTING: Tertiary referral center. PATIENTS: Nineteen patients aged 5 to 17 years. INTERVENTION: Implantation of an active middle ear implant. MAIN OUTCOME MEASURE: Improvement in word recognition scores, speech reception thresholds, and signal-to-noise ratios (SNRs) were evaluated, in addition to air and bone conduction. Oldenburger Kids Satztest/Oldenburger Satztest sentences and Göttinger/Freiburger monosyllables at 65-dB hearing level were tested in two age groups. RESULTS: Significant speech discrimination improvement was seen in all patients after 6 months. In children 5 to 9 years old, mean monosyllable recognition improved from 28.9% (unaided) to 95.5% (Soundbridge-aided). Aided 50% sentence discrimination at 44.1 dB and SNR of -4.9 dB were measured. In patients 10 to 17 years old, mean word recognition improved from 18.5% to 89.0%, sentence reception threshold improved to 40.2 dB, and SNR to -3.6 dB. Comparison between age groups indicated a slight trend toward quicker adaptation by older subjects. However, after initial adjustment, a higher level of overall benefit was seen at 6 months in younger children. CONCLUSIONS: Currently, the only middle ear implant approved for pediatric patients, the Vibrant Soundbridge, provides an option in cases of congenital aural atresia or disease-induced defects, when surgical intervention and reconstruction is indicated. The 6-month results in this comparatively large study population validated conclusions found in previous trials.

Evaluation of a minimally invasive surgical fixation technique for young children with the Concerto Pin cochlear implant system.

In 2011, Med-El (Innsbruck, Austria) introduced a new cochlear implant system, designed to require a minimally invasive surgical technique and allow greater positional flexibility for its fixation on the skull. The Concerto Pin implant system is a good option for patients with thinner bone, such as children and elderly. The aim of this study was to investigate the implant's stability in children using our minimally invasive surgical technique. This was a prospective, longitudinal study with a single-subject, repeated-examination design. Six children, implanted with a Concerto Pin using our minimally invasive surgical technique between October 2011 and September 2012, were assessed 1, 3 and 6 months after surgery. In each case, the implant remained in a stable position and no adverse events or problems with healing were observed at any time during the investigation. The minimally invasive technique and the method of implant fixation that bypass drilling a deep implant bed constitute a good option for patients with thinner bone, such as children. This clinical study shows the safety and stability of the Concerto Pin implant system using a minimally invasive surgical technique.

Intraoperative measurement for a new transcutaneous bone conduction hearing implant.

OBJECTIVE: To investigate the possibility of using a modified reverse transfer function (RTF) measurement intraoperatively during surgery of a new transcutaneous bone conduction hearing implant to evaluate the status of the device. METHODS: Tests were performed on a cadaver skull (preclinically) and two conductive hearing loss patients implanted with a new transcutaneous bone conduction implant. During intraoperative activation, the RTF was measured using a microphone attached perpendicularly and directly to the skin in the middle section of the forehead. RESULTS: The RTF could be measured for all frequencies from 500 to 6, 000 Hz. CONCLUSION: The usage of an intraoperative RTF measurement may be a good method to verify the mechanical coupling of the bone conduction floating mass transducer and to test the functional integrity of the implant in an objective way.

Active middle ear implant after lateral petrosectomy and radiotherapy for ear cancer.

BACKGROUND: Tumor of the temporal bone is a rare disease with a very poor prognosis. Surgery and postoperative radiotherapy are usually the recommended treatments for squamous cell carcinoma (SCC) of the external and middle ear, which may cause conductive hearing loss. The purpose of this study was to evaluate the audiologic results and compliance of active middle ear implant (AMEI) and establish the feasibility of the procedure in a patient treated for middle ear cancer. METHODS: A 73-year-old patient treated with lateral petrosectomy, neck dissection, reconstruction/obliteration by pedicled pectoralis major myocutaneous flap, and postoperative full dose radiotherapy for external and middle ear SCC was selected for AMEI. Preoperative audiometric and speech audiometry tests were performed on both ears before and after the activation. MAIN OUTCOME MEASURES: Pure tone free field audiometry. Binaural free field speech audiogram. RESULTS: Aided pure tone free field audiometry AMEI results show an increase in air conduction. Speech audiogram showed better discrimination scores in AMEI-aided situations. No complications were observed. CONCLUSION: AMEI after surgery followed by radiotherapy for middle ear cancer is feasible. Acoustic results in obliterated ear are satisfactory.

Neuropsychological profile of children after an episode of neuroborreliosis.

BACKGROUND: In the majority of patients with Lyme neuroborreliosis (LNB), neurological symptoms are transient. The extent of neuropsychological and neuropsychiatric problems in children is not well researched. OBJECTIVES: The study aimed to investigate cognitive functions and behavioral problems in children after LNB. PATIENTS AND METHODS: A total of 20 children between 6 and 16 years of age with an episode of LNB at least 4 month before neuropsychological testing were enrolled in the study and compared with 20 healthy controls. Children with LNB had cranial nerve palsies or meningoencephalitis, immunoglobulin G and immunoglobulin M antibodies for Borrelia burgdorferi in the peripheral blood, pleocytosis in the cerebrospinal fluid (leukocytes > 10 cells/µL) and/or an intrathecal synthesis of antibodies for B. burgdorferi.Neuropsychological tests assessing intellectual skills, memory, and executive functions were used. Two parental questionnaires assessing behavior, psychiatric problems, and executive functions were administered. RESULTS: Intellectual skills, memory, and executive functions of children after an episode of LNB were within the normal range. In the subcategory of working memory, children after an episode of LNB performed worse than controls. The questionnaires did not reveal behavior or psychiatric problems, although there was a tendency that children after an episode of LNB had more physical complaints. CONCLUSION: Neuropsychological deficits resulting from LNB in childhood are rare. Most children had a good cognitive, emotional, and behavioral outcome.

First European multicenter results with a new transcutaneous bone conduction hearing implant system: short-term safety and efficacy.

OBJECTIVE: To investigate safety and efficacy of a new transcutaneous bone conduction hearing implant, over a 3-month follow-up period. STUDY DESIGN: Prospective, single-subject repeated-measures design in which each subject serves as his/her own control. SETTING: Departments of Otolaryngology at 4 hospitals in Germany and Austria. PATIENTS: Subjects were 12 German-speaking adults who suffered from conductive or mixed hearing loss. The upper bone conduction threshold limit was set to 45 dB HL at frequencies between 500 Hz and 4 kHz. INTERVENTION: Implantation of a transcutaneous bone conduction hearing implant. MAIN OUTCOME MEASURES: Subjects' speech perception (word recognition scores and SRT 50%) and audiometric thresholds (air conduction, bone conduction and sound field at frequencies 500 Hz to 8 kHz) were assessed preoperatively, 1 month postoperatively and 3 months postoperatively. The subjects were monitored for adverse events and given a questionnaire to assess their satisfaction levels. RESULTS: Speech perception as measured by word recognition scores and SRT 50% improved on average about 78.8% and 25 dB HL, respectively, 3 months after implantation. Aided thresholds also improved postoperatively at all tested frequencies and continued to improve from 1 to 3 months postoperatively. Air conduction and bone conduction thresholds showed no significant changes, confirming that subjects' residual unaided hearing was not deteriorated by the treatment. Only minor adverse events were reported and resolved by the end of the study. CONCLUSION: The new transcutaneous bone conduction implant was demonstrated to be safe and effective in adults up to 3 months of device use.

Concerto Pin: a novel concept of cochlear implant fixation.

OBJECTIVE: The Concerto Pin is a new cochlear implant system, designed by Med-El to require minimally invasive surgery and to allow greater positional flexibility in its fixation on the skull. The aim of this study was to measure the load needed to displace the implant from a human skull. STUDY DESIGN: This was a laboratory investigation under controlled conditions at the Department of Anatomy, Histology und Embryology, Innsbruck Medical University. METHODS: Using the manufacturer's surgical guidelines, a Concerto Pin cochlear implant was fixed to a fresh skull from a human cadaver. Load was applied to the body of the implant at different positions and measured with a mechanical force gauge. RESULTS: The maximum load of 100N did not cause dislocation of the implant from its position or fracture of the pins. CONCLUSION: The Concerto Pin fixation method for cochlear implants provides a secure skull attachment with a direct mechanical connection between implant and bone. It requires less drilling and no tie-down sutures; surgery should therefore be quicker and less invasive.

Sheep as a large animal model for middle and inner ear implantable hearing devices: a feasibility study in cadavers.

OBJECTIVE: Currently, no large animal model exists for surgical-experimental exploratory analysis of implantable hearing devices. In a histomorphometric study, we sought to investigate whether sheep or pig cochleae are suitable for this purpose and whether device implantation is feasible. METHODS: Skulls of pig and sheep cadavers were examined using high-resolution 128-slice computed tomography (CT) to study anatomic relationships. A cochlear implant and an active middle ear implant could be successfully implanted into the sheep's inner and middle ear, respectively. Correct device placement was verified by CT and histology. The cochlear anatomy of the sheep was further studied by micro-CT and histology. RESULTS: Our investigations indicate that the sheep is a suitable animal model for implantation of implantable hearing devices. The implantation of the devices was successfully performed by access through a mastoidectomy. The histologic, morphologic, and micro-CT study of the sheep cochlea showed that it is highly similar to the human cochlea. The temporal bone of the pig was not suitable for these microsurgical procedures because the middle and inner ear were not accessible owing to distinct soft and fatty tissue coverage of the mastoid. CONCLUSION: The sheep is an appropriate large animal model for experimental studies with implantable hearing devices, whereas the pig is not.

Active middle ear implantation in elderly people: a retrospective study.

OBJECTIVE: To evaluate the outcomes of younger (<60 yr) and older (≥60 yr) patients implanted with the Vibrant Soundbridge (VSB). The aim was to determine if there were differences between groups. METHOD: A retrospective study was used to evaluate all patients who were implanted and fit with a VSB during 2008 and 2009 at the Department of Otorhinolaryngology-Head and Neck Surgery, Medical University Innsbruck. Differences in audiologic, medical, and surgical outcomes between younger and older patients were evaluated. RESULTS: No patients had major complications during or after the surgical procedure. All patients had a good hearing benefit as supported by improvements in hearing thresholds from the preoperative to the postoperative condition in the sound field. There were differences between groups in speech understanding postoperatively; however, the differences were not statistically significant. CONCLUSION: All patients had, independent of age, good audiologic benefit from VSB use. Based on the low risk of medical or surgical complications, the easy use of the hearing implant, audiologic improvements, and potential social benefits, we think that the VSB should be regularly offered to adults with hearing loss, whether they are young or old.

A comparison of outcomes after robotic open extended thymectomy for myasthenia gravis.

OBJECTIVE: The aim of this study was to analyze the effect of the surgical approach on surgical and neurologic outcomes after extended thymectomy for myasthenia gravis. METHODS: A retrospective analysis of the institutional extended thymectomies for myasthenia gravis within the last decade was performed. Patients of group A (open access by total median sternotomy; n=10; 1996-2002) and of group B (video assisted thoracoscopic surgery approach with the da Vinci robotic system; n=9; 2003-2006) did not differ with regard to gender distribution, age, body mass index, American Association of Anaesthetists score and Osserman classification of myasthenia gravis. Primary endpoints were surgical complications and the symptomatic/neurologic outcome of the extended thymectomy. Secondary endpoints were operating times and hospital stay. RESULTS: Median follow-up was 74+/-23 months in group A and 13+/-10 months in group B. Surgical complications occurred in 4 patients in group A (requiring 2 re-interventions) and in 1 patient in group B (p<0.05). The median dose of Pyridostigminbromid was reduced 3 and 6 months postoperatively in group A to 80% and 60% of the preoperative level and in group B to 66% and 60% of the preoperative level, respectively. Within the first postoperative year all patients of group B had an improvement of their disease whereas 2 patients of group A did not benefit from thymectomy or had a worsening of symptoms. Operating times were significantly shorter in group A (110 (42-152) min vs 154 (94-312) min, p<0.05), hospital stay was significantly shorter in group B (5 (4-15) vs 10 (10-23) days, p<0.05). CONCLUSIONS: The results of this small series favour the robotic approach for extended thymectomy for myasthenia gravis in respect of both surgical and early neurologic outcome. However, prospective randomized trials are required to prove a general validity.