The vibrating ossicular prosthesis in children and adolescents: a retrospective study.

PURPOSE: The primary objective of the retrospective study was to collect speech intelligibility data on children and adolescents implanted with the vibrating ossicular prosthesis (VORP) 503. METHODS: This was a retrospective, multicentre study on 55 children and adolescents from 6 German clinics aged between 5 and 17 years suffering from mixed or conductive hearing loss implanted with a VORP 503. Pre- and postoperative bone-conduction pure tone thresholds were measured at 0.5, 1, 2 and 4 kHz, and word recognition scores in the unaided and VORP 503-aided conditions using monosyllabic speech intelligibility tests measured at 65-dB sound pressure level (SPL) were determined. RESULTS: Mean pre- and postoperative bone-conduction thresholds remained unchanged, showing the preservation of inner ear hearing. Speech intelligibility assessed in quiet at 65-dB SPL improved on average from 24.5% (SD ± 25.4) unaided to 86.4% (SD ± 13.4) aided. The average improvement of 61.9% (SD ± 25.3) was clinically and statistically significant. A total of three complications were found in the medical records of 55 subjects. The responsible investigators judged these events as procedure related. CONCLUSION: The treatment of children suffering from conductive or mixed hearing loss with the VORP 503 implant demonstrates excellent aided benefit in terms of speech understanding and only minor complications.

Electrogustometry and contact endoscopy findings in patients with head and neck malignancies treated with chemotherapy, radiotherapy, or radiochemotherapy.

This study aimed to investigate in parallel changes in gustatory function, changes in morphology of the fungiform papillae, as well as changes in the shape and density of the vessels of the tip of the tongue in patients treated with chemotherapy, radiotherapy, or radiochemotherapy. Twenty patients (7 females and 13 males; age range: 42-78 years) with head and neck malignancies (hypopharynx, larynx, oropharynx, and parotid) treated with radiochemotherapy (n = 8), chemotherapy (n = 8), or radiotherapy (n = 4) were prospectively studied. In all patients, electrogustometry and contact endoscopy were performed. Radiotherapy-treated patients exhibited higher electrogustometry thresholds and greater alterations in the morphology and vascularization of the fungiform papillae than the other two groups. Radiochemotherapy patients had less pronounced changes of the electrogustometry threshold and fungiform papillae structure compared with radiotherapy patients. Chemotherapy alone caused less severe change in both electrogustometry threshold and fungiform papillae structure than radiotherapy or radiochemotherapy. Radiotherapy alone caused greater disorders of taste-related anatomic parameters and electrogustometry thresholds compared with chemotherapy and combined radiochemotherapy.

Changes in electrogustometry thresholds, tongue tip vascularization, density and form of the fungiform papillae in smokers.

The objective of this study was to evaluate differences in gustatory function in smokers of both sexes and identify any differences in the shape, density and vascularisation of the fungiform papillae (fPap) of smokers' tongue. Additional aim was to investigate any relation between the age, pack years and differences in shape, density, vascularization of fPap and sex. In 166 smokers (81 males, 85 females, age range 20-80 years), divided in age groups, electrogustometry (EGM) thresholds at the chorda tympani area, at the soft palate area and at the area of the vallate papillae were recorded bilaterally. Morphology and density of the fPap and blood vessels' density and morphology at the tip of the tongue were examined using contact endoscopy (CE). EGM thresholds of all smoking subjects tended to increase compared to the non-smoking participants. Morphology, vascularization and density of fPap were found to be worse in smokers than in non-smokers. Interestingly, some participants, despite having increased number of pack years, tended to have almost similar EGM thresholds with non-smoking subjects of the same age group. Smoking tends to affect density, morphology and vascularization of the fPap. There is a correlation between the duration of smoking (pack years) and the afore-mentioned parameters. The use of τ-Kendall criterion provided useful information about the different correlation between the EGM thresholds and vascularization, the EGM thresholds and morphology of fPap and EGM thresholds and density of fPap. The majority of smokers had elevated EGM thresholds compared to non-smokers. Smoking is an important factor which can lead to decreased taste acuity. The combination of methods, such as EGM and CE, can provide useful information about the morphology and function of taste buds. Of interest, women are less affected than men, irrespective of the age group.

Memantine's action against aminoglycoside-induced ototoxicity.

The objectives of this study were (1) to assess the protective role of NMDA antagonists against the ototoxic effects of aminoglycosides, (2) to provide any possible evidence between ototoxicity due to aminoglycosides and excitotoxicity. An animal experiment was conducted. Twenty-eight, 3-month-old female New Zealand rabbits, weighing 1,000-1,500 g, were studied prospectively for 28 days after intramuscular administration of amikacin (15 mg/kg/day divided into two equal doses) for 14 days. Twenty-one rabbits were categorized into three equal treatment groups and seven animals received no medication and served as the control group. The animals of A, B and C groups were injected, intramuscularly, with amikacin 15 mg/kg/day, divided into two equal doses every day for 14 days. Animals of group A received in parallel memantine (per os) and those of group B received p.o. the same volume of placebo solution. The rabbits of the third group (group C) received on the 15th day and every 2 days for the next 2 weeks, until the day 28, memantine of the same quantity as the members of group A. Differences in DPOAE amplitudes, and therefore in cochlear activity, between group A and group B were revealed. DPOAE amplitudes of group B were further reduced compared to the respective amplitudes in rabbits of group A. No improvement was observed in DPOAE measurements performed after the discontinuation of injections. The findings in group C should be examined separately. The measurements showed apparent reversal ototoxic effects in four of the animals. The development of aminoglycoside otoprotective strategies is a primary goal in ototoxicity research. The administration of NMDA antagonists has been shown to prevent, at least to some extent, toxic damage to hair cells in guinea pigs, treated with aminoglycoside antibiotics.

Clinical trial results with the MED-EL fine structure processing coding strategy in experienced cochlear implant users.

OBJECTIVES: To assess the subjective and objective performance of the new fine structure processing strategy (FSP) compared to the previous generation coding strategies CIS+ and HDCIS. METHODS: Forty-six adults with a minimum of 6 months of cochlear implant experience were included. CIS+, HDCIS and FSP were compared in speech perception tests in noise, pitch scaling and questionnaires. The randomized tests were performed acutely (interval 1) and again after 3 months of FSP experience (interval 3). The subjective evaluation included questionnaire 1 at intervals 1 and 3, and questionnaire 2 at interval 2, 1 month after interval 1. RESULTS: Comparison between FSP and CIS+ showed that FSP performed at least as well as CIS+ in all speech perception tests, and outperformed CIS+ in vowel and monosyllabic word discrimination. Comparison between FSP and HDCIS showed that both performed equally well in all speech perception tests. Pitch scaling showed that FSP performed at least as well as HDCIS. With FSP, sound quality was at least as good and often better than with HDCIS. CONCLUSIONS: Results indicate that FSP performs better than CIS+ in vowel and monosyllabic word understanding. Subjective evaluation demonstrates strong user preferences for FSP when listening to speech and music.

Site of cochlear stimulation and its effect on electrically evoked compound action potentials using the MED-EL standard electrode array.

BACKGROUND: The standard electrode array for the MED-EL MAESTRO cochlear implant system is 31 mm in length which allows an insertion angle of approximately 720 degrees . When fully inserted, this long electrode array is capable of stimulating the most apical region of the cochlea. No investigation has explored Electrically Evoked Compound Action Potential (ECAP) recordings in this region with a large number of subjects using a commercially available cochlear implant system. The aim of this study is to determine if certain properties of ECAP recordings vary, depending on the stimulation site in the cochlea. METHODS: Recordings of auditory nerve responses were conducted in 67 subjects to demonstrate the feasibility of ECAP recordings using the Auditory Nerve Response Telemetry (ART) feature of the MED-EL MAESTRO system software. These recordings were then analyzed based on the site of cochlear stimulation defined as basal, middle and apical to determine if the amplitude, threshold and slope of the amplitude growth function and the refractory time differs depending on the region of stimulation. RESULTS: Findings show significant differences in the ECAP recordings depending on the stimulation site. Comparing the apical with the basal region, on average higher amplitudes, lower thresholds and steeper slopes of the amplitude growth function have been observed. The refractory time shows an overall dependence on cochlear region; however post-hoc tests showed no significant effect between individual regions. CONCLUSIONS: Obtaining ECAP recordings is also possible in the most apical region of the cochlea. However, differences can be observed depending on the region of the cochlea stimulated. Specifically, significant higher ECAP amplitude, lower thresholds and steeper amplitude growth function slopes have been observed in the apical region. These differences could be explained by the location of the stimulating electrode with respect to the neural tissue in the cochlea, a higher density, or an increased neural survival rate of neural tissue in the apex. TRIAL REGISTRATION: The Clinical Investigation has the Competent Authority registration number DE/CA126/AP4/3332/18/05.

Advanced cutaneous squamous cell carcinoma: A retrospective analysis of patient profiles and treatment patterns-Results of a non-interventional study of the DeCOG.

BACKGROUND: Advanced cutaneous squamous cell carcinoma (aSCC) is an area of unmet medical need and no treatment standards are established. Recently, an anti-PD-1 inhibitor received FDA breakthrough therapy designation. The aim of the study was to describe the clinical course, therapeutic management and prognosis of aSCC under real-life conditions. PATIENTS AND METHODS: In a retrospective study performed in 24 German and Austrian hospitals and doctor's offices, patient and tumour characteristics of patients diagnosed with aSCC between January 1, 2010 and December 31, 2011 and their disease course was documented. Advanced SCC comprised either locally advanced SCCs (laSCC) or metastatic SCCs (mSCC) with any kind of metastatic spread. RESULTS: Data of 190 patients with aSCC were analysed. Median age at time of diagnosis of aSCC was 78 years. LaSCC was diagnosed in 76 patients (40%), 114 patients (60%) had mSCC. Once diagnosed with laSCC, most patients (59%) did not receive any therapy, whereas in 92% of mSCC patients at least one type of therapy was performed. Only 32 patients (29 mSCC, 3 laSCC) received systemic antitumour therapies, mostly EGFR inhibitor-based regimens. Mean duration of response was short (17-months laSCC patients, 3-months mSCC patients). Only 2 patients achieved a complete response, 27% had a partial response, 43% disease stabilisation. At diagnosis of aSCC, ECOG status was 0-1 in most patients. Non-malignant comorbidities influenced the decision on SCC-specific therapy in 39 patients (21%). CONCLUSIONS: Our data show the high medical need for efficient and tolerable antitumour therapies and demonstrate that despite older age and comorbidities, most patients can be expected to be fit for treatment. This study provides a historical context for emerging aSCC treatments.

DPOAE-grams in patients with acute tonal tinnitus.

OBJECTIVE: To investigate cochlear outer hair cell function in patients with acute tonal tinnitus and normal or near-normal hearing threshold. STUDY DESIGN AND SETTING: Prospective controlled study in an academic tertiary health center. Distortion products of otoacoustic emissions (DPOAE)-grams of 32 ears with acute tonal tinnitus and normal hearing or minimal hearing loss were compared with those of 17 healthy nontinnitus ears. RESULTS: Tinnitus ears exhibited relatively increased amplitudes of DPOAE at high frequencies (4-6.3 kHz) when compared with the group of healthy ears and relatively decreased DPOAE amplitudes at middle frequencies (1650-2400 Hz). Statistically significant ( P < 0.01) increased mean values of DPOAE amplitudes were observed only at a frequency of f2 equal to 4.9 kHz. CONCLUSIONS AND SIGNIFICANCE: These findings suggest an altered functional state of the outer hair cells at a selected high-frequency region of the cochlea in ears with acute tonal tinnitus and normal or near-normal hearing threshold.

Reliability of cochlear implants.

BACKGROUND: The long-term reliability of cochlear implants over time is an important issue for patients and cochlear implant teams. The calculation of cumulative survival rates including all hard failures of cochlear implants is suitable to report objectively about cochlear implant reliability. METHODS: This is a report of 192 cochlear implants from different manufacturers in adults (n = 58) and children (n = 134). RESULTS: The overall cumulative implant survival rate was 91.7% for a period of 11 years. The main reasons for hard failures were design errors of the products and direct or indirect trauma to the cochlea implant site (especially in children) with consecutive breaks of the implant body or electrodes. CONCLUSIONS: To improve our knowledge about reliability of cochlear implants more studies on cumulative long time survival of cochlear implants are needed, where functional failures and complications for whatever reason (design, mechanical, electronic, medical) are included. Cochlear implant reliability data should be considered during the choice of an implant for each individual patient.

Epidural hematoma after cochlear implantation in a 2.5-year-old boy.

OBJECTIVE: Report a case of an epidural hematoma after cochlear implantation in a 2.5-year-old boy, the diagnostic and therapeutical emergency management, as well as the postinterventional course and rehabilitation of the child. STUDY DESIGN: Retrospective case review. PATIENT: Two and a half-year-old boy, suffering from early onset, profound sensorineural hearing loss had been diagnosed at an age of 1.5 years, which had been more severe on the right side initially, but had progressed to bilateral deafness. INTERVENTION AND COMPLICATION: Cochlear implantation on the left side, followed up by an extensive epidural hematoma, causing intracranial compression with a midline shift of 15 mm to the right side. This initial complication was followed up by arterial infarction not only of the middle but also the posterior as well as the anterior cerebral artery, most likely caused by incarceration through the tentorium. RESULTS: After immediate neurosurgical intervention and intensive care treatment including low-dose anticoagulation and high doses of corticosteroids, the child recuperated completely within 3 weeks without any remaining neurologic deficits. CONCLUSION: In cochlear implantation, especially if placement of the implant housing is associated with considerable bone work, epidural hematoma has to be considered as an extremely rare, but life-threatening, complication.

Association of proliferative activity and size in acoustic neuroma: implications for timing of surgery.

OBJECT: Acoustic neuroma is the most frequent benign tumor of the cerebellopontine angle, and surgery is still the most common form of treatment. To gain better insight into the dysregulated mechanisms causing growth of acoustic neuroma, the authors studied the proliferative activity of 34 consecutive samples by analyzing immunohistochemical staining with Ki-67 and proliferating cell nuclear antigen (PCNA), and apoptosis based on the terminal deoxynucleotidyl transferase-mediated deoxyuridine triphosphate nick-end labeling. Data from these analyses were correlated with clinical parameters (that is, tumor size, duration of symptoms, and patient age). METHODS: Apoptotic cells were found in none of the tumors. Proliferation measured on staining with Ki-67 and PCNA correlated with tumor size, but not with patient age or duration of symptoms. The authors demonstrated that tumors 18 mm or smaller in diameter have lower proliferation indices and growth rates, compared with tumors larger than 18 mm with high proliferative indices and growth rates. Additionally, they observed that these more aggressive, larger tumors occur mostly in patients younger than 50 years of age. CONCLUSIONS: Patients with tumors larger than 18 mm in diameter and who are younger than 50 years of age sustain an enhanced risk for fast-growing tumors because of these lesions' enhanced proliferative activity. For these patients the authors recommend active therapy.

Long-term results after interval therapy with intratympanic gentamicin for Menière's disease.

OBJECTIVES: The new single-shot and interval treatment for Menière's disease with gentamicin was designed to avoid cochlear damage during treatment with gentamicin. METHODS: To date, 90 patients were treated with the single-shot or interval gentamicin therapy. Fifty-seven cases of Menière's disease were followed up prospectively between 2 and 4 years. During one treatment series, a maximum of three intratympanic gentamicin injections within 15 days were applied, each consisting of 0.3 mL (12 mg) of gentamicin (days 1, 8, and 15). Thirty of these 57 patients (53%) needed only one injection to be controlled (single-shot treatment). RESULTS: Vertigo attacks were completely controlled in 95% and partially controlled in 5%, whereas hearing remained unchanged or even improved. Tinnitus as well as aural fullness were controlled in approximately 50% of the cases. CONCLUSION: Our results with this group of patients after interval-treatment or single-shot application of intratympanic gentamicin demonstrate the effectiveness of this treatment modality with very low side effects, and, although our experience is still limited, it allows for expanding the indication on early cases of Menière's disease before permanent hearing loss occurs. Even cases of bilateral Menière's disease can be treated successfully using this method. Cochleotoxic side effects can be prevented by treatment intervals of 7 days.

Auditory late cortical response and speech recognition in Digisonic cochlear implant users.

OBJECTIVE: The purpose of the study was to test for differences in late electrically evoked auditory potentials between subjects exhibiting "good" versus "poor" speech recognition performances with their cochlear implants. METHODS: Late auditory evoked responses were measured in 30 subjects equipped with the Digisonic (MXM, Antibes, France) cochlear implant, 15 of whom had "good" speech recognition scores (i.e., more than 89% correct phoneme identification without lip reading). The 15 other subjects had poorer speech recognition scores (i.e., less than 85%). RESULTS: Differences in N1P2 amplitude, as well as P1, N1, and P2 latencies, and N1-P1 and N1-P2 latency intervals were tested. Wave P2 latency was found to be significantly different between the two groups (P =.016), being shorter in "good" than in "poor" performers. The strength of the statistical relationship between electrophysiological and speech recognition variables (r2 = 17%) was substantially smaller than that observed using electrically evoked auditory brainstem response (EABR) for the same implanted device (r2 = 49% for the EABR wave III-V latency interval). CONCLUSIONS: Some characteristics of late electrically evoked auditory potentials differ significantly among cochlear implant users depending on their speech recognition performance. However, the relationship between electrophysiological and speech recognition variables is more pronounced when early (brainstem) rather than late (cortical) evoked responses are considered.

Vestibular function after acoustic neuroma removal with preservation of one branch of the vestibular nerve.

BACKGROUND: Vestibular compensation after acoustic neuroma surgery is affected by many parameters. Apart from surgical approach, age of the patient, and comorbidity, the use of rehabilitative vestibular training and the degree of preoperative vestibular compensation play their respective roles. OBJECTIVE: To examine whether and how surgical preservation of one branch of the vestibular nerve affects the compensation process in patients after acoustic neuroma removal. STUDY DESIGN: Prospective study involving 29 patients with acoustic neuromas. In 15 patients operated on by the middle fossa or retrosigmoid approach, one branch of the vestibular nerve could be preserved intraoperatively, and the course of the compensation process was followed (Group 1). Fourteen other patients with acoustic neuroma, who were operated on via a translabyrinthine approach, served as a control group (Group 2). MAIN OUTCOME MEASURE: The evaluation of vestibular compensation was accomplished clinically, by electronystagmography, and by dynamic posturography. RESULTS: An accelerated vestibular compensation was found in all examinations for Group 1, and 3 months after surgery 47% of the patients in this group were back to work without substantial restrictions, compared with 29% of Group 2. At the end of 6 months, however, there was no more significant difference between the two groups. CONCLUSION: The long-term results of vestibular compensation do not seem to be influenced by partial preservation of the vestibular nerve, whereas the compensation process seems to be accelerated when the nerve is partially preserved.

Expression of angiogenic growth factors in acoustic neurinoma.

OBJECTIVES: Acoustic neurinoma (AN) can grow to a large size, but the growth-promoting molecular pathways remain unknown. As angiogenesis has been described as being activated in many cancers, we undertook this study in order to examine the microvascular network of AN and the expression of angiogenic growth factors and their cognate receptors in AN. The aim was to draw conclusions regarding the underlying mechanisms and potential benefit of a pathway-specific anticancer therapy. MATERIAL AND METHODS: Surgical specimens from 34 patients with AN were analysed immunohistochemically for the expression of vascular endothelial growth factor (VEGF), VEGF-receptor 1 (VEGF-R1), VEGF-receptor 2 (VEGF-R2) and transforming growth factor-beta1 (TGF-beta1). The microvessel density (MVD) was defined using CD31 staining and macrophage infiltration using CD68 staining. MVD was correlated to tumour size, patient age and duration of symptoms. RESULTS: With 1 exception each for VEGF and VEGF-R1, none of the 34 tumours expressed either VEGF, TGF-beta1, VEGF-R1 or -R2. No tumour-infiltrating macrophages were detected. The MVDs determined were low and did not correlate with tumour size, duration of symptoms or patient age. CONCLUSION: These findings indicate that ANs either do not express or express very low levels of the analysed proangiogenic growth factors. We conclude that tumour angiogenesis is not likely to be a relevant mechanism of AN growth and might therefore not be a suitable anticancer therapy target.

Steroid and vasoactive treatment for acute deafness after attempted hearing preservation acoustic neuroma surgery.

OBJECTIVE: To investigate whether intravenous steroid and vasoactive therapy in the acute postoperative period improves hearing outcome in patients who develop acute deafness after attempted hearing preservation surgery for acoustic neuroma (AN) through a retrosigmoid or a middle cranial fossa approach. STUDY DESIGN AND SETTING: Retrospective controlled study in a tertiary care center. Thirty-six patients who had developed acute deafness after hearing preservation surgery for treatment of an AN were reviewed. Preoperative AAOHNS hearing class was A in 2, B in 2 and D in 32 patients. Twenty-seven patients were treated with prednisolone, hydroxyethyl starch 3% and pentoxifylline intravenously for a period of at least 5 days. Nine patients (controls) did not receive any specific steroid or vasoactive therapy. RESULTS: All patients in both groups remained deaf. CONCLUSIONS: Intravenous therapy with prednisolone, hydroxyethyl starch 3% and pentoxifylline in the acute postoperative period does not improve hearing in patients who develop acute deafness after attempted hearing preservation surgery for AN.