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Objective:To present a historical overview of the Vibrant Soundbridge®(VSB) middle ear implant (MEI), since its beginning in the 1990s to date and to describe its course and contemplate what it might become in the future. History:MEIs started to take form in researchers’ mind in the 1930s with the first experiment of Wilska. In the 1970s, several devices, such as the Goode and Perkins’, the Maniglia’s, or the Hough and Dormer’s were created but remained prototypes. It is only in the 1990s the devices that emerged remained on the market. In 1994, Symphonix, Inc. was created and aimed to manufacture and commercialize its semi-implantable MEI, the VSB. The principle of the VSB lies on a direct drive of the sound to a vibratory structure of the middle ear through an electromagnetic transducer, the floating mass transducer (FMT). The particularity of the system VSB is the simplicity of the transducer which is made of both the magnet and the coil; thus, the FMT, fixed on a vibrating middle ear structure, mimics the natural movement of the ossicular chain by moving in the same direction. The goal of the VSB was to give an alternative to patients with mild-to-severe sensorineural hearing loss who could not wear hearing aids (HAs) or who were unsatisfied conventional HA users. Subsequent to Tjellström’s experiment in 1997, implantations started to include etiologies such as otosclerosis, radical mastoidectomy, failed ossiculoplasty/tympanoplasty, and atresia. Nowadays, the VSB, with more than 20 years of experience, is the oldest and most used middle ear implant worldwide. It is well acknowledged that the straightforward design and reliability of the transducer have certainly contributed to the success of the device. [ABSTRACT FROM PUBLISHER]

Conclusion: The comprehensive Hearing Preservation classification system presented in this paper is suitable for use for all cochlear implant users with measurable pre-operative residual hearing. If adopted as a universal reporting standard, as it was designed to be, it should prove highly beneficial by enabling future studies to quickly and easily compare the results of previous studies and meta-analyze their data. Objectives: To develop a comprehensive Hearing Preservation classification system suitable for use for all cochlear implant users with measurable pre-operative residual hearing. Methods: The HEARRING group discussed and reviewed a number of different propositions of a HP classification systems and reviewed critical appraisals to develop a qualitative system in accordance with the prerequisites. Results: The Hearing Preservation Classification System proposed herein fulfills the following necessary criteria: 1) classification is independent from users' initial hearing, 2) it is appropriate for all cochlear implant users with measurable pre-operative residual hearing, 3) it covers the whole range of pure tone average from 0 to 120 dB; 4) it is easy to use and easy to understand. [ABSTRACT FROM AUTHOR]

Conclusion: The comprehensive Hearing Preservation classification system presented in this paper is suitable for use for all cochlear implant users with measurable pre-operative residual hearing. If adopted as a universal reporting standard, as it was designed to be, it should prove highly beneficial by enabling future studies to quickly and easily compare the results of previous studies and meta-analyze their data. Objectives: To develop a comprehensive Hearing Preservation classification system suitable for use for all cochlear implant users with measurable pre-operative residual hearing. Methods: The HEARRING group discussed and reviewed a number of different propositions of a HP classification systems and reviewed critical appraisals to develop a qualitative system in accordance with the prerequisites. Results: The Hearing Preservation Classification System proposed herein fulfills the following necessary criteria: 1) classification is independent from users' initial hearing, 2) it is appropriate for all cochlear implant users with measurable pre-operative residual hearing, 3) it covers the whole range of pure tone average from 0 to 120 dB; 4) it is easy to use and easy to understand. [ABSTRACT FROM AUTHOR]

Efficacy of the SPEAK and ACE coding strategies was compared with that of a new strategy, MP3000™, by 37 European implant centers including 221 subjects. The SPEAK and ACE strategies are based on selection of 8-10 spectral components with the highest levels, while MP3000 is based on the selection of only 4-6 components, with the highest levels relative to an estimate of the spread of masking. The pulse rate per component was fixed. No significant difference was found for the speech scores and for coding preference between the SPEAK/ACE and MP3000 strategies. Battery life was 24% longer for the MP3000 strategy. With MP3000 the best results were found for a selection of six components. In addition, the best results were found for a masking function with a low-frequency slope of 50 dB/Bark and a high-frequency slope of 37 dB/Bark (50/37) as compared to the other combinations examined of 40/30 and 20/15 dB/Bark. The best results found for the steepest slopes do not seem to agree with current estimates of the spread of masking in electrical stimulation. Future research might reveal if performance with respect to SPEAK/ACE can be enhanced by increasing the number of channels in MP3000 beyond 4-6 and it should shed more light on the optimum steepness of the slopes of the masking functions applied in MP3000. [ABSTRACT FROM AUTHOR]

Conclusion. Achieving deep insertions, as well as good speech perception results, the FLEX(soft) electrode array allows for some preservation in subjects with measurable low frequency hearing, even after a period of time. This opens the door for future research in electrode design, hearing preservation research and drug delivery systems. Objectives. The FLEX(soft) electrode is designed to be atraumatic to the structures of the cochlea during deep insertion of a cochlear implant electrode. This paper reports on the surgical and functional outcomes in implantations with the FLEX(soft) electrode array. Patients and methods. Twenty-three adult subjects received a FLEX(soft) electrode array and were assessed on speech perception tests (monosyllables, sentences in quiet and in noise), a subjective questionnaire (Nijmegen Cochlear Implant Questionnaire) and a pure-tone audiogram. Results at 1, 3, 6 and 12 months post first fitting were compared to scores from the preoperative interval. Results. Surgery was uneventful in all cases, the surgical handling was satisfactory and correct position of the electrode was achieved in all cases. Hearing could be preserved (as determined by the audiogram) in half of the subjects who had measurable audiograms preoperatively at the 1 month test interval, and in a quarter of subjects after 12 months of device use, despite deep insertion of the electrode. Speech perception scores showed significant improvement over time, as did quality of life scores, and were comparable to results with the standard electrode array as used in the COMBI 40+ and PULSARCI(100). [ABSTRACT FROM AUTHOR]

Conclusion: The preliminary results suggest that in chronic unilateral tinnitus the contralateral amygdalohippocampal complex does seem to be involved in tinnitus perception of pure tones. Objectives: Functional neuroimaging studies have revealed that the hippocampus and amygdala are involved in tinnitus perception. The amygdala and hippocampus are supplied by the anterior choroidal artery. Selective amobarbital injections in the anterior choroidal artery result in a non-functional amygdalohippocampal area for 10 min. The aim of this study was to assess the influence of this procedure on tinnitus perception. Patients and methods: Amobarbital (80 mg in total) was injected selectively in two sessions in the left and right anterior choroidal artery in six male patients with tinnitus: four with unilateral tinnitus, two with bilateral tinnitus. Of the patients with unilateral tinnitus, three had right-sided tinnitus and one had left-sided tinnitus. The average age was 57.3 years (range 43-69). Average tinnitus duration was 5.3 years (range 1-10). The differences in visual analogue scale (VAS) scores before and after the amytal tests were analysed. Results: Amytal injection ipsilateral to the side where the tinnitus was perceived resulted in a maximum of 30% tinnitus suppression, whereas amytal injection contralateral to the tinnitus side yielded a 60-70% tinnitus suppression in three patients with unilateral chronic tinnitus (>4 years). Only pure tone tinnitus was suppressed, white noise was not. Two patients with bilateral tinnitus had no suppression, irrespective of the tinnitus type. A third patient without clinical tinnitus suppression had tinnitus of more recent origin (1.5 years). [ABSTRACT FROM AUTHOR]

CONCLUSION: This histo-morphometric study shows a significant reduction in the distance between the blood vessel's centre and the basal membrane of the middle ear cleft mucosa during inflammatory process. This could suggest that gaseous exchange is faster and more abundant in inflamed mucosa. The distance is significantly shorter in the postero-superior compartment of the middle ear cleft, possibly favouring a specific gas exchange function. OBJECTIVES: The aim was to try to understand the morphologic changes that occur when the middle ear cleft mucosa suffers from chronic inflammation. MATERIALS AND METHODS: Light microscopic computerized morphometry was used to measure the distance between the centre of the blood vessels and the basement membrane of the middle ear cleft mucosa. RESULTS: In inflammation, the distance from blood vessel to mucosa is reduced in all five regions of the middle ear cleft. This distance is statistically the shortest in the postero-superior compartment of the middle ear cleft. [ABSTRACT FROM AUTHOR]

Conclusion . Our data indicate that Meniett therapy is unlikely to be helpful in the long-term treatment of patients with severe, drug-resistant Ménière's disease (MD) in whom injection of intratympanic gentamicin (ITG) or another destructive procedure would otherwise be performed. Objective . To investigate the value of Meniett therapy in patients with drug-resistant MD referred for injection of ITG. Material and methods . Twelve patients referred for ITG treatment were followed during a 2-month period of Meniett therapy. Symptoms, functional level and hearing status were evaluated using a standardized staging system. Disease-specific quality-of-life measures were obtained before and after Meniett therapy. At the end of the study period, patients were followed for a mean of 37 months, thus providing long-term outcome data. Results . In two patients, Meniett treatment was interrupted after 1 month because of persistent severe vertigo. In the remaining 10 subjects, we found a significant decrease in the median number of vertigo spells from 10.0/month (25th–75th percentile 4.0–19.0) prior to treatment to 3.0/month (25th–75th percentile 1.5–4.5) after treatment ( p =0.02). There was, however, no improvement in hearing status, tinnitus, functional level or self-perceived dizziness handicap. Long-term (>1 year) follow-up data revealed that only 2 subjects preferred to continue Meniett therapy and that ablative surgery had to be performed in 6/12 study patients. [ABSTRACT FROM AUTHOR]

Temperature-controlled radiofrequency tissue volume reduction of the soft palate has been introduced as a minimally invasive, outpatient procedure for the treatment of habitual snoring and mild obstructive sleep apnea. A prospective, non-randomized multi-center European clinical study was conducted to investigate the efficacy of Somnoplasty in reducing snoring. Each patient underwent a pre- and post-treatment full-night polysomnography. TCRFe of the soft palate (1 midline lesion/session) was carried out under local anesthesia with a maximum of 3 consecutive treatment sessions. Forty-five, nonapneic snorers (RDI 5.1 +/- 4.3, BMI 26.6 +/- 3.2 kg/m2) completed the protocol. A mean of 692.3 +/- 67.7) J was delivered/treatment session. There was a significant improvement in the snoring index 7.6 (+/- 2.1 ) vs 4.1 (+/- 2.9). p < 0.001 and in the Epworth Sleepiness Score 8.5 (+/- 5.0) versus 6.0 (+/- 4.3), p = 0.001. No major adverse events were reported and postoperative pain was minimal. Overall, 45% of patients had a post-treatment snoring index < 3 (success) and 84% of the patients reported an improvement in snoring. It was concluded that Somnoplasty, following a protocol with I midline lesion of maximal 700 J/lesion for 1-3 treatment sessions, improves snoring in the majority of patients. Further studies are required to investigate whether treatment efficacy can be improved by utilizing multiple lesions/session or by increasing the amount of energy/lesion. The absence of serious adverse events and the findings of minimal postoperative pain support the use of TCRFe (Somnoplasty) as a minimally invasive surgical procedure for snoring. [ABSTRACT FROM AUTHOR]

A review of the literature on drug therapy for Ménière's disease was made using Medline to search for all publications between January 1978 and September 1998. A total of 152 publications were identified that specifically dealt with medical treatment for Ménière's disease. Only betahistine and diuretics appear to have proven efficacy in double-blind studies on the long-term control of vertigo. No treatment has a proven beneficial effect on hearing levels or on the long-term evolution of the disease. Recent publications have proposed a role for the intratympanic use of medication, mainly aminoglycosides, for control of vertigo. We conclude this review by proposing a strategy for the medical treatment of Ménière's disease. [ABSTRACT FROM AUTHOR]

Mesna (Mistabron[sup ®]) is a mucolytic substance that is also used for chemically assisted dissection during cholesteatoma surgery. The present animal study aims to evaluate its possible ototoxic side effects. To this end, the right tympanic cavity of 9 guinea pigs was filled with either 20% mesna or 10% neomycin (serving as a positive control), while the left tympanic cavity was filled with saline (serving as a negative control). One week after administration, the inner ears were dissected out and further processed for morphological evaluation by means of either interference contrast microscopy or scanning electron microscopy. No macroscopic signs of middle ear inflammation were observed in any of the ears treated. Whereas damage was obvious in all neomycin-treated specimens, the morphology of both saline- and mesna-treated inner ears was unaffected. These findings led us to conclude that, at least on a morphological basis, no indications are at hand to assume ototoxic effects of this mucolytic substance due to a single application during cholesteatoma surgery. [ABSTRACT FROM AUTHOR]

Conclusion: Flupirtine, a functional NMDA antagonist, does not seem to be efficacious in the treatment of tinnitus. Objectives: The purpose of this study was to investigate whether flupirtine has any beneficial effect on tinnitus perception. Patients and methods: Twenty-four patients were selected (6 female and 18 male patients) with continuous subjective tinnitus. Eight patients suffered left-sided tinnitus, 4 right-sided tinnitus and 12 bilateral tinnitus. We assessed the burden of the tinnitus by loudness visual analogue scale (VAS) and tinnitus questionnaire (TQ) according to Hallam et al., and Hiller and Goebel. All patients were treated with a 2×100 mg daily dosage of oral flupirtine for 3 weeks in an open prospective design. Results: There was no statistical effect on VAS and TQ of the treatment with flupirtine. Only one patient (4.2%) experienced a positive effect on the tinnitus but discontinued the treatment because of amnesia and concentration disorders. [ABSTRACT FROM AUTHOR]

The influence of two static head positions on the horizontal nystagmus induced by sinusoidal rotational stimulation in a group of 24 healthy subjects was investigated. The rotation test was performed with the subject's head in the primary position (upright) and with the head 30° pitched down. Computerized electronystagmography was used to measure the maximum slow component velocity of the horizontal nystagmus and to calculate gain, phase and asymmetry. The vestibulo-ocular reflex (VOR) gain obtained during rotation with the head in the primary position was significantly higher than with the head bent 30° forward. No other significant differences were found. [ABSTRACT FROM AUTHOR]