Transcutaneous Osseo-integrated Auditory Devices: Analysis of Two Different Implants in Adults With Different Audiological Inclusion Criteria.

OBJECTIVE: To determine and compare audiological and speech/language discrimination results in patients with osteo-integrated auditory devices, by comparing two different systems including different audiological indications in adult population. STUDY DESIGN: Descriptive and analytic, cross-sectional, cohort, and retrospective case review. SETTING: Tertiary referral center. MATERIALS AND METHODS: Fifty patients >14 years old, with conductive, mixed, or unilateral sensorineural hearing loss were compared. The variables studied were the following: pure tone audiometry results, air-bone gap, and the percentage of speech/language discrimination using Disyllabic Word Test. The patients were tested preoperative and 12 months after surgical procedure. Subsequently, a comparative analysis of the both systems was carried out. RESULTS: With both implants, pure tone audiometry results and the difference in auditory thresholds and between the air-bone gap improved significantly. Speech discrimination increased significantly after implantation too. A significant difference was observed after implantation of both devices. Patients implanted with one of the implants showed better audiological results, but no significant differences were found with the other device. So, it was shown that the type of device and the type of hearing loss have no influence on the audiological results or complications. CONCLUSION: Both implants represent a good choice for audiological rehabilitation in patients with transmissive hearing loss, mixed hearing loss, or unilateral sensorineural hearing loss with a high success and low complication rates.

Transeptal suturing - a cost-efficient alternative for nasal packing in septal surgery / Sutura transeptal - uma alternativa custo-benefício para tamponamento nasal em cirurgia do septo

ABSTRACT INTRODUCTION: Nasal packing is routinely used in septal surgery to prevent postoperative bleeding. OBJECTIVE: To demonstrate the possibility of transeptal suture as a safe and effective way to avoid nasal packing and to improve efficiency. METHODS: This is a prospective, descriptive, inferential cost study comprising 92 patients. Two randomized groups of patients were analyzed, one with nasal packing and the other with transeptal suture. RESULTS: In the group of transeptal suture no patient experienced postoperative bleeding, and a statistically significant reduction of pain and headache was demonstrated. At the same time, we improved efficiency by saving on material costs. CONCLUSIONS: Transeptal suture is an effective and safe alternative to classic nasal packing in septal surgery. Moreover, it improves the efficiency of the intervention by saving costs.

Resumo Introdução: O tamponamento nasal é usado rotineiramente na cirurgia septal para evitar sangramentos no pós-operatório. Objetivo: Demonstrar a possibilidade de se realizar uma sutura transeptal como alternativa eficaz e segura ao tamponamento nasal, com melhora na eficiência da intervenção. Método: Este é um estudo prospectivo, descritivo e de custo inferencial, compreendendo 92 pacientes. Dois grupos aleatórios foram estudados: um com tamponamento nasal e o outro com sutura transeptal. Resultado: No grupo de sutura transeptal, nenhum paciente experimentou sangramento no pós-operatório, tendo sido estatisticamente demonstrada uma significante redução de cefaléia e dor. Ao mesmo tempo, houve melhora na eficiência da intervenção, com economia no custo de material. Conclusões: A sutura transeptal é uma alternativa eficaz e segura ao tamponamento nasal clássico. Além do mais, melhora a eficiência da intervenção, economizando no custo de material.

Transeptal suturing - a cost-efficient alternative for nasal packing in septal surgery.

INTRODUCTION: Nasal packing is routinely used in septal surgery to prevent postoperative bleeding. OBJECTIVE: To demonstrate the possibility of transeptal suture as a safe and effective way to avoid nasal packing and to improve efficiency. METHODS: This is a prospective, descriptive, inferential cost study comprising 92 patients. Two randomized groups of patients were analyzed, one with nasal packing and the other with transeptal suture. RESULTS: In the group of transeptal suture no patient experienced postoperative bleeding, and a statistically significant reduction of pain and headache was demonstrated. At the same time, we improved efficiency by saving on material costs. CONCLUSIONS: Transeptal suture is an effective and safe alternative to classic nasal packing in septal surgery. Moreover, it improves the efficiency of the intervention by saving costs.

A comparative study on speech in noise understanding with a direct acoustic cochlear implant in subjects with severe to profound mixed hearing loss.

The aim of this study was to investigate the efficacy of a direct acoustic cochlear implant (DACI) for speech understanding in noise in patients suffering from severe to profound mixed hearing loss (MHL) due to various etiologies compared to the preoperative best-aided condition. The study was performed at five tertiary referral centers in Europe (Belgium, Germany, Poland and Spain). Nineteen adult subjects with severe to profound MHL due to (advanced) otosclerosis, ear canal fibrosis, chronic otitis media, tympanosclerosis or previous cholesteatoma were implanted with a DACI (Codacs™ Investigational Device) combined with a conventional stapes prosthesis. Unaided and aided speech reception scores in quiet and in noise, preoperative and postoperative air and bone conduction thresholds and aided and unaided sound field thresholds were measured prospectively during the study. Subjective benefit analysis was determined through the Abbreviated Profile of Hearing Aid Benefit questionnaire. Quality of life was measured by the Health Utilities Index. All subjects were fitted preoperatively with hearing aids and/or a bone conduction implant on a headband before DACI implantation. This allows direct comparison between different hearing rehabilitation solutions. The mean speech reception threshold in noise improved significantly by 7.9 dB signal-to-noise ratio (SNR) after activation of the DACI compared to the preoperative best-aided condition. For all 19 subjects, a mean postoperative aided speech reception threshold of 2.6 dB SNR (standard deviation: 8.3 dB) was measured. On average, no significant shift in the bone conduction thresholds was noted 4-5 months after implantation. A mean sound field threshold improvement of 46 and 16 dB was measured compared to the preoperative unaided and best-aided condition, respectively. Speech perception tests in quiet showed a mean improvement of the word recognition scores by 65 and 48% at 65 dB SPL compared to the preoperative unaided and best-aided condition, respectively. In summary, DACI provides an effective improvement of the speech perception in noise compared to the best-aided condition in subjects suffering from severe to profound MHL.

Effect of changing pulse rate on profile parameters of perceptual thresholds and loudness comfort levels and relation to ECAP thresholds in recipients of the Nucleus CI24RE device.

The Nucleus CI24RE 'Freedom' device offers higher stimulation rates and lower noise levels in action potential measurements (ECAPs) than previous devices. A study including ten European implant teams showed that the effect of changes in rate from 250 to 3500 pulses per second on tilt and curvature of the T and C profiles is insignificant. When changing rate one may change the levels at all electrodes by the same amount. Using an automated procedure ECAPs could be measured quickly and reliably at a noise level of only 1 microV, this did not result in improved correlations between the tilt and curvature parameters of the ECAP profiles and those of the T and C profiles. Average C levels appear to differ markedly among implant centers; a better assessment protocol is required. When increasing stimulus rate one should take into account that this requires higher pulse charges per second and more power consumption.

An evaluation of the preservation of residual hearing with the Nucleus Contour Advance electrode.

CONCLUSION: Our study results confirm that it is possible to preserve preoperative hearing levels in the majority of subjects when using the Nucleus 24 Contour Advance provided that there is adherence to the major principles of 'soft surgery'. Our study group demonstrated that 71-86% of subjects showed preservation of preoperative hearing thresholds at 6 months to varying degree. OBJECTIVES: The aim of the study was to assess the degree of residual hearing preserved postoperatively in a group of standard cochlear implant (CI) candidates following implantation via soft surgery with a Nucleus 24 Contour Advance CI. Surgical technique variations from the soft surgery guidelines provided were assessed and their potential impact upon the conservation of residual hearing was examined. SUBJECTS AND METHODS: A prospective multicentre study involving a within-subject repeated measures design with each subject acting as their own control was performed. Pure-tone audiometric thresholds were assessed and compared in both implanted and contralateral ears for each subject preoperatively as baseline measures and at 6 months postoperatively. Surgeons were asked to complete a questionnaire to capture various aspects of the surgical technique used for each subject. Variations in the surgical technique performed were examined for potential correlation with conservation of residual hearing. Twenty-eight adult subjects, with a severe to profound hearing impairment, were enrolled in the study across eight implant clinics in four countries. RESULTS: In all, 36% of subjects demonstrated preservation of thresholds to within 10 dB of preoperative thresholds across the frequency range (0.25, 0.5, 1.0, 2.0 and 4.0 KHz) and for the low frequency range (0.25-1.0 KHz). Approximately two-thirds of subjects demonstrated preservation of preoperative thresholds to within 20 dB. Preservation of low frequency thresholds post-implant was shown to correlate moderately with cochleostomy site, being more likely for subjects with a site anterior-inferior to the round window but also possible with inferior locations; weakly with cochleostomy size, being more likely when smaller than 1.2 mm; and also with the use of Healon as a sealant and lubricant. Preservation of hearing thresholds across up to 4000 Hz was shown to correlate weakly with the use of suction following opening of the endostium and with bone dust contamination, both having a negative effect upon preservation, while no correlation was observed with the preservation of thresholds for low frequencies alone.

Serous otitis media in children: implication of Alloiococcus otitidis.

OBJECTIVE: Otitis media with effusion (OME) has long been considered to be a noninfective disease resulting from a eustachian tube dysfunction. However, several microbiological techniques have shown bacteria in the middle ear fluids from patients with OME. Alloiococcus otitidis has been detected in the middle ear fluid from patients with OME. The exact role of this infectious agent in the pathogenesis of OME has yet to be elucidated. STUDY DESIGN: A prospective clinical trial. SETTING: A tertiary university-based referral center. PATIENTS: The inclusion criteria included 110 patients aged between 1 and 12 years. The control group included samples obtained from 30 healthy children undergoing a cochlear implantation. The second group included 40 middle ear effusions (MEEs) that were collected from 40 pediatric OME patients during the placement of the ventilation tube. As for the third group, they were 40 children with acute otitis media. INTERVENTION: The bacterial analysis of the MEE was performed by means of microbiological culture-specific techniques. MAIN OUTCOME MEASURE: Positive cultures for A. otitidis as analyzed by bacteriological analysis of samples from the middle ear mucosa and MEE. RESULTS: Bacteria were present in the culture of 72.5% (29) of the patients with OME. Alloiococcus otitidis was the most frequent bacterium in OME (48.27%) as well as Haemophilus influenzae nonserotype B (17.24%). Streptococcus pneumoniae was the most commonly detected pathogen in acute otitis media (37.5%), and then H. influenzae nonserotype B (25%). For most of the OME cases, only A. otitidis bacteria were isolated. CONCLUSION: We observed a high rate of culture positivity for A. otitidis in patients with clinical OME without suppuration. Further studies are needed to confirm whether the association of A. otitidis with OME represents causality. Antibiotic therapy aimed at A. otitidis is complicated by reported resistance, thus emphasizing the importance of our understanding of the pathogenetic role played by this organism

Residual hearing conservation and electroacoustic stimulation with the nucleus 24 contour advance cochlear implant.

OBJECTIVE: To assess the conservation of residual hearing in recipients of the Nucleus 24 Contour Advance cochlear implant (CI) and the benefits of combined electrical and acoustic stimulation. STUDY DESIGN: Prospective multicenter study. SETTING: CI clinics in Western Europe. PATIENTS: Adult candidates for conventional cochlear implantation with a minimum preoperative word recognition score of 10% in the ear to be implanted. INTERVENTION: "Soft-surgery" protocol, including a 1- to 1.2-mm anterior and inferior cochleostomy hole with the electrode array, inserted 17 mm using the "advance-off-stylet" technique. Patients with postoperative pure-tone hearing threshold levels (HTLs) of 80 dB hearing loss or less at 125 and 250 Hz and 90 dB hearing loss or less at 500 Hz were refitted with an in-the-ear hearing aid for combined ipsilateral electrical and acoustic (El-Ac) stimulation. MAIN OUTCOME MEASURES: A questionnaire to collect information regarding surgery. Pure-tone HTLs measured at intervals. Word recognition tested in quiet and sentence recognition tested in noise at 10 and 5 dB signal-to-noise ratio (SNR). HEARING CONSERVATION RESULTS: HTL data were available for 27 patients. HTLs were conserved within 20 dB of preoperative levels for 33, 26, and 19% of patients for 125, 250, and 500 Hz, respectively. However, the recommended soft-surgery protocol was strictly followed in only 12 of 27 patients. For these 12 patients, hearing thresholds were conserved within 20 dB for 50, 50, and 33% of patients. Median threshold increases were 40 dB (range, 250-500 Hz) for the whole group and 23 dB for the strict surgery group. Ten patients retained sufficient HTLs to enter the El-Ac user group. SPEECH RECOGNITION RESULTS: Group mean recognition scores for nine El-Ac users for words presented at 65 dB sound pressure level were 45% for CI alone and 55% for CI + ipsilateral hearing aid (p < 0.05, paired t). For sentences presented in noise at 5 dB SNR, mean word scores were 46% CI alone and 56% CI + ipsilateral hearing aid (p < 0.01, paired t). CONCLUSION: Hearing was conserved for conventional candidates for cochlear implantation where the recommended soft-surgery protocol was strictly adhered. Combined ipsilateral electrical and acoustic stimulation provided considerable benefits for speech recognition in noise, equivalent to between 3 and 5 dB SNR, compared with CI alone.

Preservation of residual hearing with cochlear implantation: how and why.

CONCLUSIONS: Hearing may be conserved in adults after implantation with the Nucleus Contour Advance perimodiolar electrode array. The degree of hearing preservation and the maximum insertion depth of the electrode array can vary considerably despite a defined surgical protocol. Residual hearing combined with electrical stimulation in the same ear can provide additional benefits even for conventional candidates for cochlear implantation. OBJECTIVES: We present preliminary results from a prospective multicentre study investigating the conservation of residual hearing after implantation with a standard-length Nucleus Contour Advance perimodiolar electrode array and the benefits of combined electrical and acoustic stimulation. MATERIAL AND METHODS: The subjects were 12 adult candidates for cochlear implantation recruited according to national selection criteria. A "soft" surgery protocol was defined, as follows: 1-1.2-mm cochleostomy hole anterior and inferior to the round window; Nucleus Contour Advance electrode array inserted using the "Advance-off-stylet" technique; and insertion depth controlled by means of three square marker ribs left outside the cochleostomy hole. These procedures had been shown to reduce insertion forces in temporal bone preparations. Variations in surgical techniques were monitored using a questionnaire. Pure-tone thresholds were measured pre- and postoperatively. Patients who still retained thresholds <90 dB HL for frequencies up to 500 Hz were re-fitted with an in-the-ear (ITE) hearing aid. Word recognition was tested in quiet and sentence perception in noise for the cochlear implant alone and in combination with an ipsilateral hearing aid. RESULTS: Hearing threshold level data were available for 12 patients recruited from 6 of the centres. Median increases in hearing threshold levels were 23, 27 and 33 dB for the frequencies 125, 250 and 500 Hz, respectively. These median increases include the data for two patients who had total loss of residual hearing due to difficulties encountered during surgery. "Cochlear view" X-ray images indicated that the depth of insertion varied between 300 and 430 degrees, despite modest variations in the length of the electrode inserted (17-19 mm). The insertion angle had some influence on the preservation of residual hearing at frequencies of 250-500 Hz. Six of the 12 patients retained sufficient hearing for effective use of an ipsilateral ITE hearing aid (< or = 80 dB HL at 125 and 250 Hz; < or = 90 dB HL at 500 Hz). Word recognition scores in quiet were improved from 10% to 30% with the cochlear implant plus ipsilateral hearing aid in 3 patients who had at least 3 months postoperative experience. Signal:noise ratio thresholds for sentence recognition were improved by up to 3 dB. Patients reported that they experienced greatly improved sound quality and preferred to use the two devices together.