Improving quality of life in the elderly: hearing loss treatment with cochlear implants.

BACKGROUND: Hearing loss impacts health-related quality of life and general well-being and was identified in a Lancet report as one of the largest potentially modifiable factors for the prevention of age-related dementia. There is a lack of robust data on how cochlear implant treatment in the elderly impacts quality of life. The primary objective was to measure the change in health utility following cochlear implantation in individuals aged ≥ 60 years. METHODS: This study uniquely prospectively recruited a large multinational sample of 100 older adults (mean age 71.7 (SD7.6) range 60-91 years) with severe to profound hearing loss. In a repeated-measures design, pre and post implant outcome measures were analysed using mixed-effect models. Health utility was assessed with the Health Utilities Index Mark III (HUI3). Subjects were divided into groups of 60-64, 65-74 and 75 + years. RESULTS: At 18 months post implant, the mean HUI3 score improved by 0.13 (95%CI: 0.07-0.18 p < 0.001). There was no statistically significant difference in the HUI3 between age groups (F[2,9228] = 0.53, p = 0.59). The De Jong Loneliness scale reduced by an average of 0.61 (95%CI: 0.25-0.97 p < 0.014) and the Lawton Instrumental Activities of Daily Living Scale improved on average (1.25, 95%CI: 0.85-1.65 p < 0.001). Hearing Handicap Inventory for the Elderly Screening reduced by an average of 8.7 (95%CI: 6.7-10.8, p < 0.001) from a significant to mild-moderate hearing handicap. Age was not a statistically significant factor for any of the other measures (p > 0.20). At baseline 90% of participants had no or mild depression and there was no change in mean depression scores after implant. Categories of Auditory perception scale showed that all subjects achieved a level of speech sound discrimination without lip reading post implantation (level 4) and at least 50% could use the telephone with a known speaker. CONCLUSIONS: Better hearing improved individuals' quality of life, ability to communicate verbally and their ability to function independently. They felt less lonely and less handicapped by their hearing loss. Benefits were independent of age group. Cochlear implants should be considered as a routine treatment option for those over 60 years with bilateral severe to profound hearing loss. TRIAL REGISTRATION: ClinicalTrials.gov ( http://www. CLINICALTRIALS: gov/ ), 7 March 2017, NCT03072862.

An innovative method for trans-impedance matrix interpretation in hearing pathologies discrimination.

Trans-impedance measurement is a novel methodology for assessing the positioning of a cochlear implant (CI). This study proposes an innovative use of trans-impedance measurements to characterize specific hearing pathologies by means of the trans-impedance matrix (TIM) quantitative analysis. Three indices are used: Shannon Entropy, the Exponential Decay constant and Spatial Correlation. These indices were computed on the TIMs of two groups of patients, clustered in terms of hearing pathology: (i) congenital hearing loss (CONG) and (ii) otosclerosis (OTO). The study aimed to demonstrate the sensitivity of the above synthetic indices in relation to the considered hearing pathologies. Furthermore, the first two indices were employed to explore the influence of the positioning of the electrode, either over (i) the basal or (ii) the apical regions, on the TIMs patterns. The results suggest that the indices were statistically different for the patient groups and the positioning impacted solely on OTO patients. In particular: (i) CONG patients displayed significantly higher Shannon Entropy (p = 0.0002) and (ii) a lower Exponential Decay constant than OTO patients (p = 0.001); (iii) the OTO patients exhibited a lower Shannon Entropy and a higher Exponential Decay constant over the basal regions than the apical regions (p < 0.008); (iv) Spatial Correlation demonstrated that TIMs had specific patterns according to the hearing pathology (p < 0.008).

Healthy aging in elderly cochlear implant recipients: a multinational observational study.

BACKGROUND: Given an increase in the aging population and its impact on healthcare systems, policy makers for provision of health and social services are aiming to keep older adults in good health for longer, in other words towards 'healthy aging'. Our study objective is to show that rehabilitation with cochlear implant treatment in the elderly with hearing impairment improves the overall health-related quality of life and general well-being that translate into healthy aging. METHODS: The multicentre, prospective, repeated measures, single-subject, clinical observational study will accrue 100 elderly, first-time, unilateral CI recipients (≥ 60 years) and analyze changes on specific measurement tools over ca. 20 months from preimplant to postimplant. Evaluations will consist of details collected through case history and interview questionnaires by clinicians, data logging, self-report questionnaires completed by the recipients and a series of commonly used audiometric measures and geriatric assessment tools. The primary indicator of changes in overall quality of life will be the HUI-3. DISCUSSION: The protocol is designed to make use of measurement tools that have already been applied to the hearing-impaired population in order to compare effects of CI rehabilitation in adults immediately before their implantation, (pre-implant) and after gaining 1-1.5 years of experience (post-implant). The broad approach will lead to a greater understanding of how useful hearing impacts the quality of life in elderly individuals, and thus improves potentials for healthy aging. Outcomes will be described and analyzed in detail. TRIAL REGISTRATION: This research has been registered in ClinicalTrials.gov (http://www.clinicaltrials.gov/), 7 March 2017 under the n° NCT03072862 .

Early prelingual auditory development in Italian infants and toddlers analysed through the Italian version of the Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS).

PURPOSE: To evaluate the reliability and validity of the Italian version of the Infant-Toddler Meaningful Auditory Integration Scale (I-IT-MAIS), and to assess the normal trajectory of early prelingual auditory (EPLAD) development from birth to 24 months in a group of normal-hearing Italian children using the I-IT-MAIS. METHODS: The study consisted of four phases: item generation, reliability analysis, assessment of the normal trajectory for EPLAD, and validity analysis. A group of 120 normal-hearing children and a group of 31 deaf children wearing hearing aids and on a waiting list for cochlear implantation were enrolled. All the parents completed the I-IT-MAIS. Sixty of them completed the I-IT-MAIS twice, 2 weeks apart, for test-retest reliability analysis. The I-IT-MAIS scores were used to assess the normal trajectory of EPLAD development from birth to 24 months in normal-hearing children. For criterion validity analysis, the I-IT-MAIS scores were correlated with production of infant scale evaluation (PRISE) scores in 60 normal-hearing children. For discriminant validity analysis, the I-IT-MAIS scores obtained in normal and deaf children were compared. RESULTS: Internal consistency of I-IT-MAIS was satisfactory as well as individual item reliability, test-retest reliability, and discriminant validity. EPLAD development in normal-hearing Italian-speaking children was evaluated. As far as the criterion validity of the I-IT-MAIS is concerned, a strong correlation between I-IT-MAIS and PRISE scores was found. CONCLUSION: I-IT-MAIS is reliable and valid. Its application is recommended for clinical practice and outcome research.

Cochlear implantation in delayed sudden hearing loss after conservative vestibular schwannoma surgery.

This is a case of successful cochlear implantation in a 50-year-old man who experienced sudden hearing loss and developed ipsilateral severe tinnitus at three years following conservative stage 1 vestibular schwannoma retrosigmoid surgery. After cochlear implantation, tinnitus improved from THI grade 4 to 2. Localisation skills improved. Hearing in noise (S/N + 7 dB) with target signal from the operated side improved from 38 to 100% of correct answers. A significant improvement of spatial and speech items of the "speech, spatial and qualities of sounds" questionnaire was also measured. In conclusion, cochlear implantation is a feasible and effective solution after conservative vestibular schwannoma surgery should delayed hearing loss occur.

Focused tight dressing does not prevent cochlear implant magnet migration under 1.5 Tesla MRI.

We report a retrospective case of inner magnet migration, which occurred after 1.5 Tesla MRI scanning in an adult recipient of a bilateral cochlear implant (CI) despite a focused head dressing. The patient, bilaterally implanted with Nucleus 5 CIs (Cochlear LTD, Sydney, Australia), underwent a 1.5 Tesla cholangio-MRI scan for biliary duct pathology. In subsequent days, a focal skin alteration appeared over the left inner coil. Plain skull radiographs showed partial magnet migration on the left side. Surgical exploration confirmed magnet twisting; the magnet was effectively repositioned. Left CI performance was restored to pre-migration level. The wound healed without complications. Thus, focused dressing does not prevent magnet migration in CI recipients undergoing 1.5 Tesla MRI. All patients should be counselled on this potential complication. A minor surgical procedure is required to reposition the magnet. Nevertheless, timely diagnosis is necessary to prevent skin breakdown and subsequent device contamination. Plain skull radiograph is very effective in identifying magnet twisting; it should be performed systematically after MRI or minimally on all suspected cases.

Analysis of the impact of professional involvement in evidence generation for the HTA Process, subproject "cochlear implants": methodology, results and recommendations.

The aim of Health Technology Assessment (HTA) is to provide decision-makers, distributors and recipients with information on the effectiveness, cost and impact of health technologies. The present study constitutes a subproject within the wider project "Analysis of the impact of professional involvement in evidence generation for the HTA process", which is part of the strategic programme "Transfer of the results of the research in clinical practice and organisation of healthcare services", coordinated by Laziosanità - Agency of Public Healthcare of the Lazio Region and AgeNaS (National Agency for Regional Healthcare Services). The objectives of the present subproject (cochlear implants) are as follows: a) to produce a report regarding the health impact of cochlear implants (CI) on their recipients, through a systematic review of literature and extensive selection of relative studies, combining the outcomes with metanalytical techniques. Output: report on the indications of usage in the groups of population for which benefits are controversial; b) to create a registry of patients using cochlear implants. The registry should contain a selection of anagraphic and clinical information relative to patient follow-up in order to assess factors associated with safety and impact on cochlear implant users. This source of information is essential for future observational studies. This was divided into 4 phases: 1(st) phase: definition of key participants in the assessment process; 2(nd) phase: definition of methods and timing of "Aims" (definition of the objective); 3(rd) phase: definition of the methods and times of the "assessment process", 4(th) phase: production of the final report. From the analysis of systematic reviews and italian and international guidelines, the Working Group members approved recommendations on the following topics: results after CI in children in relation to age at implantation, bilateral CI in children, CI in deaf children with associated disabilities, CI in adults with advanced age, bilateral CI in adults and CI in adults with pre-lingual deafness. These recommendations have also been evaluated by the Consulting Committee members and approved with minimal suggestions.

Systematic review of the literature on the clinical effectiveness of the cochlear implant procedure in adult patients.

The aim of this systematic review was to summarize the results of scientific publications on the clinical effectiveness of the cochlear implant (CI) procedure in adults. The members of the Working Group first examined existing research evidence from the national and international literature and main international guidelines. They considered as universally accepted the usefulness/effectiveness of unilateral cochlear implantation in severely-profoundly adult patients. Accordingly, they focused their attention on the systematic reviews addressing clinical effectiveness and cost/efficacy of CI procedures, with particular regard to the most controversial issues for which international consensus is still lacking. The following aspects were evaluated: monolateral CI in advanced-age adult patients; bilateral (simultaneous/sequential) CI vs. unilateral CI and vs. bimodal stimulation; benefits derived from the monolateral CI procedure in adult patients with prelingual deafness. With regard to CI in elderly patients, the selected studies document an improvement of the quality of life and perceptive abilities after CI, even if the benefits were found to be inferior in patients over 70 years at the time of surgery. Thus, from the results of the studies included in the review, advanced age is not a contraindication for the CI procedure. With respect to unilateral CI, bilateral CI offers advantages in hearing in noise, in sound localization and less during hearing in a silent environment. However, high interindividual variability is reported in terms of benefits from the second implant. With regard to CI in prelingually deaf adults, the selected studies document benefits deriving from the CI procedure in terms of improvement of perceptive abilities and in the quality of life after CI, as well as subjectively perceived benefits. However, there is high interindividual variability and the study sample is limited.

A registry for the collection of data in cochlear implant patients.

The need to optimize the use of all the information that modern technological tools have made available to the physician ENT/audiologist has increasingly emerged within the Italian scientific community. Towards this purpose, it is necessary to create a registry of the patients using cochlear implants (CIs). This registry will include a homogeneous summary of the information deriving from multiple sources related to daily clinical practice, in order to assess auditory benefits, safety and reliability in patients with cochlear implants, and organization over the national territory. The primary objectives relative to the above-mentioned analysis are to assess the impact of the use of cochlear implants on patient health, to ensure traceability of the devices currently used, monitoring their safety and reliability over time, to guarantee access of the technique in clinical and organizational conditions that can allow the best possible benefits. The aspects concerning implementation of the registry were discussed extensively during the first meetings of the Working Group (WG). In particular, owing to the complexity and high costs related mainly to the development of the technological aspects and the need to involve technological partners external to the WG, and to respect current privacy laws, the WG members decided that the project should be limited to proposal of a paper registry to be implemented at a later stage, possibly within the framework of successive research projects. During meetings, the WG members discussed various aspects of implementation of the registry, and in particular the scientific features connected to objectives, inclusion criteria, and structure of the forms needed for data collection and organizational aspects. A registry is proposed herein.

Cochlear implantation with Pulsar Med El: a novel small incision technique.

Although still widely implanted, Pulsar Med-El is rarely considered for small incision approach. Overall, 30 teen-age and adult patients were operated upon with a novel small incision (4-5 cm). Full insertion of the electrode array was achieved in all cases. No major intra-operative complications occurred. At follow-up, no flap-related complications and no migration of the receiver-stimulator were observed in the "device suture" (14 patients) or "no device suture" groups (16 patients). All patients are full-time users of the device. In conclusion, a small incision for the Pulsar Med-El cochlear implant is feasible, safe and reproducible. Ligature fixation of the device is not critical with this operation. Also with this device, in adult and teen-age patients, it is, therefore, possible to retain several typical advantages of small incision approaches.

Transmission electron microscopic pathoanatomy of congenital trigger thumb.

Previous studies of trigger digits in children have been limited to gross morphology and light-microscopic histology. Nine children with 11 trigger thumbs formed a preliminary study group for electron-microscopic evaluation of tendon nodules and A-1 pulleys. This pathoanatomic investigation was not previously reported. Comparison was made with light-microscopic sections. Large amounts of mature collagen was observed. Fibroblasts with prominent rough endoplasmic reticulum were present. No degenerative or inflammatory changes were noted in either tendon or sheath. We believe that although the etiology of trigger digits is still uncertain, an infectious, inflammatory, or degenerative process is unlikely.

[Nasal packing and antibiotic prophylaxis in septoplasty: a controlled study]. / Tamponamento nasale e profilassi antibiotica nella settoplastica: uno studio controllato.

Systematic use of preoperative antibiotic prophylaxis (PAP) and nasal packing (NP) in septoplasty-both directly and indirectly affecting the cost of surgery (length of hospitalization)-appear based on controversial scientific data and, at times, even on unjustified clinical "habits". A controlled study was thus performed on 100 adults undergoing exclusive nasal septoplasty to determine whether these techniques are actually useful. The subjects were randomly divided into four groups: TN-PAP-(29 subjects), TN-PAP+ (25 subjects), TN+ PAP- (21 subjects) and TN+ PAP+ (25 subjects). Surgery was always performed by the same surgeon and was concluded with continuous suture of the mucoperichondrial layers. Only one patient (TN-PAP-) presented complications of infection (vestibulitis). Three patients in the TN- group required nasal packing a few hours after surgery because of moderate bleeding. As of three months after surgery no other complications had arisen. Postoperative pain, evaluated on an analogicalvisual scale, was higher during the 12 hours after surgery. Analysis of variance showed that the only pain-related factor was nasal packing while PAP and the interaction between TN and PAP did not prove significant. The above results suggest that PAP and TN should not be systematically used, thus reducing the hospitalization period for septoplasty to the day of surgery (Day surgery).

[Elaboration of a hearing disability scale]. / Elaborazione di una scala di disabilità uditiva.

On the basis of a previous pilot study a multiple-choice questionnaire about hearing disabilities was developed. The questionnaire (SDU) allowed 20 items. The answers were tailored to the single question and scaled in increasingly order of disability (form A) or in random order (form B). Modalities of administration (self-report or interview) and form (A or B) were randomized in a group of 123 adult subjects with different degree of hearing impairment. Only one factor, attributable to hearing disability, was extracted by a factor analysis. This factor explains a major variance ratio of items related to speech perception in difficult listening context. A good correlation (r = .74) was found between SDU total score and hearing threshold in the better ear. No difference in mean score, variance and time of reduction of the SDU was found between form A and B. The Authors so propose the use of form A because of a more easy compute of the total score. Self-report was more time-consuming respect to interview (11.7' vs. 8.4'). Furthermore, self-report was non possible in 13.8% of subjects for severe virus impairment and illiteracy and in 6.1% some form of support was necessary. No difference of mean score and variance between self-report and interview was found. SDU represents a tool for hearing disability evaluation useful in aural rehabilitation protocols. The principal advantage is high applicability thanks to short time required, simplicity of task and flexibility in the modality of administration.

[Elaboration of the hearing disability scale]. / Elaborazione di una scala delle disabilità uditive.

On the basis of a previous pilot study, a multiple-choice questionnaire regarding hearing disabilities was developed. The questionnaire (SDU) was made up of 20 items. The answers were tailored to the single question and scaled according to the increasing degree of disability (form A) or in random order (form B). Administration modality (self-report or interview) and form (A or B) were randomized in a group of 123 adult subjects with different degrees of hearing impairment. Only one factor, attributable to hearing disability, was extracted by factor analysis. This factor explains a major variance ratio of items related to speech perception in difficult listening context. A good correlation (r = .74) was found between SDU total score and hearing threshold in the better ear. No difference in mean score, variance and necessary scoring time of the SDU was found between form A and B. The Authors thus propose the use of form A because of a more easy computation of the total score. Self-report was more time consuming with respect to interview (11.7' vs. 8.4'). Furthermore, self-report was non possible in 13.8% of subjects for severe sign impairment and illiteracy and in 6.1% some form of support was necessary. No difference in mean score and variance between self-report and interview was found. SDU represent a tool for hearing disability evaluation useful in aural rehabilitation protocols. The principal advantage is high applicability thanks to the short time required, simplicity of task and flexibility of administration modality.

[The variability of functional gain and insertion gain in hearing aid fitting]. / Variabilità del guadagno funzionale e del guadagno di inserzione nell'adattamento protesico.

Functional gain (FG) and insertion gain (IG) are currently used as real ear gain measurement of hearing aids. The gain differences observed with hearing aid modifications made in order to achieve the desired prescriptive target must be greater than the variability associated with repetition of measurement in order to be really useful. Limited research is available on FG and IG intratester variability. In order to evaluate single variability factors, some studies use experimental designs not common in clinical work-up while others use equipment mot available commercially. The present study evaluates intratester variability of FG and IG (Madsen IGO 1500 equipment) in a typical clinical configuration in 42 users of behind-ear hearing aids. Mean standard deviation of FG test-retest differences was 5.19 dB. Range of variability was expressed in term of centiles. 5-- and 95-- centiles were -9.8 and 8.7 dB respectively. Mean s.d. of IG test-retest differences was 3.18 dB; 5-- and 95-- centiles were -5.2 and 6.05 dB respectively. Major variability was found at higher frequencies. High variability at lower frequencies was also found probably due to sealing problems of ear molds in the ear canal. Accord between FG and IG was also examined. A good mean correspondence in mid frequency range was found (FG-IG mean difference less than 5 dB) with large inter-subject differences between the two measurements (s.d. 11 dB).

[Diurnal hypersomnolence and chronic snoring: an epidemiological study]. / Ipersonnolenza diurna e roncopatia cronica: indagine epidemiologica.

Excessive daytime somnolence (EDS) is highly correlated to the presence of obstructive sleep apnea syndrome (OSAS). It appears that interest in such disorders may also be extended to extraneurological fields. The Authors report the results of a study on EDS in 1,146 adult subjects seen consecutively by different physicians. Excessive Somnolence during normal activity was reported in 4.5% of the subjects studied. In a subgroup of habitual snorers, EDS was observed in 8.3% of the subjects and in 2.0% in a group of non-snorers. The subjects with EDS has a mean age and body mass index (BMI) greater than those of the control group and a higher frequency of certain performance disturbances. No sex differences were found. EDS and habitual snoring had a similar age-related trend.