scholarly journals The Limitations of FDA Criteria: Inconsistencies with Clinical Practice, Findings, and Adult Criteria as a Barrier to Pediatric Implantation

2021 ◽  
Vol 42 (04) ◽  
pp. 373-380
Author(s):  
Lisa R. Park ◽  
Erika B. Gagnon ◽  
Kevin D. Brown
Keyword(s):  
Clinical Practice ◽  
Cochlear Implant ◽  
Cochlear Implants ◽  
Cochlear Implantation ◽  
Spoken Language ◽  
Evidence Based ◽  
Residual Hearing ◽  
Off Label ◽  
Single Side ◽  
Hearing Children

AbstractChildren require greater access to sound than adults as they are learning to communicate using hearing and spoken language. Yet when it comes to cochlear implant candidacy, currently approved Food and Drug Administration (FDA) criteria for adults are much less restrictive than those for children, allowing for greater levels of residual hearing and aided speech recognition in adults. Cochlear implant guidelines for children have changed very little in the 30 years since cochlear implants have been approved for pediatrics, and this lack of change has proven to be a barrier to implantation. Using evidence-based practice, centers have been providing off-label implantation for children who fall outside of current FDA criteria, including children with more residual hearing, children with single-side deafness younger than 5 years, and infants with bilateral profound loss younger than 9 months. The purpose of this article is to outline how these restrictions impede access to implants for children and describe the evidence supporting cochlear implantation in children who fall outside of current criteria.

scholarly journals Costs involved in using a cochlear implant in South Africa

2012 ◽  
Vol 59 (1) ◽  
Author(s):  
Gillian Robyn Kerr ◽  
Seppo Tuomi ◽  
Alida Müller
Keyword(s):  
South Africa ◽  
Cochlear Implant ◽  
Cochlear Implants ◽  
Cochlear Implantation ◽  
Consumer Price Index ◽  
Information Costs ◽  
Profound Hearing Loss ◽  
Short And Long Term ◽  
Implant System

Cochlear implantation is an expensive but effective lifelong intervention for individuals with a severe-to-profound hearing loss. The primary aim of this study was to survey the short- and long-term costs of cochlear implantation. Individuals (N=154) using cochlear implants obtained from the University of Stellenbosch-Tygerberg Hospital Cochlear Implant Unit in Cape Town, South Africa were surveyed using a questionnaire and patient record review. The questionnaire used a combination of closed and open-ended questions to gather both quantitative and qualitative information. Costs were categorised as short- and long-term costs. All costs were converted to constant rands (June 2010) using the Consumer Price Index to allow for comparison in real terms over time. In the first 10 years of implantation the average estimated costs incurred by adults totalled R379 626, and by children R455 225. The initial purchase of the implant system was the most substantial cost, followed by upgrading of the processor. Travel and accommodation costs peaked in the first 2 years. On average the participants spent R2 550 per year on batteries and spares. Rehabilitation for children cost an average of R7 200. Insurance costs averaged R4 040 per year, and processor repairs R3 000 each. In addition to the upfront expense of obtaining the cochlear implant system, individuals using a cochlear implant in South Africa should be prepared for the long-term costs of maintenance, accessing the unit, support services and additional costs associated with use. Knowledge of these costs is important to ensure that individuals are successful users of their cochlear implants in the long term.

scholarly journals Mismatch Negativity in Children with Cochlear Implant

2019 ◽  
Vol 23 (03) ◽  
pp. e292-e298
Author(s):  
Natalia Martinez Fernandes ◽  
Daniela Gil ◽  
Marisa Frasson de Azevedo
Keyword(s):  
Speech Perception ◽  
Language Development ◽  
Cochlear Implant ◽  
Cochlear Implants ◽  
Family Involvement ◽  
Mismatch Negativity ◽  
Control Group ◽  
Study Group ◽  
Cross Sectional ◽  
Hearing Children

Introduction The mismatch negativity (MMN) is a negative long-latency auditory potential elicited by any discriminable change in a repetitive aspect of auditory stimulation. This evoked potential can provide cortical information about the sound processing, including in children who use cochlear implants. Objective To identify MMN characteristics regarding latency, amplitude, and wave area in cochlear implanted children and to identify associations among language development, speech perception and family involvement. Methods This is a descriptive, observational, cross-sectional study, which compared two groups: study group—children with cochlear implant, and control group—hearing children. The children were submitted to MMN evaluation with non-verbal tone burst stimulus, differing in frequency in sound field at 70 dBHL, with SmartEP equipment (Intelligent Hearing Systems, Miami, FL, USA). Speech perception and language development questionnaires were also applied, and the family participation in the rehabilitation process was classified. Results The occurrence of MMN was 73.3% for the control group and 53.3% for the study group. Values of latency, amplitude and area of MMN of children using cochlear implants were similar to those of hearing children, and did not differ between groups. The occurrence of MMN was not correlated to the variables of hearing, language and family categories. Conclusion Children with cochlear implants showed similar MMN responses to those of the children in the control group, with mean latency, amplitude and area of 208.9 ms (±12.8), -2.37 μV (±0.38) and 86.5 μVms (±23.4), respectively. There was no correlation between the presence of MMN and children's performance in the auditory and language development tests or family involvement during rehabilitation.

scholarly journals A comparison of maternal and child language in normally-hearing and hearing-impaired children with cochlear implants

2016 ◽  
Vol 7 (2) ◽  
pp. 145-179 ◽  
Author(s):  
Liesbeth Vanormelingen ◽  
Sven De Maeyer ◽  
Steven Gillis
Keyword(s):  
Cochlear Implant ◽  
Cochlear Implants ◽  
Hearing Impaired ◽  
Expressive Vocabulary ◽  
Vocabulary Size ◽  
Input And Output ◽  
Hearing Status ◽  
Hearing Children ◽  
Impaired Children ◽  
Hearing Impaired Children

The present study examines the amount of input and output in congenitally hearing-impaired children with a cochlear implant (CI) and normally-hearing children (NH) and their normally-hearing mothers. The aim of the study was threefold: (a) to investigate the input provided by the two groups of mothers, (b) to investigate the output of the two groups of children, and (c) to investigate the influence of the mothers’ input on child output and expressive vocabulary size. Mothers are less influenced by their children’s hearing status than the children are: CI children are more talkative and slower speakers. Mothers influenced their children on most parameters, but strikingly, it was not maternal talkativeness as such, but the number of maternal turns that is the best predictor of a child’s expressive vocabulary size.

Musical ear syndrome in adult cochlear implant patients

2013 ◽  
Vol 127 (9) ◽  
pp. 854-858 ◽  
Author(s):  
W-K Low ◽  
C A Tham ◽  
V-D D'Souza ◽  
S-W Teng
Keyword(s):  
Cochlear Implant ◽  
Cochlear Implants ◽  
Cochlear Implantation ◽  
Instrumental Music ◽  
Single Case ◽  
Well Being ◽  
Cross Sectional Survey ◽  
Profound Hearing Loss ◽  
Cross Sectional ◽  
Single Case Report

AbstractObjective:Except for a single case report, musical ear syndrome in cochlear implantees has not been studied. We aimed to study the prevalence and nature of musical ear syndrome among adult cochlear implant patients, as well as the effect on their emotional well-being.Study design, patients and intervention:A cross-sectional survey of patients aged 18 years and above who had received cochlear implants for profound hearing loss between 1997 and 2010.Results:Of the 82 patients studied, 18 (22 per cent) were found to have experienced musical ear syndrome. Seven and 11 patients had musical ear syndrome prior to and after cochlear implantation, respectively. The character of musical ear syndrome symptoms was described as instrumental music (n = 2), singing (6) or both (10). Fourteen patients reported an adverse emotional effect, with three expressing ‘intolerance’.Conclusions:In this study, 22 per cent of cochlear implantees experienced musical ear syndrome. These symptoms affected patients' emotional state, but most coped well. Musical ear syndrome can occur prior to and after cochlear implantation.

scholarly journals Electroacoustic Stimulation: Now and into the Future

2014 ◽  
Vol 2014 ◽  
pp. 1-17 ◽  
Author(s):  
S. Irving ◽  
L. Gillespie ◽  
R. Richardson ◽  
D. Rowe ◽  
J. B. Fallon ◽  
...  
Keyword(s):  
Cochlear Implants ◽  
Cochlear Implantation ◽  
Auditory Pathway ◽  
Acoustic Stimulation ◽  
Music Appreciation ◽  
Residual Hearing ◽  
Current Field ◽  
Eligibility Criteria ◽  
Gene Therapies ◽  
Current Trends

Cochlear implants have provided hearing to hundreds of thousands of profoundly deaf people around the world. Recently, the eligibility criteria for cochlear implantation have been relaxed to include individuals who have some useful residual hearing. These recipients receive inputs from both electric and acoustic stimulation (EAS). Implant recipients who can combine these hearing modalities demonstrate pronounced benefit in speech perception, listening in background noise, and music appreciation over implant recipients that rely on electrical stimulation alone. The mechanisms bestowing this benefit are unknown, but it is likely that interaction of the electric and acoustic signals in the auditory pathway plays a role. Protection of residual hearing both during and following cochlear implantation is critical for EAS. A number of surgical refinements have been implemented to protect residual hearing, and the development of hearing-protective drug and gene therapies is promising for EAS recipients. This review outlines the current field of EAS, with a focus on interactions that are observed between these modalities in animal models. It also outlines current trends in EAS surgery and gives an overview of the drug and gene therapies that are clinically translatable and may one day provide protection of residual hearing for cochlear implant recipients.

Model for Understanding the Influence of Some Parameters in Cochlear Implantation

1992 ◽  
Vol 101 (1) ◽  
pp. 42-45 ◽  
Author(s):  
Christian Berger-Vachon ◽  
Bachir Djedou ◽  
Lionel Collet ◽  
Alain Morgon
Keyword(s):  
Cochlear Implant ◽  
Cochlear Implants ◽  
Cochlear Implantation ◽  
Recognition Performance ◽  
Open Channels ◽  
Major Goal ◽  
Good Selection ◽  
Selection Of

Considering the recognition performance obtained by an implanted patient, the authors have developed models to explain the decrease in performance when the number of open channels on the prosthesis is increased. The French cochlear implant Chorimac was used in this experiment. Two models have been developed. The first is monodimensional and the second is multidimensional. They respectively represent an increase in information and its superposition. Results suggest that for the patient, the superposition factor prevails and is detrimental to recognition. Its elimination should be a major goal. A good selection of electrodes in a relatively small number seems to be the best policy. This is already done in some cochlear implants. Some other parameters in the signal that seem worth being analyzed are introduced.

scholarly journals Cochlear Implant Outcomes and Genetic Mutations in Children with Ear and Brain Anomalies

2015 ◽  
Vol 2015 ◽  
pp. 1-19 ◽  
Author(s):  
Micol Busi ◽  
Monica Rosignoli ◽  
Alessandro Castiglione ◽  
Federica Minazzi ◽  
Patrizia Trevisi ◽  
...  
Keyword(s):  
Cochlear Implant ◽  
Inner Ear ◽  
Cochlear Implants ◽  
Cochlear Implantation ◽  
Developmental Disorders ◽  
Statistical Tests ◽  
Study Group ◽  
Brain Abnormalities ◽  
Brain Anomalies ◽  
Ear Malformations

Background. Specific clinical conditions could compromise cochlear implantation outcomes and drastically reduce the chance of an acceptable development of perceptual and linguistic capabilities. These conditions should certainly include the presence of inner ear malformations or brain abnormalities. The aims of this work were to study the diagnostic value of high resolution computed tomography (HRCT) and magnetic resonance imaging (MRI) in children with sensorineural hearing loss who were candidates for cochlear implants and to analyse the anatomic abnormalities of the ear and brain in patients who underwent cochlear implantation. We also analysed the effects of ear malformations and brain anomalies on the CI outcomes, speculating on their potential role in the management of language developmental disorders.Methods. The present study is a retrospective observational review of cochlear implant outcomes among hearing-impaired children who presented ear and/or brain anomalies at neuroimaging investigations with MRI and HRCT. Furthermore, genetic results from molecular genetic investigations (GJB2/GJB6and, additionally, in selected cases,SLC26A4or mitochondrial-DNA mutations) on this study group were herein described. Longitudinal and cross-sectional analysis was conducted using statistical tests.Results. Between January 1, 1996 and April 1, 2012, at the ENT-Audiology Department of the University Hospital of Ferrara, 620 cochlear implantations were performed. There were 426 implanted children at the time of the present study (who were <18 years). Among these, 143 patients (64 females and 79 males) presented ear and/or brain anomalies/lesions/malformations at neuroimaging investigations with MRI and HRCT. The age of the main study group (143 implanted children) ranged from 9 months and 16 years (average = 4.4; median = 3.0).Conclusions. Good outcomes with cochlear implants are possible in patients who present with inner ear or brain abnormalities, even if central nervous system anomalies represent a negative prognostic factor that is made worse by the concomitant presence of cochlear malformations. Common cavity and stenosis of the internal auditory canal (less than 2 mm) are negative prognostic factors even if brain lesions are absent.

Delayed loss of residual hearing in Clarion® cochlear implant users

2003 ◽  
Vol 117 (11) ◽  
pp. 850-853 ◽  
Author(s):  
M. Barbara ◽  
A. Mattioni ◽  
S. Monini ◽  
I. Chiappini ◽  
F. Ronchetti ◽  
...  
Keyword(s):  
Cochlear Implant ◽  
Cochlear Implantation ◽  
Pure Tone ◽  
Hearing Threshold ◽  
Auditory Threshold ◽  
Residual Hearing ◽  
Equal Distribution ◽  
Hearing Thresholds ◽  
Number Of Patients ◽  
Over Time

Hearing threshold has been measured in a group of patients following cochlear implantation with a Clarion® device for the last eight years. The patients had received either a pre-curved carrier or the Hi-Focus I plus Electrode Positioner System (EPS). The assessment was carried out within the first post-operative week as well as at a later stage, between six and 87 months, post-operatively. Residual hearing thresholds were still measurable early after surgery in 24.5 per cent of the patients, without differences between the two different Clarion® models. However, the number of subjects with measurable hearing dropped to 16.3 per cent as observed when hearing was measured at a later stage, with an equal distribution between the two groups of patients. From this study it has been possible to observe that only a limited number of patients maintain residual hearing after Clarion® cochlear implantation, and that this tends to decrease further over time. Nevertheless, the performance of these patients for speech tests did not appear to be affected by deterioration of the pure-tone auditory threshold.

scholarly journals Extra- and Intracochlear Electrocochleography in Cochlear Implant Recipients

2015 ◽  
Vol 20 (5) ◽  
pp. 339-348 ◽  
Author(s):  
Adrian Dalbert ◽  
Flurin Pfiffner ◽  
Christof Röösli ◽  
Konrad Thoele ◽  
Jae Hoon Sim ◽  
...  
Keyword(s):  
Cochlear Implant ◽  
Middle Ear ◽  
Cochlear Implantation ◽  
Low Frequency ◽  
Electrode Array ◽  
Postoperative Phase ◽  
Residual Hearing ◽  
Middle Ear Effusion ◽  
Cochlear Function ◽  
Ear Effusion

Objective: To monitor cochlear function by extra- and intracochlear electrocochleography (ECoG) during and after cochlear implantation and thereby to enhance the understanding of changes in cochlear function following cochlear implantation surgery. Methods: ECoG responses to acoustic stimuli of 250, 500 and 1,000 Hz were recorded in 9 cochlear implant recipients with presurgical residual hearing. During surgery extracochlear ECoG recordings were performed before and after insertion of the cochlear implant electrode array. After insertion of the electrode array, intracochlear ECoG recordings were conducted using intracochlear electrode contacts as recording electrodes. Intracochlear ECoG recordings were performed up to 6 months after implantation. ECoG findings were correlated with findings from audiometric tests. Results: Extra- and intracochlear ECoG responses could be recorded in all subjects. Extracochlear ECoG recordings during surgery showed moderate changes. Loss or reduction of the ECoG signal at all three frequencies did not occur during cochlear implantation. During the first week following surgery, conductive hearing loss, due to middle ear effusion, led to a decrease in intracochlear ECoG signal amplitudes. This was not attributable to changes of cochlear function. All persistent reductions in ECoG response magnitude after normalization of the tympanogram occurred during the first week following implantation. Thresholds of ECoG signals were at or below hearing thresholds in all cases. Conclusion: Gross intracochlear trauma during surgery appears to be rare. In the early postoperative phase the ability to assess cochlear status by ECoG recordings was limited due to the regular occurrence of middle ear effusion. Still, intracochlear ECoG along with tympanogram recordings suggests that any changes of low-frequency cochlear function occur mainly during the first week after cochlear implantation. ECoG seems to be a promising tool to objectively assess changes in cochlear function in cochlear implant recipients and may allow further insight into the mechanisms underlying the loss of residual hearing.

Cochlear Implants in Children: Reliability of Computed Tomography

1992 ◽  
Vol 107 (3) ◽  
pp. 410-417 ◽  
Author(s):  
Michael A. Seicshnaydre ◽  
Michele H. Johnson ◽  
M. Suzanne Hasenstab ◽  
George H. Williams
Keyword(s):  
Computed Tomography ◽  
Hearing Loss ◽  
Cochlear Implant ◽  
Temporal Bone ◽  
Cochlear Implants ◽  
Cochlear Implantation ◽  
Ct Scans ◽  
Presurgical Evaluation ◽  
Preoperative Ct ◽  
Ct Studies

Preoperative temporal bone computed tomography (CT) can demonstrate anatomic details relevant to surgical management and is therefore essential in the presurgical evaluation of patients receiving cochlear implants. The purpose of this study was to evaluate preoperative CT studies and compare them to surgical findings in 34 children who received the Nucleus multichannel cochlear implant. The focus of this report is to discuss the dependability of CT scans in predicting surgical findings at the time of cochlear implantation. Results indicate that agreement of CT interpretations with surgical findings is partially related to the etiology of hearing loss and the experience of the surgeon and neuroradiologist. Advantages and limitations of the CT scans in predicting surgical findings are discussed.

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