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SANpulse to Preview Next Generation of Storage Migration and Data Center Consolidation Technologies at Storage Decisions New York - Joe Austin - ContactCenterWorld.com Blog
SANpulse to Preview Next Generation of Storage Migration and Data Center Consolidation Technologies at Storage Decisions New York
Joe Austin
Jersey City, NJ –Paving the path to the next generation data center through people, process and technology, SANpulse Technologies, Inc. will showcase its award-winning SANlogics™ technology platform and preview the future of storage migration and data center consolidation at Storage Decisions, September 20-21 at the Hilton New York City. ??
SANpulse will feature its SANlogics platform which has been successfully serving the FORTUNE 500® to analyze, optimize and or migrate more than 25,000 servers attached to greater than 40 petabytes of data. Research has shown that typical enterprise storage migration and data center consolidation projects have a success rate of only 16%. The lack of automation in the lifecycle of a migration from data collection through correlation leading to generation of work-files and execution causes chaos and in turn leads to elevated risk levels when performing these activities. SANpulse changes the landscape for large scale consolidations and migrations by providing infrastructure information insight that empowers proactive decisions by embedding processes into the SANlogics technology platform, facilitating a repetitive, modular and scalable process. ??
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Storage Decisions attendees will have an opportunity to preview the next phase in SANpulse's campaign to simplify the inherent complexities of storage migration. SANpulse's new software reigns in the chaos of traditional enterprise storage migration and consolidation efforts and addresses the SAN infrastructure information void to produce a comprehensive view of the entire data center environment, including servers, storage and switches. The latest solution by SANpulse offers the best approach when addressing the challenges of migrating to new technologies such as virtualization and new technology platforms such as cloud computing.
Bringing years of experience in helping large organizations with these complex issues, SANpulse CEO Peter Mehta will present in a session titled, "SANpulse: Partnering to Deliver Data Migration and Data Center Consolidation On-Time and On-Budget". In this discussion, Peter will focus on leveraging technology to reduce OpEx and CapEx through the reduction in time and resources required. The session will take place on Monday, September 20th at 3:10pm. ??
About SANlogics
SANlogics is an innovative, multi-vendor software platform that simplifies and accelerates SAN migration, consolidation, and infrastructure optimization. The patent-pending technology combines on-demand data analysis, business-process aware functionality, and rapid execution into a powerful solution that FORTUNE 500 organizations leverage to upgrade and optimize their IT storage infrastructures.
About Storage Decisions
The Storage Decisions Conference brings together the top storage professionals, most relevant vendors in the space and world-renowned independent storage expert speakers to share tactical tips, and actionable advice that can immediately be put to use in solving the most pressing storage problems. The event enables top storage professionals from local, national and global companies to exchange ideas with their peers and hear what others are doing to both solve their day-to-day storage headaches and implement proven and effective best practices.?
Tweet This: SANpulse to Preview Next Generation of Storage Migration and Data ?Center Consolidation Technology at Storage Decisions New York
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About SANpulse Technologies, Inc.
SANpulse paves the path to next generation data centers, transforming the world's largest IT infrastructures and creating efficiencies to help reduce IT-related operational and capital expenses. Through the combination of people, process and technology, the company's SANlogics solution provides actionable insight to mitigate the risk of navigating complex data center infrastructures. SANlogics adaptive technology supports organizations in meeting new technology and business requirements through discovery, analytics and auto-generation of executables that simplify data center migration, consolidation and optimization processes. Since its inception in 2005, SANpulse has helped Fortune 500 clients across the globe maximize the efficiency of their storage infrastructure, mitigate risk and guarantee greater business agility. SANpulse is headquartered in Jersey City, NJ, with regional offices in Dallas, TX, Tampa, FL, Pune, India and London, UK. For more information, please visit www.SANpulse.com.
Publish Date: September 16, 2010 11:27 AM
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Hiring the Best Air Conditioning Company; Things that you Need to Consider.
It is your responsibility as a homeowner to make sure that there is peace and comfort that is needed in your home and everything else is running the right way. One of the appliances that you need in your home is an air conditioner to keep your air cool and comfortable at all times. You will find that just like other appliances around the home air conditioner can develop some problems which will make it not to function well, and it can even be worse when it happens during the hot Season . For that reason it is important for you to look for an expert who specializes in repairing air-conditioners, so that he can service it at regular intervals to keep it away from inconveniencing you. There are a number of air conditioner repair companies in your city, but it is important for you to select the best company which will offer you the best to a repair services; in this article, we are going to discuss some of the factors that you need to consider when you are looking for the right air conditioning company in your city.
1. The certifications and license of a company.
When you are looking for any service provider in your city, one of the most important thing that you might need to put into consideration is whether they have the license to offer their services around the city, and they are certified by the relevant boards. Here when you are looking for an air conditioning repair company in your city, you need to consider that company which has relevant certification and license to show that they are allowed to offer air conditioning services in the city and they are competent in their services. The truth of the matter is that if you will be able to hire a company that will show you the relevant documentation to show that they are qualified to offer their services, there are high chances that they will offer you the best quality air conditioning repair service. You will be able to know more about the licensing and certification of a company, if you can check from their websites where they have all their details, or you can just ask them to produce their certificates and license.
2. The reputation of a company.
Another important thing that you need to consider when you are looking for an air conditioning company in your city, is the reputation of a company, in the terms of their services; consider that air conditioning company which is well known in the city because it is the one which of us the best air conditioning services.


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Student Advisory Group
Our charitable purpose
AQA in numbers
AQA Research and Analysis
Our Student Advisory Group (SAG) gives young people who are still in school, a voice in the exam system.
The group, made of 15 selected students, normally meets three to four times a year, and provides us with students' insights and perspectives on key areas of assessment, such as the use of technology and the design of question papers - helping us to make important decisions about the future of exams.
Chair of the group, Victoria Wong, said:
"Participating in the SAG has been an all-round incredible experience over the past two years. I am grateful to have met so many wonderful like-minded young people who share the same enthusiasm for student advocacy, as well as the attentive AQA staff who have taken precious time out of their day to really engage us. It speaks volumes of AQA's commitment to supporting and listening to students. Having this opportunity to speak up for those who aren't necessarily being heard means a great deal to me, especially during the pandemic when every student's life has been turned upside down."
Supporting our student community
This group will help us shape the ways we listen to the school and college student community, and in return students will gain valuable experience and develop skills that will help them in their future careers.
Student Chloe Elliot said: "Being on the student advisory group has given me a valuable insight into how exam boards work and helped me meet likeminded students."
If you're a student, or you know a student who may be interested, then please apply when the next cohort becomes available. All job opportunities will be featured on our jobs site.

redpajama_set_name: RedPajamaCommonCrawl


Looking for a discount at Ridge Wallet? Follow this page to check for current offers, and trust BestBuyPros.com for online shopping savings. Check out our top April 2019 Ridge wallet discount code: Save an 17% off on select items. There are 15 awesome offers currently available at Ridge Wallet, including Ridge wallet discount code. It is a great time to buy, prices like this won't stay long!


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Wiener Psychoanalytische Akademie
Study abroad in Wien, Austria
Erasmus Code AWIEN72
#Wien #Austria Apply for Erasmus
Wiener Psychoanalytische Akademie is an educational institution that is located in a region known as Wien, which is found in the country of Austria.
Wiener Psychoanalytische Akademie Review
Wiener Psychoanalytische Akademie gets a ranking of 92 out of a possible 100.
Wiener Psychoanalytische Akademie is one of the best Erasmus locations in all of Europe, and is certainly regarded as a top choice in Austria.
The official name of this Erasmus listing is Wiener Psychoanalytische Akademie.
The address is Salzgries 16/3, postcode of 1010.
It is located in the region of Wien in the country of Austria.
To apply to Wiener Psychoanalytische Akademie, you need to consult your course coordinator, Erasmus manager or the International Office at your home school and follow these steps:
Note the Erasmus code: AWIEN72
Prepare a cover letter of why you desire to study at Wiener Psychoanalytische Akademie.
Visit their website at www.psy-akademie.at
Is Wiener Psychoanalytische Akademie a top ranked university in Austria?
So, when it comes to comparing Wiener Psychoanalytische Akademie with the rest, is it in the Top 10 Erasmus destinations in Europe? Well, the best way to find out is to check our Current Erasmus Top 100 Rankings and see if Wiener Psychoanalytische Akademie makes the top of the list!
There have been no negative reports recieved from Erasmus Students, Tourists, Staff, Visitors, Parents or Professors at Wiener Psychoanalytische Akademie.
Place delivers when is came to adventure.
There is no information available that confirms whether Wiener Psychoanalytische Akademie has limited Erasmus placements. As a general rule, unless there is clear indication, you can assume that an Erasmus position in Austria is available given it still has it's Erasmus code AWIEN72.
See also: Wirtschaftsuniversitat Wien
See also: International Academy of Music and Performing Arts Vienna
See also: Lauder Business School
Universitat Fur Angewandte Kunst Wien
Anton Bruckner Privatuniversitat
Universitat Fur Weiterbildung Krems
Medizinische Universitat Graz
Universitat Fur Kunstlerische Und Industrielle Gestaltung Linz


NovaBay® Pharmaceuticals, Inc. (NYSE MKT: NBY), a biotechnology company focused on addressing the large unmet therapeutic needs of the global anti-infective market with first-in-class compounds such as its proprietary Aganocides®, today announced that Dr. Ron Najafi, NovaBay's Chairman and Chief Executive Officer, was featured on the RedChip Money Report episode that aired on Fox Business on March 16, 2013. Dr. Najafi provided an overview of the Company's anti-infective programs and highlighted the Company's three Phase 2 trials currently underway, studying the Company's lead Aganocide auriclosene (NVC-422) in dermatology, ophthalmology, and urology. NovaBay's partnership with the world leading dermatology company, Galderma, SA., as well as its recently launched product for the treatment of chronic non-healing wounds, NeutroPhase®, were also highlighted.
In addition, Dr. Najafi recently published a comprehensive discussion regarding the growing crisis of antibiotic resistance, addressing the rise of resistance and outlining a number of potential solutions. To access Dr. Najafi's CEO blog, as well as more information about NovaBay's technology, non-antibiotics that mimic the body's own defense systems, visit the Company's website, www.novabay.com.
NovaBay Pharmaceuticals is a biotechnology company focused on addressing the large unmet therapeutic needs of the global anti-infective market with its two distinct categories of compounds, Aganocides® and NeutroPhase® Skin and Wound Cleanser. The Company's four core business units, DermaBay, UroBay, EyeBay and MediBay, are developing treatments that tackle infections in the dermatology, urology, ophthalmology, and wound care areas.
Dermatology – Partnered with Galderma, a leading dermatology company, to develop a formulation of NVC-422 for treatment of highly contagious skin infection, impetigo, which occurs most commonly in children. Enrollment into a global Phase 2b clinical study has begun and clinical data results are expected in second half 2013.
Ophthalmology – NovaBay is developing an eye drop formulation of NVC-422 for treating adenoviral conjunctivitis, a highly contagious viral eye infection for which there is no approved acute treatment. Enrollment into a global Phase 2b clinical study has begun, and clinical data results are expected in the second half of 2013.
Urology – NovaBay's urinary catheter irrigation solution containing NVC-422 is currently in a Phase 2b study, with the goal of reducing the incidence of urinary catheter blockage and encrustation (UCBE) and associated urinary tract infections. The Company reported positive data from the Phase 2a study and is evaluating the effect of an alternate more potent formulation of NVC-422 in Phase 2b. Results are expected in the first half of 2013.
NeutroPhase is the only pure hypochlorous acid (HOCI) skin and wound cleanser cleared by the U.S. Food and Drug Administration (FDA) to target the six-million-patient U.S. market of chronic non-healing wounds, such as pressure, venous stasis and diabetic ulcers. The saline-based solution is the only wound cleanser on the market to include a stabilized, pure form of HOCl shown in studies to kill bacteria in solution, including flesh-eating bacteria. For additional information, visit: www.neutrophase.com.
This release contains forward-looking statements, which are based upon management's current expectations, assumptions, estimates, projections and beliefs. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results or achievements to be materially different and adverse from those expressed in or implied by the forward-looking statements. Factors that might cause or contribute to such differences include, but are not limited to, risks and uncertainties relating to difficulties or delays in development, clinical trial, regulatory approval, production and marketing of the company's product candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the product candidates, the uncertainty of patent protection for the company's intellectual property or trade secrets, the company's ability to obtain additional financing as necessary and unanticipated research and development and other costs. Other risks relating to NovaBay and Aganocide compounds, including risks that could cause results to differ materially from those projected in the forward-looking statements in this press release, are detailed in NovaBay's Form 10-K and Form 10-Q filings with the Securities and Exchange Commission, especially under the heading "Risk Factors." The forward-looking statements in this release speak only as of this date, and NovaBay disclaims any intent or obligation to revise or update publicly any forward-looking statement except as required by law.


Today i will be discuss how to Configure VLAN in ZTE OLT service port.
Log in to ZXA10 C220 through HyperTerminal or Telnet.
Service port provides service access to user through ONU.
Step-2. Use the interface to enter the GPON-ONU interface configuration mode.
Step-3. Use the switchport vlan command to configure VLAN service port.
Step-4. Use the show vlan port command to query port VLAN configuration.


If there would be anything in this world that I can't live without I'd obviously say it would be my laptop.
For years, I've grown dependent on my home computer where I would spend hours blogging, surfing the net, creating trip itineraries, typing compositions for school and a lot more. In fact, my work is very computer dependent too where I would have to regularly check my mail in Microsoft Outlook and since the digital age has made work more efficient and paper-less, majority of our correspondence are done via email and reports sent using the programs of Microsoft Office.
At home, my nightly routine is that I would open my handy-dandy laptop the moment I get home from work to write an entry in this blog. This had, in fact, became part of my packing list on my recent trip to the US. It's what Paul and I used to chat with my family and to update ourselves with what's happening in Manila while we're away.
I believe that behind an efficient laptop should be a comfy-carrying bag.
One thing that I do not like though is having to lug around my laptop using a not-very-functional-laptop-bag that we got upon purchase of this laptop. It's this bulky black bag that says nothing about being fashionable nor does it help lighten the load off your shoulders. No padding, no extra cushion, it was simply just a bag that fits our laptop.
Right now, our slim handy laptop has a new home.Thanks to the guys behind Golla who sent us this pretty floral red bag, we can proudly carry our laptop around with ease.
I love it that our laptop snugly fits into its compartment and there are a lot more pockets for me to slide in some magazines, my notebook and a lot more! It's very pretty in red too!
You too can have your own Golla gadget bag!! :) Three winners will be chosen to win their very own Golla bag!
2) The photo should have a 1024x768 resolution and should not exceed 1MB. It can be modified or edited and may contain text but should not have offensive content.
3) Golla Philippines will upload your contest entry in their Official Facebook Page.
4) Upon seeing your entry in their page, tag 50 of your friend to your entry. Ask your friends to like and comment on your entry.
7) Winners will be notified through email.
Golla Bags are available at The Travel Club, Globe Telecom, Bratpack, Fullybooked, iStudio, Hello Telecom, Power Mac, Island Souvenir, A shop and Fashion Rack.


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Books > Fiction > Contemporary > Loveless
Alice Oseman
1/Mar/2022
Loveless quantity
Expected publication: March 1, 2022
For fans of Love, Simon and I Wish You All the Best, a funny, honest, messy, completely relatable story of a girl who realizes that love can be found in many ways that don't involve sex or romance.
From the marvelous author of Heartstopper comes an exceptional YA novel about discovering that it's okay if you don't have sexual or romantic feelings for anyone . . . since there are plenty of other ways to find love and connection.
This is the funny, honest, messy, completely relatable story of Georgia, who doesn't understand why she can't crush and kiss and make out like her friends do. She's surrounded by the narrative that dating + sex = love. It's not until she gets to college that she discovers the A range of the LGBTQIA+ spectrum — coming to understand herself as asexual/aromantic. Disrupting the narrative that she's been told since birth isn't easy — there are many mistakes along the way to inviting people into a newly found articulation of an always-known part of your identity. But Georgia's determined to get her life right, with the help of (and despite the major drama of) her friends.
Scholastic Press
The Princess and the Fangirl...
Malibu Rising : A Novel
Sweetness and Lightning, Vol. 2
Love & Misadventure
Under the Whispering Door
Hide and Seek (The Lying...
Puddin' (Dumplin' #2)
One Moment in Time (Moment...
Lethal White (Cormoran Strike #4)
The Glass Magician (The Paper...


Dee's hair has grown, indicating this new scene is at least several months later. She is awoken by a beautiful man who is tickling her.
DEE, burrowing and looking up at her boyfriend: 'mgonna make coffee. You want any?
MAN: Nahh- coffee is way too bitter.
Dee recoils in horror from him as he says this.
MAN: I'll just grab some soda at work. Go make your coffee, love.
Dee puts on her glasses as he speaks from the bed.


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Lasianthus subcalvus är en måreväxtart som beskrevs av William Grant Craib. Lasianthus subcalvus ingår i släktet Lasianthus och familjen måreväxter.

Artens utbredningsområde är Thailand. Inga underarter finns listade i Catalogue of Life.

Källor

Måreväxter
subcalvus

redpajama_set_name: RedPajamaWikipedia


Posted on March 1, 2018 by Navid Dayzad, Esq.
We are pleased to announce that our Managing Attorney, Navid Dayzad, has been included in another leading industry publications, Who's Who Legal: Corporate Immigration 2018. Who's Who Legal compiles the leading attorneys in the field and selection is based upon comprehensive, independent surveys of lawyers worldwide. Only specialists who have met independent international research criteria are listed.
This recognitions reflect the high level of service that Dayzad Law Offices has provided over the past 12 years and our continued commitment to providing high quality immigration advice to current and future clients.


A Cochlear implant is a device for individuals with severe-to-profound hearing loss who only receive limited benefit from amplification with hearing aids. A cochlear implant provides direct electrical stimulation to the auditory nerve, bypassing the usual transducer cells that are absent or nonfunctional in deaf cochlea. The basic components of a cochlear implant include both external and internal components. The external components include a microphone, an external sound processor, and an external transmitter. The internal components are implanted surgically and include an internal receiver implanted within the temporal bone and an electrode array that extends from the receiver into the cochlea through a surgically created opening in the round window of the middle ear.
Sounds that are picked up by the microphone are carried to the external sound processor, which transforms sound into coded signals that are then transmitted transcutaneously to the implanted internal receiver. The receiver converts the incoming signals to electrical impulses that are then conveyed to the electrode array, ultimately resulting in stimulation of the auditory nerve.
Hearing loss is rated on a scale based on the threshold of hearing. Severe hearing loss is defined as a hearing threshold of 70-90 decibels (dB) and profound hearing loss is defined as a hearing threshold of 90 dB and above.
Several cochlear implants are commercially available in the U.S. and are manufactured by Cochlear Corporation, Advanced Bionics, and the Med El Corporation. Over the years, subsequent generations of the various components of the devices have been approved by the U.S. Food and Drug Administration (FDA), focusing on improved electrode design and speech-processing capabilities. Furthermore, smaller devices and the accumulating experience in children have resulted in broadening of the selection criteria to include children as young as 12 months. The labeled indications from the FDA for currently marketed implant devices are summarized below.
The following is a summary of the labeled indications from the FDA for currently marketed implanted devices.
*Note: Cochlear, Ltd. voluntarily recalled the Nucleus CI500 range in September 2011 for device malfunction in the CI512 implant. The external Nucleus 5 sound processor is not a part of the recall.
*Note: Advanced Bionics HiRes90K was voluntarily recalled in November 2010 and given FDA-approval for re-entry to market the device in September 2011.
In July, 2003, the FDA began notifying healthcare providers about a recent study showing that children with cochlear implants are at greater risk of developing bacterial meningitis caused by Streptococcus pneumoniae than children in the general population. Recommendations for vaccination with Pneumococcal Conjugate Vaccine (PCV7) are found in the coverage section of this policy.
While cochlear implants have typically been used unilaterally, in recent years, interest in bilateral cochlear implantation has arisen. The proposed benefits of bilateral cochlear implants are to improve understanding of speech in noise and localization of sounds. Improvements in speech intelligibility may occur with bilateral cochlear implants through binaural summation; i.e., signal processing of sound input from 2 sides may provide a better representation of sound and allow one to separate out noise from speech. Speech intelligibility and localization of sound or spatial hearing may also be improved with head shadow and squelch effects, i.e., the ear that is closest to the noise will be received at a different frequency and with different intensity, allowing one to sort out noise and identify the direction of sound. Bilateral cochlear implantation may be performed independently with separate implants and speech processors in each ear or with a single processor. However, no single processor for bilateral cochlear implantation has been approved by the FDA for use in the U.S. In addition, single processors do not provide binaural benefit and may impair sound localization and increase the signal to noise ratio received by the cochlear implant.
A FDA-approved cochlear implant and associated aural rehabilitation meets primary coverage criteria for effectiveness and is covered when the device is implanted for FDA approved indications subject to all member contract limitations.
Persons planning to receive a cochlear implant should be up-to-date on age-appropriate pneumococcal vaccination at least two weeks prior to surgery, if possible.
Replacement of internal and/or external components meets member benefit certificate primary coverage criteria and is covered only in a small subset of members who have inadequate response to existing component(s) to the point of interfering with the individual's activities of daily living, or the component(s) is/are no longer functional and cannot be repaired. Copies of original medical records must be submitted either hard copy or electronically to support medical necessity.
Upgrades of an existing, functioning external system to achieve aesthetic improvement, such as smaller profile components or a switch from a body-worn, external sound processor to a behind-the-ear model do not meet member benefit certificates of coverage.
For members with contracts without primary coverage criteria, upgrades of an existing, functioning external system to achieve aesthetic improvement, such as smaller profile components or a switch from a body-worn, external sound processor to a behind-the-ear model, are considered not medically necessary. Services that are considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
Replacement of internal and/or external components solely for the purpose of upgrading to a system with advanced technology or to a next-generation device does not meet member benefit certificates of coverage.
For members with contracts without primary coverage criteria, replacement of internal and/or external components solely for the purpose of upgrading to a system with advanced technology or to a next-generation device is considered not medically necessary. Services that are considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
Radiographic evidence of absent cochlear development.
A FDA-approved cochlear implant and associated aural rehabilitation meets primary coverage criteria for effectiveness and is covered when the device is implanted for FDA approved indications subject to all member contract limitations including maximum dollar allowance.
Next generation devices have typically offered a marginal improvement over previous devices, such that replacement of the internally implanted components is not routinely performed and would not be covered. Upgrades of an existing, functioning external system to achieve aesthetic improvement, such as smaller profile components, or a switch from a body-worn, external sound processor to a behind-the-ear (BTE) model are not covered. This denial is based on the "least costly alternative" language in the member benefit contract.
An FDA-approved cochlear implant and associated aural rehabilitation is covered when the device is implanted for FDA approved indications.
Cochlear implantation is not covered for: (1) Deafness due to lesions of the acoustic nerve or central auditory pathway; (2) Otitis media or other active, unresolved ear problems; (3) Radiographic evidence of absent cochlear development.
Next generation devices have typically offered a marginal improvement over previous devices, such that replacement of the internally implanted components is not routinely performed and would not be covered. Upgrades of an existing, functioning external system to achieve aesthetic improvement, such as smaller profile components, or a switch from a body-worn, external sound processor to a behind-the-ear (BTE) model are not covered.
A single or multi-channel cochlear implantation is considered medically necessary in patients of at least two years of age with severe or profound sensorineural deafness (hearing threshold of 70 decibels or greater) who cannot benefit from a hearing aid, including those with hearing loss due to meningitis.
Cochlear implantation has a profound impact on hearing and speech reception in post lingually deafened adults with positive impacts on psychological and social functioning.
The results are more variable in children. Benefits are not realized immediately but rather are manifested over time, with some children continuing to show improvement over several years.
Prelingually deafened adults may also benefit, although to a lessor extent than post lingually deafened adults. These individuals achieve minimal improvement in speech recognition skills. However, other basic benefits, such as improved sound awareness, may meet safety needs.
Training and educational intervention are fundamental for optimal post implant benefit.
Cochlear implants in children under 2 years old are complicated by the inability to perform detailed assessment of hearing and functional communication. However, a younger age of implantation may limit the negative consequences of auditory deprivation and may allow more efficient acquisition of speech and language. Some children with post meningitis hearing loss have been implanted under the age of 2 years due to the risk of new bone formation associated with meningitis, which may preclude a cochlear implant at a later date.
While use of a monolateral cochlear implant in patients with severe to profound hearing loss has become standard clinical practice, bilateral cochlear implantation was less common. A search of the MEDLINE database was conducted. A summary of the available relevant literature follows.
A number of studies have reported results with bilateral cochlear implants. Litovsky reported that 9 of 13 (70%) children with bilateral cochlear implants discriminated source separations of ≥20 degrees and 7 of 9 performed better when using bilateral (vs. unilateral) devices (Litovsky, 2006). Schoen and colleagues reported that bilateral cochlear implants were able to restore spatial hearing in 11 cochlear implant patients (Schoen, 2005). Litovsky and colleagues reported on a multicenter prospective study of 37 adults with post-linguistic bilateral hearing loss (Litovsky, 2006). Bilateral benefit (speech understanding in quiet and noise) was seen in 32 of the 34 subjects. The authors indicate that the 3dB improvement in signal to noise ratio noted in the study would result in an average improvement of 28% in speech understanding and that this improvement could be crucial. Questionnaire data (subjects used only the "best" unilateral device for 3 weeks) also indicated that bilateral users perceived their performance to be better than when using a single device. Ricketts and colleagues reported on 16 similar adults with postlinguistic bilateral hearing loss (Ricketts, 2006). They found a small but significant advantage with bilateral implants for speech recognition in noise. While a training effect was noted over time for a subset of patients followed up to 17 months, a consistent bilateral advantage was noted.
Ramsden and colleagues reported on 30 adults in England who had bilateral cochlear implants and received their second implant a mean of 3 years after the first (Ramsden, 2005). At 9 months, a significant (12.6%, p < 0.001) binaural advantage was seen for speech and noise from the front. They were not able to predict when the second ear would be the better performer. Sequential implantation with long delays between ears resulted in poor second ear performance for some of their subjects. Kuhn-Inacker reported on a group of 39 European children who had bilateral cochlear implants (Kuhn-Inacker, 2004). From qualitative and quantitative data, they concluded that bilateral implants improve the children's communicative behavior, especially in complex listening situations.
1. "Unilateral cochlear implantation is recommended as an option for people with severe to profound deafness who do not receive adequate benefit from acoustic hearing aids.
· adults who are blind or who have other disabilities that increase their reliance on auditory stimuli as a primary sensory mechanism for spatial awareness.
3. Sequential bilateral cochlear implantation is not recommended as an option for people with severe to profound deafness.
· For children, speech, language and listening skills appropriate to age, developmental stage and cognitive ability.
A review article by Firszt et al. evaluates the advantages of binaural hearing and the disadvantages of hearing with only one ear or hearing with two ears with significantly different sound thresholds (Firszt, 2008). A case study is presented that demonstrates the benefit of bimodal hearing (i.e., a cochlear implant [CI] in one ear and a contralateral hearing aid [HA]) in a nontraditional CI candidate with asymmetrical hearing thresholds. Selected studies in adult recipients who use a CI and contralateral HA or who use two CIs are summarized. The data overall demonstrates that bilateral CI recipients experience substantial binaural hearing advantages, including improved speech recognition in noise, localization, and functional everyday communication. These results suggest that bilateral stimulation of the auditory system through a CI and contralateral HA or two CIs is beneficial.
· "For all profoundly deaf children in order to stimulate both auditory pathways and optimize speech, language and auditory development and maximize potential academic achievement.
Johr et al. highlight the surgical and anesthesiological considerations when performing cochlear implant surgery in very young infants (younger than 1 year of age) (Johr, 2008). This is an observational and literature review by pediatricians at a tertiary children's hospital in Switzerland. Patients younger than 1 year of age undergoing cochlear implant surgeries were analyzed concerning surgical techniques, and anesthesiological aspects of elective surgeries in small infants. The results demonstrated that the age of the patient and the pediatric experience of the anesthesiologist, but not the duration of the surgery, are relevant risk factors. The authors concluded, "Further research is needed to provide more conclusive evidence that the performance outcome for children implanted before 12 months of age does not converge with the results of children implanted between 12 and 18 months." Currently, there is no conclusive published evidence to support performing cochlear implant surgery on an infant younger than 12 months of age.
A number of small studies from outside the U.S. have reported results on cochlear implantation in infants younger than 12 months, which would be an off-label indication. For example, in a study from Australia, Ching and colleagues (Ching, 2009) published an interim report on early language outcomes of children with cochlear implants. This study evaluated 16 children who had implants before 12 months of age compared to 23 who had implants after 12 months (specific time of implantation was not provided). The preliminary results demonstrated that children who received an implant before 12 months of age developed normal language skills at a rate comparable to normal-hearing children, while those with later implants performed at two standard deviations below normal. The authors noted that these results are preliminary as there is a need to examine the effect of multiple factors on language outcomes and the rate of language development. Similarly, in a study from Italy, Colletti (40) reported on findings from 13 infants who had implants placed before 12 months. The procedures were performed between 1998 and 2004. In this small study, the rate of receptive language growth for these early implant infants overlapped scores of normal-hearing children. This overlap was not detected for those implanted at 12–23 or 24–36 months. Data from these small studies are viewed as preliminary and not conclusive.
In 2006, the American Academy of Otolaryngology-Head and Neck Surgery Foundation (Blakely, 2006) released criteria for cochlear implants for adults and pediatric patients.
3. Have sentence recognition score of 50 percent or less in the ear to be implanted and 60 percent or less in the contralateral ear in best aided conditions using Hearing in Noise Test (HINT) or City University of New York (CUNY) tests.
1. Be 12 months to 17 years of age.
2. Infants age 12-24 months should have bilateral, profound hearing loss with thresholds of 90dB or greater at 100 Hz.
3. Children 24 months to 17 years should have bilateral severe to profound (greater than 70dB) hearing loss.
4. Infants and older children should demonstrate lack of progress in simple auditory skills in conjunction with appropriate auditory amplification and participation in intensive aural habilitation for three to six months. Less than 0.14520 percent correct on the Multi-syllabic Lexical Neighborhood Test (MLNT) or Lexical Neighborhood Test (LNT), depending on the child's cognitive and linguistic abilities.
In May 2008, The British Cochlear Implant Group (BCIG) released a position paper on "Bilateral Cochlear Implants." The position paper includes indications for use of bilateral implantation as noted above.
In January 2009, the National Institute for Health and Clinical Excellence (NICE) released technology appraisal guidance 166, "Cochlear Implants for children and adults with severe to profound deafness," which includes recommendations for use of unilateral and bilateral cochlear implants in children and adults as noted above.
In summary, these studies show consistent improvement in speech reception (especially in noise) and in sound localization with bilateral devices. These are important attributes. Studies also suggest that earlier implantation may be preferred. Based on the available evidence, the use of unilateral and bilateral cochlear implant devices is sufficient to improve net health outcomes.
In April 2011, a technology assessment was completed by the Tufts Evidence-based Practice Center for the Agency for Health Care Research and Quality on the effectiveness of cochlear implants in adults (Raman, 2011). This assessment examined 22 studies with 30 or more patients and concluded that while the studies reviewed were rated as poor to fair quality, unilateral cochlear implants are effective in adults with sensorineural hearing loss. Pre- and post-cochlear implant scores on multi-syllable tests and open-set sentence tests demonstrated significant gains in speech perception regardless of whether a contralateral hearing aid was used along with the cochlear implant. Additionally, the assessment found generic and disease-specific health-related quality of life improved with unilateral cochlear implants. However, the available evidence was insufficient to draw conclusions on improvements in open-set sentence test scores (i.e., >40% and ≤50% or >50% and ≤60%), and any relationship between pre-implantation patient characteristics and outcomes (e.g., age, duration of hearing impairment, Hearing in Noise Test [HINT] scores and pre- or post-linguistic deafness). A 2012 systematic review of 11 studies by Bittencourt et al. also concluded cochlear implants improved hearing outcomes over conventional hearing aids in patients with severe to profound postlingual deafness (Bittencourt, 2012).
In October 2011, Berrettini and colleagues published results of a systematic review of cochlear implant effectiveness in adults (Berrettini, 2011). Included in the review, were 8 articles on unilateral cochlear implants in advanced age patients. All of the studies reported benefits with cochlear implantation despite advanced age at time of implant (age 70 years or older). In 6 studies, results were not significantly different between younger and older patients. However, 2 studies reported statistically significant inferior perceptive results (e.g., hearing in noise test and consonant nucleus consonant test) in older patients. This systematic review also examined 3 studies totaling 56 adults with pre-lingual deafness who received unilateral cochlear implants. The authors concluded unilateral cochlear implants provided hearing and quality-of-life benefits in prelingually deaf patients, but results were variable.
The April 2011 technology assessment, noted above, completed by the Tufts Evidence-based Practice Center on the effectiveness of cochlear implants in adults examined 16 studies on bilateral cochlear implantation of fair to moderate quality published since 2004 (Raman, 2011). The assessment concluded bilateral cochlear implants provide greater benefits in speech perception test scores, especially in noise, when compared to unilateral cochlear implants (with or without contralateral hearing aids). Significant binaural head shadow benefits were noted along with some benefit in binaural summation, binaural squelch effects, and sound localization with bilateral cochlear implants. However, it was unclear if these benefits were experienced under quiet conditions, although benefits increased with longer bilateral cochlear implant usage indicating a need for longer term studies. Hearing-specific quality of life could not be assessed because only one study evaluated this outcome. Additionally, the evidence available on simultaneous bilateral implantation was found to be insufficient, although gains were experienced in speech perception using open-set sentences or multi-syllable tests compared to unilateral cochlear implants or unilateral listening conditions. The assessment noted longer term studies are needed to further understand the benefits with bilateral cochlear implantation and identify candidacy criteria given the risks of a second surgery and the destruction of the cochlea preventing future medical intervention.
In the 2011 Berrettini et al. review of cochlear implant effectiveness in adults (noted above), 13 articles on bilateral cochlear implants were reviewed (Berrettini, 2011). Sound localization improved with bilateral cochlear implants compared to monaural hearing in 6 studies. Significant improvements in hearing in noise and in quiet environments with bilateral implants compared to unilateral implants were reported in 10 studies and 7 studies, respectively. Five of the studies reviewed addressed simultaneous implantation, 5 studies reviewed sequential implantation, and 3 studies included a mix of simultaneous and sequential implantation. However, no studies compared simultaneous to sequential bilateral implantation results, and no conclusions could be made on the timing of bilateral cochlear implantation. Smulders et al. also examined the timing of cochlear implantation in a systematic review of 11 studies; 5 studies addressed postlingually deafened adults and 7 studies addressed prelingually deafened children (discussed below) (Smulders, 2011). One study on adults showed a delay in the timing of the second implantation resulted in poorer outcomes in quiet environments. Nevertheless, all studies reported benefits with bilateral implants, but all studies were considered to be of poor quality and with a high risk of bias.
In 2011, Forli and colleagues conducted a systematic review of 49 studies on cochlear implant effectiveness in children (Forli, 2011). Heterogeneity of studies precluded performance of a meta-analysis. Early implantation was examined in 22 studies, but few studies compared outcomes of implantations performed prior to one year of age to implantations performed after one year of age. Studies suggest improvements in hearing and communicative outcomes in children receiving implants prior to one year of age, although, it is not certain whether these improvements are related to duration of cochlear implant usage rather than age of implantation. However, the reviewers noted hearing outcomes have been shown to be significantly inferior in patients implanted after 24-36 months. Bilateral cochlear implants improved verbal perception in noise and sound localization compared to unilateral implants in 19 of 20 studies reviewed, but none of the studies compared learning development and language in bilateral versus unilateral cochlear implant recipients. Simultaneous versus sequential bilateral cochlear implantation results were not examined in any of the studies reviewed. Finally, 7 studies were reviewed that examined cochlear implant outcomes in children with associated disabilities. In this population, cochlear implant outcomes were inferior and occurred more slowly but were considered to be beneficial.
In a 2011 systematic review of 38 studies, Black and colleagues sought to identify prognostic factors for cochlear implantation in pediatric patients (Black, 2011). A quantitative meta-analysis was not able to be performed due to study heterogeneity. However, 4 prognostic factors: age at implantation, inner ear malformations, meningitis, and Connexin 26 (a genetic cause of hearing loss), consistently influenced hearing outcomes.
Pakdaman et al. conducted a systematic review of cochlear implants in children with cochleovestibular anomalies in 2011 (Pakdaman, 2011). Anomalies included inner ear dysplasia such as large vestibular aqueduct and anomalous facial nerve anatomy. Twenty-two studies were reviewed totaling 311 patients. The authors found implantation surgery was more difficult and speech perception was lower in patients with severe inner ear dysplasia. However, heterogeneity in the studies limited interpretation of these findings.
In another 2011 systematic review, Roush and colleagues examined the audiologic management of children with auditory neuropathy spectrum disorder (Roush, 2011). The review included 15 studies that addressed cochlear implantation in these patients. All of the studies reported auditory benefit with cochlear implantation in children with auditory neuropathy spectrum disorder. However, the studies were noted to be limited methodologically and further research is needed in this population.
A May 26, 2012 search of clinical trials at online site: ClinicalTrials.gov identified 2 randomized trials on cochlear implant outcomes. In a prospective, randomized, controlled, multicenter study in Finland, auditory performance skills will be assessed in 40 children with bilateral or unilateral cochlear implants for up to 5 years of hearing age (NCT00960102). In this study, speech perception ability, language acquisition, and speech production and speech recognition will be evaluated in addition to quality of life and parent assessment of functional communication performance. In another prospective, randomized trial in the United States, auditory, linguistic and cognitive development, along with quality-of-life outcomes will be evaluated in 252 children up to age 5 years with developmental delay and deafness (NCT01256229). Children with cochlear implants or hearing aids and developmental delays will be compared to children with cochlear implants and without developmental delay.
The available evidence for use of unilateral and bilateral cochlear implant devices is sufficient to improve net health outcome. Therefore, the policy statement for their use in accordance with FDA approval is unchanged.
A literature search conducted using the MEDLINE database through August 2013 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
In 2013, Gaylor and colleagues published an update to the AHRQ technology assessment (discussed previously) (Gaylor, 2013). Sixteen (of 42) studies published through May 2012 were of unilateral cochlear implants. Most unilateral implant studies showed a statistically significant improvement in mean speech scores, as measured by open-set sentence or multisyllable word tests; meta-analysis of 4 studies revealed a significant improvement in cochlear-implant relevant QOL after unilateral implantation (standard mean difference: 1.71; 95% confidence interval [CI]: 1.15-2.27). However, these studies varied in design and there was considerable heterogeneity observed across studies (Gaylor, 2013).
Crathorne and colleagues published an update of the NICE systematic review (discussed previously) in 2012 (Crathorne, 2012). The objective was to conduct a systematic review of the clinical and cost-effectiveness of bilateral multichannel cochlear implants compared with unilateral cochlear implantation alone or in conjunction with an acoustic hearing aid, in adults with severe-to-profound hearing loss. A literature search was updated in July 2011 and January 2012. Nineteen studies were included in this update; 6 of these studies were included in the original NICE review. Two studies were RCTs with waiting list controls, 10 were prospective pre-⁄post repeated measure or cohort designs, 6 were cross-sectional in design, and one was an economic evaluation. The studies were conducted in the U.S. and Europe; all compared bilateral with unilateral implantation, and 2 compared bilateral implants with a unilateral implant plus acoustic hearing aid (Crathorne, 2012).
The included studies in the Crathorne review were of moderate-to-poor quality, including 2 RCTs (Crathorne, 2012). Meta-analyses could not be performed due to heterogeneity between studies in outcome measures and study design. However, all studies reported that bilateral cochlear implants improved hearing and speech perception. One RCT found a significant binaural benefit over the first ear alone for speech and noise from the front (12.6 + 5.4%, p<0.001) and when noise was ipsilateral to the first ear (21 + 6%, p<0.001), and another RCT found a significant benefit for spatial hearing at 3 months post-implantation compared with preimplantation (mean difference [standard deviation] scores: 1.46 [0.83–2.09], p<0.01). QOL results varied, showing bilateral implantation may improve QOL in the absence of worsening tinnitus (Crathorne, 2012).
van Schoonhoven and colleagues independently published a systematic review in 2013 as an update to the original NICE review (van Schoonhoven, 2013). As with the Crathorne review, all studies (n=19, published through March 2011) showed a significant bilateral benefit in localization over unilateral cochlear implantation. Similarly, meta-analyses could not be performed due to the heterogeneity of the studies and the level of evidence of the included studies, which was of moderate-to-poor quality (van Schoonhoven, 2013).
A number of small observational studies from outside the U.S. have reported results on cochlear implantation primarily for adult patients with unilateral deafness, which would be an off-label indication (Arndt, 2011; Van de Heyning, 2008). At least 3 narrative literature reviews on this indication have also been published (Arts, 2012; Kamal, 2012; Sampaio, 2011).
Arndt and colleagues, for example, published a German pilot study in 2010 of 11 adult patients with unilateral hearing loss of various causes (Arndt, 2011). The aim was to evaluate the use of unilateral electrical stimulation with normal hearing on the contralateral side and after a period of 6 months compared with the preoperative unaided situation, conventional contralateral routing of signal or bone-anchored hearing aid hearing aids. Ten (of 11) patients also suffered from tinnitus. Two tests were used to assess speech comprehension, localization was assessed using an array of multiple speakers, and QOL was evaluated using 3 questionnaires. The study results were presented as p values without adjustment for multiple testing. The authors reported that cochlear implantation improved hearing abilities in these study patients and was superior to the above alternative treatment options. The use of the cochlear implant did not interfere with speech understanding in the normal-hearing ear.
The application of cochlear implants for tinnitus relief in patients with unilateral deafness has also been described in previous studies. van de Heyning and colleagues, for example, published a study in 2008 of 21 patients with unilateral hearing loss accompanied by severe tinnitus for at least 2 years who underwent cochlear implants at a university center in Belgium (Van de Heyning, 2008). Three (of 21) patients showed complete tinnitus relief, whereas the majority demonstrated a significant reduction in tinnitus loudness based on a visual analogue scale (2 years after implantation, 2.5 +/- 1.9; before implantation, 8.5 +/- 1.3). Based on the above data and narrative reviews, the evidence-base to date on unilateral hearing loss is based on a few observational studies with a small number of patients (n ≤30), with a tendency toward reporting bias across these studies (Arts, 2012).
Studies published since the above systematic reviews suggest that cochlear implant removal and reimplantation (due to device malfunction or medical/surgical complications) in children is not associated with worsened hearing outcomes (Sterkers, 2015).
Fernandes and colleagues evaluated 18 published studies and 2 dissertations that reported hearing performance outcomes for children with ANSD and cochlear implants (Fernandes, 2015). Studies included 4 nonrandomized controlled studies considered high quality, 5 RCTs considered low quality, and 10 clinical outcome studies. Most studies (n=14) compared the speech perception in children with ANSD and cochlear implants with the speech perception in children with sensorineural hearing loss and cochlear implants. Most of these studies concluded that children with ANSD and cochlear implants developed hearing skills similar to those with sensorineural hearing loss and cochlear implants; however, these types of studies do not allow comparisons of outcomes between ANSD patients treated with cochlear implants and those treated with usual care.
In a subsequent small retrospective case series not included in the Humphriss, Fernandes, or Roush systematic reviews, Kontorinis and colleagues described pre- and post-cochlear implantation hearing outcomes (Kontorinis, 2014).among 27 children with ANSD.24 Candidacy for cochlear implants in patients with ANSD was considered if they had severe or even moderate hearing loss when there were deficits in auditory skills and the perception and development of language, and it is not clear how many children would have qualified for a cochlear implant without ANSD.
In 2015, van Zon et al published another systematic review of studies evaluating cochlear implantation for single-sided deafness or asymmetric hearing loss (van Zon, 2015). The authors reviewed 15 studies, 9 of which (n=112 patients) were considered high enough quality to be included in data review. The authors identified no high-quality studies of cochlear implantation in this population. Data were not able to be pooled for meta-analysis due to high between-study heterogeneity, but the authors conclude that studies generally report improvements in sound localization, QOL scores, and tinnitus after cochlear implantation, with varying results for speech perception in noise.
In 2014, Blasco and Redleaf published a systematic review and meta-analysis of studies evaluating cochlear implantation for unilateral sudden deafness (Blasco, Redleaf, 2014). The review included 9 studies with a total of 36 patients. In pooled analysis, subjective improvement in tinnitus occurred in 96% of patients (of 27 assessed), subjective improvement in speech understanding occurred in 100% of patients (of 16 assessed), and subjective improvement in sound localization occurred in 87% of patients (of 16 assessed). However, the small number of patients in which each outcome was assessed limits conclusions that may be drawn.
Santa Maria and colleagues conducted a systematic review and meta-analysis of hearing outcomes after various types of hearing-preservation cochlear implantation, including implantation hybrid devices, cochlear implantation with surgical techniques designed to preserve hearing, and the use of post-operative systemic steroids (Santa, 2014). The study included 24 studies, but only 2 focused specifically on a hybrid cochlear implant system, and no specific benefit from a hybrid system was reported.
A small number of studies in a small number of patients suggest that a hybrid cochlear implant system is associated with improvements in hearing of speech in quiet and noise. However, there are currently not available studies that compare the use of a standard hearing aid with a hybrid cochlear implant, which would be an appropriate comparison to determine if a hybrid device improves outcomes for patients who currently have hearing loss but might not be candidate for a cochlear implant. In addition, there is only limited data to suggest that the preservation of residual hearing associated with a hybrid device is associated with improved outcomes compared with a standard cochlear implant.
The available evidence suggests that a hybrid cochlear implant system is associated with improvements in hearing of speech in quiet and noise. However, the evidence is not sufficient to demonstrate that hybrid cochlear implant/hearing aid systems to improve outcomes compared with either hearing aid or cochlear implant alone; therefore, they are considered to be investigational.
A recent (2015) prospective study of 28 children with profound sensorineural hearing loss who were implanted early with cochlear implants (mean age at device activation: 13.3 months) reported that children had social and conversational skills in the range of normal peers (Guerzoni, 2015).
Studies, ranging in size from 91 to 961 patients, generally report improved speech outcomes with bilateral implantation, compared with unilateral implantation. In another retrospective case series of 73 children and adolescents who underwent sequential bilateral cochlear implantation with a long (>5 year) interval between implants, performance on the second implanted side was worse than the primary implanted side, with outcomes significantly associated with the inter-implant interval (Illg, 2013).
Several individual studies have reported on outcomes for cochlear implantation for single-sided deafness since the publication of the systematic reviews described above. The longest follow-up was reported by Mertens and colleagues, in a case series with structured interviews, including 23 individuals who received cochlear implants for single-sided deafness with tinnitus (Mertens, 2016). Eligible patients had either single-sided deafness or asymmetric hearing loss and ipsilateral tinnitus. Subjects had a mean 8 years of experience with their cochlear implant (range, 3-10 years). Tinnitus symptoms were assessed by structured interview, visual analog scale (VAS), and the Tinnitus Questionnaire. Patients demonstrated improvements in VAS from baseline (mean score, 8) to 1 month (mean score: 4; p<0.01 vs baseline) and 3 months (mean score: 3; p<0.01 vs baseline) after the first fitting. Tinnitus scores improved from baseline to 3 months post fitting (55 vs 31, p<0.05) and were stable for the remainder of follow-up.
In 2015, Arndt and colleagues reported outcomes for 20 children who underwent cochlear implantation for single-sided deafness, which represented a portion of their center's cohort of 32 pediatric patients with single-sided deafness who qualified for cochlear implants (Arndt, 2015). Repeated-measure analyses of hearing data sets were available for 13 implanted children, excluding 5 who had undergone surgery too recently to be evaluated and 2 children who were too young to be evaluated for binaural hearing benefit. There was variability in the change in localization ability across the tested children. Self- (or child-) reported hearing benefit was measured with the Speech, Spatial and Qualities of Hearing Scale (SSQ). Significant improvements were reported on the child and parent evaluations for the scale's 3 subcategories: speech hearing, spatial hearing, hearing quality, and total hearing.
Earlier, smaller studies, such as those reported by Arndt and colleagues (2010) with 11 adult patients, and by Hanset and colleagues (2013) with 29 patients, reported improvements in hearing ability compared with baseline.
The application of cochlear implants for tinnitus relief in patients with unilateral deafness has also been described. Studies of cochlear implants in patients with bilateral hearing loss, which is often associated with tinnitus, have reported improvements in tinnitus. For example, Von Zon and colleagues reported on a prospective study focusing on tinnitus perception conducted as a part of a multicenter RCT comparing unilateral with bilateral cochlear implantation in patients with severe bilateral sensorineural hearing loss (van Zon, 2015). This analysis included 38 adults enrolled from 2010-2012 and randomized to simultaneous bilateral or unilateral cochlear implants. At 1 year post-implantation, both unilaterally and bilaterally implanted patients had significant decreases in score on the Tinnitus Handicap Inventory (THI; a validated scale): change in score of 8 to 2 (p=0.03) and from 22 to 12 (p=0.04) for unilaterally and bilaterally implanted patients, respectively. Bilaterally implanted patients had a significant decrease in Tinnitus Questionnaire (TQ; a validated scale): change in score of 20 to 9 (p=0.04).
Several individual studies have reported on outcomes for cochlear implantation for single-sided deafness since the publication of the systematic reviews described above.
The longest follow-up was reported by Mertens and colleagues, in a case series with structured interviews, including 23 individuals who received cochlear implants for single-sided deafness with tinnitus (Mertens, 2016). Eligible patients had either single-sided deafness or asymmetric hearing loss and ipsilateral tinnitus. Subjects had a mean 8 years of experience with their cochlear implant (range, 3-10 years). Tinnitus symptoms were assessed by structured interview, visual analog scale (VAS), and the Tinnitus Questionnaire. Patients demonstrated improvements in VAS from baseline (mean score, 8) to 1 month (mean score: 4; p<0.01 vs baseline) and 3 months (mean score: 3; p<0.01 vs baseline) after the first fitting. Tinnitus scores improved from baseline to 3 months post fitting (55 vs 31, p<0.05) and were stable for the remainder of follow-up.
Based on observations about tinnitus improvement with cochlear implants, several studies have reported on improvements in tinnitus after cochlear implantation in individuals with unilateral hearing loss. In the meta-analysis by Vlastarakos and colleagues (2013) described above, for example, unilateral tinnitus improved in most patients (95%).
Ramos Macias et al (2015) reported results of a prospective multicenter study with repeated measures related to tinnitus, hearing, and quality of life, among 16 individuals with unilateral hearing loss and severe tinnitus who underwent cochlear implantation.47 All patients had a severe tinnitus handicap (THI score ≥ 58%). Eight (62%) of the 13 patients who completed the 6-month follow-up visit reported a lower tinnitus handicap on the THI score. Perceived loudness/annoyingness of the tinnitus was evaluated with a 10-point VAS. When the CI was on, tinnitus loudness decreased from 8.4 preoperatively to 2.6 at the 6-month follow-up; 11 of 13 patients reported a change in score of 3 or more.
Roland and colleagues reported FDA documentation and in per-reviewed form on pivotal trial was a prospective, multicenter, 1-arm, nonrandomized, non-blinded, repeated-measures clinical study among 50 subjects at 10 U.S. sites.
Performance was compared pre- with post-implant within each subject; outcomes were measured at 3, 6, and 12 months postoperatively. The study tested 2 co-primary efficacy hypotheses: (1) that outcomes on consonant-nucleus-consonant (CNC; a measure of word recognition); and (2) that AzBio sentences in noise presented through the hybrid implant system would be better at 6 months postimplantation than preoperative performance using a hearing aid.
Causon and colleagues evaluated factors associated with cochlear implant outcomes in a meta-analysis of articles published from 2003 to 2013 which reported on PTA measurements pre- and post-cochlear implantation (Causon, .015). Twelve studies with available audiometric data (total N=200 patients) were included. The authors applied a formula to attempt to standardize degree of hearing preservation after cochlear implant, described as the HEARRING consensus statement formula, which calculates a percentage of hearing preservation at a specific frequency band, which is scaled to the preoperative audiogram by dividing the change in hearing by the difference between the maximum measurable threshold and the preoperative hearing threshold. The association of a variety of patient- and surgery-related factors, including insertion depth, and improvement in low-frequency hearing were evaluated. In this analysis, insertion depth was not significantly associated with low-frequency residual hearing.
In a retrospective review that included 10 subjects implanted with a cochlear implant with either a standard electrode (n=12) or the Nucleus Hybrid L24 electrode (n=10), loss of acoustic hearing to the severe-profound level occurred in a higher proportion of patients who received a standard electrode (58% vs 30%).
Prospective and retrospective studies using a single-arm, within-subjects comparison pre- and post-intervention suggest that a hybrid cochlear implant system is associated with improvements in hearing of speech in quiet and noise. For patients who would typically meet criteria for a cochlear implant, the evidence would suggest that outcomes with a hybrid device are at least as good as those with a standard cochlear implant. There are currently not available studies that compare the use of a standard hearing aid with a hybrid cochlear implant, which would be an appropriate comparison to determine if a hybrid device improves outcomes for patients who currently have hearing loss but are not necessarily current candidates for a cochlear implant.
(NCT02204618) Cochlear Implantation in Single Sided Deafness and Asymmetrical Hearing Loss: a Cost/Utility Study; planned enrollment 150; completion date August 2017.
The evidence for cochlear implants in individuals who have bilateral sensorineural hearing loss includes randomized controlled trials (RCTs) and multiple systematic reviews and technology assessments. Relevant outcomes include symptoms, functional outcomes, and treatment-related morbidity and mortality. The available studies report improvements in speech reception and quality of life measures. Although the available RCTs and other studies measure heterogeneous outcomes and have varying patient populations, the findings are consistent across multiple studies and settings. In addition, studies show consistent improvement in speech reception (especially in noise) and in sound localization with bilateral devices. Studies also suggest that earlier implantation may be preferred. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome.
The evidence for cochlear implants in individuals who have unilateral sensorineural hearing loss includes prospective and retrospective studies reporting within-subjects comparisons and systematic reviews of these studies. Relevant outcomes include symptoms, functional outcomes, and treatment-related morbidity and mortality. Given the natural history of hearing loss, pre- and postimplantation comparisons may be appropriate for objectively measured outcomes. However, the available evidence for the use of cochlear implants in improving outcomes for patients with unilateral hearing loss, with or without tinnitus, is limited by small sample sizes, short follow-up times, and heterogeneity in evaluation protocols and outcome measurements. The evidence is insufficient to determine the effects of the technology on health outcomes.
A literature search conducted using the Medline database through August 2017. The key identified literature is summarized below. There were no new randomized controlled trials identified.
Several case series assessing cochlear implantation for unilateral sensorineural hearing loss were identified.
In 2017, Sladen et al retrospectively reviewed prospectively collected data of short-term (6-month) follow-up for 23 adults and children with single-sided deafness from a variety of mechanisms who received a cochlear implant (Sladen, 2017). In the implanted ear, CNC word recognition improved significantly from preimplantation to 3 months postactivation (p=0.001). However, for AzBio sentence understanding in noise (+5 dB signal-to-noise), there was no ignificant improvement from preimplantation to 6 months postactivation.
In a prospective repeated-measures cohort study that included 20 subjects with single-sided deafness implanted with cochlear implants (15 of whom had reached 6-month follow-up), Sladen et al (2016) reported on speech recognition and QOL (Sladen, 2017). Pure-tone audiometry improved with air conduction in the implanted ear. CNC scores in quiet improved from 4.8% in the preoperative period to 42.3% at the 6-month postactivation check in patients who reached that follow-up.
Also in 2016, Rahne et al reported on a retrospective review of 4 children and 17 adults with single-sided deafness treated with cochlear implants and followed for 12 months (Rhane, 2016). Sound localization with aided hearing improved from preimplantation for all individuals. The speech recognition threshold in noise (signal-to-noise) ratio improved from -1.95 dB (CI off, SD=2.7 dB) to -4.0 dB after 3 months (SD=1.3 dB; p<0.05), with continued improvements through 6 months.
The available evidence for the use of cochlear implants in improving outcomes for patients with unilateral hearing loss, with or without tinnitus, is limited by small sample sizes, short follow-up times, and heterogeneity in evaluation protocols and outcome measurements. The coverage statement is changed to specify non-coverage for cochlear implants for the treatment of unilateral sensorineural hearing loss.
Annual policy review completed with a literature search using the MEDLINE database through September 2018. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
References: American Academy of Otolarygology -- Head and Neck Surgery.(2014) Position Statement: Cochlear Implants. http://www.entnet.org/Practice/policyCochlearImplants.cfm. Accessed January 25, 2018.
Arndt S, Aschendorff A, Laszig R et al.(2011) Comparison of pseudobinaural hearing to real binaural hearing rehabilitation after cochlear implantation in patients with unilateral deafness and tinnitus. Otol Neurotol 2011; 32(1):39-47.
Arts RA, George EL, Stokroos RJ et al.(2012) Review: cochlear implants as a treatment of tinnitus in single-sided deafness. Curr Opin Otolaryngol Head Neck Surg 2012; 20(5):398-403.
Berrettini S, Baggiani A, Bruschini L et al.(2011) Systematic review of the literature on the clinical effectiveness of the cochlear implant procedure in adult patients. Acta Otorhinolaryngol Ital 2011; 31(5):299-310.
Bittencourt AG, Ikari LS, Della Torre AA et al.(2012) Post-lingual deafness: benefits of cochlear implants vs. conventional hearing aids. Braz J Otorhinolaryngol 2012; 78(2):124-7.
Black J, Hickson L, Black B et al.(2011) Prognostic indicators in paediatric cochlear implant surgery: a systematic literature review. Cochlear Implants Int 2011; 12(2):67-93.
Bond M, Mealing S, Anderson R et al.(2009) The effectiveness and cost-effectiveness of cochlear implants for severe to profound deafness in children and adults: a systematic review and economic model. Health Technol Assess 2009; 13(44):1-330.
British Cochlear Implant Group (BCIG).(2007) Position Statement - Bilateral Cochlear Implantation. Revised May 2008. Accessed September 2009. Available at: http://www.bcig.org.uk/downloads/pdfs/BCIG%20position%20statement%20-%20Bilateral%20Cochlear%20Implantation%20May%2007.pdf .
Centers for Medicare & Medicaid.(2013) Cochlear Implantation. https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/Cochlear-Implantation-.html. Accessed January 25, 2018.
Ching TY, Dillon H, Day J et al.(2009) Early language outcomes of children with cochlear implants: Interim findings of the NAL study on longitudinal outcomes of children with hearing impairment. Cochlear Implants Int 2009; 10(suppl 1):28-32.
Colletti L.(2009) Long-term follow-up of infants (4-11 months) fitted with cochlear implants. Acta Otolaryngol 2009; 129(4):361-6.
Crathorne L, Bond M, Cooper C et al.(2012) A systematic review of the effectiveness and cost-effectiveness of bilateral multichannel cochlear implants in adults with severe-to-profound hearing loss. Clin Otolaryngol 2012; 37(5):342-54.
Firszt JB, Reeder RM, Skinner MW.(2008) Restoring hearing symmetry with two cochlear implants or one cochlear implant and a contralateral hearing aid. J Rehabil Res Dev 2008; 45(5):749-67.
Forli F, Arslan E, Bellelli S et al.(2011) Systematic review of the literature on the clinical effectiveness of the cochlear implant procedure in paediatric patients. Acta Otorhinolaryngol Ital 2011; 31(5):281-98.
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text:
Pray kneel before the altar of EU religious correctness
October 29, 2003 5:00 pm CET
There's no Holy smoke without fire…
Doing God's work will soon have a whole new meaning for employers across parts of the European Union.
The UK, for example, has interpreted Commissioner Anna Diamantopoulou and her team's Equality in Employment Directive in such a way that it is about to add to the Bible – or perhaps the Koran – on working practices. How so? By issuing holy orders forcing bosses to create a place for worship in every office or factory, if requested by a worker.
The law enters into force on 2 December, during the run-up to Christmas no less, and will be just the job – or time off the job – for followers of all the main religions.
Very important taxpayers
Media choice: Juncker channels his frustration
By Paul Dallison
To dream the (mission) impossible dream
Here's the deal – Christians can no longer be forced to work on Sundays and will be allowed time off (or a chance to leave work early) during religious festivals, Jews can refuse to work on Saturdays, and Muslims can now take time off for the two festivals of Eid.
Any Muslim will also be entitled to extended leave for one pilgrimage to Mecca during his working career, while a Hindu suffering a bereavement may be allowed to head for the River Ganges to folow tradition and spread his loved one's ashes.
Although employers will not be forced to build a chapel or mosque, firms with sufficient space must create room for somewhere to pray, if so requested.
At least one European boss took it in the right 'spirit': "For Heaven's sake, it's beyond belief. These regulations are simply preying on the goodwill of employers. I'm incensed. Brussels will have us on our knees next."
All puns were intended, EN can confirm. Amen to that, then…
Perceptions of peace
Grappling with the big issues
You're for the chop!
Tech Reporter (London)
Location: London | Department: Editorial
Junior Salesforce Administrator
Business Development Associate (Paris) POLITICO Pro
The fine art of finance
April 1, 2015 4:50 am CET
By Jeanette Minns
A close shave
Plan C fails to win over MEPs


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