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      One-year experience with the Cochlear™ Paediatric Implanted Recipient Observational Study (Cochlear P-IROS) in New Delhi, India

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          Abstract

          Background

          Currently, there is a significant lack of data concerning long-term outcomes following paediatric cochlear implantation in terms of quality of life. There is a need for a long-term, prospective study in this regard. This study aims at highlighting the preliminary results, one year post surgery of a five year prospective study.

          Methods

          The Cochlear™ Paediatric Implanted Recipient Observational Study (P-IROS) is a prospective, patient outcomes registry for routinely implanted children. The study collects data using questionnaires post-surgery and at regular intervals up to five years.

          Results

          At our Centre, 159 cochlear implant surgery procedures were carried out between January 2014 and December 2014. Category of Auditory Performance II score increased from ‘0’ to ‘3’ at six months and to ‘5’ at 12 months for children aged 0–3 years, although this was not statistically significant. However, the same trend was statistically significant for the age 3–6 year and age 6–10 year brackets. The quality of life of the child improved significantly. Analysis of communication mode revealed a statistically significant overall shift to the auditory-oral mode from total communication.

          Conclusion

          Cochlear implantation is a life-changing intervention. The evidence in support of what it can achieve safely is clear. However, the costs associated with it raise the question if it will remain an effective option for life in all children. The Cochlear P-IROS is an attempt to answer the same over a five year period. Our study in New Delhi, so far concludes that cochlear implantation in a population with limited access to funds is very effective, one year after surgery.

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          Most cited references10

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          The effectiveness and cost-effectiveness of cochlear implants for severe to profound deafness in children and adults: a systematic review and economic model.

          To investigate whether it is clinically effective and cost-effective to provide (i) a unilateral cochlear implant for severely to profoundly deaf people (using or not using hearing aids), and (ii) a bilateral cochlear implant for severely to profoundly deaf people with a single cochlear implant (unilateral or unilateral plus hearing aid). Main electronic databases [MEDLINE; EMBASE; Cochrane Database of Systematic Reviews; CENTRAL; NHS EED; DARE; HTA (NHS-CRD); EconLit; National Research Register; and ClinicalTrials.gov] searched in October 2006, updated July 2007. A systematic review of the literature was undertaken according to standard methods. A state-transition (Markov) model of the main care pathways deaf people might follow and the main complications and device failures was developed. The clinical effectiveness review included 33 papers, of which only two were RCTs. They used 62 different outcome measures and overall were of moderate to poor quality. All studies in children comparing one cochlear implant with non-technological support or an acoustic hearing aid reported gains on all outcome measures, some demonstrating greater gain from earlier implantation. The strongest evidence for an advantage from bilateral over unilateral implantation was for understanding speech in noisy conditions (mean improvement 13.2%, p < 0.0001); those receiving their second implant earlier made greater gains. Comparison of bilateral with unilateral cochlear implants plus an acoustic hearing aid was compromised by small sample sizes and poor reporting, but benefits were seen with bilateral implants. Cochlear implants improved children's quality of life, and those who were implanted before attending school were more likely to do well academically and attend mainstream education than those implanted later. In adults, there was a greater benefit from cochlear implants than from non-technological support in terms of speech perception. Increased age at implantation may reduce effectiveness and there is a negative correlation between duration of deafness and effectiveness. Speech perception measures all showed benefits for cochlear implants over acoustic hearing aids [e.g. mean increase in score of 37 points in noisy conditions (p < 0.001) with BKB sentences]; however, prelingually deafened adults benefited less than those postlingually deafened (mean change scores 20% versus 62%). For unilateral versus bilateral implantation, benefits in speech perception were significant in noisy conditions on all measures [e.g. 76% for HINT sentences (p < 0.0001)]. Quality of life measured with generic and disease-specific instruments or by interview mostly showed significant gains or positive trends from using cochlear implants. The Markov model base-case analysis estimated that, for prelingually profoundly deaf children, the incremental cost-effectiveness ratio (ICER) for unilateral implantation compared with no implantation was 13,413 pounds per quality-adjusted life-year (QALY). Assuming the utility gain for bilateral implantation is the same for adults and children, the ICERs for simultaneous and sequential bilateral implantation versus unilateral implantation were 40,410 pounds and 54,098 pounds per QALY respectively. For postlingually sensorineurally profoundly deaf adults, the corresponding ICERs were 14,163 pounds, 49,559 pounds and 60,301 pounds per QALY respectively. Probabilistic threshold analyses suggest that unilateral implants are highly likely to be cost-effective for adults and children at willingness to pay thresholds of 20,000 pounds or 30,000 pounds per QALY. There are likely to be overall additional benefits from bilateral implantation, enabling children and adults to hold conversations more easily in social situations. Unilateral cochlear implantation is safe and effective for adults and children and likely to be cost-effective in profoundly deaf adults and profoundly and prelingually deaf children. However, decisions on the cost-effectiveness of bilateral cochlear implants should take into account the high degree of uncertainty within the model regarding the probable utility gain.
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            Global burden of hearing loss in the year 2000

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              Cochlear implants in children--a review.

              Over the past two decades, cochlear implantation has become a widely accepted treatment of deafness in children. Over 20,000 children have received cochlear implants worldwide. Hearing, language and social development outcomes have been positive. We review current issues in cochlear implantation, candidacy, evaluation, surgery, habilitation, ethics and outcomes.
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                Author and article information

                Contributors
                Journal
                J Otol
                J Otol
                Journal of Otology
                Chinese PLA General Hospital
                1672-2930
                30 September 2015
                June 2015
                30 September 2015
                : 10
                : 2
                : 57-65
                Affiliations
                [a ]The ENT Clinic, A7 Neeti Bagh, New Delhi, 110049, India
                [b ]Columbia Asia Hospital, Palam Vihar, Gurgaon, Haryana, India
                [c ]Cochlear Limited – Asia Pacific, 1 University Avenue, Macquarie University, NSW 2109, Australia
                Author notes
                []Corresponding author. A7 Neeti Bagh, New Delhi 110049, India. Tel.: +91 9958725553. shomeshwars@ 123456me.com
                Article
                S1672-2930(15)00059-8
                10.1016/j.joto.2015.09.002
                6002571
                29937783
                6dc4037c-fb65-45d9-8546-732f6f5d0196
                © 2015 PLA General Hospital Department of Otolaryngology Head and Neck Surgery

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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                Categories
                Original article

                cochlear implant surgery,hearing loss,cochlear implant outcome,category of auditory performance,quality of life

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