Henrique Tiggemann.et al. Int. Journal of Engineering Research and Application www.ijera.com ISSN : 2248-9622, Vol. 6, Issue 7, ( Part -2) July 2016, pp.25-30 www.ijera.com 25|Page Reliability of Med-El Cochlear Implants in children. The Romania Experience. Eugen Horatiu Stefanescu 1¶* , Marioara Poenaru 1¶ , Nicolae Constantin Balica 1¶ , Anca Tudor 2¶ , Andreea Marinescu 3¶ , Madalina Georgescu 3¶ , Luminita Radulescu 4¶ , Sebastian Cozma 4¶ , Violeta Necula 5¶ , Marcel Cosgarea 5 ¶ 1 Department of Otolaryngology, “Victor Babes” University of Medicine and Pharmacy Timisoara, Romania 2 Department of Medical Informatics and Biostatistics, “Victor Babes” University of Medicine and Pharmacy Timisoara, Romania 3 Department of Otolaryngology, Institute of Phono-Audiology and Functional Surgery, “Carol Davila” University of Medicine and Pharmacy Bucuresti, Romania 4 Department of Otolaryngology, “Grigore T. Popa” University of Medicine and Pharmacy Iasi, Romania 5 Department of Otolaryngology, ¶“Iuliu Hateganu” University of Medicine and Pharmacy Cluj Napoca, Romania ABSTRACT Introduction: Early detection of hearing loss significantly lowered the age of cochlear implantation. A failed CI is a very problematic issue for the child and family and seems to be, for the moment, inevitable. This is a retrospective review aimed to evaluate the reliability of Med-El devices implanted in children in Romania. Materials and Methods: We designed a questionnaire to assess the incidence, the time elapsed and the reason of total device failure. Medical-surgical data were collected from children who received Med-El cochlear implants since the start of the National Cochlear Implant Program in 2001. Results: There were 256 patients included. Failure Rate (6,64%) and Cumulative Survival Rate (95,31%) at 5 years were calculated. The majority of the hard and soft failures were encountered in Pulsar devices. Flap necrosis was the most frequent medical/surgical reason for re-plantation. There was only one case of posttraumatic device failure. Time elapsed to device failure was short – 22 months on average. Conclusion: Cochlear implant reliability data should be considered during the choice of an implant for each individual patient. This study confirms the safety and efficacy of Med-El cochlear implants in children for both ceramic and non-ceramic devices. I. INTRODUCTION Device reliability is a very important issue for both surgeons and patients (their parents, to be more specific, as we are talking about children) when considering a particular device for implantation. Device failure is defined as when the device is not functioning inside the manufacturer’s specification and/or there is no or just insufficient clinical benefit for the patient [1]. There also are situations when the device needs to be removed for medical/surgical reasons, such as infection or flap necrosis. Device failure is classified according to the guidelines of the 2005 Cochlear Implant Soft Failures Consensus Development Conference Statement into hard and soft failures [2]. According to these guidelines, a hard failure refers to detectable hardware problem and a soft failure refers to underperformance, hearing and/or non- hearing related problems and side effects, or discontinuous function of the device. One should always keep in mind that the manufacturer’s examination of the explanted device takes place after the surgical removal that can, by itself, create a trauma to the device and can result in failure that is sometimes difficult to be distinguished from a previous (pre-explantation) problem. Bearing this in mind is sometimes difficult to accurately defining failures into hard or soft. The reliability of cochlear implants over time is an important issue for doctors and the calculation of cumulative survival rate (CSR) is an objective tool when reporting about this issue. Failure Rate (FR, i.e., failed to implanted devices ratio) is another method to evaluate reliability. In this study we followed the ISO reporting standards (ISO 5841-2, 2002) for cardiac pacemakers and we considered the Cumulative Survival Rate a reliable measure that indicates that a device will probably still be functioning after a certain period of time. The Cumulative Survival Rate (CSR) is the cumulative percentage of functioning implant over time and can be used to RESEARCH ARTICLE OPEN ACCESS