Hearing Implant Reliability Reporting

Peter Grasso and Florian Feichtner talk to Marcus Schmidt about how the clinical support they provide increases reliability: they work in multidisciplinary teams to aid clinicians along the entire patient pathway, answer questions, make expert recommendations, and provide training. Weblinks: (free professional myMED-EL login required, sign up at https://my.medel.com/) MED-EL Academy Course: Clinical Support Materials (medel.com)

MED-EL’s audio processors have low average monthly repair rates, but sometimes issues do arise. Audiological scientist Katherine Wilson, Peter Konecny, and Manfred Pieber discuss design aspects that keep this number low - such as analyzing weakness in devices that do break and improving them with each new generation - and how devices are serviced reliably when there are problems to get users hearing again as quickly as possible. Weblinks: Cochlear Implant Safety and Reliability (medel.pro) Enjoying All-Day Hearing With the RONDO 3 Audio Processor | MED-EL - YouTube

MRI is a very common medical procedure for both otological and non-otological reasons, so it shouldn’t have complications or be painful for hearing implant recipients. Dr. Ingo Todt and Dr. Martin Zimmerling talk to Manfred Pieber about the features of MED-EL implants that reduce or eliminate complications - such as magnet dislocation - during MRI: a freely rotating, robust, diametrically bipolar magnet that is removable when it is necessary to reduce the size of imaging artifacts. Weblinks: Importance of Safe MRI Access in Cochlear Implants: Dr. Nancy M. Young - MED-EL Professionals Blog (medel.pro) MRI Scans with MED-EL Cochlear Implants - MED-EL Professionals Blog (medel.pro) Important Safety Information MRI & Hearing Implants: Reducing Image Artifacts With the BONEBRIDGE Bone Conduction Implant - MED-EL Professionals Blog (medel.pro) Experiences and Key Learnings in MRI Scanning with MED-EL Hearing Implants Literature Links: MRI Observation After Intralabyrinthine and Vestibular Schwannoma Resection and Cochlear Implantation (https://pubmed.ncbi.nlm.nih.gov/32903399/) Quality Control after Intracochlear Intralabyrinthine Schwannoma Resection and Cochlear Implantation (https://pubmed.ncbi.nlm.nih.gov/34573240/) Prevalence and complications of MRI scans of cochlear implant patients: English version (https://pubmed.ncbi.nlm.nih.gov/26886493/) Cochlear implants and 1.5 T MRI scans: the effect of diametrically bipolar magnets and screw fixation on pain (https://pubmed.ncbi.nlm.nih.gov/29402322/) Pain Free 3 T MRI Scans in Cochlear Implantees (https://pubmed.ncbi.nlm.nih.gov/28938274/) Comparison of Cochlear Implant Magnets and Their MRI Artifact Size (https://pubmed.ncbi.nlm.nih.gov/32420348/) MRI Artifacts and Cochlear Implant Positioning at 3 T In Vivo (https://pubmed.ncbi.nlm.nih.gov/25634466/) Prospective Evaluation of 3 T MRI Effect on Residual Hearing Function of Cochlea Implantees (https://pubmed.ncbi.nlm.nih.gov/36291339/)

Prof. Dr. Kristen Rak and Patrick Müller talk to Marcus Schmidt about their clinical experiences with the VIBRANT SOUNDBRIDGE, the active middle ear implant that has been on the market the longest. They discuss its simplicity and flexibility, the characteristics that ensure its reliability, and the importance of considering feedback from surgeons when refining features to improve reliability for future implant generations.   Weblinks: 25 Years of VIBRANT SOUNDBRIDGE: A Success Story - MED-EL Professionals Blog (medel.pro) VIBRANT SOUNDBRIDGE VORP 503 Active Middle Ear Implant Important Safety Information Performance Assessment: VIBRANT SOUNDBRIDGE VORP 503 Middle Ear Implant - MED-EL Professionals Blog (medel.pro) Literature Links: Long-Term Safety and Quality of Life after Vibroplasty in Sensorineural Hearing Loss: Short/Long Incus Process Coupler (https://pubmed.ncbi.nlm.nih.gov/34044387/) Long-Term Stability and Safety of the Soundbridge Coupled to the Round Window (https://pubmed.ncbi.nlm.nih.gov/33210744/) Long-term results of incus vibroplasty in patients with moderate-to-severe sensorineural hearing loss (https://pubmed.ncbi.nlm.nih.gov/25824716/) Health at a Glance 2021: OECD Indicators (https://doi.org/10.1787/ae3016b9-en)

BONEBRIDGE is different from other bone conduction devices. Prof. Georg Sprinzl, Christine Mühlöcker, and Marcus Schmidt discuss how design differences allow BONEBRIDGE to provide outstanding safety and reliability to users, along with what makes it an ideal choice for pediatric patients. The BCI 602 implant has a robust transducer, a low profile, and is transcutaneous for intact skin. It has two-point fixation and is embedded in the bone for stability, and is MR-conditional at 1.5 Tesla.* * The BONEBRIDGE bone conduction implant is MR conditional. Recipients with BONEBRIDGE may be safely MRI scanned at 1.5 Tesla following the conditions detailed in the instructions for use. Weblinks: Is BONEBRIDGE a Good Hearing Solution for Children? - MED-EL Professionals Blog (medel.pro) Bone Conduction Implant Safety and Reliability (medel.pro) Safety outcomes of bone conduction and middle ear implants: a systematic review Reliable Hearing by Design: MED-EL’s BONEBRIDGE MRI & Hearing Implants: Reducing Image Artifacts With the BONEBRIDGE Bone Conduction Implant - MED-EL Professionals Blog (medel.pro)

Speech and language therapist Pedro Brás da Silva and Joanna Shepherd talk to Manfred Pieber about the aspects of reliability that are especially important for children with cochlear implants. Receiving quality sound all day is crucial to children’s learning and development, so having a reliable audio processor and implant is therefore essential. Weblinks: Factors Affecting Communication Outcomes in Pediatric Cochlear Implantation - MED-EL Professionals Blog (medel.pro) Is BONEBRIDGE a Good Hearing Solution for Children? - MED-EL Professionals Blog (medel.pro)

Prof. Dr. med. Sebastian Schmerber and Dr. Anandhan Dhanasingh talk to Manfred Pieber about how the design features of MED-EL’s flexible, free-fitting, straight FLEX series electrode arrays contribute to implant safety and reliability by reducing the occurrence of common problems such as tip fold-over, scalar deviation, and migration and also preserve intracochlear structures.   Weblinks: Cochlear Implant Safety and Reliability (medel.pro) Electrode Arrays | MED-EL Pro (medel.pro) FLEX Series: Most Atraumatic Cochlear Implant Electrode Arrays - MED-EL Professionals Blog (medel.pro) Download the full Reliability Report at: Reliable Cochlear Implants by Design from MED-EL (medel.com) Literature Links: An overview of cochlear implant electrode array designs (https://pubmed.ncbi.nlm.nih.gov/29102129/) Review on cochlear implant electrode array tip fold-over and scalar deviation (https://pubmed.ncbi.nlm.nih.gov/31467506/) Scalar localization by cone-beam computed tomography of cochlear implant carriers: a comparative study between straight and periomodiolar precurved electrode arrays (https://pubmed.ncbi.nlm.nih.gov/25575374/) Correlation Between Cochlear Length, Insertion Angle, and Tonotopic Mismatch for MED-EL FLEX28 Electrode Arrays (https://pubmed.ncbi.nlm.nih.gov/34538852/) Suitable Electrode Choice for Robotic-Assisted Cochlear Implant Surgery: A Systematic Literature Review of Manual Electrode Insertion Adverse Events (https://pubmed.ncbi.nlm.nih.gov/35402479/)

Comparing manufacturer reliability data can be difficult. Surgeon and researcher Sumit Agrawal and MED-EL reliability expert Manfred Pieber share their professional insights into this topic with Marcus Schmidt. Clinical studies on reliability can also provide valuable insights into implant manufacturers. Weblinks: Refer to pages 4-14 and 32 after downloading the report from: Reliable Hearing by Design: MED-EL Cochlear Implants Reliable Hearing by Design: MED-EL’s BONEBRIDGE Literature Links: Cochlear implant failures and reimplantation: A 30-year analysis and literature review (https://pubmed.ncbi.nlm.nih.gov/31112331/) Evaluating Reasons for Revision Surgery and Device Failure Rates in Patients Who Underwent Cochlear Implantation Surgery (https://pubmed.ncbi.nlm.nih.gov/32134441/) The reliability of hearing implants: report on the type and incidence of cochlear implant failures (https://pubmed.ncbi.nlm.nih.gov/32156201/) The French Cochlear Implant Registry (EPIIC): Cochlear implantation complications (https://pubmed.ncbi.nlm.nih.gov/32861600/) The French National Cochlear Implant Registry (EPIIC): Cochlear explantation and reimplantation (https://pubmed.ncbi.nlm.nih.gov/32826202/)

Hearing implant reliability starts with the design process. Dominik Hammerer and Bernhard Jamnig talk to Manfred Pieber about new device development and steps in the manufacturing process that contribute to reliability, including feasibility, hermeticity, impact, environmental, and vibration testing that ensure all requirements are met. Results from thorough investigations of explanted devices are also considered when designing new implants.  Weblinks: Cochlear Implant Safety and Reliability (medel.pro) Bone Conduction Implant Safety and Reliability (medel.pro)

Since reliability is an important topic for hearing implant recipients and surgeons, MED-EL publishes reliability reports regularly. But there is more to reliability than high cumulative survival rates. Manfred Pieber and Marcus Schmidt discuss the aspects of design and technology that contribute to implant and audio processor safety and reliability, including structure preservation and independent safety capacitors. Weblinks: Reliable Cochlear Implants by Design from MED-EL (medel.com) Cochlear Implant Safety and Reliability (medel.pro)