Design, implementation, and management of an international medical device registry.

BACKGROUND: Registries are powerful clinical investigational tools. Although in hospitals registries may be mandated, industry-sponsored, international registries are voluntary and therefore can require clearer objectives and more planning. The registry also needs sufficient resources and appropriate measurement tools to motivate long-term participation and ensure success. METHODS: We summarize our learnings from 10 years of running a medical device registry that surveys patient-reported benefits of hearing implants. RESULTS: We enlisted 77 participating clinics globally, who actively recruited a total of more than 1500 hearing implant users. We identified the stages in developing a registry specific to hearing loss. Furthermore, we report the challenges and successes in design and implementation and make recommendations for future registries. CONCLUSIONS: Data collection infrastructure needs to be kept up to date throughout the defined registry lifetime, and it is essential to oversee data quality and completeness. Compliance at registry sites is important for data quality and needs to be weighed against the cost of site monitoring. To motivate sites to enter data accurately and expeditiously, we facilitated easy access to their own data which helped to support their clinical routine. TRIAL REGISTRATION: ClinicalTrials.gov NCT02004353. 9th December 2013.

Use of remote control in the intraoperative telemetry of cochlear implant: multicentric study / Uso do controle remoto na telemetria intraoperatória do implante coclear: estudo multicêntrico

Abstract Introduction: The conventional evaluation of neural telemetry and impedance requires the use of the computer coupled to an interface, with software that provides visualization of the stimulus and response. Recently, a remote control (CR220®) was launched in the market, that allows the performance of intraoperative tests with minimal instrumentation. Objective: To evaluate the agreement of the impedance values and neural telemetry thresholds, and the time of performance in the conventional procedure and by the remote control. Methods: Multicentric prospective cross-sectional study. Intraoperative evaluations of cochlear implants compatible with the use of CR220® were included. The tests were carried out in the 22 electrodes to compare the time of performance in the two situations. The agreement of the neural telemetry threshold values obtained from five electrodes was analyzed, and the agreement of impedance was evaluated by the number of electrodes with altered values in each procedure. Results: There were no significant difference between the impedance values. There was a moderate to strong correlation between the electrically-evoked compound action potential thresholds. The mean time to perform the procedures using the CR220 was significantly lower than that with the conventional procedure. Conclusion: The use of the CR220 provided successful records for impedance telemetry and automatic neural response telemetry.

Resumo Introdução: A avaliação convencional da telemetria neural e de impedâncias implica o uso do computador acoplado a uma interface, o software fornece o estímulo e a visualização das respostas. Recentemente, foi lançado um controle remoto (CR220®), que possibilita testes intraoperatórios com instrumental mínimo. Objetivo: Avaliar a concordância dos valores das impedâncias e dos limiares da telemetria neural e o tempo de execução no procedimento convencional e pelo controle remoto. Método: Estudo prospectivo transversal multicêntrico. Foram incluídas as avaliações intraoperatórias de implante coclear compatível com o uso do CR220®. Os testes foram realizados nos 22 eletrodos para comparar os tempos de execução nas duas situações. Foi analisada a concordância dos valores do limiar da telemetria neural obtidos em cinco eletrodos e a concordância das impedâncias foi avaliada pelo número de eletrodos com valores alterados em cada procedimento. Resultados: Não houve diferença significante entre as impedâncias. Obteve-se moderada a forte correlação entre os limiares do potencial de ação composto eletricamente evocado. O tempo médio para os procedimentos com o CR220 foi significativamente menor do que com o procedimento convencional. Conclusão: O uso do CR220 proporcionou registros bem-sucedidos para a telemetria de impedância e a telemetria automática de respostas neurais.

Use of remote control in the intraoperative telemetry of cochlear implant: multicentric study.

INTRODUCTION: The conventional evaluation of neural telemetry and impedance requires the use of the computer coupled to an interface, with software that provides visualization of the stimulus and response. Recently, a remote control (CR220®) was launched in the market, that allows the performance of intraoperative tests with minimal instrumentation. OBJECTIVE: To evaluate the agreement of the impedance values and neural telemetry thresholds, and the time of performance in the conventional procedure and by the remote control. METHODS: Multicentric prospective cross-sectional study. Intraoperative evaluations of cochlear implants compatible with the use of CR220® were included. The tests were carried out in the 22 electrodes to compare the time of performance in the two situations. The agreement of the neural telemetry threshold values obtained from five electrodes was analyzed, and the agreement of impedance was evaluated by the number of electrodes with altered values in each procedure. RESULTS: There were no significant difference between the impedance values. There was a moderate to strong correlation between the electrically-evoked compound action potential thresholds. The mean time to perform the procedures using the CR220 was significantly lower than that with the conventional procedure. CONCLUSION: The use of the CR220 provided successful records for impedance telemetry and automatic neural response telemetry.

The Intra-Cochlear Impedance-Matrix (IIM) test for the Nucleus® cochlear implant.

OBJECTIVE: To describe the principles and operation of a new telemetry-based function test for the Nucleus® cochlear implant, known as the CS19 Intra-Cochlear Impedance Matrix (IIM) and to present results from a multicentre clinical study to establish reproducibility (test-retest reliability) and normative ranges. METHOD: The IIM test measures bipolar impedances between all electrode pairs and employs a normalization procedure based on common ground impedances in order to identify abnormal current paths among electrodes. Six European clinics collected IIM data from a total of 192 devices. RESULTS: Reproducibility was high between initial and repeat measurements. The normative analysis demonstrated narrow ranges among devices after normalization of impedance data. The IIM is able to identify abnormal current paths that are not evident from standard impedance telemetry and may otherwise only be found utilising average electrode voltage measurements (AEV). CONCLUSIONS: The IIM test was found to be straightforward to perform clinically and demonstrated reproducible data with narrow ranges in normally-functioning devices. Because this test uses a very low stimulation level the IIM test is well suited for children or multiply handicapped CI users who cannot reliably report on their auditory percepts. The new algorithms show potential to improve implant integrity testing capabilities if implemented in future clinical software.

Remote fitting in Nucleus cochlear implant recipients.

CONCLUSION: Remote programming is a viable alternative to face-to-face programming. The procedure can be regarded as safe, time and cost saving, and clinically feasible. OBJECTIVES: The aim of this study was to determine the suitability of commercially available video conferencing technology and remote control software for remote programming of sound processors in Nucleus cochlear implant recipients by assessing the feasibility, efficiency, risks, and benefits of remote programming compared to face-to-face programming. METHODS: This was a randomized, prospective study. Seventy Nucleus implant recipients were recruited for a random sequence comparison of one remote and one local programming session each. The time required for local or remote programming was measured and resulting MAP T and C levels were compared. The recipient provided feedback on the local and remote programming session. The audiologist and monitoring clinician were asked for their feedback on remote programming. RESULTS: Remote programming sessions were successfully finished for 69 recipients. No significant differences between T and C levels obtained by local and remote programming were found. The audiologists and monitoring clinicians agreed that the remote programming system provided an acceptable level of performance after most sessions. More than 50 participating recipients considered remote programming an efficient alternative to face-to-face-programming.