Clinical performance of the Osia™ system, a new active osseointegrated implant system. Results from a prospective clinical investigation.

Background: Bone-conduction hearing implants are standard of care devices.Aims/Objectives: Evaluation of a new active magnetic bone-conduction hearing implant: Cochlear Osia™ system.Material and methods: This device uses a transcutaneous connection between an external sound-processor and an osseointegrated implant that generates vibrations using a piezoelectricity-based internal bone-conduction system. Nine patients with conductive-hearing loss were implanted. Surgical efficacy, hearing performance and quality-of-life were evaluated. Hearing performance in quiet and in noise was compared with unaided hearing and hearing with the Baha 5 Power® Sound Processor on a softband.Results: Surgery and healing were uneventful. Statistically significant improvements in audibility, speech-understanding, speech-recognition and quality-of-sound in noise and quiet were found for the Osia™ compared to preoperative unaided hearing and aided hearing with the Baha 5 Power® Sound Processor on a softband. The active vibration system provided improvement at low and high frequencies. At 6 months postoperatively, all patients continue to use the device.Conclusions and significance: The Osia™ is safe and effective, improving speech-recognition in quiet and in noise, at low and high frequencies, thus delivering better quality-of-hearing than passive devices.

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.

Auditory results from cochlear implants in elderly people.

UNLABELLED: According to data from the Brazilian Institute of Geography and Statistics, the elderly population grew 47.8% in the last decade in Brazil. A portion of this population has severe and/or profound hearing loss and do not benefit from conventional hearing aids. Thus, the use of cochlear implant is required. AIM: To analyze the benefits of cochlear implants in the elderly based on the comparison of primary auditory thresholds before and after the operation, discrimination of sentences in speech and in talking on the telephone. METHODOLOGY: Retrospective cohort study, analyzing medical records from patients aged over 60 years, users of cochlear implant for at least 1 year. RESULTS: Fourteen medical records were analyzed. Mean age of patients was 63.07 years. The mean pure tone thresholds between 500Hz, 1kHz, 2kHz and 4kHz before the implantation was 113dBHL. None of the patients, before operation, could discriminate sentences in open sets and only 3 scored 17% in closed sets sentence recognition. After one year of implantation, the mean sound field thresholds reached 34dBHL, and open set sentences recognition of 93.57%, while 71% of the patients had become able to have a conversation on the telephone. CONCLUSION: The elderly users of cochlear implant showed important outcomes, with significant improvement in understanding in the open set and in using the telephone.

Resultados audiológicos do implante coclear em idosos / Auditory results from cochlear implants in elderly people

Segundo dados do Instituto Brasileiro de Geografia e Estatística, a população de idosos cresceu 47,8 por cento na última década no Brasil. Parte desta população tem surdez severa a profunda, não se beneficiando com o uso dos aparelhos auditivos convencionais. Desse modo, torna-se necessária a indicação do implante coclear. OBJETIVO: Analisar os benefícios do implante coclear nos idosos com relação à audibilidade, ao reconhecimento de fala e ao uso do telefone. MATERIAL E MÉTODO: Estudo retrospectivo transversal por meio da análise de prontuários de pacientes com faixa etária acima de 60 anos usuários de implante coclear há pelo menos 1 ano. RESULTADOS: Foram analisados 14 prontuários. A média de idade dos pacientes foi de 63,07 anos. A média dos limiares tonais entre 500Hz,1kHz,2kHz e 4kHz antes da implantação foi de 113dBNA. Nenhum dos pacientes, antes de implantar, conseguia discriminar frases em contexto aberto e fechado, apenas 3 conseguiam fazê-lo com uma média de 17 por cento de acertos. Após um ano de uso de implante, a média dos limiares em campo passou a ser de 34 dBNA, a discriminação de frases em contexto aberto de 93,57 por cento e 71 por cento dos pacientes já conseguiam estabelecer uma conversa ao telefone. CONCLUSÃO: Os pacientes idosos usuários de implante coclear apresentaram ganhos auditivos relevantes, com melhora significativa da compreensão em contexto aberto e no uso de telefones.

According to data from the Brazilian Institute of Geography and Statistics, the elderly population grew 47.8 percent in the last decade in Brazil. A portion of this population has severe and/or profound hearing loss and do not benefit from conventional hearing aids. Thus, the use of cochlear implant is required. AIM: To analyze the benefits of cochlear implants in the elderly based on the comparison of primary auditory thresholds before and after the operation, discrimination of sentences in speech and in talking on the telephone. METHODOLOGY: Retrospective cohort study, analyzing medical records from patients aged over 60 years, users of cochlear implant for at least 1 year. RESULTS: Fourteen medical records were analyzed. Mean age of patients was 63.07 years. The mean pure tone thresholds between 500Hz, 1kHz, 2kHz and 4kHz before the implantation was 113dBHL. None of the patients, before operation, could discriminate sentences in open sets and only 3 scored 17 percent in closed sets sentence recognition. After one year of implantation, the mean sound field thresholds reached 34dBHL, and open set sentences recognition of 93.57 percent, while 71 percent of the patients had become able to have a conversation on the telephone. CONCLUSION: The elderly users of cochlear implant showed important outcomes, with significant improvement in understanding in the open set and in using the telephone.