Dispositivo totalmente implantable Esteem en el tratamiento de la hipoacusia neurosensorial

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Teresa Correa González
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1 Dispositivo totalmente implantable Esteem en el tratamiento de la hipoacusia neurosensorial Revisión sistemática Esteem totally implantable hearing device for treatment of sensorineural hearing loss. Systematic review. Executive summary INFORMES DE EVALUACIÓN DE TECNOLOGÍAS SANITARIAS AETSA INFORMES, ESTUDIOS E INVESTIGACIÓN

3 Dispositivo totalmente implantable Esteem en el tratamiento de la hipoacusia neurosensorial Revisión sistemática Esteem totally implantable hearing device for treatment of sensorineural hearing loss. Systematic review. Executive summary INFORMES DE EVALUACIÓN DE TECNOLOGÍAS SANITARIAS AETSA INFORMES, ESTUDIOS E INVESTIGACIÓN

4 Llanos Méndez, Aurora Dispositivo totalmente implantable Esteem en el tratamiento de la hipoacusia neurosensorial. Revisión sistemática. Aurora Llanos Méndez, Antonio Romero Tabares Sevilla: Agencia de Evaluación de Tecnologías Sanitarias de Andalucía, p; 24 cm. (Colección: Informes, estudios e investigación. Ministerio de Sanidad, Servicios Sociales e Igualdad. Serie: Informes de Evaluación de Tecnologías Sanitarias) 1. Hipoacusia neurosensorial / rehabilitación 2. Prótesis auditiva / utilización 3. Prótesis osicular I. Romero Tabares, Antonio II. Andalucía. Agencia de Evaluación de Tecnologías Sanitarias III. España. Ministerio de Sanidad, Servicios Sociales e Igualdad IV. España. Ministerio de Economía y Competitividad Autores: Aurora Llanos-Méndez, Antonio Romero-Tabares Este documento se ha realizado al amparo del convenio de colaboración suscrito por el Instituto de Salud Carlos III, organismo autónomo del Ministerio de Economía y Competitividad, y la Fundación Progreso y Salud de la Consejería de Igualdad, Salud y Políticas Sociales de la Junta de Andalucía, en el marco del desarrollo de actividades de la Red Española de Agencias de Evaluación de Tecnologías Sanitarias y Prestaciones del SNS, financiadas por el Ministerio de Sanidad, Servicios Sociales e Igualdad Edita: Agencia de Evaluación de Tecnologías Sanitarias de Andalucía Consejería de Igualdad, Salud y Políticas Sociales JUNTA DE ANDALUCÍA Avda. de la Innovación, s/n. Edificio ARENA 1, s/n. Planta baja Sevilla España Spain ISBN: NIPO: Este documento puede ser reproducido en todo o en parte, por cualquier medio, siempre que se cite explícitamente su procedencia

5 Dispositivo totalmente implantable Esteem en el tratamiento de la hipoacusia neurosensorial Revisión sistemática Esteem totally implantable hearing device for treatment of sensorineural hearing loss. Systematic review. Executive summary INFORMES DE EVALUACIÓN DE TECNOLOGÍAS SANITARIAS AETSA

6 Key points The Esteem system is a totally implantable hearing system that uses piezoelectric technology. It is indicated for the treatment of moderate to severe sensorineural hearing loss in adults. This system uses the tympanic membrane as a microphone allowing the amplification of the natural accoustic properties of the outer ear and the ear canal, with no obstructions, interferences or external devices. A systematic review of literature was performed to assess the safety and effectiveness of the Esteem system in terms of hearing gain, speech recognition and improvement in the quality of life of patients with moderate to severe sensorineural hearing loss. Data sources were MedLine, EMBASE, Web of Science, the Center for Reviews and Dissemination (CRD) database, the Cochrane Library, the Nacional Institute for Health and Clinical Excellence (NICE) and other emerging technologies sources. We selected comparative studies assessing the effectiveness of the Esteem system versus other interventions for treating patients with moderate to severe sensorineural hearing loss. Only those studies collecting hearing gain, hearing quality, quality of life and safety outcomes were selected. A reviewer extracted data from articles included data from the studies selected. Studies were assessed for quality, and the level of evidence was rated following the Scottish Intercollegiate Guidelines Network (SIGN) recommendations. We conducted a qualitative data synthesis. We identified 202 references without duplicates. A briefing report and five original before-and-after studies were selected. The mean hearing threshold levels with Esteem was between 31 db and 52 db. Two studies reported an improvement in hearing loss from moderate to mild. An improvement in speech recognition was also observed, with an average 29.5 db decrease in speech reception threshold without hearing aid, as compared with the 11.8 db decrease achieved through the use of the Esteem system. The percentage of words that were correctly recognized with the Esteem system ranged from 69 % and 80 % in all studies. Over 80 % of patients stated that the effectiveness of the Esteem system was similar, better or much better than other hearing aids. ESTEEM EN EL TRATAMIENTO DE LA HIPOACUSIA 13

7 Adverse events were generally mild. Explantations were mostly related to insufficient hearing gain or appearance of background noise. However, these results should be interpreted with caution due to the significant methodological limitations of the before-after studies (level of evidence 3). These studies were insufficient for the assessment of the effectiveness of the Esteem system, since sudden changes occurred between measurements might alter the outcomes and cannot be undoubtedly attributed to the intervention. In addition, the sample size in most studies was small. However, the risk of bias in most studies was low in terms of losses and outcome evaluation. 14 INFORMES, ESTUDIOS E INVESTIGACIÓN

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