Lumity CI Study - Clinical Evaluation of Next Generation Cochlear Implant Sound Processor
Evaluation of Advanced Bionics Next Generation CI Sound Processor Programmed With Target CI v.1.6 Fitting Software in Adult Users of the HiResolution™ Bionic Ear System
This is a prospective within-subjects repeated-measures study that will enroll 18 bilateral adult users implanted with a HiResolution Bionic Ear System (HiRes 90KTM, HiRes 90K TM Advantage, HiResTM Ultra, HiResTM Ultra 3D and CII with HiFocus electrode).
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
The overall goal of this clinical study is to demonstrate the safety and efficacy of next generation sound processor in users of the HiResolution Bionic Ear System. Speech understanding outcomes are expected to be similar with the new sound processor as compared to the Naída CI M90 processor. Therefore, the study uses a non-inferiority design to demonstrate non-inferiority of the next generation processor, relative to the currently approved Naída CI M90 for sentence understanding in quiet and in noise. Additionally, the features on the new device will be evaluated to demonstrate spatial situational awareness using a localization tasks.
Tipo de estudio
Inscripción (Actual)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Ability to provide Informed Consent
- 18 years of age or older
- Bilateral users of a HiResolution™ Bionic Ear System (HiRes 90K™, HiRes 90K™ Advantage, HiRes™ Ultra, HiRes™ Ultra 3D and CII with HiFocus electrode)
- Willingness to participate in all scheduled procedures outlined in the study investigational plan
- Minimum of 6 months of CI experience for each ear
- At least moderate open-set speech recognition abilities with implant in each individual implanted ear, as defined by achieving a score of ≥ 50% words correct in the AzBio Sentence Test in quiet using a Naída CI M90 research processor
- English language proficiency, as determined by the investigator
- Willingness to use a behind-the-ear research processor for the duration of the study
Exclusion Criteria:
- Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the investigator
- Unwillingness or physical / cognitive inability of subject to comply with all investigational requirements as determined by the investigator
- < 50% words correct AzBio Sentence Test in quiet in either ear using the Naída CI M90 research processor
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Bilateral Users of a HiResolution Bionic Ear System
Control Device followed by experimental Device. |
Device: Naida M90 sound processor programmed with Target CI v1.5 software Device: Next generation sound processor programmed with investigation software |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Speech Recognition in Quiet
Periodo de tiempo: 1 Day
|
The primary objective is to demonstrate that speech recognition in quiet on a Next Generation CI sound processor is no worse than speech recognition in quiet on the currently approved Naída CI M90 processor for speech understanding in quiet. Scores are expressed as a percentage of words correct from 0% to 100% with higher scores indicating a better outcome. During the test the subject will be presented with a minimum of 133 words up to a maximum 159. |
1 Day
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CR0124
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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