Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Zurich
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Stäfa, Zurich, Suiza, 8712
- Sonova AG
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adult hearing impaired persons (minimum age: 18 years) with and without experience with) hearing aids
- Healthy outer ear (without previous surgical procedures)
- Ability to fill in a questionnaire conscientiously
- Informed Consent as documented by signature
Exclusion Criteria:
- Contraindications to the medical device in this study, e.g. known hypersensitivity or allergy to the investigational product
- Limited mobility and not in the position to attend weekly appointments
- Limited ability to describe listening impressions/experiences and the use of the hearing aid
- Inability to produce a reliable hearing test result
- Massively limited dexterity
- Known psychological problems
- Known central hearing disorders
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Sound Processing Principle 1
Sound Processing Principle 1 will be applied in the hearing aid.
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Compensation of a hearing loss with Sound Processing Principle 1.
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Experimental: Sound Processing Principle 2
Sound Processing Principle 2 will be applied in the hearing aid.
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Compensation of a hearing loss with Sound Processing Principle 2.
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Experimental: Sound Processing Principle 3
Sound Processing Principle 3 will be applied in the hearing aid.
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Compensation of a hearing loss with Sound Processing Principle 3.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Speech Intelligibility in Noise
Periodo de tiempo: 4 weeks
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The speech intelligibility in noise with the three different sound processing principles will be assessed with the aid of the Oldenburg Sentence Test.
The result will be shown in dB (decibel) SRT (Speech Reception Threshold).
|
4 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Sound Quality - Overall
Periodo de tiempo: 16 weeks
|
The overall sound quality of sounds with the three different sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (bad) to 10 (excellent). |
16 weeks
|
|
Loudness - Laboratory
Periodo de tiempo: 8 weeks
|
The loudness of sounds with the three different sound processing principles will be assessed in laboratory with the aid of a MUSHRA (Multi-Stimulus Test with Hidden Reference and Anchor) test. The results are ratings on a numeric scale, ranging from 0 (very soft), 50 (just right) to 100 (very loud). |
8 weeks
|
|
Loudness - Daily Life
Periodo de tiempo: 16 weeks
|
The loudness of sounds with the three different sound processing principles will be assessed in daily life with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (very soft) to 10 (very loud). |
16 weeks
|
|
Clarity - Daily Life
Periodo de tiempo: 16 weeks
|
The clarity of sounds with the three sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (very unclear) to 10 (very clear). |
16 weeks
|
|
Preferred Sound Processing Principle
Periodo de tiempo: 16 weeks
|
The preferred sound processing principle will be assessed with the aid of a questionnaire. The results will be a ranking, ranging from 1 (most preferred) to 3 (least preferred). |
16 weeks
|
|
Naturalness - Daily Life
Periodo de tiempo: 16 weeks
|
The sound quality with the three different sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (unnatural) to 10 (natural). |
16 weeks
|
|
Localization - Daily Life
Periodo de tiempo: 16 weeks
|
The ability to localize sounds with the three different sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (not at all locatable) to 10 (very well locatable). |
16 weeks
|
|
Reverberation - Daily Life
Periodo de tiempo: 16 weeks
|
The reverberation of sounds with the three different sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (not at all reverberant) to 10 (very reverberant). |
16 weeks
|
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Satisfaction - Overall in Daily Life
Periodo de tiempo: 16 weeks
|
The overall satisfaction in daily life with the three different sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (very dissatisfied) to 10 (very satisfied). |
16 weeks
|
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
- Sonova2018_37
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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