NCT03253003|Completed
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Sponsor study identifier
interventional
19
1 country
1
Study Start
August 7, 2017
Actual (reported)Primary Completion
August 25, 2017
Actual (reported)Study Completion
August 25, 2017
Actual (reported)A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch. The aim of the investigation series is to ensure a stable overall performance of the new hearing systems, a good sound quality during phone calls as well as maximum benefit for the participant with the devices.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 25, 2017
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 7, 2017
Actual (reported)August 14, 2017
Actual (reported)August 17, 2017
Actual (reported)August 25, 2017
Actual (reported)August 25, 2017
Actual (reported)Stable performance in daily life
The data, serving as primary outcomes are collected in a series of home trials, taking place between the lab trial appointments. The stable performance in daily life (that means: no significant interruptions, distortions, artefacts, feedback, system noise or other malfunctions) will be assessed with the aid of quantitative questionnaires. Descriptive statistics will be executed. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued.
Three weeks
Phone call - Sound Quality
The data serving as primary outcomes are collected in a lab appointment. The participants will be asked to have a phone call with the investigator in the lab. The sound quality will be subjectively assessed by the participants and additionally by the investigators on given scales. Descriptive statistics will be executed. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued.
One week
The line extension of the Phonak Audéo B product family will be fitted to the participants individual hearing loss.
The line extension of Phonak Audéo B product family will be fitted to the participants individual hearing loss.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sonova AG
Stäfa, Canton of Zurich, 8712, Switzerland
Simone Ebbing, B. Sc.
Sonova AG
19 participants (actual enrollment reported by the registry).
First Submitted
August 14, 2017
First Posted
August 17, 2017
Study Start
August 7, 2017
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
August 25, 2017
Actual (reported)Study Completion
August 25, 2017
Actual (reported)Last Updated
September 25, 2017
Record last verified: 2017-09
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Source: ClinicalTrials.gov.
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