Sponsor study identifier
interventional
20
1 country
1
Study Start
June 12, 2017
Actual (reported)Primary Completion
July 18, 2017
Actual (reported)Study Completion
July 18, 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 usability, zero-defect overall performance of the new hearing systems as well as maximum benefit for the participant with the devices in comparison to previously outstanding Phonak Hearing Systems.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 18, 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.
April 24, 2017
Actual (reported)April 27, 2017
Actual (reported)June 12, 2017
Actual (reported)July 18, 2017
Actual (reported)July 18, 2017
Actual (reported)Usability (phone calls)
The data, serving as primary outcomes are collected in a lab appointment. The participants will be asked to accept, reject and hang up phone calls with the aid of the push button of the hearing aid. The usability 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
Zero-defect performance in daily life
Three weeks
Speech intelligibility in noise as signal to noise ratio in dB (dB SNR)
One week
The line extension of the Phonak Audéo B product family will be fitted to the participants individual hearing loss.
Phonak Audéo B will be fitted to the participants individual hearing loss.
The line extension of the Phonak Audéo B product family will be fitted to the participants individual hearing loss.
Phonak Audéo B will be fitted to the participants individual hearing loss.
Sonova AG
Stäfa, Canton of Zurich, 8712, Switzerland
Simone Ebbing, B.Sc.
Sonova AG
20 participants (actual enrollment reported by the registry).
First Submitted
April 24, 2017
First Posted
April 27, 2017
Study Start
June 12, 2017
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
July 18, 2017
Actual (reported)Study Completion
July 18, 2017
Actual (reported)Last Updated
August 17, 2017
Record last verified: 2017-08
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Source: ClinicalTrials.gov.
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