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Structured Post Market Clinical Follow-up (PMCF) to Evaluate the Quality of a New Hearing Aid Product Generation.
The reason for this study is to evaluate a new hearing aid product generation replacing the one on the market. The goal is to evaluate the audiological performance, usability as well as features and functions.
This is a controlled, single blinded comparative study which is conducted monocentric at Phonak Headquarters in Staefa. The focus is to compare a new hearing aid product generation with the one on the market as well as with competitor devices regarding the audiological performance, usability as well as features and functions with the aid of 382 mild to profound hearing impaired subjects (18-90 yrs). The subjects, all of them native (Swiss) German speakers, individually conduct a number of laboratory standard tests and home trials (questionnaires) during nine weeks including weekly appointments of 2 hours.
Age
18 - 90 years
Sex
ALL
Healthy Volunteers
No
Phonak AG
Stäfa, Canton of Zurich, Switzerland
Start Date
May 1, 2013
Primary Completion Date
August 1, 2015
Completion Date
September 1, 2015
Last Updated
May 3, 2016
253
ACTUAL participants
Hearing aid.
DEVICE
Lead Sponsor
Phonak AG, Switzerland
NCT06641999
NCT06642935
Data Source & Attribution
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