Hearing Loss Clinical Trial
Official title:
Quality Control of CE-Certified Phonak Hearing Aids - 2019_34
Phonak Hearing Devices pass through different development and study phases. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, resulting from the pre-validation studies, they get optimized. Prior to product launch, the Phonak Hearing Systems get reviewed by a final quality control in terms of clinical trials. This is a validation study, investigating improved algorithms, features, functions and wearing comfort. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
This study will compare two settings of an external microphone under real life conditions
with experienced hearing aid users.
The external microphone streams the signal (e.g. speaker) directly into the hearing
instrument (HI).
The subject should rate the devices in the lab and after a hometrial. The comfort, regarding
to the loudness and the sound quality will be tested with the two settings at home and in the
lab. Also the speech intelligibility will be tested in the lab.
This will be a clinical investigation which will be conducted mono centric at Sonova AG
Headquarters based in Stäfa (Switzerland).
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