Hearing Loss Clinical Trial
Official title:
A Comparative, Controlled, Clinical Investigation of a Currently Marketed Hearing Aid When Programmed With Two Different Fitting Methods
This study is designed to investigate the benefits of the hearing aid in the laboratory and in daily life when fitted with two different methods. Subjective and objective evaluations will be made. The aim is to show the benefits of the hearing aids with both fitting methods with the help of data obtained, and to improve the available fitting methods in order to further increase the benefit for people with hearing disorders in situations where the standard method and those trained to perform it are not available.
Benefits of amplification and accessories used with it outweigh anticipated risks in mild to
profound hearing impaired subjects. The basic benefit of amplification should be present with
any method that the trained professional fitting the instruments uses. The goal of this study
is to compare two fitting methods and determine whether the end user perceives more benefit
from one fitting method over the other. The objective benefit is expected to be the same;
however, the subjective benefit may be different due to a possible psychological effect from
more effort or time spent by the trained professional.
Bernafon will conduct this clinical investigation to test current hearing instruments fitted
with the standard procedure and a self-directed procedure. Safety and performance validation
of the new self-directed fitting software is needed before release to the market.
The reason for this study is to evaluate a currently marketed, CE certified, hearing aid and
determine whether different fitting methods provide the same perceived benefit. Additionally,
this study will validate the safety of the fitting procedure as well as collect post market
safety information about the devices themselves. The goal is to evaluate the audiological
performance objectively as well as the subjective benefit. Furthermore, it is important to
identify unexpected, unwanted behavior from the fitting software and the devices.
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