With an influx of PSAP’s arriving in stores and online, the FDA
felt it was necessary to explain to the public, what it saw as the differences
between Personal Sound Amplifiers (also known as PSAP) and hearing aids. For consumers needing a boost, a PSAP can be
a very viable option. They are
inexpensive compared to hearing aids, are discreet and work in many types of
situations. The FDA describes the
difference below.
The FDA said “PSAP’s are intended to amplify environmental
sound for non-hearing impaired consumers. They are not intended to compensate
for hearing impairment. Examples of situations in which PSAPs typically are
used include listening to lectures with a distant speaker, listening to soft
sounds that would be difficult for normal hearing individuals to hear (e.g.
distant conversations, performances, bird watching, and hunting (listening for
prey).”
The FDA goes on to say that “PSAPs are not intended to diagnose,
treat, cure or mitigate disease and do not alter the structure or function of
the body, they are not devices as defined by in the Food, Drug and Cosmetic
Act. As such, there is no regulatory
classification, product code, or definition for these products (PSAPs)”.
The FDA also states that although both affect our ability to
hear sound, “a PSAP is a wearable electronic product that is not intended to
compensate for impaired hearing, but rather is intended for non-hearing
impaired consumers to amplify sounds in the environment for a number of
reasons, such as for recreational activities.”
Personal Sound Amplifiers (PSAP) takes hearing to new levels. This device was designed to help the average
person hear better in noisier environments, reducing the background noise all
while amplifying hard-to-hear sounds. To
learn more, please visit www.hear4youtoday.com
