Regulatory Information
Regulatory Information
45
44
CHILDREN WITH HEARING LOSS
In addition to seeing a physician for a medical evaluation, a child with a hearing loss
should be directed to an audiologist for evaluation and rehabilitation since hearing
loss may cause problems in language development and the educational and social
growth of a child. An audiologist is qualified by training and experience to assist in
the evaluation and rehabilitation of a child with a hearing loss.
Required Custom Tinnitus
™
Information for Miracle-Ear
®
Hearing
Care Professionals
INDICATIONS FOR USE
The Custom Tinnitus
™
Technology is a tool to generate sounds to be used in a
Tinnitus Management Program to relieve patients suffering from tinnitus. The target
population is primarily the adult population over 18 years of age.
The Custom Tinnitus
™
Technology is targeted for healthcare professionals, which are
treating patients suffering from tinnitus, as well as conventional hearing disorders.
The fitting of the Custom Tinnitus™ Technology must be done by a Miracle-Ear
®
Hearing Care Professional participating in a Tinnitus Management Program.
INSTRUMENT DESCRIPTION
Custom Tinnitus
™
Technology is a software function that generates sound which is
programmed into a hearing aid. The hearing aid may be used in one of three modes
of operation: as a hearing aid, as a tinnitus treatment instrument or as a hearing aid
and tinnitus treatment instrument.
When enabled, the Custom Tinnitus
™
Technology generates the sound and allows a
patient’s Miracle-Ear Hearing Care Professional to design and program appropriate
settings for an individually prescribed sound treatment plan. The treatment plan
should be used in a tinnitus management program for relief of tinnitus.
