Regulatory Information
Regulatory Information
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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.
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.
DEVICE 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 device or as a hearing aid and
tinnitus treatment device.
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.
Custom Tinnitus
™
Technology generates a broadband white noise signal that varies
in frequency and amplitude. These characteristics are adjustable by the Miracle-Ear
Hearing Care Professional and are specific to the prescribed therapy designed by the
professional for the patient’s needs and comfort.
The patient may have some control of the level or volume of the signal and the
patient should discuss this adjustment as well as his or her comfort level and sound of
the signal with their Miracle-Ear
®
Hearing Care Professional.
WARNING TO HEARING CARE PROFESSIONAL
A hearing care professional should advise a prospective sound generator user to
consult promptly with a licensed physician (preferably an ear specialist) before using
a sound generator if the hearing care professional determines through inquiry, actual
observation or review or any other available information concerning the prospective
user that the prospective user has any of the following conditions:
i.
Visible congenital or traumatic deformity of the ear.
ii.
History of active drainage from the ear within the previous 90 days.
iii.
History of sudden or rapidly progressive hearing loss within the previous
90 days.
iv.
Acute or chronic dizziness.
v.
Unilateral hearing loss of sudden or recent onset within the previous 90 days.
