Miracle-Ear EarENERGY 5 BTE R EV User Manual page 25

Regulatory Information
Custom Tinnitus ™ Technology generates a broadband white noise signal that varies
in frequency and amplitude. These characteristics are adjustable by the hearing
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 hearing 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.
CAUTION:
If set to the maximum output level and worn for periods of time
exceeding the recommendations below, the patient's exposure to sound energy has
the potential to exceed noise exposure limits. This hearing aid is intended for use for
a maximum of sixteen (16) hours a day when set at the maximum output level.
48
Regulatory Information
For the Patient
A tinnitus therapy instrument is an electronic instrument intended to generate noise
of sufficient intensity and bandwidth to treat ringing in the ears. It can also be used as
an aid in hearing external sounds and speech.
Custom Tinnitus Technology is a tool to generate sounds. It is recommended that
™
this tool be used with appropriate counseling and/or in a tinnitus management
program to relieve patients suffering from tinnitus.
TINNITUS THERAPY CONCEPTS AND BENEFITS
Custom Tinnitus ™ Technology can be used as a part of a tinnitus treatment program.
Custom Tinnitus Technology plays a white noise through the hearing aid.
™
Custom Tinnitus Technology is programmed according to your hearing loss and
™
preference, and your hearing professional can adjust the settings of Custom Tinnitus
Technology to meet your needs.
Custom Tinnitus Technology may provide temporary relief of your tinnitus.
™
™
49