42 | Regulatory Information
WARNING TO HEARING CARE PRACTITIONER
A hearing care practitioner 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 practitioner 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.
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.
Multiflex 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
Multiflex Tinnitus Technology can be used as a part of a tinnitus treatment program.
Multiflex Tinnitus Technology plays a white noise through the hearing aid.
Multiflex Tinnitus Technology is programmed according to your hearing loss and
preference, and your hearing professional can adjust the settings of Multiflex
Tinnitus Technology to meet your needs.
Multiflex Tinnitus Technology may provide temporary relief of your tinnitus.