Starkey RIC 10 Operation Manual page 46

FDA Information
These characteristics are adjustable by the 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 hearing care professional.
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.
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