16
FDA STATEMENTS
Important notice for prospective hearing aid users
If you have any of the following conditions, please see your
physician:
• Visible congenital or traumatic deformity of the ear.
• History of active drainage from the ear within the previous
90 days.
• History of sudden or rapidly progressive hearing loss
within the previous 90 days.
• Acute or chronic dizziness.
• Unilateral hearing loss of sudden or recent onset within the
previous 90 days.
• Audiometric air-bone gap equal to or greater than 15
decibels at 500 hertz (Hz), 1,000 Hz, and 2,000 Hz.
• Visible evidence of significant cerumen accumulation or a
foreign body in the ear canal.
• Pain or discomfort in the ear.
Special care should be exercised in selecting and fitting a
hearing aid whose maximum sound pressure level exceeds 132
decibels because there may be risk of impairing the remaining
hearing of the hearing aid user. (This provision is required
only for those hearing aids with a maximum sound pressure
capability greater than 132 decibels (dB
).)
The audiologist or
hearing aid dispenser will conduct a hearing aid evaluation to
assess your ability to hear with and without a hearing aid. The
hearing aid evaluation will enable the audiologist or dispenser
to select and fit a hearing aid to your individual needs.
Summary of Contents for hi ITC
Page 6: ...6 HEARING AID AT A GLANCE 1 2 3 5 4 6...
Page 19: ...19 NOTES...
Page 21: ...1 hi ITC hearing aids Essential Guide Addendum...
