Fda Warnings And Cautions (Us Only) - ReSound Nexia NX960S-DRWC User Manual

FDA warnings and cautions (US only)
WARNING: People younger than 18 should go to a doctor before using this
People younger than 18 years old need specialized care, and using this without a medical evaluation may
worsen impairment or disability. A hearing aid user who is younger than 18 should have a recent medical
evaluation from a doctor, preferably an ear-nose-throat doctor (an ENT). Before using this, a doctor should
determine that the use of a hearing aid is appropriate.
WARNINGS to Hearing Aid Dispensers
You should advise a prospective hearing aid user to consult promptly with a doctor, preferably an ear
specialist such as an ENT, before dispensing a hearing aid if you determine through inquiry, actual
observation, or review of any other available information concerning the prospective user, that the
prospective user has any of the following conditions:
•
Visible deformity of the ear, either congenital or traumatic
•
Fluid, pus, or blood coming out of the ear within the previous 6 months
•
Pain or discomfort in the ear
•
History of excessive ear wax or suspicion that something is in the ear canal
•
Dizziness, either recent or long-standing
•
Sudden, quickly worsening, or fluctuating hearing loss within the previous 6 months
•
Hearing loss or ringing (tinnitus) only in one ear or noticeable difference in hearing between ears
•
Audiometric air-bone gap equal to or greater than 15 dB at 500 Hz, 1000 Hz, and 2000 Hz.
FDA warnings and cautions (US only) 3