Eargo 99-0001-001, Manual

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Indications for Use
The hearing instrument is intended to amplify and transmit
sound to the ear and thereby compensate for mild to
moderate impaired hearing.
Warning to Hearing Aid Dispensers
A hearing aid dispenser should advise a prospective hearing
aid user to consult promptly with a licensed physician
(preferably an ear specialist) before dispensing a hearing aid
if the hearing aid dispenser determines 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:
(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.
(vi) Audiometric air bone gap equal to or greater than 15
decibels at 500 hertz (Hz), 1,000 Hz, and 2,000 Hz.