Indications For Use - NANO X2 Rechargeable Instruction Manual

Indications for Use

This hearing aid device is intended to amplify and transmit sound to the ear and
thereby compensate for mild to severe impaired Hearing.
Advisory Statement -Warning-
Nano Hearing Aids advise prospective hearing aid users to consult promptly with a
licensed physician (preferably an ear specialist before dispensing a hearing aid if Nano
Hearing Aids 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 90days.
(iii) History of sudden or rapidly progressive hearing loss withinthe previous 90 days.
(iv) Acute or chronic dizziness
(v) Unilateral hearing loss of sudden or recent onset within theprevious 90 days.
(vi) Audiometric air-bone gap equal to or greater than 15 decibelsat 500 hertz (Hz),
1,000 Hz, and 2,000 Hz.
(vii) Visible evidence of significant cerumen accumulation or aforeign body in the ear canal.
(viii) 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).)