Regulatory Information | 39
We are required by regulations to provide the following warnings:
WARNING:
Use of wireless hearing aids directly next to other electronic
equipment should be avoided because it could result in improper performance.
If such use is necessary, note as to whether your hearing aids and the other
equipment are operating normally.
WARNING:
Use of accessories, components or replacement parts other than
those provided by the manufacturer of your hearing aids could result in increased
electromagnetic emissions and decreased electromagnetic immunity and could
result in degradation of performance.
WARNING:
If Portable Radio Frequency communications equipment is
used closer than 30 cm (12 inches) from your hearing aid, degradation of the
performance of your hearing aid could result. If this occurs, move away from the
communications equipment.
Required Hearing Aid Information
The following additional information is provided in compliance with U.S. Food
and Drug Administration (FDA) regulations:
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.
vii. Visible evidence of significant cerumen accumulation or a foreign
body in the ear canal.
viii. Pain or discomfort in the ear.