Service And Warranty - OTOFONIX HELIX Quick Start Manual

Notice to Hearing Healthcare Providers
A hearing aid dispenser should advise a prospective hearing aid user to consult promptly with a
licensed physician (referable and 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, then
consult a physician.
Visible congenital or dramatic deformity of the ear
•
Unilateral hearing loss of sudden or recent onset within the previous 90 days.
•
History of active drainage from the ear within the previous 90 days
•
Audiometric air-bone gap equal to or greater then 15 decibels at 500 hertz (Hz), 1000 Hz, and 2000 Hz
•
History of sudden or rapidly progressive hearing loss wishing the previous 90 days
•
• Visible evidence of sudden cerumen accumulation or a foreign body in the ear canal
• Acute or chronic dizziness
• 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
A hearing aid will not restore normal hearing and will not prevent or improve a hearing impairment
resulting from organic conditions. In most cases infrequent use of a hearing aid does not permit a user
to attain full benefit from it. The use of hearing aid(s) is only part of hearing rehabilitation and may
need to be supplemented by auditory training and instruction in lip reading.

Service and Warranty

Otofonix provides a one year warranty from manufacture defects. Warranty does not cover malfunc-
tions due to unusual wear and tear or mistreatment of the Hearing Aid, such as physical shock, damage
from moisture or sweat, excessive ear wax build-up, or tampering with the instrument, all of which void
the warranty.
If you feel the Hearing Aid has failed due to a manufacture defect, please contact Customer Support at
704-380-0508 or info@otofonix.com for a Return Merchandise.
NOT FOR USE BY ANYONE UNDER AGE 18. KEEP HEARING AID OUT OF REACH OF INFANTS,
CHILDREN AND PETS AS IT MAY CAUSE A CHOKING OR INGESTION HAZARD
Otofonix
20484 Chartwell Center Dr. Suite I
Cornelius, NC 28031
FDA Registration #:
FDA Owner/Operator #:
This is a Class 1 Hearing device under
FDA Regulations per 21 C.F.R. Sec 874.3300
Made in China
Technical Specifications:
Max Output (OSPL 90dB): 110
HFA Avg Output (OSPL 90dB): 105
HFA Full On-Gain : 32
EQ Input Noise (dB): 20
Total Harmonic Distortion % (500Hz): 2.0
Total Harmonic Distortion % (800Hz): 2.0
Total Harmonic Distortion % (1600Hz) : 2.0
Frequency Range (Hz): 250-5500
Battery Size: Ni-MH
Battery Current (mA): 1.0