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Required 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.

IMPORTANT NOTICE FOR PROSPECTIVE HEARING AID USERS.

  

Good health practice requires that a person with a hearing loss have a 

medical evaluation by a licensed physician (preferably a physician who 

specializes in diseases of the ear) before purchasing a hearing aid.  

Licensed physicians who specialize in diseases of the ear are often referred 

to as otolaryngologists, otologists, or otorhynolaryngologists. The purpose 

of the medical evaluation is to assure that all medically treatable conditions 

that may affect hearing are identified and treated before the hearing aid is 

purchased.
Following the medical evaluation, the physician will give you a written 

statement that states that your hearing loss has been medically evaluated 

and that you may be considered a candidate for a hearing aid. The 

physician will refer you to an audiologist or hearing aid dispenser, as 

appropriate, for a hearing aid evaluation.

FDA Information

The audiologist or hearing aid dispenser will conduct a hearing aid 

evaluation to assess your ability to hear with and without a hearing aid.  

The hearing aid evaluation will enable the audiologist or dispenser to  

select and fit a hearing aid to your individual needs.
If you have reservations about your ability to adapt to amplification, you 

should inquire about the availability of a trial-rental or purchase-option 

program. Many hearing aid dispensers now offer programs that permit  

you to wear a hearing aid for a period of time for a nominal fee after  

which you may decide if you want to purchase the hearing aid.
Federal law restricts the sale of hearing aids to those individuals who 

have obtained a medical evaluation from a licensed physician. Federal 

law permits a fully informed adult to sign a waiver statement declining 

the medical evaluation for religious or personal beliefs that preclude 

consultation with a physician. The exercise of such a waiver is not in  

your best health interest and its use is strongly discouraged.
A hearing aid will not restore normal hearing and will not prevent or 

improve a hearing impairment resulting from organic conditions. Use 

of a hearing aid is only part of hearing habilitation and may need to be 

supplemented by auditory training and instruction in lip reading. In most 

cases infrequent use of a hearing aid does not permit a user to attain full 

benefit from it.

CHILDREN WITH HEARING LOSS.

 In addition to seeing a physician for 

a medical evaluation, a child with a hearing loss should be directed to an 

audiologist for evaluation and rehabilitation since hearing loss may cause 

problems in language development and the educational and social growth 

of a child. An audiologist is qualified by training and experience to assist in 

the evaluation and rehabilitation of a child with a hearing loss.

For hearing care professionals

INDICATIONS FOR USE

The Multiflex Tinnitus Technology is a tool to generate sounds to be  

used in a Tinnitus Management Program to relieve patients suffering  

from tinnitus. The target population is primarily the adult population  

over 18 years of age.
The Multiflex Tinnitus Technology is targeted for healthcare professionals, 

which are treating patients suffering from tinnitus, as well as conventional 

hearing disorders. The fitting of the Multiflex Tinnitus Technology  

must be done by a hearing professional participating in a Tinnitus 

Management Program.

FDA Information

Содержание RIC 10

Страница 1: ...Multiflex Tinnitus Technology O P E R A T I O N S M A N U A L ...

Страница 2: ...oval 10 Operation On Off 12 Multifunction Switch 12 Volume Control 13 Multimemory 14 Tinnitus Stimulus Control 14 Telephone Use 16 Hearing System Care Instrument Care 19 Service and Repair 21 Troubleshooting Guide 22 Tips for Better Communication For You 23 For Your Family and Friends 24 Safety Information 25 FDA Information 26 Table of Contents ...

Страница 3: ...f the tinnitus stimulus to meet your needs Features Controls and Identification Your hearing system controls include 1 Hearing Instrument 2 Cable 3 Receiver 4 Microphone 5 Multifunction Switch 6 Battery Compartment on off control Location of serial number Location of left right side device indicator 7 Retention Lock 8 Location of manufacturer s name and model name 9 Location of left right side rec...

Страница 4: ...10 code on the packaging To insert or replace the battery 1 Use the nail grip on the battery door 2 Open the battery door gently and remove the old battery 3 Remove the tab from the new battery 4 Line up the battery s plus sign flat side of the battery with the on the battery door 5 Close the battery door Preparation Preparation ...

Страница 5: ...oor will not close securely check that the battery is inserted correctly Do not open the battery door too far or damage is likely to occur Dispose of used batteries immediately in the proper waste or recycling container Because batteries can vary in size and performance your hearing care professional is your best source for lifespan estimates and verification that you are using the proper size and...

Страница 6: ...ring instrument from behind your ear 3 Grasp the receiver with your thumb and forefinger Gently pull out of your ear canal Do not pull with the hearing instrument case as this may damage the connection Helpful Hints Minor irritation and inflammation may occur as your ear becomes accustomed to having an object in it if so please contact your hearing care professional If an actual allergic reaction ...

Страница 7: ...ery and completely close the battery door To turn OFF Open the battery door until the battery is no longer touching the battery contacts Your instrument has a Power On delay and may require a few seconds to power on You may hear a tone series indicating that your device is fully powered on Multifunction Switch Your switch can be set to perform different functions Ask your hearing care professional...

Страница 8: ...anges the volume one increment Combined Volume and Tinnitus Stimulus Control Your hearing system is set up to adjust volume and tinnitus stimulus To adjust volume press then release the switch until the desired volume level is reached To adjust the tinnitus stimulus press and hold the switch The hearing aid will cycle through the tinnitus stimulus levels Release the switch when you are at the desi...

Страница 9: ...ne Ask your hearing professional about your telephone solution Automatic Telephone and Automatic Telecoil These options activate the telephone response automatically when used with a hearing aid compatible telephone To use place the telephone receiver on your ear as you normally would and the hearing instrument will select the telephone setting It might be necessary to move the telephone receiver ...

Страница 10: ...ined rating of 6 or greater would indicate excellent performance The immunity of this hearing aid is at least M2 T2 The equipment performance measurements categories and system classifications are based upon the best information available but cannot guarantee that all users will be satisfied NOTE The performance of individual hearing aids may vary with individual cell phones Therefore please try t...

Страница 11: ...ice and assistance Many common problems may be solved right in your hearing care professional s office or clinic Helpful Hints When not wearing your hearing system open the battery door to allow any moisture to evaporate When not in use remove the batteries completely place your hearing system in the storage container and store In a dry safe place Away from direct sunlight or heat to avoid extreme...

Страница 12: ...are professional will recommend an appropriate schedule to help you adapt to your new hearing system It will take practice time and patience for your brain to adapt to the new sounds that your hearing system provides Hearing is only part of how we share thoughts ideas and feelings Reading lips facial expressions and gestures can help the learning process and add to what amplification alone may mis...

Страница 13: ...tion Safety Information Safety Information Your hearing instruments should not be worn during an MRI procedure or in a hyperbaric chamber Your hearing instruments are classified as a Type B applied part under the IEC 60601 1 medical device standard Your hearing instruments are not formally certified to operate in explosive atmospheres such as may be found in coal mines or certain chemical factorie...

Страница 14: ...ty to hear with and without a hearing aid The hearing aid evaluation will enable the audiologist or dispenser to select and fit a hearing aid to your individual needs If you have reservations about your ability to adapt to amplification you should inquire about the availability of a trial rental or purchase option program Many hearing aid dispensers now offer programs that permit you to wear a hea...

Страница 15: ...hen set at the maximum output level FDA Information For the patient A tinnitus therapy device is an electronic device intended to generate noise of sufficient intensity and bandwidth to treat ringing in the ears It can also be used as an aid in hearing external sounds and speech Multiflex Tinnitus Technology is a tool to generate sounds It is recommended that this tool be used with appropriate cou...

Страница 16: ...rs Good health practice requires that a person with tinnitus have a medical evaluation by a licensed physician preferably a physician who specializes in diseases of the ear before using a sound generator Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists otologists or otorhinolaryngologists The purpose of a medical evaluation is to assure that all ...

Страница 17: ... 2012 Starkey Hearing Technologies All Rights Reserved 81016 007 12 12 BKLT2606 00 EE XX Rev A ...

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