hi Health Innavations hi BTE mini Gebruikershandleiding - Pagina 13

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FDA statements

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 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 otorhinolaryngologists . The purpose of 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 a hearing aid dispenser, as appropriate, for a

hearing aid evaluation .

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 .

Children with hearing loss

In addition to seeing a physician for a medical evaluation, a

child with 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 hearing loss .