Warnings To Hearing Care Professionals; Warning To Hearing Care Professionals (Us Only); Important Notice For Prospective Hearing Aid Users (Us Only) - ReSound LiNX Quattro User Manual

i
22

Warnings to hearing care professionals

1. Special care should be exercised in selecting and fitting hearing aids with maximum sound pres-
sure level that exceeds 132 dB SPL with an IEC 60711:1981 occluded ear simulator. The remain-
ing hearing may risk further impairment.
2. External devices connected to the electrical input must be safe according to the requirements of
IEC 60601-1, IEC 60065, or IEC 60950-1, as appropriate (wired connection, for example HI-PRO,
SpeedLink)
i
23

Warning to hearing care professionals (US only)

A hearing care professional 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 care
professional 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:
1. Visible congenital or traumatic deformity of the ear.
2. History of active drainage from the ear within the previous 90 days.
3. History of sudden or rapidly progressive hearing loss within the previous 90 days.
4. Acute or chronic dizziness.
5. Unilateral hearing loss of sudden or recent onset within the previous 90 days.
6. Audiometric air-bone gap equal to or greater than 15 decibels at 500 hertz (Hz), 1,000 Hz, and
2,000 Hz.
7. Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
8. Pain or discomfort in the ear.
50
i
24

Important notice for prospective hearing aid users (US only)

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, otolo-
gists or otorhinolaryngologists. The purpose of medical evaluation is to assure that all medically treat-
able 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 care professional, as appropriate, for a hearing
aid evaluation.
The audiologist or hearing care professional 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 hearing
care professional 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 programme. Many hearing care professionals now offer
programmes 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.
51