Important FDA Regulations
Especially if this is your first time buying a hearing aid, we (and the FDA) suggest that you first get an examination by a medical doctor (preferably an ear specialist) to specifically check for any of the following conditions:
Visible congenital or traumatic deformity of the ear
History of active drainage from the ear within the last 90 days
History of sudden or rapidly progressive hearing loss within the last 90 days
Acute or chronic dizziness
Unilateral hearing loss of sudden or recent onset within the previous 90 days
Audiometric air-bone gap equal to or greater than 15 decibels at 500 (Hz), 1000 (Hz) and 2000 (Hz)
Visible evidence of earwax (cerumen) or any foreign body in the ear canal
Pain or discomfort in the ear
If you have any of the above symptoms please consult a medical doctor first. You must have your hearing tested before you can order a hearing aid, so you should have your hearing tested by an Ear, Nose and Throat (ENT) Doctor. If you have your hearing tested by an audiologist that is not part of an ENT office, they will not be able to give you the same level of care, in case you have any type of medical condition.
If you do not want a medical examination, Federal Law allows a fully-informed adult to sign a waiver statement declining the medical evaluation.
Example:
" I have been advised by Hear-Tech that the Food and Drug Administration has determined that my best health interest would be served if I had a medical evaluation by a licensed physician ( preferably a physician who specializes in diseases of the ear ) before purchasing a hearing aid. I do not wish a medical evaluation before purchasing a hearing aid."
Waiver Signature: ________________________________Date_________
Obviously, if you have already seen a medical doctor, there is no need to sign the "waiver." In addition to placing your order, by purchasing a hearing aid from Hear-Tech, you are also stating that you are age 18 or over, you have read and understand the required FDA notice and have made an informed decision to proceed to order your hearing aid.
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