FDA Regulations
If this is your first time buying a hearing aid, we 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 please consult a medical doctor first. If you do not want a medical examination, the Federal Law allows a fully-informed adult to sign a waiver statement declining the medical evaluation.
" I have been advised by ( ear 2 ear and representatives ) 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 aids."
Waiver Signature: ____________________________________
In addition to placing your order, by signing the above line, you are also stating that you are age 18 or over, you have read and understand the required F.D.A. notice and have made an informed decision to proceed to order your hearing aid.
Please print and mail to: Hearing aids wholesale c/o Ear 2 Ear 778 Garrett Rd. Upper Darby Pa 19082
Ear 2 Ear®
Hearing Aids Wholesale
c/o Forwarding agent
778 Garrett Road Upper Darby
19082 Pennsylvania, USA
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