FDA Waiver

I acknowledge that I am eighteen (18) years of age or older and Lively has advised me that the Food and Drug Administration (FDA) has determined that my best health interest would be served if I had a medical evaluation by a licensed physician (preferably a physician specializing in diseases of the ear) before purchasing a hearing aid. I do not wish for a medical evaluation before purchasing a hearing aid. I have also been advised that although any examination in connection with my purchase of hearing aid conducted by a Lively audiologist may reveal no indicators mandating referral to a licensed physician, preferably one specializing in diseases of the ear, for medical evaluation as required by law, it is in my best health interest to be examined by a physician specializing in diseases of the ear for any medical condition or disease at least once every three (3) years. Lastly, I acknowledge that none of the below conditions or symptoms apply to me and that the existence of such conditions would prohibit Lively from selling a hearing aid to me without medical clearance:

  • visible congenital or traumatic deformity of the ear;
  • history of, or active drainage from the ear within the previous ninety (90) days;
  • history of sudden or rapidly progressive hearing loss within the previous ninety (90) days;
  • acute or chronic dizziness;
  • unilateral hearing loss of sudden or recent onset within the previous ninety (90) days;
  • air bone gaps;
  • visible evidence of bleeding, significant earwax accumulation, or a foreign body in the ear canal; or
  • pain or discomfort in the ear.