FDA Waiver

FDA Waiver


I acknowledge that I am 18 years of age or older and that I have been advised by Earsmile.com 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 who specializes in diseases of the ear) before purchasing a hearing aid. I do not wish a medical evaluation before purchasing a hearing device.


Additional Considerations
If you have or think you may have any of the following conditions, Earsmile.com advises you to consult promptly with a licensed physician (preferably an ear specialist) prior to purchase:

  • Visible deformity of the ear
  • Fluid or drainage from the ear within the past 90 days
  • Sudden, rapidly progressing, or fluctuating hearing loss
  • Spells of acute or chronic dizziness
  • Hearing loss only on one side that worsened in the past 90 days
  • Ear canal blockage, a lasting ear infection or a plugged up fullness feeling
  • Excessive wax buildup, or a history of excessive wax buildup
  • Pain or discomfort in the ear
  • Ringing in one or both ears within last 90 days


Hearing Aids:
You are purchasing a hearing aid  based upon the information you have submitted to Earsmile.com. Any examination or representation made by a hearing aid provider or audiologist in connection with the practice of dispensing, fitting, or dealing in hearing aids is not an examination, diagnosis, or prescription by a person licensed to practice medicine and, therefore, must NOT be regarded as medical opinion or advice. Hearing aids will NOT restore normal hearing, nor will it prevent further hearing loss. It is also recommended that an Otoscopic exam is performed before the purchase of a hearing aid.


By purchasing from Earsmile.com, you also agree that you are the person that will be the end user and wearer of these hearing devices, and that the reason for purchasing these hearing devices from Earsmile.com is for the sole purpose of personal use only and not for competitive research, resale, or any other reason. You also agree that you have read and understand that you have read this FDA Waiver, understand and agree to our “Terms of Service” and “Privacy Policy.”

Earsmile Digital Hearing Aids © 2016