FDA Waiver

I acknowledge that I am 18 years of age or older and that I have been advised by Top Notch Hearing 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 aid.

If you have or think you may have any of the following conditions, Top Notch Hearing 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
- Pain or discomfort in the ear
- Sudden onset of ringing in one or both ears within last 90 days

You are purchasing a hearing aid based upon the information you have submitted to Top Notch Hearing. 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. A hearing aid 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.

In addition, by agreeing to this waiver you are also stating that you agree that you are the person that will be the end user and wearer of these hearing aids, and that the reason for purchasing these hearing aids from Top Notch Hearing is for the sole purpose of personal use only and not for competitive research, resale, or any other reason.