FDA Medical Hearing Aid Waiver

FDA Waiver


 

I acknowledge that I am 18 years of age or older and that I have been advised by Audicus 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 or personal sound amplifier (PSA). 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, Audicus 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 (such as the Audicus Uno, Audicus Dia, Audicus Canto, or Audicus Alto) based upon the information you have submitted to Audicus. 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.

Personal Sound Amplification Products (PSAPs):
Personal Sound Amplifiers (or PSAs), such as the Audicus Solo, are intended to amplify sounds in situations that would be difficult for normal hearing individuals to hear. A personal sound amplifier is NOT a hearing aid and is not intended to treat hearing loss. It is not intended to diagnose, treat, cure any disease or alter the structure or function of the body. It will not restore normal hearing and will not prevent or improve a hearing impairment resulting from organic conditions. PSAs are designed for occasional and recreational use for amplifying and filtering sounds that are inherently difficult to hear. If you believe you have hearing loss, you are encouraged by Audicus to seek help from a qualified professional. To protect your hearing, avoid having the volume at high levels for extended periods of time. Permanent hearing loss can result from high sound volumes.

 

By purchasing from Audicus, 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 Audicus 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, understand and agree to our “Terms of Service” and “Privacy Policy.”