FDA RegulationsThe FDA recommends that you get an examination by a medical doctor or an ear specialist to specifically check for any "Red Flag" conditions. Whenever any of the following conditions are found to exist either from observations by the hearing practitioner or on the basis of information furnished by the prospective hearing aid user, the hearing practitioner shall, prior to fitting and selling a hearing aid to any individual, suggest to that individual in writing that his best interests would be served if he would consult a licensed physcian specializing in diseases of the ear, or if no such licensed physician is available, then to a duly licensed physician. (1) Visible congential or traumatic deformity of the ear. (2) Active drainage from the ear within the previous 90 days or history of this symptom. (3) Sudden or rapidly progressive hearing loss within the previous 90 days or history of this symptom. (4) Acute or chronic dizziness. (5) Unilateral hearing loss of sudden or recent onset within the previous 90 days. (6) Visible evidence of cerumen(earwax) accumulation or a foreign body in the ear canal. (7) Significant air-bone gap, when generally acceptable standards have been established. (8) Pain in the ear within the previous 90 days. If you have any of the above conditions please consult a medical doctor. You must also have your hearing tested before you can order a hearing aid. If you do not want a medical examination, Federal Law allows a fully informed adult to sign a waiver declining the medical examination. The waiver form should read as follows: "I have been advised that my best interests would be served if I had a medical examination by an otologist or otolaryngologist or any licensed physician before my purchase of a hearing aid. (Hearing practitioner's name) has fully and clearly informed me of the value of such medical examination. After such explanation, I voluntarily sign this waiver. I choose not to seek a medical examination before the purchase of the hearing aid."
|
