Important Notice for Prospective Hearing Aid Users (FDA Required Warning)
Good health practice requires that a person with a hearing loss have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before purchasing a hearing aid.
Licensed physicians who specialize in diseases of the ear are often
referred to as otolaryngologists, otologists or otorhinolaryngologists.
The purpose of a medical evaluation is to assure that all medically
treatable conditions that may affect hearing are identified and treated
before the hearing aid is purchased.
We
advise all prospective hearing aid buyers to consult promptly with a
licensed physician (preferably an ear specialist) immediately if you
have any of the following conditions:
(i) Visible congenital or traumatic deformity of the ear.
(ii) History of active drainage from the ear within the previous 90 days.
(iii) History of sudden or rapidly progressive hearing loss within the previous 90 days.
(iv) Acute or chronic dizziness.
(v) Unilateral (one ear only) hearing loss of sudden or recent onset within the previous 90 days.
(vi) Audiometric air-bone gap equal to or greater than 15 decibels at 500 hertz (Hz), 1,000 Hz, and 2,000 Hz.
(vii) Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
(viii) Pain or discomfort in the ear.
FDA Regulations
If you have any of the above conditions please consult your doctor first before ordering a hearing aid.
If you do not want a medical examination, Federal Law allows for a
fully-informed adult to sign a "Medical Exam Waiver Statement" declining the medical
evaluation. A copy of this waiver is below for your use.
Medical Exam Waiver Statement
I have been advised by DiY Hearing Aids and it's representatives, that the
Food and Drug Administration 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 aids.
Waiver Signature ____________________________________ Date _______________
In addition to placing your order, by signing the above line,
you are also stating that you are age 18 years of age or older, you have read and
understand the required F.D.A. notice and have made an informed
decision to purchase hearing aids without being seen by a physician. Additionally, By purchasing hearing aids from D0-it-Yourself Hearing you agree
that you are the person that will be the end user and wearer. You also
agree that the reason for purchasing hearing aids from HearSource.com
is for the purpose of personal use only and not for competitive
research, resale or any other reason.
