Hearing Aids - FAQ

Are there Federal Regulations regarding hearing aids?
Before a person is to be fitted with hearing instruments, he/she must:
Obtain a medical clearance from a licensed physician, or;
Sign a waiver to decline the medical evaluation (only for fully informed adults).

Hearing AidsFDA regulations require that the hearing aid dispenser provide you with the following list of medical danger signals. Consult with a physician if it is determined that you have any of the following conditions:

Visible congenital traumatic deformity of the ear.
History of active drainage from the ear within the previous 90 days.
History of sudden or rapidly progressive hearing loss within the previous 90 days.
Acute or chronic dizziness.

Unilateral hearing loss of sudden or recent onset within the previous 90 days. Audiometric air-bone gap equal to or greater than 15dB at 500 Hz, 1000 Hz, and 2000 Hz. Visible evidence of significant cerumen (ear wax) accumulation or a foreign body in the ear canal. Pain or discomfort in the ear.

Should you require an extremely powerful hearing aid whose maximum sound pressure level exceeds 132 dB, special care is required in selecting and fitting the hearing aid due to the risk of impairing remaining hearing. Your audiologist of hearing aid specialist will advise you if you are being fitted with such an instrument.