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FDA Information
Warning to Hearing Care Professionals (continued):
(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 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), 1000 Hz and 2000 Hz.
(vii) Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
(viii) Pain or discomfort in the ear. Special care should be exercised in selecting and fitting a
hearing aid whose maximum sound pressure level exceeds 132 decibels because there may be risk of
impairing the remaining hearing of the hearing aid user.
Information for U.S. users from the Federal Drug Administration, Department of Health, Edu-
cation, and Welfare, Rules and Regulations for Medical Devices part 801- Hearing Aid Devices,
Professional and Patient Labeling and Conditions for Sale:
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 medical evaluation is to assure that all medically treatable conditions that may affect
hearing are identified and treated before the hearing aid is purchased.
Following the medical evaluation, the physician will give you a written statement that your hearing loss
has been medically evaluated and you may be considered a candidate for a hearing aid.
