Audicus aSwing, Instruction Manual

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Information for Prospective Users
Information for U.S. users from the Federal Drug Administration, Department of Health, Education,
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.
Federal law restricts the sale of hearing aids to those individuals who have obtained a medical
evaluation from a licensed physician. Federal law permits a fully informed adult to sign a waiver
statement declining the medical evaluation for religious or personal beliefs that preclude
consultation with a physician. The exercise of such a waiver is not in your best health interest and
its use is strongly discouraged.
This product is manufactured for Audicus by Audina.
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