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FDA Regulations for Hearing Aids
FDA Regulations
The Food and Drug Administration (FDA) enforces regulations that deal specifically with the manufacture and sale of hearing aids.
According to the FDA, the following conditions must be met before a hearing aid is dispensed: First a written statement signed by a licensed physician that the patient is cleared for fitting with a hearing aid is necessary. The statement must be dated within the previous six months and state that the patient's ears have been medically evaluated.
At Stanford, you may bring this statement with you from your own physician, or if you wish, such an evaluation can be provided by our own physicians. A patient age 18 years or older can sign a waiver for this medical examination.
FDA regulations also require that an instruction brochure be provided with the hearing aid that illustrates and describes its operation, use, and care. The brochure must list sources for repair and maintenance, and include a statement that the use of a hearing aid may be only part of a rehabilitative program.
Over thirty-three million Americans 55 and up have age-related hearing loss, yet people wait seven years, on average, to seek treatment. The reason? Often, it's vanity. There's an everyone-will-stare-at-me stigma that makes us more worried about how we look than how we listen. But current, advanced, high technology hearing aids are less noticeable than ever and more effective than ever. Patients often actually feel younger, smarter, and happier after obtaining a current, properly fitted and adjusted hearing aid.
The price of a hearing aid depends on the type. Medicare and most insurance companies do not cover the costs. The newest high-tech digital models typically cost from $2,000 to $3,500 per ear.
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