The FDA and Hearing Aid Dispensing Exam with complete solution graded A+
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Module
The FDA and Hearing Aid Dispensing
Institution
The FDA And Hearing Aid Dispensing
Background - 1. Effective August 25, 1977 the Food and Drug Administration (FDA) of the United
States established a national Regulation for the provision of hearing aids to the haring impaired. The
Regulation was developed to protect the healthy and safety of hearing impaired Americans.
2. The r...
Background - ✔✔ 1. Effective August 25, 1977 the Food and Drug Administration (FDA) of the United States established a national Regulation for the provision of hearing aids to the haring impaired. Th e Regulation was developed to protect the healthy and safety of hearing impaired Americans. 2. The regulation is divided into 2 sections: A. Section 801.420 - Hearing aid devices; professional and patient labeling a. Relates to identification markings of H As, packaging, and to technical and cautionary statements in the User instructional Brochure. This section pertains primarily to activities required of the manufacturer B. Section 801.421 - Hearing aid devices; conditions for sale a. Relates to conditions of sale required by the HA dispenser Section 801.421: Conditions of Sale - ✔✔ Must be met before a HA is sold 1. Written statement signed by licensed physician 2. Must advise patients who appear to have any of the following otologi c conditions (8 red flags) to consult promptly with a physician 3. A User Instructional Brochure (UIB) must be provided for the HA selected 4. Record Keeping 5. Penalties 6. Definitions Section 801.421 (Conditions of Sale): Written statement signed by lic ensed physician stating - ✔✔ 1. Written statement signed by licensed physician stating: a. Patient's hearing has been medically evaluated b. Patient is considered a candidate for a HA c. Must be no longer than 6 months before date of sale Section 801.421 ( Conditions of Sale): Must advise patients who appear to have any of the following otologic conditions (8 red flags) to consult promptly with a physician - ✔✔ 1. Must advise patients
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