(2) A " + " symbol to indicate the positive connection for battery insertion, unless it is physically impossible to insert the battery in the reversed position. (1) The name of the manufacturer or distributor, the model name or number, the serial number, and the year of manufacture. Hearing aids shall be clearly and permanently marked with: However, a hearing aid shall not be considered "used" merely because it has been worn by a prospective user as a part of a bona fide hearing aid evaluation conducted to determine whether to select that particular hearing aid for that prospective user, if such evaluation has been conducted in the presence of the dispenser or a hearing aid health professional selected by the dispenser to assist the buyer in making such a determination. (6) Used hearing aid means any hearing aid that has been worn for any period of time by a user. (5) Sale or purchase includes any lease or rental of a hearing aid to a member of the consuming public who is a user or prospective user of a hearing aid. In some states audiologists must satisfy specific requirements for licensure. (4) Audiologist means any person qualified by training and experience to specialize in the evaluation and rehabilitation of individuals whose communication disorders center in whole or in part in the hearing function. (3) Dispenser means any person, partnership, corporation, or association engaged in the sale, lease, or rental of hearing aids to any member of the consuming public or any employee, agent, sales person, and/or representative of such a person, partnership, corporation, or association. Such physicians are also known as otolaryngologists, otologists, and otorhinolaryngologists. (2) Ear specialist means any licensed physician who specializes in diseases of the ear and is medically trained to identify the symptoms of deafness in the context of the total health of the patient, and is qualified by special training to diagnose and treat hearing loss. (1) Hearing aid means any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing. (a) Definitions for the purposes of this section and § 801.421. 801.420 Hearing aid devices professional and patient labeling. Subpart H - Special Requirements for Specific Devices The information on this page is current as of Jul 20, 2022.įor the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).
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