Requirements concerning waiver by client of medical evaluation.

If a hearing aid specialist or dispensing audiologist offers a client a waiver of the medical evaluation required by 21 C.F.R. § 801.421, the hearing aid specialist or dispensing audiologist shall: 1. Verbally explain the waiver to the client before the client signs the waiver; and 2. Provide the written waiver on a form separate from any other form that the client is required to sign.