; (B) in the case of an individual who has a hearing loss (as defined by the Secretary), a comprehensive audiologic assessment to determine if a hearing aid is appropriate and to determine the need for other diagnostic medical or audiologic testing; and (C) a threshold test to determine audio acuity. (3) (A) The term hearing aid means a hearing aid described in subparagraph (B), including the services described in subparagraph (C) furnished by a physician or qualified audiologist, who is legally authorized to supply such hearing aid under the State law (or State regulatory mechanism provided by State law) of the State in which the hearing aid is supplied, to an individual described in subparagraph (D). (B) A hearing aid described in this subparagraph is any wearable instrument or device for, offered for the purpose of, or represented as aiding individuals with, or compensating for, hearing loss that meets requirements of the Food and Drug Administration for marketing. (C) The services described in this subparagraph include— (i) audiology services (as defined in subsection (ll)(2)); (ii) a hearing aid assessment to determine the appropriate hearing aid for the individual; (iii) procurement of an appropriate hearing aid; (iv) initial fitting and adjustment of the hearing aid; (v) appropriate instruction on the use of the hearing aid; (vi) periodic refittings and adjustments; and (vii) rehabilitation, including counseling on hearing loss, speech reading, and auditory training. (D) The individuals described in this subparagraph— (i) have been determined (as a result of a comprehensive audiologic assessment) to have a hearing loss which can be appropriately treated with a hearing aid; (ii) have not been supplied with one monaural hearing aid or two binaural hearing aids during the preceding 3 years