Equipment and procedures

(a) Each licensed hearing aid dealer and each person holding a temporary permit shall comply with the following while testing for the fitting or sale of any hearing aid: (1) test in a room which shall have a maximum ambient noise level of fifty-five (55) dBA slow scale; and (2) within six (6) months after the adoption of these regulations, employ audiometers which conform to the standards of the American National Standards Institute (ANSI) approved by the department. (b) Each licensed hearing aid dealer and each person holding a temporary permit shall maintain a copy of the calibration certificate of each audiometer used during the preceding year. For the purposes of this provision the term "the preceding year" shall mean the twelve month period ending on the thirty-first day of August immediately prior to said September first. The calibration certificate shall bear the name and address of the calibrator and shall state that the calibration was done according to the requirements of the standards of ANSI approved by the department. Said certificate shall be available to the department for review. (c) Biological checks of audiometers shall be accomplished at least once a month and records of such checks shall be maintained for at least three (3) years. (d) The department may make random unannounced examinations or inspections of any audiometric facility. (e) Prospective hearing aid purchasers who, during testing, fitting and taking of history evince any of the following, shall be advised to consult a physician or an otolaryngologist (ear, nose and throat specialist), and a written statement regarding such advice shall accompany the sale of a hearing aid and proof of receipt by the purchaser shall be maintained on file: (1) visible congenital or traumatic deformity or injury to the ear; (2) a history of, or active drainage from the ear within the previous ninety (90) days, or complaint of ear pain or discomfort within the previous sixty (60) days; (3) a history of sudden or rapidly progressive hearing loss within the previous ninety (90) days; (4) complaint of acute or chronic dizziness; (5) unilateral hearing loss of sudden or recent onset within the previous ninety (90) days; (6) an audiometric air-bone gap of 15 dB or greater at 500, 1000, or 2000 Hz; (7) visible evidence of cerumen accumulation or a foreign body in the ear canal; (8) a history of, or onset of, or changes in tinnitus within the previous sixty (60) days. (f) (1) Testing by a licensed hearing aid dealer or each person holding a temporary permit for the purpose of fitting and selling hearing aids shall be conducted as follows: (a) pure tone testing for air conduction from 250 through 8000 Hz, with masking where appropriate; (b) pure tone testing for bone conduction from 250 through 4000 Hz, with masking where appropriate; (c) speech testing to determine the feasibility of the use of a hearing aid by means of formalized audiometry or by the use of a master or live hearing aid. (2) The tests described in subsection (f) (1) of this regulation may be omitted, in whole or in part when prohibited or expressly not required, by a licensed physician or an otolaryngologist in writing, or when an audiological examination incorporating at least the requirements of section 20-406 (f) (1) of these regulations performed by a licensed audiologist or a licensed physician has been performed upon the prospective hearing aid purchaser within the ninety (90) days preceding, and a copy of the results furnished to the licensed hearing aid dealer or the person holding a temporary permit.