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24.150.402    RECORD RETENTION

(1) All licensed hearing aid dispensers shall retain the following records on all patients to whom they sell hearing aids:

(a) dates and places patient contacted;

(b) method of contact, whether in home, office, or by telephone, and the identity of the individual initiating the contact;

(c) description of services delivered;

(d) when applicable, a record of the return of the hearing aids for service, setting forth the date and problem, and a corresponding record of the return to the patient setting forth the corrective action taken;

(e) a copy of the sale contract, purchase agreement, or bill of sale, including a three-day cancellation notice where applicable, signed and dated by the parties, the original delivered to the patient;

(f) when applicable, a copy of the medical recommendation and receipt required pursuant to 37-16-303, MCA, the original delivered to the patient;

(g) a copy of the delivery verification form, in accordance with ARM 24.150.602, the original delivered to the patient;

(h) a copy of the receipt for refund as set forth in 37-16-304, MCA, the original delivered to the patient;

(i) a record of hearing tests or evaluations performed on the patient, in accordance with ARM 24.150.601. Reports of audiometric test results on the patient's audiogram for the purpose of fitting and dispensing hearing aids shall include the following information:

(i) name and age of the patient;

(ii) date of the test;

(iii) name and license number of the person performing the test; and

(iv) whether the test was calibrated in SPL or HTL; and

(j) a copy of the physician's statement regarding the patient's candidacy for a hearing aid or the medical waiver in accordance with 21 CFR 801.421 (April 1995).

(2) Patient records shall be retained by dispensers for a minimum of seven years from the last recorded date of service, except records relating to deceased patients may be discarded one year after the date of death.

(3) All licensed hearing aid dispensers shall maintain all copies of advertisements, including all advertisements placed on behalf of the permanent place of business, encompassing written scripts of radio and television advertisements, in compliance with 37-16-301, MCA.


History: 37-1-131, 37-16-202, MCA; IMP, 37-1-131, 37-16-301, 37-16-303, 37-16-304, 37-16-411, MCA; NEW, Eff. 2/5/76; AMD, Eff. 6/5/76; TRANS, from Dept. of Prof. & Occup. Lic., Ch. 274, L. 1981, Eff. 7/1/81; AMD, 1991 MAR p. 1273, Eff. 7/26/91; AMD, 1993 MAR p. 534, Eff. 4/16/93; AMD, 1997 MAR p. 832, Eff. 5/6/97; AMD, 2000 MAR p. 2514, Eff. 9/22/00; AMD, 2001 MAR p. 781, Eff. 5/11/01; TRANS, from Commerce, 2002 MAR p. 395; AMD, 2010 MAR p. 1085, Eff. 4/30/10; AMD, 2012 MAR p. 894, Eff. 4/27/12; AMD, 2019 MAR p. 1862, Eff. 10/19/19.

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