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Chapter 276-5 PROCEDURES, EQUIPMENT, CALIBRATIONS AND RECORDS

Rule 276-5-.01 Procedures

(1) Appropriate procedures to be employed in the selection of a hearing aid shall mean the making and recording results of tests of air and bone conduction for both ears; testing and recording level of most comfortable loudness and level of discomfort (Tolerance Level). Masking shall be employed and results recorded when appropriate. Speech discrimination tests shall be made, recorded, and used in the selection of hearing aids. Test data used in the selection process shall not be more than 6 months old.
(a) All practices by licensees shall be in the best interest of persons served professionally.
(b) Licensees shall counsel persons served as to the nature and limitations of the services and products.
(c) Minimal procedures used in the dispensing of hearing aids shall be appropriate to the individual subject. Deviations from 276-5-.01(1) shall be supported by the test record and defensible by the responsible dispenser.
(2) Licensees shall evaluate products dispensed to determine effectiveness based on recognized standards of practice. Measures of evaluation may include but are not limited to: sound field measurement, real ear measurement and client evaluation sheets.

Rule 276-5-.02 Equipment

Each dispenser shall have available an instrument or instruments approved by the Board capable of performing the tests described under the procedure section of these rules.

Rule 276-5-.03 Calibration

Licensees shall use calibrated equipment in the delivery of professional services and shall maintain calibration reports for six (6) years. Equipment shall be calibrated annually, or more frequently if in accordance with the manufacturer's specifications, and shall have calibrator's certification that post-calibration readings meet or exceed American National Standards Institute ("ANSI") standards. Calibration reports shall contain as a minimum the following:

(a) Audiometer's identification including make, model, and serial number;
(b) Calibrator's identification including company name and location and name of technician responsible for work;
(c) Post calibration readings for air and bone conduction, speech, signal leakage, attenuation linearity, and masking;
(d) Calibrator's certification that post calibration readings meet or exceed ANSI standards;
(e) Date of calibration.

Rule 276-5-.04 Records

(1) Records required. Required records include results of all hearing tests given, copies of medical information and waivers provided voluntarily, bills of sale, and equipment calibration reports. Test results must include the date of test and the name and license or permit number of the tester. Tests conducted under the supervision of a physician, state licensed audiologist, or masters degree audiologist may be accepted, at the discretion of the dealership, but the records of tests must be part of the dealers records and must show the date of test, name of tester, and the name of the supervising physician or audiologist.
(2) Record retention. The dealer shall (upon the consummation of a sale of a hearing aid) keep and maintain records in his or her office or place of businesses at all times and maintained for a period of six years each records listed below:
(a) the original of all equipment calibration reports, tests, bills of sale, and related documentation for all fittings made or recommended by all dispensers (apprentices) and trainees working within the dealership.
(b) Records of outside tests, records of tests made by a physician, state licensed audiologist, or masters degree audiologist, who have not entered into a satisfactory relationship with the dealer, where a hearing aid selection is made. It is the responsibility of the dispenser to insure that all tests required by the Board rules have been conducted and used in the selection process.
(c) In complying with the Board regulation on Records, licensees are required to maintain evidence that they have met all of the regulations embodied in section 801.421 of the Department of H.E.W.; FDA, regulations on Hearing Aid Devices.