Section 682.105  Incorporated and Referenced Materials

The following materials are incorporated or referenced in this Part:

a)         The following materials are incorporated in this Part:  

1)         ANSI S3.6-2004

            Specifications for Audiometers

            American National Standards Institute

            1430 Broadway

            New York, New York 10018, or

            ASA Standards Distribution Center

            1650 Bluegrass Lakes Parkway

            P.O. Box 6996

            Alpharetta GA  30239-6996

            (See Sections 682.170(c), 682.170(e)(4), 682.300(b) and 682.300(d))

2)         ANSI S3.21-2004

            Methods for Pure Tone Threshold Audiometry

            American National Standards Institute

            1430 Broadway

            New York, New York 10018

            (See Section 682.300(a))

3)         ANSI S3.1-2004

            Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms

            American National Standards Institute

            1430 Broadway

            New York, New York 10018

            (See Section 682.300)

b)         The following federal regulations are incorporated in this Part:  

1)         21 CFR 801.420:  Food and Drug Administration:  Hearing aid devices; professional and patient labeling (April 1, 2010);

2)         21 CFR 801.421:  Food and Drug Administration:  Hearing aid devices; conditions for sale (April 1, 2010).

c)         The following State rules and State statutes are referenced in this Part:

1)         Practice and Procedures in Administrative Hearings (77 Ill. Adm. Code 100);

2)         Hearing Aid Consumer Protection Continuing Education Requirements (77 Ill. Adm. Code 3000);

3)         Consumer Fraud and Deceptive Business Practices Act [815 ILCS 505];

4)         Hearing Instrument Consumer Protection Act [225 ILCS 50]; and

5)         Illinois Speech-Language Pathology and Audiology Practice Act [225 ILCS 110].

d)         All incorporations by reference of federal regulations and the standards of nationally recognized organizations refer to the regulations and standards on the date specified and do not include any amendments or editions subsequent to the date specified.

e)         Copies of all incorporated materials are available for public inspection and duplication at the Department's Central Office, Division of Health Assessment and Screening (535 West Jefferson, Springfield, Illinois 62761).

(Source:  Amended at 35 Ill. Reg. 10312, effective June 17, 2011)