AUTHORITY: Implementing and authorized by the Hearing Instrument Consumer Protection Act [225 ILCS 50].
SOURCE: Adopted at 11 Ill. Reg. 7690, effective April 15, 1987; amended at 12 Ill. Reg. 4720, effective February 22, 1988; amended at 14 Ill. Reg. 10447, effective June 18, 1990; amended at 17 Ill. Reg. 8825, effective June 10, 1993; amended at 21 Ill. Reg. 4799, effective April 1, 1997; amended at 26 Ill. Reg. 11995, effective July 22, 2002; amended at 35 Ill. Reg. 10312, effective June 17, 2011; amended at 37 Ill. Reg. 19331, effective November 13, 2013.
SUBPART A: GENERAL PROVISIONS
Section 682.100 Definitions
"Abuse" means any physical or mental injury or sexual assault, inflicted on a consumer other than by accidental means.
"Act" means the Hearing Instrument Consumer Protection Act [225 ILCS 50].
"Advertisement" means any printed or spoken information that is provided to the public group, pursuant to the practice of fitting, dispensing or servicing hearing instruments or by persons engaged in these activities.
"Audiometric Test" means any test, using calibrated audiometric equipment, to determine the status of the hearing system.
"Authorized Designee" means any organization that is approved by the Department to offer and conduct a written or practical examination in accordance with Department guidelines.
"Board" means the Hearing Instrument Consumer Protection Board. (Section 3 of the Act)
"Cost" means any expense resulting from activities mandated by the Hearing Instrument Consumer Protection Act or this Part.
"Decibel" or "dB" means a numerical expression of the relative intensity of a sound.
"Department" means the Department of Public Health. (Section 3(a) of the Act)
"Direct Supervision" means that the licensed hearing instrument dispenser/audiologist designated as supervisor of a licensed trainee shall give final approval to all work performed by the trainee, shall sign off on all progress notes and contracts, and shall be physically present 100 percent of the time while the trainee has contact with the client. (Section 9.5 of the Act)
"Director" means the Director of the Department of Public Health. (Section 3(b) of the Act)
"Disposable Hearing Instrument" or "Disposable Hearing Aid" means any instrument or device designed, intended, or offered for the purpose of improving a person's hearing that uses a self-contained, non-renewable, non-replaceable battery of limited life span.
"Entity" means a person or group of persons engaged in dispensing activities.
"Fund" means the Hearing Instrument Dispenser Examining and Disciplinary Fund. (Section 3 of the Act)
"Hearing Care Professional" means a person who is a licensed audiologist, a licensed hearing instrument dispenser, or a licensed physician. (Section 3 of the Act)
"Hearing Instrument" or "Hearing Aid" means any instrument or device designed, intended, or offered for the purpose of improving a person's hearing and any parts, attachments, or accessories, including earmold. Batteries, cords, and individual or group auditory training devices and any instrument or device used by a public utility in providing telephone or other communication services are excluded. (Section 3(i) of the Act)
"Hearing Instrument Dispenser" or "Dispenser" means a person who is a hearing care professional that engages in the selling, practice of fitting, selecting, recommending, dispensing, or servicing of hearing instruments or the testing for means of hearing instrument selection or who advertises or displays a sign or represents himself or herself as a person who practices the testing, fitting, selecting, servicing, dispensing, or selling of hearing instruments. (Section 3 of the Act)
"Liability Insurance" means malpractice insurance in the minimum amount of $200,000.
"License" means a license issued by the State under the Act to a hearing instrument dispenser. (Section 3 of the Act)
"Licensed Audiologist" means a person licensed as an audiologist under the Illinois Speech-Language Pathology and Audiology Practice Act [225 ILCS 110] (Section 3 of the Act)
"Licensed Hearing Instrument Dispenser" or "Licensee" means a hearing instrument dispenser who has met the educational requirements, has passed the Department's required Hearing Instrument Dispenser Examinations, and has paid the appropriate fees for the license.
"Licensed Physician" or "Physician" means a physician licensed in Illinois to practice medicine in all of its branches, pursuant to the Medical Practice Act of 1987 [225 ILCS 60]. (Section 3 of the Act)
"Masking" means the process by which a second sound stimulus is introduced to the non-test ear to isolate the response of the test ear from that of the non-test ear.
"Medical Evaluation" means a written statement, signed by a licensed physician, , which states that the patient's hearing loss has been medically evaluated and the patient is considered a candidate for a hearing instrument. The medical evaluation must have taken place within 6 months immediately preceding the date of the sale of the hearing instrument to the prospective hearing instrument user. (Section 4 of the Act)
"Most Comfortable Loudness" or "MCL" means a level at which sound is most comfortable for the client, that is, loudness of sound sufficient and adequate to be easily heard by the listener without the sound being painful or having disturbing features.
"National Board Certified Hearing Instrument Specialist" means a person who has had at least 2 years in practice as a hearing instrument dispenser and has been certified after qualification by examination by the National Board for Certification in Hearing Instruments Sciences. (Section 3 of the Act)
"Observer" means a licensed hearing instrument dispenser/audiologist who directly observes students or licensed trainees engaged in dispensing activities described in Section 682.215(d).
"Place of Business" means a location where hearing instruments are exhibited or the services are offered for sale or lease on a continuing basis; where the hearing instrument purchaser can have personal contact and counsel with the licensed hearing instrument dispenser/audiologist and obtain service during the firm's business hours; where the licensed hearing instrument dispenser/audiologist maintains a depository of all client records; where the licensee normally conducts business; and that is the address given for the purpose of retail sales tax to the Illinois Department of Revenue.
"Practice of Fitting, Dispensing or Servicing of Hearing Instruments " means the measurement of human hearing with an audiometer, calibrated to the current American National Standard Institute standards, for the purpose of making selections, recommendations, adaptations, services, or sales of hearing instruments including the making of earmolds as part of the hearing instrument. (Section 3 of the Act)
"Reciprocity" means the licensing of a dispenser who holds a current license in another State that determines competency through the International Institute for Hearing Instrument Studies (IIHIS) International Licensing Examination (ILE) or who holds a valid current license from another state that has an examination substantially similar to the examination required under the Act, as determined by the Department.
"Reciprocity Fee" means a fee equivalent to the fee for one entire administration of the licensing competency examination (see Section 682.200(a)(3)).
"Sell" or "Sale" means any transfer of title or of the right to use by lease, bailment, or any other contract, excluding wholesale transactions with distributors or dealers. (Section 3 of the Act)
"Speech Reception Threshold" means the lowest hearing level in decibels at which the client can respond correctly to at least 50% of the two-syllable words (spondaic words) presented via recording or live voice.
"Spondaic Words" means words containing two syllables that are pronounced with equal emphasis.
"Student" means any non-licensed individual, involved in supervised hearing instrument dispensing activities, who is enrolled full-time in a graduate program of audiology in an accredited college or university. (Section 11 of the Act)
"Supervisor" means the licensed hearing instrument dispenser or audiologist, with at least two years of practice dispensing hearing aids, who is responsible for the hearing instrument dispensing activities of a student or trainee. The licensed hearing instrument dispenser/audiologist is responsible for all of the work that is performed by the trainee or student.
"Trainee" means a person who is licensed to perform the functions of a hearing instrument dispenser in accordance with this Part and only under the direct supervision of a hearing instrument dispenser or audiologist who is licensed in this State. (Section 3 of the Act)
"Uncomfortable Loudness Level" or "UCL" means the level at which the client indicates that sound is uncomfortably loud.
(Source: Amended at 37 Ill. Reg. 19331, effective November 13, 2013)
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)