DIVISION 640
PRACTICE STANDARDS
331-640-0000
Assistive Listening Devices
Assistive listening devices which are exempt from the provisions of ORS Chapter 694 are defined as products designed to solve one or more specific listening problems created by a hearing loss, and include personal or group listening devices, telephone listening devices, or alert/alarm systems. The primary difference between listening devices and hearing aids is that an assistive listening device is designed to assist in only one, or a few, listening environments, and is for temporary use only. A hearing aid is designed for use in a wide range of listening environments and is primarily for full time use. The following criteria shall be considered in categorizing an assistive listening device:
(1) Personal Assistive Listening Device:
(a) Is used for the assistance of only one person;
(b) May be used either hardwired or wireless type;
(c) May be adaptable to particular environments;
(d) May not be fitted to an individual hearing loss;
(e) May not be sold as a standard hearing aid;
(f) May be an external option that will work with a hearing aid either through the telecoil or by direct audio input coupler built into a hearing aid.
(2) Group Assistive Listening Device:
(a) Includes infrared and FM systems and induction loop systems;
(b) Includes auditory trainers that are classified as such by the FDA exemption for group auditory trainers (21 CFR 801.421(e));
(c) May include telecaption decorders.
(3) Telephone Devices for the Hearing Impaired:
(a) Amplified handsets;
(b) In-line amplifiers for modular telephones;
(c) Receiver add-ons;
(d) An external option that will work with a hearing aid.
(4) Telecommunications Devices for the Deaf (TDD):
(a) Typically visually based;
(b) TDD and Teletypewriter for the deaf (TTY) systems.
(5) Alert/Alarm Systems:
(a) Systems that use a form of visual or vibratory stimuli to alert an individual;
(b) May be hardwired or use an acoustic pickup.
[Publications: Publications referenced are available from the
agency.]
Stat. Auth.: ORS 676.615, 694.155
Stats. Implemented: ORS 676.615, 694.155
Hist.: HD 8-1986, f. & ef. 5-29-86; HD 8-1990, f. 4-4-90, cert.
ef. 4-5-90; Renumbered from 333-025-0050, HLO 6-2004, f. 6-29-04,
cert. ef. 7-1-04
331-640-0010
Safety and Infection Control Requirements
(1) Each licensee shall keep areas of their facility for otoscopic examination, earmold impression taking, and audiometric examination clean and sanitary.
(2) Impression tools, otoscopic examination equipment and other devices that come in direct contact with the client must be disinfected prior to use. Licensees shall use an EPA registered high-level disinfectant, following the manufacturer's directions, to disinfect nondisposable equipment and tools.
(3) Disposable or disinfected otoscopic specula must be used when examining each ear.
(4) Licensees must wash or sanitize hands prior to taking an earmold impression.
(5) Licensees must observe the Universal Precautions as defined in Oregon Administrative Rule 437-002-0360(25), and 29 CFR 1910.1030 standards, when providing services to consumers. Universal Precautions describe an approach to infection control that assumes exposure to all human blood and specified human body fluids are infectious for HIV, HBV, and other blood borne pathogens. Precautions to reduce the likelihood of exposure include hand washing, gloving, using personal protective equipment, preventing injury, ensuring proper handling and disposal of needles and other sharp instruments and of products or equipment contaminated with blood and body fluids.
Stat. Auth.: ORS 676.615 & 694.155
Stats. Implemented: ORS 676.615 & 694.155
Hist.: HD 23-1993, f. 12-30-93, cert. ef. 1-1-94; Renumbered from
333-025-0014, HLO 6-2004, f. 6-29-04, cert. ef. 7-1-04; HLA 1-2006,
f. 8-31-06, cert. ef. 9-1-06
331-640-0020
Audiometric Testing Equipment
Licensed hearing aid specialists shall maintain audiometric testing equipment, currently used in the practice of administering evaluations, in proper working order at all times and shall be prepared to provide their record of at least annual calibration to a representative of the agency when so requested, upon inspection, or during an investigation conducted by the agency.
Stat. Auth.: ORS 676.615 & 694.155
Stats. Implemented: ORS 676.615 & 694.155
Hist.: HD 8-1990, f. 4-4-90, cert. ef. 4-5-90; HD 23-1993, f.
12-30-93, cert. ef. 1-1-94; Renumbered from 333-025-0027, HLO 6-2004,
f. 6-29-04, cert. ef. 7-1-04
331-640-0030
Disclosure Statements to Prospective Purchaser; Delivery Information
(1) The term "purchaser" as used in ORS chapter 694 and OAR chapter 331, division 640, means any person who purchases or proposes to purchase hearing aid(s) and any person on whose behalf hearing aid(s) are purchased or proposed to be purchased. In the case of a client who is a minor child or other person without legal capacity to contract, the person's parent, legal guardian, or legal representative is the "purchaser."
(2) To assist prospective purchasers in making an informed decision regarding the sale of hearing aid(s), licensees must provide prospective purchasers with complete and accurate disclosure of facts regarding licensee services, the hearing aid(s) purchase price, delivery and consummation of sale defined in OAR 331-601-0000, and information about the purchaser's right to rescind or cancel a sale and the procedures for rescinding the sale and returning the hearing aid(s) according to the provisions of ORS 694.042.
(3) The Statement to Prospective Purchaser (Statement) is a contract prepared and signed by the licensee and agreed to by the purchaser. This Statement contains required information listed in ORS 694.036 regarding licensee and purchaser information, medical observation criteria and referral to physician if medical conditions are present, specifications and conditions of the hearing aid(s), terms of any warranty or expressed guarantee, and how to file a complaint with the agency.
(4) Licensees are required to provide all information and facts specified in this rule before the consummation of the sale, which is the delivery of the hearing aid(s) to the purchaser and the date that starts the 30-day rescission period.
(5) Statement Content. In addition to the information prescribed by ORS 694.036, the Statement must include the following information and facts about the purchase of hearing aid(s):
(a) Date of sale;
(b) Purchaser name, address and signature;
(c) Licensee name, address, telephone number, license number and signature;
(d) The purchase price, which includes the cost of the hearing aid(s) and all related fees;
(e) An accurate description of the hearing aid as new, demonstration instrument, reconditioned, or used;
(f) Delivery date of hearing aid(s);
(g) Date the 30-day rescission period ends;
(h) The portion of the total purchase price that will be retained by the licensee, not to exceed 10% of the contract purchase amount or $250 per hearing aid, whichever amount is less, if the purchaser rescinds the sale under provisions of ORS 694.042 within the 30-day rescission period;
(i) Date and place of post-delivery follow-up session agreed upon by the licensee and hearing aid user as stated in subsection (9) of this rule;
(j) A printed or reproduced copy of ORS 694.042 Right to Rescind A Hearing Aid Purchase in its entirety, which includes the procedures for returning the hearing aid(s) to the licensee;
(k) The following statement, initialed by the purchaser: "Copies of my audiogram and the results of tests or verification procedures were offered to me by the licensee, and I hereby acknowledge receipt of the records or that I declined the offer.";
(l) The following statement about filing complaints: "Complaints regarding the sale, lease, or attempted sale or lease of hearing aids should be directed in writing to: Oregon Health Licensing Agency, 700 Summer Street NE, Suite 320, Salem, OR 97301-1287. Complaint forms may be obtained by calling 503-378-8667 or at the Agency's Web site: http://www.oregon.gov/OHLA/Consumer_help_complaint.shtml"; and
(m) A statement acknowledging that the purchaser has read and understands the information contained in the Statement, signed by the purchaser and dated;
(6) Statement Format. The Statement must be printed on forms measuring no less than 8 1/2 inches wide by 11 inches long, with a minimum 10-point typeset, and be legibly written.
(7) Licensees must provide the purchaser a new Statement for each hearing aid or set of hearing aids, unless the hearing aid(s) is an exact replacement of the device listed in a previous Statement provided to the purchaser.
(8) Refund. Any monies paid by or on behalf of the purchaser toward the hearing aid must be refunded to the payer if the delivery of the hearing aid to the purchaser is cancelled. The purchaser shall incur no additional liability for the cancellation.
(9) Post Delivery Follow-Up.
(a) Licensees will conduct and document a minimum of one post-delivery follow-up session with the hearing aid user before the expiration of the 30-day rescission period. The follow-up session will take place at the original place of the sale or at a predetermined location agreed upon at the time of initial delivery, or at a time and place agreed to within the 30-day rescission period.
(b) The licensee must document in the hearing aid user record any change to the agreed-upon location or date of the post-delivery follow-up session, and, if the licensee is unable to contact or the hearing aid user or to provide the follow-up session, the reason(s) why.
(10) In Home Sales. Sales of hearing aids made at the purchaser's residence and not at the licensee's place of business, require disclosure of federal guidelines related to "in home sales" and the purchaser's right to cancel the transaction and receive a full refund of monies paid to the licensee. The following federal disclosure statement must be completed and affixed to the Statement to Prospective Purchaser when a licensee sells a hearing aid(s) at the purchaser's home.
[ED. NOTE: Statemen referenced are available from the agency.]
Stat. Auth.: ORS 676.605, 676.615, 694.036,
694.042, 694.155 & 694.170
Stats. Implemented: ORS 676.605, 676.615, 694.036, 694.042, 694.155,
694.170
Hist.: HD 8-1986, f. & ef. 5-29-86; HD 8-1990, f. 4-4-90, cert.
ef. 4-5-90; HD 23-1993, f. 12-30-93, cert. ef. 1-1-94 ; Renumbered
from 333-025-0065, HLO 6-2004, f. 6-29-04, cert. ef. 7-1-04; HLA
1-2006, f. 8-31-06, cert. ef. 9-1-06
331-640-0040
Additional Conditions for Referral
(1) In addition to the conditions listed in ORS 694.142 a hearing aid specialist shall not fit or dispense a hearing aid for use without first determining if the following conditions exist and, if so, referring the prospective purchaser to a physician:
(a) Evidence of significant cerumen accumulation in the auditory canal preventing visual inspection of the external auditory canal or external auditory meatus and tympanic membrane or foreign body in the ear canal; or
(b) Pain or discomfort in the ear.
(2) A Waiver of Medical Opinion form as required by ORS 694.142(6) must include the hearing aid specialist's name and license number, the purchaser's name, address and signature with date as well as the following statement:"I do not desire to have a medical evaluation before purchasing a hearing aid."
Stat. Auth.: ORS 694.142, 694.155 & 694.170
Stats. Implemented: ORS 694.142, 694.155 & 694.170
Hist.: HD 8-1990, f. 4-4-90, cert. ef. 4-5-90; HD 23-1993, f.
12-30-93, cert. ef. 1-1-94; Renumbered from 333-025-0029, HLO 6-2004,
f. 6-29-04, cert. ef. 7-1-04
331-640-0050
Additional Standards of Conduct
(1) Licensees must comply with the requirements of ORS 694.142, and all other applicable statutes and rules.
(2) Licensees must conform to state or federal laws regulating retail contracts or to any affirmation of fact or promise made by the licensee which relates to the hearing aid or fitting and dispensing services and which becomes a part of the basis of the transaction when the purchaser relies on it or is, in part, induced into making purchase by it.
(3) Licensees must not make inaccurate or misleading representations or statements as to the efficacy of a hearing aid(s) for improving hearing.
(4) Licensees may not use a title or abbreviation that is misleading or may convey that the licensee holds a credential that is not related to hearing instrument sciences, without designating the professional field for which the credential was issued. Hearing instrument sciences includes, but is not limited to, core competencies identified in ORS 694.075.
(5) The Council recognizes and adopts the revised International Hearing Society's Code of Ethics, adopted October 1983 and revised October 1996, October 1998, and May 2003, as its professional standards model. A copy of the document is on file at the agency for review, and may be accessed at the following Web site: http://ihsinfo.org/IhsV2/Resources/020_Code_Of_Ethics.cfm
(6) During the hearing test or evaluation for fitting a client with a hearing aid(s), the following items must be completed. If the case history and tests were completed within the previous six months and there has been no substantial change in the client's hearing, the following tests may be performed at the discretion of the licensee:
(a) Confidential client case history;
(b) Puretone Air Conduction Threshold testing (should include at a minimum, the following frequencies -- 250, 500, 1000, 2000, 3000, 4000, and 6000 or 8000 Hz);
(c) Puretone Bone Conduction Threshold testing (should include at a minimum, the following frequencies -- 500, 1000, 2000, and 4000 Hz);
(d) Speech Recognition Threshold testing (SRT);
(e) Word Recognition Score (WRS) also known as speech discrimination testing;
(f) Most Comfortable Listening Level (MCL); and
(g) Uncomfortable Listening Level (UCL).
(7) For children who are unable to perform the tests listed in subsection (6) of this rule, an objective measure that meets prevailing professional standards can be used to assess auditory function. The test must be completed by a licensed audiologist or physician.
(8) Licensees must perform one or more of the following verification procedures, within the 30-day rescission period.
(a) Soundfield testing for speech discrimination;
(b) Soundfield testing for puretone thresholds;
(c) Real-ear probe microphone measurements;
(d) Speech mapping; and
(e) Other industry accepted objective measures.
(9) Licensees must post the following statement in public view on the business premises or provide the purchaser with a written notice stating: "Individuals are entitled to a copy of the audiogram used to conduct hearing evaluations and any test results." If copies of the audiogram specified in OAR 331-640-0055, or results of tests or verification procedures conducted under subsections (6) and (8) of this rule are requested, they must be provided to the purchaser.
(10) Licensees who are unable to complete testing for reasons such as a client's medical condition or inability to perform tests or verification procedures are excused from compliance with the relevant parts of subsections (6) and (8) but must document the reasons in the client's record.
(11) Tests listed in subsection (8) of this rule will be used to determine the fitted hearing aid(s) ability to meet current industry standards in reference to ORS 694.042(1)(c), during investigation of complaints filed with the agency.
(12) Licensees must maintain a record of the technical specifications issued by a manufacturer for the hearing aid(s) that have been delivered to or purchased by their clients. The specifications must be available for inspection by the agency's representatives upon request.
Stat. Auth.: ORS 676.605, 676.615, 694.155
& 694.170
Stats. Implemented: ORS 676.605, 676.615, 694.155 & 694.170
Hist. Hist.: HD 23-1993, f. 12-30-93, cert. ef. 1-1-94; Renumbered
from 333-025-0012, HLO 6-2004, f. 6-29-04, cert. ef. 7-1-04; HLA
1-2006, f. 8-31-06, cert. ef. 9-1-06
331-640-0055
Uniform Measurement Standards
(1) As of December 1, 2006, the Council recognizes and adopts the following uniform set of hearing loss measurement standards required for use when interpreting audiograms using 0 - 110 for degrees of decibel hearing loss (dB HL) and 125 - 8000 Hz for frequency. This set of uniform measurement standards must be used for advising consumers on peripheral or cochlear hearing loss: [Table not included. See ED. NOTE.]
(2) Hearing loss may have a greater effect on children than adults. The degree of hearing loss does not necessarily reflect the degree of impairment.
(3) Audiologists licensed under ORS 681, and physicians licensed under ORS 677, may use prevailing professional measurement standards when counseling consumers or purchasers on the effect of hearing loss, in conformance with their training, professional license, code of ethics and practice standards.
[ED. NOTE: Tables referenced are available from the agency.]
Stat. Auth.: ORS 676.605, 694.036, 694.042,
694.1142, 694.155 & 694.170
Stats. Implemented: ORS 676.605, 676.607, 676.615
Hist.: HLA 1-2006, f. 8-31-06, cert. ef. 9-1-06
331-640-0060
Client Record Requirements
For the purpose of clarifying record keeping requirements, the term "client" as used in this rule, means the individual who is a consumer, purchaser, potential purchaser or hearing-aid wearer.
(1) Required Records. Licensees must record, update and maintain documentation for each client relevant to health history, clinical examinations and treatment, and financial data. Documentation shall be written or computerized. Records must include the following information:
(a) Basic client information, including name, address, telephone number and dates of service;
(b) Health history relevant to hearing evaluation or fitting of a hearing aid(s), including referral to a physician or a Waiver of Medical Opinion form required by ORS 694.142(6);
(c) Identification of any conditions that would require referral to a physician licensed under ORS Chapter 677, as required in ORS 694.142(1) and OAR 331-640-0040, and a notation that the client was referred;
(d) Audiograms as specified in OAR 331-640-0055 and results of tests or verification procedures as specified in 331-640-0050;
(e) A copy of the Statement to Prospective Purchaser required by ORS 694.036 and OAR 331-640-0030, including client's signature and date acknowledging that the client has read and understands the information contained in the purchase agreement;
(f) A copy of the Right to Rescind a Hearing Aid Purchase giving notice of rights under ORS 694.042; and
(g) Date and description of services rendered in the form of "chart notes", including any complications. Chart notes must include the recorder's initials, license number and professional title if multiple practitioners provide service to the client.
(2) Record Format. Records and documentation must be accurate, complete, and legible, typed or recorded using ink. Legible hand-written or electronic records are acceptable.
(3) Record Identifiers. Client records listed in subsection (1) of the rule must include the licensee's name, license number, professional title or abbreviation, and signature or initials somewhere on the documentation as a means of identifying the person who is providing service to the client. This information may be affixed to the record(s) in the form of a professional stamp or handwritten entry.
(4) Record Retention. All client records and documentation, written or archived electronically by computer, must be stored and maintained for a minimum of seven years after the licensee has last seen the client or past the age of minority, so that the records are safeguarded, readily retrievable, and available for inspection by the Oregon Health Licensing Agency's representative.
Stat. Auth.: ORS 676.605, 694.036, 694.042,
694.1142, 694.155 & 694.170
Stats. Implemented: ORS 676.605, 676.607, 676.615
Hist.: HLA 1-2006, f. 8-31-06, cert. ef. 9-1-06
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