USA Statutes : minnesota
Title : HEALTH
Chapter : Hearing instrument dispensing
153A.01 Repealed, 1988 c 689 art 2 s 269
153A.02 Repealed, 1988 c 689 art 2 s 269
153A.03 Repealed, 1988 c 689 art 2 s 269
153A.04 Repealed, 1988 c 689 art 2 s 269
153A.05 Repealed, 1988 c 689 art 2 s 269
153A.06 Repealed, 1988 c 689 art 2 s 269
153A.07 Repealed, 1988 c 689 art 2 s 269
153A.08 Repealed, 1988 c 689 art 2 s 269
153A.09 Repealed, 1988 c 689 art 2 s 269
153A.10 Repealed, 1988 c 689 art 2 s 269
153A.11 Repealed, 1988 c 689 art 2 s 269
153A.12 Repealed, 1988 c 689 art 2 s 269
Subdivision 1. Applicability. The definitions in this section apply to sections 153A.13 to 153A.18.
Subd. 2. Commissioner. "Commissioner" means the commissioner of the Department of Health or a designee.
Subd. 3. Hearing instrument. "Hearing instrument" means an instrument, or any of its parts, worn in the ear canal and designed to or represented as being able to aid or enhance human hearing. "Hearing instrument" includes the instrument's parts, attachments, or accessories, including, but not limited to, ear molds and behind the ear (BTE) devices with or without an ear mold. Batteries and cords are not parts, attachments, or accessories of a hearing instrument. Surgically implanted hearing instruments, and assistive listening devices not worn within the ear canal, are not hearing instruments.
Subd. 4. Hearing instrument dispensing. "Hearing instrument dispensing" means making ear mold impressions, prescribing, or recommending a hearing instrument, assisting the consumer in instrument selection, selling hearing instruments at retail, or testing human hearing in connection with these activities when the person conducting these activities has a monetary interest in the sale of hearing instruments to the consumer.
Subd. 5. Dispenser of hearing instruments. "Dispenser of hearing instruments" means a natural person who engages in hearing instrument dispensing whether or not certified by the commissioner of health or licensed by an existing health-related board, except that a person described as follows is not a dispenser of hearing instruments:
(1) a student participating in supervised field work that is necessary to meet requirements of an accredited educational program if the student is designated by a title which clearly indicates the student's status as a student trainee; or
(2) a person who helps a dispenser of hearing instruments in an administrative or clerical manner and does not engage in hearing instrument dispensing.
A person who offers to dispense a hearing instrument, or a person who advertises, holds out to the public, or otherwise represents that the person is authorized to dispense hearing instruments must be certified by the commissioner except when the person is an audiologist as defined in section 148.512.
Subd. 6. Advisory council. "Advisory council" means the Minnesota Hearing Instrument Dispenser Advisory Council, or a committee of it, established under section 153A.20.
Subd. 7. ANSI. "ANSI" means ANSI S3.6-1989, American National Standard Specification for Audiometers from the American National Standards Institute. This document is available through the Minitex interlibrary loan system.
Subd. 8. Certification number. "Certification number"means the number assigned to each certification by the commissioner.
Subd. 9. Supervision. "Supervision" means monitoring activities of, and accepting responsibility for, the hearing instrument dispensing activities of a trainee.
Subd. 10. Direct supervision or directly supervised. "Direct supervision" or "directly supervised" means the on-site and contemporaneous location of a supervisor and trainee, when the supervisor observes the trainee engaging in hearing instrument dispensing with a consumer.
Subd. 11. Indirect supervision or indirectly supervised. "Indirect supervision" or "indirectly supervised" means the remote and independent performance of hearing instrument dispensing by a trainee when authorized under section 153A.14, subdivision 4a, paragraph (b). 153A.14 Regulation.
Subdivision 1. Application for certificate. An applicant must:
(1) be 21 years of age or older;
(2) apply to the commissioner for a certificate to dispense hearing instruments on application forms provided by the commissioner;
(3) at a minimum, provide the applicant's name, Social Security number, business address and phone number, employer, and information about the applicant's education, training, and experience in testing human hearing and fitting hearing instruments;
(4) include with the application a statement that the statements in the application are true and correct to the best of the applicant's knowledge and belief;
(5) include with the application a written and signed authorization that authorizes the commissioner to make inquiries to appropriate regulatory agencies in this or any other state where the applicant has sold hearing instruments;
(6) submit certification to the commissioner that the applicant's audiometric equipment has been calibrated to meet current ANSI standards within 12 months of the date of the application;
(7) submit evidence of continuing education credits, if required; and
(8) submit all fees as required under section 153A.17.
Subd. 2. Issuance of certificate. The commissioner shall issue a certificate to each dispenser of hearing instruments who applies under subdivision 1 if the commissioner determines that the applicant is in compliance with this chapter, has passed an examination administered by the commissioner, has met the continuing education requirements, if required, and has paid the fee set by the commissioner. The commissioner may reject or deny an application for a certificate if there is evidence of a violation or failure to comply with this chapter.
Subd. 2a. Repealed, 2005 c 147 art 7 s 20
Subd. 2b. Action on applications for certification. The commissioner shall act on applications for certification, and applications for renewal of certification, according to paragraphs (a) to (c).
(a) The commissioner shall determine if the applicant meets the requirements for certification. The commissioner may investigate information provided by an applicant to determine whether the information is accurate and complete.
(b) The commissioner shall notify each applicant of action taken on the application and of the grounds for denying certification if certification is denied.
(c) The commissioner shall comply with contested case procedures in chapter 14 when suspending, revoking, or refusing to issue or renew a certificate under this section.
Subd. 2c. Reapplication following denial, rejection, revocation, or suspension of certification. After two years, upon application and evidence that the disqualifying behavior has ceased, the commissioner may restore or approve certification previously denied, rejected, revoked, or suspended, provided that the applicant has met all conditions and terms of any orders to which the applicant is a subject.
Subd. 2d. Certification renewal notice. Certification must be renewed annually. The commissioner shall mail a renewal notice to the dispenser's last known address by September 1 of each year. The notice must include a renewal application and notice of fees required for renewal. A dispenser is not relieved from meeting the renewal deadline on the basis that the dispenser did not receive the renewal notice. In renewing a certificate, a dispenser shall follow the procedures for applying for a certificate specified in subdivision 1.
Subd. 2e. Renewal requirements. A certificate must be renewed effective November 1 of each year. To renew a certificate, an applicant must:
(1) annually complete a renewal application on a form provided by the commissioner and submit the annual renewal fee by the deadline;
(2) submit certification to the commissioner that the applicant's audiometric equipment has been calibrated to meet current ANSI standards within 12 months of the date of the application, if the applicant tests hearing;
(3) submit evidence of completion of continuing education requirements, if required; and
(4) submit additional information if requested by the commissioner to clarify information presented in the renewal application. The information must be submitted within 30 days of the commissioner's request.
Subd. 2f. Late renewals. The deadline for application to renew certification is October 1 of each year. An application for certification renewal must be received by the Department of Health or postmarked by October 1. An application not received or postmarked by October 1 shall be a late renewal and must be accompanied by a late fee as required in section 153A.17. If the postmark is illegible, the application shall be considered timely if received by October 7.
Subd. 2g. Lapse in certification. Certification shall lapse if not renewed before November 1 of each year. An applicant whose certification has lapsed less than two years must meet all the requirements of this chapter except the certification by examination requirements of subdivision 2h. The application fees to renew certification following a lapse of less than two years must include the late fee. An applicant whose certification has lapsed for two years or more must meet all the requirements of this chapter except the continuing education requirement of subdivision 2i. Certification application fees of applicants whose certification has lapsed for any amount of time shall not be prorated over the time remaining in the annual certification period.
Subd. 2h. Certification by examination. An applicant must achieve a passing score, as determined by the commissioner, on an examination according to paragraphs (a) to (c).
(a) The examination must include, but is not limited to:
(1) A written examination approved by the commissioner covering the following areas as they pertain to hearing instrument selling:
(i) basic physics of sound;
(ii) the anatomy and physiology of the ear;
(iii) the function of hearing instruments; and
(iv) the principles of hearing instrument selection.
(2) Practical tests of proficiency in the following techniques as they pertain to hearing instrument selling:
(i) pure tone audiometry, including air conduction testing and bone conduction testing;
(ii) live voice or recorded voice speech audiometry including speech recognition (discrimination) testing, most comfortable loudness level, and uncomfortable loudness measurements of tolerance thresholds;
(iii) masking when indicated;
(iv) recording and evaluation of audiograms and speech audiometry to determine proper selection and fitting of a hearing instrument;
(v) taking ear mold impressions;
(vi) using an otoscope for the visual observation of the entire ear canal; and
(vii) state and federal laws, rules, and regulations.
(b) The examination shall be administered by the commissioner at least twice a year.
(c) An applicant must achieve a passing score on all portions of the examination within a two-year period. An applicant who does not achieve a passing score on all portions of the examination within a two-year period must retake the entire examination and achieve a passing score on each portion of the examination. An applicant who does not apply for certification within one year of successful completion of the examination must retake the examination and achieve a passing score on each portion of the examination. An applicant may not take any part of the examination more than three times in a two-year period.
Subd. 2i. Continuing education requirement. On forms provided by the commissioner, each certified dispenser must submit with the application for renewal of certification evidence of completion of ten course hours of continuing education earned within the 12-month period of July 1 to June 30 immediately preceding renewal. Continuing education courses must be directly related to hearing instrument dispensing and approved by the International Hearing Society. Evidence of completion of the ten course hours of continuing education must be submitted with renewal applications by October 1 of each year. This requirement does not apply to dispensers certified for less than one year. The first report of evidence of completion of the continuing education credits shall be due October 1, 1997.
Subd. 2j. Required use of certification number. The certification holder must use the certification number on all contracts, bills of sale, and receipts used in the sale of hearing instruments.
Subd. 3. Nontransferability of certificate. A certificate may not be transferred.
Subd. 4. Dispensing of hearing instruments without certificate. Except as provided in subdivisions 4a and 4c, and in sections 148.512 to 148.5198, it is unlawful for any person not holding a valid certificate to dispense a hearing instrument as defined in section 153A.13, subdivision 3. A person who dispenses a hearing instrument without the certificate required by this section is guilty of a gross misdemeanor.
Subd. 4a. Trainees. (a) A person who is not certified under this section may dispense hearing instruments as a trainee for a period not to exceed 12 months if the person:
(1) submits an application on forms provided by the commissioner;
(2) is under the supervision of a certified dispenser meeting the requirements of this subdivision; and
(3) meets all requirements for certification except passage of the examination required by this section.
(b) A certified hearing instrument dispenser may not supervise more than two trainees at the same time and may not directly supervise more than one trainee at a time. The certified dispenser is responsible for all actions or omissions of a trainee in connection with the dispensing of hearing instruments. A certified dispenser may not supervise a trainee if there are any commissioner, court, or other orders, currently in effect or issued within the last five years, that were issued with respect to an action or omission of a certified dispenser or a trainee under the certified dispenser's supervision.
Until taking and passing the practical examination testing the techniques described in subdivision 2h, paragraph (a), clause (2), trainees must be directly supervised in all areas described in subdivision 4b, and the activities tested by the practical examination. Thereafter, trainees may dispense hearing instruments under indirect supervision until expiration of the trainee period. Under indirect supervision, the trainee must complete two monitored activities a week. Monitored activities may be executed by correspondence, telephone, or other telephonic devices, and include, but are not limited to, evaluation of audiograms, written reports, and contracts. The time spent in supervision must be recorded and the record retained by the supervisor.
Subd. 4b. Hearing testing protocol. (a) A dispenser when conducting a hearing test for the purpose of hearing instrument dispensing must:
(1) comply with the United States Food and Drug Administration warning regarding potential medical conditions required by Code of Federal Regulations, title 21, section 801.420;
(2) complete a case history of the client's hearing;
(3) inspect the client's ears with an otoscope; and
(4) conduct the following tests on both ears of the client and document the results, and if for any reason one of the following tests cannot be performed pursuant to the United States Food and Drug Administration guidelines, an audiologist shall evaluate the hearing and the need for a hearing instrument:
(i) air conduction at 250, 500, 1,000, 2,000, 4,000, and 8,000 Hertz. When a difference of 20 dB or more occurs between adjacent octave frequencies the interoctave frequency must be tested;
(ii) bone conduction at 500, 1,000, 2,000, and 4,000 Hertz for any frequency where the air conduction threshold is greater than 15 dB HL;
(iii) monaural word recognition (discrimination), with a minimum of 25 words presented for each ear; and
(iv) loudness discomfort level, monaural, for setting a hearing instrument's maximum power output; and
(5) include masking in all tests whenever necessary to ensure accurate results.
Subd. 4c. Reciprocity. (a) A person applying for certification as a hearing instrument dispenser under subdivision 1 who has dispensed hearing instruments in another jurisdiction may dispense hearing instruments as a trainee under indirect supervision if the person:
(1) satisfies the provisions of subdivision 4a, paragraph (a);
(2) submits a signed and dated affidavit stating that the applicant is not the subject of a disciplinary action or past disciplinary action in this or another jurisdiction and is not disqualified on the basis of section 153A.15, subdivision 1; and
(3) provides a copy of a current credential as a hearing instrument dispenser held in the District of Columbia or a state or territory of the United States.
(b) A person becoming a trainee under this subdivision who fails to take and pass the practical examination described in subdivision 2h, paragraph (a), clause (2), when next offered must cease dispensing hearing instruments unless under direct supervision.
Subd. 4d. Expiration of trainee period. The trainee period automatically expires two months following notice of passing all examination requirements of subdivision 2h.
Subd. 5. Rulemaking authority. The commissioner shall adopt rules under chapter 14 to implement this chapter. The rules may include procedures and standards relating to the certification requirement, the scope of authorized practice, fees, supervision required, continuing education, career progression, disciplinary matters, and examination procedures.
Subd. 6. Hearing instruments to comply with federal and state requirements. The commissioner shall ensure that hearing instruments are dispensed in compliance with state requirements and the requirements of the United States Food and Drug Administration. Failure to comply with state or federal regulations may be grounds for enforcement actions under section 153A.15, subdivision 2.
Subd. 7. Repealed, 1998 c 317 s 29
Subd. 8. Repealed, 2005 c 147 art 7 s 20
Subd. 9. Consumer rights. A hearing instrument dispenser shall comply with the requirements of sections 148.5195, subdivision 3, clause (20); 148.5197; and 148.5198.
Subd. 10. Repealed, 2005 c 147 art 7 s 20
Subd. 11. Requirement to maintain current information. A dispenser must notify the commissioner in writing within 30 days of the occurrence of any of the following:
(1) a change of address, home or business telephone number, or business name;
(2) the occurrence of conduct prohibited by section 153A.15;
(3) a settlement, conciliation court judgment, or award based on negligence, intentional acts, or contractual violations committed in the dispensing of hearing instruments by the dispenser; and
(4) the cessation of hearing instrument dispensing activities as an individual or a business. 153A.15 Prohibited acts; enforcement; and penalty.
Subdivision 1. Prohibited acts. The commissioner may take enforcement action as provided under subdivision 2 against a dispenser of hearing instruments for the following acts and conduct:
(1) dispensing a hearing instrument to a minor person 18 years or younger unless evaluated by an audiologist for hearing evaluation and hearing aid evaluation;
(2) being disciplined through a revocation, suspension, restriction, or limitation by another state for conduct subject to action under this chapter;
(3) presenting advertising that is false or misleading;
(4) providing the commissioner with false or misleading statements of credentials, training, or experience;
(5) engaging in conduct likely to deceive, defraud, or harm the public; or demonstrating a willful or careless disregard for the health, welfare, or safety of a consumer;
(6) splitting fees or promising to pay a portion of a fee to any other professional other than a fee for services rendered by the other professional to the client;
(7) engaging in abusive or fraudulent billing practices, including violations of federal Medicare and Medicaid laws, Food and Drug Administration regulations, or state medical assistance laws;
(8) obtaining money, property, or services from a consumer through the use of undue influence, high pressure sales tactics, harassment, duress, deception, or fraud;
(9) performing the services of a certified hearing instrument dispenser in an incompetent or negligent manner;
(10) failing to comply with the requirements of this chapter as an employer, supervisor, or trainee;
(11) failing to provide information in a timely manner in response to a request by the commissioner, commissioner's designee, or the advisory council;
(12) being convicted within the past five years of violating any laws of the United States, or any state or territory of the United States, and the violation is a felony, gross misdemeanor, or misdemeanor, an essential element of which relates to hearing instrument dispensing, except as provided in chapter 364;
(13) failing to cooperate with the commissioner, the commissioner's designee, or the advisory council in any investigation;
(14) failing to perform hearing instrument dispensing with reasonable judgment, skill, or safety due to the use of alcohol or drugs, or other physical or mental impairment;
(15) failing to fully disclose actions taken against the applicant or the applicant's legal authorization to dispense hearing instruments in this or another state;
(16) violating a state or federal court order or judgment, including a conciliation court judgment, relating to the activities of the applicant in hearing instrument dispensing;
(17) having been or being disciplined by the commissioner of the Department of Health, or other authority, in this or another jurisdiction, if any of the grounds for the discipline are the same or substantially equivalent to those in sections 153A.13 to 153A.19;
(18) misrepresenting the purpose of hearing tests, or in any way communicating that the hearing test or hearing test protocol required by section 153A.14, subdivision 4b, is a medical evaluation, a diagnostic hearing evaluation conducted by an audiologist, or is other than a test to select a hearing instrument, except that the hearing instrument dispenser can determine the need for or recommend the consumer obtain a medical evaluation consistent with requirements of the United States Food and Drug Administration;
(19) violating any of the provisions of sections 148.5195, subdivision 3, clause (20); 148.5197; 148.5198; and 153A.13 to 153A.18; and
(20) aiding or abetting another person in violating any of the provisions of sections 148.5195, subdivision 3, clause (20); 148.5197; 148.5198; and 153A.13 to 153A.18.
Subd. 2. Enforcement actions. When the commissioner finds that a dispenser of hearing instruments has violated one or more provisions of this chapter, the commissioner may do one or more of the following:
(1) deny or reject the application for a certificate;
(2) revoke the certificate;
(3) suspend the certificate;
(4) impose, for each violation, a civil penalty that deprives the dispenser of any economic advantage gained by the violation and that reimburses the Department of Health for costs of the investigation and proceeding resulting in disciplinary action, including the amount paid for services of the Office of Administrative Hearings, the amount paid for services of the Office of the Attorney General, attorney fees, court reporters, witnesses, reproduction of records, advisory council members' per diem compensation, department staff time, and expenses incurred by advisory council members and department staff;
(5) censure or reprimand the dispenser;
(6) revoke or suspend the right to supervise trainees;
(7) revoke or suspend the right to be a trainee;
(8) impose a civil penalty not to exceed $10,000 for each separate violation; or
(9) any other action reasonably justified by the individual case.
Subd. 2a. Hearings. If the commissioner proposes to take action against the dispenser as described in subdivision 2, the commissioner must first notify the person against whom the action is proposed to be taken and provide the person with an opportunity to request a hearing under the contested case provisions of chapter 14. If the person does not request a hearing by notifying the commissioner within 30 days after service of the notice of the proposed action, the commissioner may proceed with the action without a hearing.
Subd. 3. Procedures. The commissioner shall establish, in writing, internal operating procedures for receiving and investigating complaints and imposing enforcement actions. The written internal operating procedures may include procedures for sharing complaint information with government agencies in this and other states. Procedures for sharing complaint information must be consistent with the requirements for handling government data under chapter 13.
Subd. 3a. Discovery. In all matters relating to the lawful regulation activities under this chapter, the commissioner may issue subpoenas to require the attendance and testimony of witnesses and production of books, records, correspondence, and other information relevant to any matter involved in the investigation. The commissioner or the commissioner's designee may administer oaths to witnesses or take their affirmation. A subpoena may be served upon any person it names anywhere in the state by any person authorized to serve subpoenas or other processes in civil actions of the district courts. If a person to whom a subpoena is issued does not comply with the subpoena, the commissioner may apply to the district court in any district and the court shall order the person to comply with the subpoena. Failure to obey the order of the court may be punished by the court as contempt of court. All information pertaining to individual medical records obtained under this section is health data under section 13.3805, subdivision 1.
Subd. 4. Penalties. Except as provided in section 153A.14, subdivision 4, a person violating this chapter is guilty of a misdemeanor. The commissioner may impose an automatic civil penalty equal to one-fourth the renewal fee on each hearing instrument seller who fails to renew the certificate required in section 153A.14 by the renewal deadline.
153A.16 Repealed, 1991 c 202 s 42
153A.17 Expenses; fees.
The expenses for administering the certification requirements including the complaint handling system for hearing aid dispensers in sections 153A.14 and 153A.15 and the Consumer Information Center under section 153A.18 must be paid from initial application and examination fees, renewal fees, penalties, and fines. All fees are nonrefundable. The certificate application fee is $350, the examination fee is $250 for the written portion and $250 for the practical portion each time one or the other is taken, and the trainee application fee is $200. The penalty fee for late submission of a renewal application is $200. The fee for verification of certification to other jurisdictions or entities is $25. All fees, penalties, and fines received must be deposited in the state government special revenue fund. The commissioner may prorate the certification fee for new applicants based on the number of quarters remaining in the annual certification period. 153A.175 Penalty fees.
(a) The penalty fee for holding oneself out as a hearing instrument dispenser without a current certificate after the credential has expired and before it is renewed is one-half the amount of the certificate renewal fee for any part of the first day, plus one-half the certificate renewal fee for any part of any subsequent days up to 30 days.
(b) The penalty fee for applicants who hold themselves out as hearing instrument dispensers after expiration of the trainee period and before being issued a certificate is one-half the amount of the certificate application fee for any part of the first day, plus one-half the certificate application fee for any part of any subsequent days up to 30 days. This paragraph does not apply to applicants not qualifying for a certificate who hold themselves out as hearing instrument dispensers.
(c) The penalty fee for failing to submit a continuing education report by the due date with the correct number or type of hours in the correct time period is $200 plus $200 for each missing clock hour. The certificate holder must obtain the missing number of continuing education hours by the next reporting due date.
(d) Civil penalties and discipline incurred by certificate holders prior to August 1, 2005, for conduct described in paragraph (a), (b), or (c) shall be recorded as nondisciplinary penalty fees. Payment of a penalty fee does not preclude any disciplinary action reasonably justified by the individual case. 153A.18 Consumer Information Center.
The commissioner shall establish a Consumer Information Center to assist actual and potential purchasers of hearing aids by providing them with information regarding hearing instrument sales. The Consumer Information Center shall disseminate information about consumers' legal rights related to hearing instrument sales, provide information relating to complaints about dispensers of hearing instruments, and provide information about outreach and advocacy services for consumers of hearing instruments. In establishing the center and developing the information, the commissioner shall consult with representatives of hearing instrument dispensers, audiologists, physicians, and consumers.
153A.19 Repealed, 2005 c 147 art 7 s 20
153A.20 Hearing Instrument Dispenser Advisory Council.
Subdivision 1. Membership. The commissioner shall appoint seven persons to a Hearing Instrument Dispenser Advisory Council.
(a) The seven persons must include:
(1) three public members, as defined in section 214.02. At least one of the public members shall be a hearing instrument user and one of the public members shall be either a hearing instrument user or an advocate of one; and
(2) three hearing instrument dispensers certified under sections 153A.14 to 153A.20, each of whom is currently, and has been for the five years immediately preceding their appointment, engaged in hearing instrument dispensing in Minnesota and who represent the occupation of hearing instrument dispensing and who are not audiologists; and
(3) one audiologist licensed as an audiologist under chapter 148 who dispenses hearing instruments, recommended by a professional association representing audiologists and speech-language pathologists.
(b) The factors the commissioner may consider when appointing advisory council members include, but are not limited to, professional affiliation, geographical location, and type of practice.
(c) No two members of the advisory council shall be employees of, or have binding contracts requiring sales exclusively for, the same hearing instrument manufacturer or the same employer.
Subd. 2. Organization. The advisory council shall be organized and administered according to section 15.059, except that, notwithstanding any other law to the contrary, the advisory council shall not expire. The council may form committees to carry out its duties.
Subd. 3. Duties. At the commissioner's request, the advisory council shall:
(1) advise the commissioner regarding hearing instrument dispenser certification standards;
(2) provide for distribution of information regarding hearing instrument dispenser certification standards;
(3) review investigation summaries of competency violations and make recommendations to the commissioner as to whether the allegations of incompetency are substantiated; and
(4) perform other duties as directed by the commissioner.