CHAPTER 209

FORMERLY

HOUSE SUBSTITUTE NO. 1

FOR HOUSE BILL NO. 155

AS AMENDED BY HOUSE AMENDMENTS NO. 1 AND 2

AN ACT TO AMEND PART II, TITLE 16 OF THE DELAWARE CODE RELATING TO REGULATION OF HEARING AID DEALERS.

Be it enacted by the General Assembly of the State of Delaware:

Section 1. Amend Part II, Title 16 of the Delaware Code, by adding thereto a new Chapter, designated as Chapter 20, which shall read as follows:

CHAPTER 20. LICENSING OF HEARING AID DEALERS

§ 2001. Definitions

The following words, terms and phrases, when used in this Chapter, shall have the meaning ascribed to them except where the context clearly indicates a different meaning:

(a) "Business Resident" mean a person who lives in the State or does business in the State with the intention of doing business regularly from a permanently established commercial location which may be within or without the State.

(b) "Certificate of license" includes a temporary permit;

(c) "Council" means the Advisory Council to the Division of Public Health on hearing aids;

(d) "Hearing Aid" means any instrument or device designed as aiding or compensating for defective human hearing and any parts, attachments or accessories of such an instrument or device, exclusive of batteries and cords;

(e) "Practice of Fitting Hearing Aids" and "Dealing in Hearing Aids" means:

1. the evaluation or measurement of the power or range of human hearing by means of an audiometer or any other means devised for the purpose of fitting hearing aids or for industrial screening purposes, but which testing shall in no way include medical or audiologic diagnosis.

2. the selection, adaption and distribution or sale of hearing aids;

3. the instruction and counseling pertaining thereto;

4. the use of an otoscope or ear-light to evaluate feasibility of and use in earmolds and earmold impressions;

(f) "Practitioner" means a person who practices the fitting of hearing aids;

(g) "Licensee" means a person who holds a license issued pursuant to this Chapter;

(h) "Unethical Conduct" means:

1. the obtaining of any fee or the making of any sale by fraud or misrepresentation;

2. employing directly or indirectly any suspended or unlicensed person to perform any work covered by this Act;

3. permitting another to use one's license or temporary permit;

4. using, or causing or promoting the use of any advertising matter, promotional literature, testimonial, guarantee, warranty, label, brand, insignia or any other representation, however disseminated or published, which is misleading, deceiving, improbable or untruthful ;

5. advertising a particular model, type or kind of hearing aid for sale on particular terms when purchasers or prospective purchasers responding to the advertisement cannot purchase or are dissuaded from purchasing that advertised model, type or kind of hearing aid, or from purchasing on the advertised terms where it is established that the purpose of the advertisement is to obtain prospects for the sale of a different model, type or kind from that advertised, or on different terms from those advertised;

6. representing that a hearing aid is guaranteed without clearly disclosing the identity of the guarantor, the nature and extent of the guarantee and any conditions or limitations;

7. representing that the services or advice of a person licensed to practice medicine will be used or made available in the practice of fitting hearing aids when that is not true, or using the word "doctor", "clinic", "audiologist", "hearing aid audiologist" or other like words, abbreviations or symbols which tend to connote the medical or audiology profession when such is not accurate ;

8. making any medical analysis, medical prediction or other medical statement about the cause or future course of a hearing impairment, or about the effect of a hearing aid on a hearing impairment, either in general terms or with reference to an individual person; except that the licensee shall be able to counsel and instruct the hearing aid user in the use of a hearing aid;

9. selling a hearing aid to a person who has not been given a test utilizing appropriate established procedure and instrumentation in the fitting of hearing aids, other than a sale made pursuant to the recommendation of a medical doctor or audiologist or the sale of a replacement hearing aid;

10. directly or indirectly paying or offering to pay any sum of money or any other thing of value to a person who advises others in a professional capacity as consideration for influencing the purchase of hearing aids or services from the practitioner;

11. directly or indirectly accepting or soliciting any sum of money or any other thing of value from any person who advises others in a professional capacity as consideration for the practitioner referring customers to such person ;

12. fitting and selling a hearing aid to any individual whenever any of the following conditions are found to exist either from observation by the licensee or on the basis of information furnished by the prospective hearing aid user without first giving the individual a written statement that his best interest would be served if he would consult a licensed physician specializing in diseases of the ear of if no such licensed physician is available in the community then with a duly licensed physician:

(1) Visible congenital or traumatic deformity of the ear

(2) History of or active drainage from the ear within the previous 90 days

(3) History of sudden or rapidly progressive hearing loss within the previous 90 days

(4) Acute or chronic dizziness

(5) Unilateral hearing loss of sudden or recent onset within the previous 90 days

(6) Significant air-born gap when generally acceptable standards have been established by the Advisory Council.

The provisions of this subsection shall not apply if the fitting and sale of a replacement hearing aid which has been lost or damaged beyond repair within one year of the date of purchase. A copy of the written statement required by this subsection shall be retained by the licensee. A person who, after receiving the written statement required by this subsection elects to purchase a hearing aid shall sign a receipt acknowledging receipt of such statement, and the receipt shall be kept with the other papers retained by the licensee. Nothing required by this subsection shall be construed to mean that the licensee is engaged in the diagnosis of illness or the practice of medicine or any other activity prohibited by the provisions of this code.

13. Selling a hearing aid by an individual licensed under this chapter, to a person 17 years of age or younger, unless within the preceding six months a recommendation for a hearing aid has been made by both a board-certified physician specializing in otolaryngology and by a certified audiologist. A replacement of an identical hearing aid within two years shall be an exception to this requirement.

§2002. Certificate of license required

(a) No person shall engage in the practice of fitting hearing aids or display a sign or in any other way advertise or hold himself out as a person who engages in the practice of fitting hearing aids unless he holds a current, unsuspended, unrevoked license issued by the Division of Public Health as provided in this Chapter, or unless he holds a current, unsuspended, unrevoked temporary permit issued pursuant to Section 2008 (b) of this Act. The license or temporary permit required by this Section shall be kept conspicuously posted in his office or place of business at all times.

(b) Nothing in this Act prohibits a person from engaging in the practice of fitting hearing aids at retail without a license if all the practitioners employed by such person hold licenses; however, no such unlicensed person shall be permitted to fit hearing aids. Those persons shall file annually with the Division of Public Health a list of license holders which it employs directly or indirectly. Those persons shall also be subject to any rules and regulations issued by the Division of Public Health pursuant to this chapter.

§2003. Receipts

A licensee shall, upon the consummation of a sale of a hearing aid, deliver to the purchaser a written receipt, signed by or on behalf of the licensee, containing all of the following:

(a) The date of consummation of the sale

(b) The address of the principal place of business of the licensee

(c) Specifications as to the make, serial number, and model number of the hearing aid or aids sold

(d) A statement to the effect that the aid or aids delivered to the purchaser are used or reconditioned, as the case may be, if that is the fact

(e) The number of the licensee's license

(f) The terms of any guarantee or express warranty, if any, made to the purchaser with respect to such hearing aid or hearing aids

(g) Such receipt shall bear, or have attached to it in no smaller type than the largest used in the body copy portion, the following: "The purchaser has been advised at the outset of his relationship with the hearing aid dealer that any examination or representation made by a licensed hearing aid dealer in connection with the practice of fitting this hearing aid is not an examination, diagnosis, or prescription by a person licensed to practice medicine in this State and therefore must not be regarded as medical opinion or professional advice."

§2004. Persons and practices not affected

(a) This Chapter does not apply to a person while he is engaged in the practice of fitting hearing aids if his practice is part of the academic curriculum of an accredited institution of higher education or part of a program conducted by a government, charitable, public or private institution or by a non-profit organization which is primarily supported by voluntary contributions, so long as such persons or institutions do not engage in the sale of hearing aids.

(b) This Chapter shall not be construed to prevent any person who is a medical or osteopathic physician licensed to practice by the Division of Public Health from treating the ear or fitting hearing aids.

(c) This chapter shall not be construed to prevent any person who is an audiologist from testing hearing or fitting hearing aids as long as he is not engaged in the sale of hearing aids.

§2005. Qualifications for licensing fee

An applicant for license shall pay a fee of One Hundred Dollars ($100.00) and present proof that:

1. he is a business resident of this State;

2. he has an education equivalent to a four-year course in a standard high school and has continuously and principally engaged in the practice of fitting hearing aids during at least two of three years immediately prior to his application; or currently holds a temporary permit as provided in Section 2009

3. he is free from contagious or infectious diseases

4. he is of good moral character

5. he is 18 years of age or older

§2006. Examination

(a) An applicant for license who fulfills the requirements of Section 2005 shall appear at a time and place set by the Advisory Council to be examined to determine whether he is qualified to engage in the practice of fitting hearing aids.

(b) The Advisory Council shall hold or make available at least two examinations each year and additional examinations as necessary.

2007. Scope of examination

The examination provided in Section 2006 shall consist of:

(a) testing pertaining to the fitting of hearing aids, including the basic physics of sound, the human hearing mechanism (including the science of hearing the causes and rehabilitation of abnormal hearing and hearing disorders) and the structure and function of hearing aids;

(b) tests of proficiency in the following techniques as they pertain to the fitting of hearing aids;

(1) pure tone audiometry, including air conduction testing and bone conduction testing;

(2) live voice or recorded speech audiometry including speech reception, threshhold testing and speech discrimination testing;

(3) effective masking;

(4) recording and evaluation of audiogram and speech audiometry to determine hearing aid candidacy ;

(5) selection and adaptation of hearing aids and testing of hearing aids;

(0) taking earmold impressions and the use of an otoscope or ear-light;

(1) evidence of knowledge regarding the medical and rehabilitation facilities for children and adults that are available in the area served which are concerned with hearing impairment.

§2008. Registration and issuance of license; fees

(a) Upon payment of the licensing fee, the Division of Public Health shall issue each applicant who satisfactorily passes the examination a certificate of license. The license shall be effective for one (1) year.

(b) Whenever the Advisory Council determines that another State or jurisdiction has requirements equivalent to or higher than those in effect pursuant to this Chapter for the practice of fitting hearing aids, and that the other State or jurisdiction has a program equivalent to or stricter than the program for determining whether applicants pursuant to this Chapter are qualified to conduct the practice of fitting of hearing aids, the Division of Public Health may issue a license to applicants therefor who hold current unsuspended and unrevoked certificates or licenses to conduct the practice of fitting hearing aids in the other State or jurisdiction. No applicant for a license pursuant to this Section shall be required to submit to or undergo any examination, investigation or other procedure, other than the payment of fees, pursuant to Sections 2005, 2006 and 2007 of this Act. An applicant for a license shall agree to submit to the personal jurisdiction of the court of this State upon issuance of the license.

(c) The Division of Public Health shall issue, for a period of six (6) months immediately following the effective date of this Act, a license to any applicant without examination provided applicant :

1. Is a business resident of this State

2. Has been continuously and principally engaged in the practice of fitting hearing aids in this state at least two of the three years immediately prior to his application.

3. Is free from contagious or infectious diseases

4. Is of good moral character

5. Is 18 years of age or older

§2009. Temporary permit

(a) A person who has not previously applied to take the examination provided in Section 2006 may file an application with the Division of Public Health for a temporary permit if he :

1. Has an education equivalent to a four year course in a standard high school

2. Is free from contagious or infectious diseases

0. Is of good moral character

1. Is 18 years of age or older

(b) Upon receiving an application as provided under this Section and accompanied by a fee of Fifty Dollars ($50.00), the Division of Public Health shall issue a temporary permit which shall entitle the applicant to engage in the fitting and sale of hearing aids for a period of one year.

(c) No temporary permit shall be issued unless a person holding a valid hearing aid dealer's license consents, on a form provided by the Division of Public Health, to be responsible for the supervision and training of the applicant and maintain adequate personal contact with the applicant.

(d) A person who holds a temporary permit under this Section must successfully pass the licensing examination within one year from date of issuance; a temporary permit may not be renewed.

(e) The Division of Public Health shall issue a temporary permit, for use without supervision of a licensed hearing aid dealer, to an applicant entering into a hearing aid dealership as sole owner, principal of a firm or as a member-manager of a corporation if he fulfills the requirements regarding age, character, education and health as set forth in Sections 2005 and 2006, and has been principally engaged in the practice of fitting and dealing in hearing aids for a period of at least one year within a period of three years immediately prior to his application.

§2010. Renewal

A person who conducts the practice of fitting hearing aids shall annually pay to the Division of Public Health a fee of Fifty Dollars ($50.00) for a renewal of his license. A thirty-day grace period shall be allowed after expiration of a license during which a license may be renewed on payment of an additional fee of Twenty-Five Dollars ($25.00) to the Division of Public Health.

§2011. Grounds foe suspension or revocation of license or temporary permit

Upon the recommendation of the Advisory Council, any person licensed under this Chapter may have his license revoked or suspended for a fixed period by the Division of Public Health for any of the following causes:

1. Conviction for an offense involving unethical conduct or otherwise directly indicating unfair or unjust treatment to customers. The record of conviction or a copy certified by the Clerk or the Judge of the Court where conviction occurred shall constitute conclusive evidence of conviction.

2. Obtaining a license or temporary permit by fraud or deceit practiced upon the Division of Public Health.

3. Unethical conduct or gross incompetence in the fitting of hearing aids.

4. Practicing the fitting of hearing aids while knowingly suffering from a contagious or infectious disease.

5. False advertising of professional methods or professional superiority.

6. Practicing the fitting of hearing aids under a false name or alias with fraudulent intent.

7. Any other violation of the provisions of this Chapter or the rules and regulations issued pursuant hereto by the Division of Public Health to Advisory Council.

§2012. Prohibited acts and practices No person shall:

(a) sell, barter or offer to sell or barter a license or temporary permit;

(b) purchase or procure by barter a license or temporary permit with intent to use it as evidence of the holder's qualification to practice the fitting of hearing aids;

(c) alter materially a license or temporary permit with fraudulent intent;

(d) use or attempt to use as valid a license or temporary permit which is known to be purchased, fraudulently obtained, counterfeited or materially altered;

(e) knowingly make a false material statement in the application for renewal of license or temporary permit.

§2013. Powers and duties of the Division of Public Health

The Division of Public Health shall:

(a) authorize all disbursements necessary to carry out the provisions of this Chapter;

(b) register persons who are qualified to engage in the practice of fitting hearing aids upon approval of the Advisory Council;

(c) issue licenses and temporary permits;

(d) revoke or suspend licenses or temporary permits under Section 2011 and institute proceedings under Section 2017, but only upon recommendation of the Advisory Council;

(e) keep a register which includes the names and places of business of persons licensed and issued temporary permits under this Chapter;

() purchase and maintain or rent audiometric equipment and facilities necessary for the examination of applicants for registration.

§2014. Advisory Council on Hearing Aids

(a) There is established an Advisory Council on hearing aids in the Division of Public Health.

(b) The Council shall consist of five (5) members appointed by the Governor for a term of three years. Three members shall be licensed hearing aid practitioners, one member shall be a person licensed to practice medicine in the State who holds a certificate of qualification from the American Board of Otolaryngology, or certified by the American Osteopathic Board of Otolaryngology, one member shall have at least four years of paid work experience in audiology. Initial appointments shall be: one member for a term of one year, two members for a term of two years, two members for a term of three years. Terms shall expire on the appropriate date of each year. Vacancies shall be filed for the remainder of any unexpired term in the same manner as the original appointment. No member of the Council shall be an elected or appointed official of the State Government.

(c) A Chairman shall be elected from the membership of the Council to serve for a term of one year.

(d) The Council shall meet at least once a year and the Chairman may call additional meetings as necessary.

(e) Members of the Council shall be compensated for actual and necessary expenses incurred in the performance of their duties as members of the Council.

(f) Council shall have the power to employ at a reasonable rate, a person, qualified and competent to inspect and check calibration of audiologic testing equipment and facilities of persons who practice the fitting of hearing aids.

(g) Council shall have the power to perform the duties as provided in Section 2015.

(h) The Council shall not consist of more than a bare majority representation of one major political party over the other major political party.

() All expenses incurred by the Council in the administration of this Act shall be paid on prescribed reimbursement vouchers when approved by the Council; however, such expenses shall not exceed the appropriations authorized by the General Assembly.

§2015. Duties of the Council

The Council shall:

(a) Prepare examinations for applicants and establish standards for inspection of equipment and facilities of practitioners; provided, however, the examination for applicants shall not be prepared in such a manner that college training is required in order to pass the examination. Nothing in the examination shall imply that the applicant shall possess the degree of medical competence normally expected of a physician;

(b) evaluate applications, administer examinations and conduct investigations of equipment and facilities of practitioners, and make recommendations to the Division of Public Health with respect to those matters;

(c) develop and promote a standardized educational procedure for all who wish to become licensed practitioners;

(d) investigate alleged irregularities in practice of fitting hearing aids, including alleged violations of this Chapter, and make recommendations to the Division of Public Health with respect to them;

(e) keep a record of all proceedings under this Chapter;

(f) report annually to the Division of Public Health on all its official acts during the preceding year;

(g) determine as needed if other states have equal or higher qualifications for licensing with reference to Section 2008 (b).

§2016. Disposition of receipts

All moneys received from receipts of fees charged for applications and renewals shall be forwarded to the State Treasurer to be deposited in the General Fund.

§2017. Penalties and remedies

(a) Whoever violates any of the provisions of this Chapter shall be guilty of a misdemeanor and fined not more than Five Hundred Dollars ($500.00) or be imprisoned for not more than ninety (90) days, or both.

(b) The Division of Public Health may enforce any provision of this Chapter by injunction or by any other appropriate proceeding. No proceeding shall be barred by any proceeding had or pending pursuant to subsection (a) of this Section or by the imposition of any fine or term of imprisonment pursuant thereto.

§2018. Complaints

Any person wishing to make a complaint against a licensee under this Chapter shall reduce the same to writing and file this complaint to the Council within one year from the date of the action upon which the complaint is based. If the Council determines the charges made in the complaint are sufficient to warrant a hearing to determine whether the license issued under this Chapter shall be suspended or revoked, it shall make an order fixing a time and place for a hearing and require the licensee complained against to appear and defend against the complaint. The order shall have annexed thereto a copy of the complaint.

The order and copy of the complaint shall be served upon the licensee at least twenty (20) days before the date set for hearing, either personally or by registered mail sent to licensee's last known address. Continuances or adjournment of hearing date shall be made if for good cause. At the hearing the licensee complained against may be represented by counsel. The licensee complained against and the Council shall have the right to take depositions in advance of hearing and after service of the complaint and either may compel the attendance of witnesses by subpoenas issued by the Council under its seal. Either party taking depositions shall give at least five (5) days' written notice to the other party of the time and place of such depositions, and the other party shall have the right to attend (with counsel if desired) and cross-examine. Appeals from suspension or revocation shall be made to the Superior Court having jurisdiction where the alleged offense took place.

§2019. Jurisdiction

The Superior Court of the State of Delaware shall have exclusive original jurisdiction of any violation of this Chapter punishable under the provisions of Section 2017 (a).

§2020. Home Solicitation Sales Act applicable

The provisions of Chapter 44, Title 6, Delaware Code, the Home Solicitation Sales Act, shall be applicable to the sale of hearing aids in the State of Delaware to the extent that such sales otherwise fit within the purview of that act.

Approved July 14, 1973.