By: Zaffirini  S.B. No. 2017          (In the Senate - Filed March 9, 2023; March 21, 2023, read   first time and referred to Committee on Health & Human Services;   April 24, 2023, reported favorably by the following vote:  Yeas 9,   Nays 0; April 24, 2023, sent to printer.)Click here to see the committee vote     A BILL TO BE ENTITLED   AN ACT     relating to the regulation of hearing aids and the practices of   audiology and the fitting and dispensing of hearing instruments.          BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:          SECTION 1.  Section 401.001(4-b), Occupations Code, is   amended to read as follows:                (4-b) "Fitting and dispensing hearing instruments,"   "hearing instrument," "over-the-counter hearing aid," and "sale"   have the meanings ["Hearing instrument" has the meaning] assigned   to those terms by Section 402.001.          SECTION 2.  Section 401.058(a), Occupations Code, is amended   to read as follows:          (a)  This chapter does not prohibit, prevent, or restrict a   person licensed under Chapter 402 from engaging in the practice of   fitting and dispensing hearing instruments.          SECTION 3.  Subchapter B, Chapter 401, Occupations Code, is   amended by adding Section 401.061 to read as follows:          Sec. 401.061.  OVER-THE-COUNTER HEARING AIDS.  (a)  Except   as provided by this section, this chapter does not apply to   servicing, marketing, selling, dispensing, providing customer   support for, acquiring, or distributing over-the-counter hearing   aids, regardless of whether the transaction occurs in person,   online, or through other means.          (b)  A person is not required to obtain a license under this   chapter or Chapter 402 to engage in an activity described by   Subsection (a).          (c)  A person may not use the title "licensed dispenser" or   "licensed seller" with respect to over-the-counter hearing aids or   otherwise represent that the person holds a license to sell or   dispense over-the-counter hearing aids unless the person is   licensed as an audiologist or audiologist intern under this chapter   or as a hearing instrument fitter and dispenser under Chapter 402.          (d)  The supervision, prescription, order, involvement, or   intervention of a person licensed in this state is not required   under this chapter for a consumer to access over-the-counter   hearing aids.          (e)  A person licensed under this chapter may service,   market, sell, dispense, provide customer support for, or distribute   over-the-counter hearing aids.  These activities do not exempt a   person licensed under this chapter from any applicable provision of   this chapter or Chapter 402.          SECTION 4.  Section 401.403(b), Occupations Code, is amended   to read as follows:          (b)  A person who holds a license as an audiologist or   audiologist intern and who fits and dispenses hearing instruments   must:                (1)  comply with rules adopted under this chapter   related to fitting and dispensing hearing instruments;                (2)  comply with the federal Food and Drug   Administration rules and guidelines for fitting and dispensing   hearing instruments;                (3)  when providing services in this state, use a   written contract that contains the information prescribed by   commission rule [the department's name, mailing address, telephone   number, and Internet website address]; and                (4)  follow the guidelines adopted by commission rule   for a 30-day trial period on every hearing instrument purchased.          SECTION 5.  Section 402.001, Occupations Code, is amended by   amending Subdivisions (4), (5), and (7) and adding Subdivisions   (4-a) and (6-a) to read as follows:                (4)  "Fitting and dispensing hearing instruments"   means the measurement of human hearing by the use of an audiometer   or other means to make selections, adaptations, or sales of hearing   instruments. The term includes prescribing, ordering, or   authorizing the use of hearing instruments, the making of   impressions for earmolds to be used as a part of the hearing   instruments, and providing any necessary postfitting counseling   for the purpose of fitting and dispensing hearing instruments.                (4-a)  "Hearing aid" means any wearable device designed   for, offered for the purpose of, or represented as aiding persons   with or compensating for impaired hearing.  The term includes   hearing instruments and over-the-counter hearing aids.                (5)  "Hearing instrument" means a prescription hearing   aid as that term is defined by 21 C.F.R. Section 800.30 [any   wearable instrument or device designed for, or represented as,   aiding, improving, or correcting defective human hearing.  The term   includes the instrument's parts and any attachment, including an   earmold, or accessory to the instrument. The term does not include   a battery or cord].                (6-a)  "Over-the-counter hearing aid" has the meaning   assigned by 21 C.F.R. Section 800.30.                (7)  "Sale" includes a lease, rental, or any other   purchase or exchange for value [transfer of title or of the right to   use by lease, bailment, or other contract]. The term does not   include a sale at wholesale by a manufacturer to a person licensed   under this chapter or to a distributor for distribution and sale to   a person licensed under this chapter.          SECTION 6.  Subchapter A, Chapter 402, Occupations Code, is   amended by adding Section 402.004 to read as follows:          Sec. 402.004.  OVER-THE-COUNTER HEARING AIDS.  (a)  Except   as provided by this section, this chapter does not apply to   servicing, marketing, selling, dispensing, providing customer   support for, acquiring, or distributing over-the-counter hearing   aids, regardless of whether the transaction occurs in person,   online, or through other means.          (b)  A person is not required to obtain a license under this   chapter or Chapter 401 to engage in an activity described by   Subsection (a).          (c)  A person may not use the title "licensed dispenser" or   "licensed seller" with respect to over-the-counter hearing aids or   otherwise represent that the person holds a license to sell or   dispense over-the-counter hearing aids unless the person is   licensed as a hearing instrument fitter and dispenser under this   chapter or as an audiologist or audiologist intern under Chapter   401.          (d)  The supervision, prescription, order, involvement, or   intervention of a person licensed in this state is not required   under this chapter for a consumer to access over-the-counter   hearing aids.          (e)  A person licensed under this chapter may service,   market, sell, dispense, provide customer support for, or distribute   over-the-counter hearing aids.  These activities do not exempt a   person licensed under this chapter from any applicable provision of   this chapter or Chapter 401.          SECTION 7.  Section 402.152, Occupations Code, is amended to   read as follows:          Sec. 402.152.  COMPLAINTS. (a)  Each license or permit   holder under this chapter shall at all times prominently display in   the person's place of business a sign containing information about   filing a complaint as prescribed by commission rule[:                [(1)  the name, mailing address, e-mail address, and   telephone number of the department; and                [(2)  a statement informing consumers that a complaint   against a license or permit holder may be directed to the   department].          (b)  Each written contract for services in this state of a   license holder must contain the information prescribed by   commission rule [the department's name, mailing address, e-mail   address, and telephone number].          SECTION 8.  Section 402.403, Occupations Code, is amended to   read as follows:          Sec. 402.403.  WRITTEN CONTRACT.  The owner of a hearing   instrument fitting and dispensing practice shall ensure that each   client receives a written contract at the time of purchase of a   hearing instrument that contains the information prescribed by   commission rule[:                [(1)  the signature of the license holder who dispensed   the hearing instrument;                [(2)  the printed name of the license holder who   dispensed the hearing instrument;                [(3)  the address of the principal office of the   license holder who dispensed the hearing instrument;                [(4)  the license number of the license holder who   dispensed the hearing instrument;                [(5)  a description of the make and model of the hearing   instrument;                [(6)  the amount charged for the hearing instrument;                [(7)  a statement of whether the hearing instrument is   new, used, or rebuilt;                [(8)  notice of the 30-day trial period under Section   402.401; and                [(9)  the name, mailing address, e-mail address, and   telephone number of the department].          SECTION 9.  Section 401.058(b), Occupations Code, is   repealed.          SECTION 10.  Not later than December 1, 2023, the Texas   Commission of Licensing and Regulation shall adopt rules   prescribing the information required to be included:                (1)  in a contract, as required by Sections 401.403(b),   402.152(b), and 402.403, Occupations Code, as amended by this Act;   and                (2)  on a sign, as required by Section 402.152(a),   Occupations Code, as amended by this Act.          SECTION 11.  (a)  The changes in law made by this Act apply   only to a contract provided to a patient on or after December 1,   2023.          (b)  The changes in law made by this Act apply only to a sign   displayed on or after December 1, 2023.          SECTION 12.  This Act takes effect immediately if it   receives a vote of two-thirds of all the members elected to each   house, as provided by Section 39, Article III, Texas Constitution.     If this Act does not receive the vote necessary for immediate   effect, this Act takes effect September 1, 2023.     * * * * *