Bill Text: TX SB2017 | 2023-2024 | 88th Legislature | Comm Sub

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Bill Title: Relating to the regulation of hearing aids and the practices of audiology and the fitting and dispensing of hearing instruments.

Spectrum: Bipartisan Bill

Status: (Passed) 2023-06-18 - Effective immediately [SB2017 Detail]

Download: Texas-2023-SB2017-Comm_Sub.html

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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.
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