Part 7.
STATE COMMITTEE OF EXAMINERS IN THE FITTING AND DISPENSING OF HEARING INSTRUMENTS
Chapter 141.
FITTING AND DISPENSING OF HEARING INSTRUMENTS
22 TAC §§141.1 - 141.24
The State Committee of Examiners in the Fitting and Dispensing
of Hearing Instruments (committee) adopts amendments to §§141.1
- 141.24, concerning the licensure and regulation of hearing instrument fitters
and dispensers. Amendments to §141.2 and §141.16 are adopted with
changes to the proposed text as published in the January 13, 2006, issue of
the
Texas Register
(31 TexReg 222). Amendments
to §§141.1, 141.3 - 141.15, and 141.17 - 141.24 are adopted without
changes, and the sections will not be republished.
BACKGROUND AND PURPOSE
Government Code, §2001.039, requires that each state agency review
and consider for readoption each rule adopted by that agency pursuant to the
Government Code, Chapter 2001 (Administrative Procedure Act). Sections 141.1
- 141.24 have been reviewed and the committee has determined that the reasons
for adopting the sections continue to exist because rules relating to the
licensure and regulation of hearing instrument fitters and dispensers are
needed in order to protect and promote public health, safety, and welfare.
The amendments are the result of the comprehensive rule review undertaken
by the committee and the committee's staff. In general, each section was reviewed
and amended in order to ensure clarity; to ensure that the rules reflect current
legal, policy, and operational considerations; to ensure accuracy; to improve
draftsmanship; and to make the rules more accessible, understandable, and
usable, to the extent possible.
SECTION BY SECTION SUMMARY
The amendments to §§141.1, 141.4 - 141.6, 141.9, 141.10, 141.12,
141.19, 141.20, 141.23, and 141.24 improve draftsmanship; delete obsolete
language; and reflect current operating procedures.
Amendments to §141.2 reflect changes in terminology from "Certification
of testing equipment" to "Certification, proof of" adding the definition as
a means to clarify the intent of the rules; and modify the definition of "department"
to reflect the current name of the agency.
Amendments to §141.3 are adopted to clarify the purpose of each standing
subcommittee; to clarify that the executive director is the custodian of the
committee's records; to correct inaccurate language; and to improve draftsmanship.
Amendments to §141.7 are adopted to reflect current operating procedure;
to eliminate references to requiring notarization of documents; to improve
draftsmanship; and to delete unnecessary language.
Amendments to §141.8 are adopted to eliminate references to requiring
notarization of documents and to improve draftsmanship.
The amendment to §141.11 is adopted to eliminate the option of filing
a cash deposit with the committee. A deposit or negotiable security may not
be in cash.
Amendments to §141.13 are adopted to delete unnecessary language;
to improve draftsmanship; to reflect two-year license terms; to provide for
electronic license renewal forms; to clarify that certification of testing
equipment and continuing education documentation shall be submitted only if
selected for audit; and to require that licensees maintain continuing education
and certification of testing equipment documentation for a period of three
years.
Amendments to §141.14 are adopted to delete unnecessary language;
to update language relating to two year license terms; to move language relating
to credit for publications to a more appropriate subsection; and to clarify
expectations regarding the submission of continuing education documentation
at the time of audit. The amendment to §141.14(b)(3) provides for the
acceptance of no more than 5 contact hours annually of online continuing education
courses and manufacturer continuing education courses.
Amendments to §141.15(d) are adopted to require that a person who
fails the examination must repeat the hours of direct supervision required
for the sections that were failed and to eliminate the requirement that a
person may only take the examination three times.
Amendments to §141.16 are adopted to improve draftsmanship; to delete
unnecessary language; to require that it is the responsibility of the owner
of the dispensing practice to maintain client records; to reduce the time
period for maintaining records from five to three years after the latest date
of fitting and dispensing of hearing instruments; and to clarify standards
for audiometric testing devices and submission of proof of certification of
testing equipment.
Amendments to §141.17 are adopted to improve draftsmanship; to delete
unnecessary language; to update language to reflect current legal, policy,
and operational considerations; to clarify that all disciplinary action and
license or application denial proposals shall be followed by written notice
of violation and option for formal hearing; to provide that the executive
director may accept a complaint that is not on the official form; and to set
out procedures relating to the surrender of a license after a complaint has
been filed.
Amendments to §141.18 are adopted to improve draftsmanship and clarify
the section's purpose.
Amendments to §141.21 are adopted to delete unnecessary language and
update the section title to accurately reflect its contents.
Amendments to §141.22 are adopted to delete unnecessary language,
to improve draftsmanship, to clarify the prohibition on sexual activity with
clients, and to require compliance with the Health Insurance Portability and
Accountability Act of 1996.
COMMENTS
The department, on behalf of the commission, has reviewed the prepared
responses to verbal and written comments received during the comment period
regarding the rule amendments, which the commission has reviewed and accepts.
Why is this necessary? The legal authority to review and respond to comments
lies with the committee not the agency or the commission. A total of 519 comments
were received in the form of letters, signatures on petitions, and signatures
on form letters. Of those, 518 commenters were individuals or businesses.
One commenter was Texas Hearing Aid Association. Commenters were generally
neutral or in favor of the rule proposal as a whole, but expressed concerns,
asked questions, and made recommendations. Some commenters did express opposition
to specific provisions, as described in this preamble.
Comment: Regarding §141.2(7), one commenter noted that the committee
proposed a definition of "certification of testing equipment" but that phrase
does not appear in the rules. The commenter rightly noted that the new definition
was proposed based on the amendment to §141.16(f)(2) which refers to
"proof of certification." The commenter recommends that "certification of
testing equipment" be replaced with "proof of certification."
Response: The committee agreed. In the interest of maintaining alphabetical
order within the definitions, the committee has replaced "certification of
testing equipment" with "certification, proof of".
Comment: Regarding §141.2(22), one commenter recommended that the
committee add language to the definition of "sell or sale" that the commenter
believes would clarify that licensed dispensers from other states may sell
hearing instruments by mail order to Texas customers. Additionally, 413 persons
signed and mailed to the committee form letters endorsing this recommendation.
Response: The committee engaged in significant dialogue with the commenter
and disagreed with the commenter's recommendation. Section 141.2(22) was not
proposed for modification. The committee also notes that the language of the
statute in Texas Occupations Code, §402.451(a)(7), appears to prohibit
the sale of a hearing instrument by mail. As a means to clarify this topic,
the committee will seek an opinion from the office of the Attorney General
regarding the applicability of Texas Occupations Code, §402.451(a)(7)
to licensed dispensers from other states who sell hearing instruments by mail
order. No change was made as a result of this comment.
Comment: Regarding §141.16(c)(12), one commenter opposes the amendment
as written and requests that the committee not adopt the rule. The commenter
stated that no change in the original contract should be required after its
issuance because most clients fail to bring their copy of the contract on
return visits. The commenter states that the current rule has created no problems
for license holders. Additionally, the commenter states that the rule is micromanagement
by regulation and is intended to mirror requirements relating to licensed
audiologists, both of which are unnecessary. The commenter offered a proposed
amendment to §141.16(b)(3) that would carry out the intent of the proposed
rule if the committee chooses not to accept the commenter's recommendation
that §141.16(c)(12) not be adopted or if the committee wishes to pursue
the intent of the proposed rule.
Response: The committee agrees that §141.16(c)(12) should not be adopted
as written. This matter will be studied for possible future rule amendments.
Section 141.16(c)(12) is not adopted and has been deleted, and conforming
punctuation changes are adopted and added to §141.16(c)(11).
Comment: Regarding §141.16(f)(2), one commenter opposes the rules
as written and maintains that the rules will cause confusion for license holders,
as the rule does not specify which pieces of equipment are referred to in
the rule. The commenter opposes the amendment to this rule, but also offered
alternate acceptable language. The commenter notes that the statute has not
changed and states that if the committee is broadening the rule's scope to
include equipment not used in the hearing evaluation, that the additional
equipment should be specified and an explanation for the change should be
given to license holders. The commenter states that if the phrase "used in
the hearing evaluation" were added to the amended rule, that addition would
clarify the rule.
Another commenter opposed the rule for similar reasons and stated that
the rule should only apply to audiometers used to test hearing.
Response: The committee notes that the proposed rule mirrors the language
of the statute. However, the committee agrees with the commenter's position
and has added the phrase "used in the hearing evaluation" to the text of §141.16(f)(2).
Comment: Regarding §141.14(b)(3), one commenter recommends that the
rule be modified to allow 5 hours of online continuing education, 5 hours
of manufacturer-sponsored continuing education, and 10 hours of non-manufacturer
sponsored continuing education.
Additionally, a total of 105 persons wrote letters or signed petitions
expressing opposition to the rule limiting online continuing education and
recommending that there be no limit on the number of hours that can be earned
through online continuing education experiences. Two commenters stated their
belief that the committee's rule is for the benefit of groups who offer classroom
continuing education and questioned the committee's rationale for limiting
online continuing education.
Response: The committee disagrees and believes that the proposed amendment
allowing for a total of 5 hours of online and manufacturer-sponsored continuing
education, with a balance of 15 hours of non-manufacturer sponsored continuing
education, is an appropriate rule which will ensure quality continuing education
of Texas licensed fitters and dispensers of hearing instruments. No change
was made as a result of the comment.
Comment: Regarding §141.14(b)(3), one commenter recommends using the
term "electronic learning" instead of "online" when referring to continuing
education experiences.
Response: The committee disagrees, as the proposed term may be too broad.
No change was made as a result of the comment.
Comment: Regarding §141.14(b)(3), one commenter supports the rule
and believes that failure to limit online continuing education hours as proposed
will result in dominance by manufacturers in this area and a lowering of the
quality of continuing education for license holders. The commenter expresses
concerns regarding abuse of online continuing education indicating the length
of time that a program may remain available online, the number of times that
a license holder may take the same online course, the number of hours to be
awarded to an online course, and verification of completion of online courses.
Response: The committee agrees with the commenter that §141.14(b)(3)
should be adopted and notes that the commenter originally proposed the rule
to the committee at a stakeholder rule review meeting. The committee notes
that other allied health occupational regulatory bodies allow all or part
of the continuing education requirement to be completed online and believes
that its rule is appropriate. No change was made as a result of this comment.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Cathy Campbell,
certifies that the rules, as adopted, have been reviewed by legal counsel
and found to be a valid exercise of the committee's legal authority.
STATUTORY AUTHORITY
The adopted amendments are authorized by Occupations Code, §402.102,
which authorizes the committee to adopt rules necessary for the performance
of its duties. The review of the rules implements Government Code, §2001.039.
§141.2.Definitions.
The following words and terms, when used in this chapter, shall have
the following meanings, unless the context clearly indicates otherwise.
(1)
Act--Texas Occupations Code, Chapter 402, concerning the
licensing of persons authorized to fit and dispense hearing instruments.
(2)
Administrative Law Judge--A judge employed by the State
Office of Administrative Hearings.
(3)
APA--Administrative Procedure Act, the Government Code,
Chapter 2001.
(4)
Applicant--A person who applies for licensure under the
Act.
(5)
Apprentice permit--A permit issued by the committee to
a person who meets the requirements of Texas Occupations Code, §402.207.
(6)
Bill of sale--See definition for "written contract for
services."
(7)
Certification, proof of--A certificate of calibration,
compliance, conformance, or performance.
(8)
Committee--The State Committee of Examiners in the Fitting
and Dispensing of Hearing Instruments.
(9)
Contact hour--A period of time equal to 55 minutes.
(10)
Contract--See definition for "written contract for services."
(11)
Contested case--A proceeding in accordance with Administrative
Procedure Act (APA) in this chapter, including but not restricted to rule
enforcement and licensing, in which the legal rights, duties, or privileges
of a party are to be determined by the committee after an opportunity for
an adjudicative hearing.
(12)
Continuing education--Education intended to maintain and
improve the quality of professional services in the fitting and dispensing
of hearing instruments, to keep licensees knowledgeable of current research,
techniques, and practices, and provide other resources which will improve
skills and competence in the fitting and dispensing of hearing instruments.
(13)
Department--Department of State Health Services.
(14)
Direct supervision--The physical presence with prompt
evaluation, review and consultation of a supervisor anytime a temporary training
permit holder is engaged in the act of fitting and dispensing of hearing instruments.
(15)
Fitting and dispensing hearing instruments--The measurement
of human hearing by the use of an audiometer, or by any means, for the purpose
of making selections, adaptations, or sales of hearing instruments. The term
includes the making of impressions for earmolds to be used as a part of the
hearing instrument and any necessary post-fitting counseling for the purpose
of fitting and dispensing hearing instruments.
(16)
Formal hearing--A hearing or proceeding in accordance
with this chapter, including a "contested case" as defined in this section.
(17)
Indirect supervision--The daily evaluation, review, and
prompt consultation of a supervisor anytime a permit holder is engaged in
the act of fitting and dispensing hearing instruments.
(18)
License--A license issued by the committee under Texas
Occupations Code, Chapter 402, and this chapter to a person authorized to
fit and dispense hearing instruments.
(19)
Licensee--Any person licensed by the committee.
(20)
Ownership of dispensing practice--A person who owns, maintains,
or operates an office or place of business where the person employs or engages
under contract a person who practices the fitting and dispensing of hearing
instruments shall be considered also to be engaged in the practice of fitting
and dispensing of hearing instruments under this Act.
(21)
Person--An individual, corporation, partnership, or other
legal entity.
(22)
Sell or sale--A transfer of title or the right to use
by lease, bailment, or any other contract. For the purpose of Texas Occupations
Code, §402.001(7), the term "sell" or "sale" shall not include sales
at wholesale by manufacturers to persons licensed under this Act, or to the
distributors for distribution and sale to persons licensed under Texas Occupations
Code, §402.001(7), and this chapter.
(23)
Selling of hearing instrument by mail--Anytime a hearing
instrument is not sold, fitted or dispensed in person by a licensee or permit
holder.
(24)
Specific Product--Specific product shall include, but
not be limited to, brand name, model number, shell type, and circuit type.
(25)
Sponsor--Provider of a continuing education activity.
(26)
Supervisor--A supervisor is a person licensed by the committee
as a licensed hearing instrument dispenser who:
(A)
meets the qualifications established by Texas Occupations
Code, §402.255 and this chapter;
(B)
has an established place of business;
(C)
is responsible for direct and indirect supervision and
available for consultation and education of a temporary training permit holder;
or
(D)
is responsible for indirect supervision and available for
consultation of an apprentice permit holder.
(27)
Temporary training permit--A permit issued by the committee
to persons authorized to fit and dispense hearing instruments only under the
direct or indirect supervision as appropriate of a person who holds a license
under Texas Occupations Code, Chapter 402, and this chapter.
(28)
Working days--Working days are Monday through Friday,
8:00 a.m. to 5:00 p.m.
(29)
Written contract for services--A written agreement or
bill of sale, between the licensee and purchaser of a hearing instrument as
set out in §141.16(c) of this title (relating to Conditions of Sale).
(30)
30-day trial period--The period in which a person may
cancel the purchase of a hearing instrument.
§141.16.Conditions of Sale.
(a)
Compliance with other state and federal regulations.
(1)
A licensee or permit holder shall adhere to the Federal
Food and Drug Administration regulations in accordance with 21 Code of Federal
Regulations (CFR) §801.420 and §801.421.
(2)
A licensee or permit holder shall receive a written statement
before selling a hearing instrument that is signed by a physician or surgeon
duly licensed by the Texas Medical Board who specializes in diseases of the
ear. The written statement shall confirm that the client's hearing loss has
been medically evaluated during the preceding six-month period and that the
client is age 18 or older. The licensee may inform the client that the medical
evaluation requirement may be waived as long as the licensee:
(A)
informs the client that the exercise of the waiver is not
in the client's best health interest;
(B)
does not encourage the client to waive the medical evaluation;
and
(C)
gives the client an opportunity to sign a statement on
the contract that says: "I have been advised by (licensee's or permit holder's
name) that the Food and Drug Administration has determined that my best health
interest would be served if I had a medical evaluation by a licensed physician
(preferably a physician or surgeon who specializes in diseases of the ear)
before purchasing one or more hearing instruments. I do not wish to receive
a medical evaluation before purchasing a hearing instrument".
(3)
A licensee or permit holder shall not sell a hearing instrument
to a person under 18 years of age unless the prospective user, parent, or
guardian has presented to the licensee or permit holder a written statement
signed by a licensed physician specializing in diseases of the ear that states
that the client's hearing loss has been medically evaluated and the client
may be considered a candidate for a hearing instrument. The evaluation must
have taken place within the preceding six months.
(4)
A licensee or permit holder shall advise clients who appear
to have any of the following otologic conditions to consult promptly with
a physician:
(A)
visible, congenital or traumatic deformity of the ear;
(B)
history of active drainage from the ear within the previous
90 days;
(C)
history of sudden or rapidly progressive hearing loss within
the previous 90 days;
(D)
acute or chronic dizziness;
(E)
unilateral hearing loss of sudden or recent onset within
the previous 90 days;
(F)
audiometric air-bone gap equal to or greater than 15 decibels
at 500 hertz (Hz), 1,000 Hz, and 2,000 Hz;
(G)
visible evidence of significant cerumen accumulation or
a foreign body in the ear canal; and
(H)
pain or discomfort in the ear.
(b)
Guidelines for a 30-day trial period.
(1)
All clients shall be informed of a 30-day trial period
by written contract for services and all charges associated with such trial
period be included in this written contract for services, which shall include
the name, address, and telephone number of the State Committee of Examiners
in the Fitting and Dispensing of Hearing Instruments.
(2)
Any client purchasing one or more hearing instruments shall
be entitled to a refund of the purchase price advanced by the client for the
hearing instrument(s), less the agreed-upon amount associated with the trial
period, upon return of the instrument(s), in good condition to the licensee
within the 30-day trial period ending 30 days from the date of delivery. Should
the order be canceled by the client prior to the delivery of the hearing instrument(s),
the licensee may retain the agreed-upon charges and fees as specified in the
written contract for services. The client shall receive the refund due no
later than the 30th day after the date on which the client cancels the order
or returns the hearing instrument(s), in good condition, to the licensee.
(3)
Should the hearing instrument(s) have to be repaired, remade
or adjusted during the 30-day trial period, the 30-day trial period is suspended
for one day for each 24 hour period that the hearing instrument(s) is not
in the client's possession. The 30-day trial period resumes on the day the
client reclaims the repaired remade, or adjusted hearing instrument. If the
hearing instrument is not picked up within five working days following client
notification, the 30-day trial period resumes.
(c)
Written contract for services to client - client protection.
Upon the sale of any hearing instrument(s) or change of model or serial number
of the hearing instrument(s), the licensee or permit holder shall provide
the client with a signed, written contract for services containing the following:
(1)
the date of sale;
(2)
the make and model of the hearing instrument(s);
(3)
the name, address, and telephone number of the principal
place of business of the licensee;
(4)
a statement that the hearing instrument is new, used, or
reconditioned;
(5)
the length of time and other terms of the guarantee and
by whom the hearing instrument is guaranteed;
(6)
a copy of the written forms (relating to waiver forms);
(7)
a statement on or attached to the written contract for
services, in no smaller than 10-point bold type, as follows: "The client has
been advised at the outset of his relationship with the undersigned fitter
and dispenser of hearing instruments that any examination or representation
made by a licensed fitter and dispenser of hearing instruments in connection
with the fitting and selling of the hearing instrument(s) is not an examination,
diagnosis or prescription by a person duly licensed and qualified as a physician
or surgeon authorized to practice medicine in the State of Texas and, therefore,
must not be regarded as medical opinion or advice";
(8)
a statement on the face of the written contract for services,
in no smaller than 10-point bold type, as follows: "If you have a complaint
against a licensed fitter and dispenser of hearing instruments, you may contact
the State Committee of Examiners in the Fitting and Dispensing of Hearing
Instruments, 1100 West 49th Street, Austin, Texas 78756-3183, telephone 1-800-942-5540";
(9)
the licensee's or permit holder's printed name, signature
and license or permit number;
(10)
the supervisory arrangement reflected on a written contract
for services by signature of both the permit holder and licensee with both
the permit holder's license number and the licensee's license number; and
(11)
a serial number(s) and follow-up appointment within 30
days after the hearing instrument fitting shall be part of the patient records.
(d)
Terms of sale.
(1)
There shall be a full and complete disclosure of the cost
of financing the purchase of hearing instruments.
(2)
If the initial price of the hearing instrument(s) furnished
is reduced by trade-in allowance or discount, the written contract for services
shall conspicuously state:
(A)
the initial price of the aid before trade-in allowance
or discount;
(B)
the amount of the trade-in allowance or discount; and
(C)
the final price to the consumer.
(e)
Record keeping.
(1)
The owner of the dispensing practice shall ensure that
records are maintained on every client who receives services in connection
with the fitting and dispensing of hearing instruments. Such records shall
be preserved for at least three years after the fitting and dispensing of
the hearing instrument(s) to the client. If other hearing instruments are
subsequently fitted and dispensed to that client, cumulative records must
be maintained for at least three years after the latest fitting and dispensing
of the hearing instrument(s) to that client. The records must be available
for the committee's inspection and shall include but not be limited to the
following:
(A)
pertinent case history;
(B)
source of referral and appropriate documents;
(C)
medical evaluation or waiver of evaluation;
(D)
copies of written contracts for services and receipts executed
in connection with the fitting and dispensing of each hearing instrument provided;
(E)
a complete record of hearing tests, and services provided,
including follow-up appointment within the 30-day trial period; and
(F)
all correspondence specifically related to services provided
to the client or the hearing instrument(s) fitted and dispensed to the client.
(2)
A complete record of tests shall be available for the client.
(f)
Audiometers and audiometric testing devices.
(1)
Audiometers and audiometric testing devices shall meet
the current standards of the American National Standards Institute or the
International Electrotechnical Commission (IEC).
(2)
All portable and stationary testing equipment used in the
hearing evaluation by the license holder must be calibrated annually and proof
of certification must be provided upon renewal of license, if the licensee
is selected for audit.
(g)
Audiometric testing not conducted in a stationary acoustical
enclosure.
(1)
A notation shall be made on the hearing test if testing
was not done in a stationary acoustical enclosure.
(2)
Ambient noise level of the location of the audiometric
testing, if not done in a stationary acoustical enclosure, shall include a
notation on the hearing test of the following items:
(A)
type(s) of equipment used to determine ambient noise level;
(B)
model and serial number of equipment used to determine
ambient noise level;
(C)
date of last calibration of equipment used to determine
ambient noise level; and
(D)
the ambient noise level of the test environment.
(3)
If audiometric testing is not conducted in a stationary
acoustical enclosure, the test environment shall have a maximum allowable
ambient noise level of 42 dBA.
(h)
Audiometric testing conducted in a stationary acoustical
enclosure.
(1)
A notation shall be made on the hearing test if testing
was done in a stationary acoustical enclosure.
(2)
A stationary acoustical enclosure includes, but is not
limited to, an audiometric test room.
(A)
An audiometric test room is any enclosed space in which
a listener is located for the purpose of testing hearing. An audiometric test
room may also be known as:
(i)
an audiometric test area;
(ii)
a hearing test space; or
(iii)
a hearing test room.
(B)
An example of an audiometric test room would be a prefabricated
room known as:
(i)
an audiometric test booth;
(ii)
a suite; or
(iii)
a sound treated room.
(C)
The primary and necessary requirement of an audiometric
test room is to ensure that the maximum permissible ambient noise levels established
by the American National Standards Institute do not exceed the levels for
audiometric test room for ears covered 250 - 8000 Hz. The levels are as follows:
Figure: 22 TAC §141.16(h)(2)(C) (No change.)
This agency hereby certifies that the adoption
has been reviewed by legal counsel and found to be a valid exercise of the
agency's legal authority.
Filed with the Office of
the Secretary of State on July 12, 2006.
TRD-200603728
Ronald Ensweiler
Chair
State Committee of Examiners in the Fitting and Dispensing of Hearing Instruments
Effective date: August 1, 2006
Proposal publication date: January 13, 2006
For further information, please call: (512) 458-7111 x6972
Chapter 365.
LICENSING AND REGISTRATION
Part 17.
TEXAS STATE BOARD OF PLUMBING EXAMINERS